This post is only from the Reed Smith (more properly, the non-Dechert) side of the blog.

One hundred what, you say?

Certainly not years; the awful Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), decision just turned six – this blog is older than that.

According to our innovator liability scorecard, there are now more than 100 decisions rejecting innovator liability/Conte theories – quite a few more, if you count all the different opinions in litigation where the invalidity of innovator liability has been affirmed on appeal.

Our last post on the subject was just last Friday, to break the news of Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014), but Huck isn’t even the last  case on our scorecard any longer – that honor currently belongs to Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605 (5th Cir. 2014) (applying Louisiana law), which we later found out was decided the same day.

In one of our earlier posts, less than a week after Conte was decided, we made up an example to illustrate the potentially wide-ranging impact of allowing non-manufacturer liability for products based solely on “foreseeability”:

Plaintiff New Dad gives plaintiff New Mom his old SUV, manufactured by Gasguzzlers ‘R Us, so she has something big and safe to drive New Baby around.  To replace it, he buys a hybrid made by Minigas, Inc. to drive to work.  Wife puts New Baby’s car seat in the front seat, and plows into a telephone pole (or something else, it really doesn’t matter).  The airbag kills New Baby.  Gasguzzlers ‘R Us didn’t get its federal bailout and goes bankrupt.  But since both of the family cars had identical government-mandated (allegedly) inadequate warnings about not putting an infant car seat next to an airbag, who gets sued, Minigas – even though it’s car had nothing to do with the accident.

Farfetched?  We wish.  Isn’t it foreseeable that New Mom and Dad would have relied on the warnings in the brand new owner’s manual they just saw when buying their brand new hybrid, instead of the older manual in the SUV, which they haven’t looked at in years (assuming they still have the old manual at all)?  Under Conte’s omniforeseeability analysis, why not?

More Thoughts On Conte v. Wyeth (Nov.13, 2008).  Now we didn’t think much more about that – analogies are a dime a dozen – until we were reading another recent case rejecting Conte.  Guess what we found in Huck?

We are unwilling to make brand manufacturers the de facto insurers for competing generic manufacturers.  It may well be foreseeable that competitors will mimic a product design or label.  But, we decline [plaintiff’s] invitation to step onto the slippery slope of imposing a form of innovator liability on manufacturers for harm caused by a competitor’s product.  Where would such liability stop?  If a car seat manufacturer recognized as the industry leader designed a popular car seat, could it be sued for injuries sustained by a consumer using a competitor’s seat that copied the design?  Why not, under Huck’s theory, if it is foreseeable others will copy the design?

850 N.W.2d at 380 (citation omitted).  It’s not exact, but this eerily close for a coincidence.  So maybe we are having some sort of influence after all.

If we are, we certainly want to keep that up.  Thus, we think it’s time to take a closer look at the status of innovator liability.  A lot of states now have some sort of decision on this specific subject, but depending on the strength of that precedent, we may add some thoughts on product identification generally, since the issue comes up in other contexts, most notably market share liability and asbestos.  For example, Huck relied primarily on the Iowa Supreme Court’s prior decision rejecting market share liability – another novel claim that tries to decouple liability from actually making the allegedly injurious product.

So on the occasion of 100 decisions rejecting Conte innovator liability theories, here is a 50-state survey on the status of this benighted form of liability.

If any of our readers know of any innovator liability decisions that we have missed, by all means send them along.

The Current Restatement of Torts

True, it’s not the law of this state or that state, but the American Law Institute has been in the business of “restating” consensus/better view common-law principles for over seventy years.  The Third Restatement of Torts, Products Liability has this to say about product-related misrepresentation claims:

§9.       Liability of Commercial Product Seller or Distributor for Harm Caused by Misrepresentation

One engaged in the business of selling or otherwise distributing products who, in connection with the sale of a product, makes a fraudulent, negligent, or innocent misrepresentation of material fact concerning the product is subject to liability for harm to persons or property caused by the misrepresentation.

That’s what you call “black letter law.”  The elements of Third Restatement §9 are inconsistent with innovator liability in two ways.  First, as is true of other theories of product liability, the defendant in a claim for “misrepresentation” in the product related context must be “[o]ne engaged in the business of selling or otherwise distributing products.  Second, the claimed misrepresentation must have occurred “in connection with the sale of a product.”  Neither of these elements is present where the claimed misrepresentation was not made by the product seller at all, but rather allegedly occurred in in the labeling for a different manufacturer’s product and that labeling pre-existed the generic drug that was actually “sold” to the plaintiff and that is claimed to have caused the harm.

So, for beginners we have the current restatement of torts on our side.


Innovator liability has been statutorily abolished in Alabama:

In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.

Ala. Code §6-5-530(a) (emphasis added).  Only cases filed prior to the statute’s six-months-after-becoming-law applicability date escape.  SB-80 §4.  The legislation likewise abolishes (to the extent they ever existed in Alabama) claims for market share liability, alternative liability, and conspiracy liability, if the effect is to impose liability on non-manufacturers.  This statute means what it says, and the legislature was entitled to enact it.  Forest Laboratories, LLC v. Feheley, ___ So.3d ___, 2019 WL 5485548, *12-13 (Ala. Oct. 25, 2019).

The Alabama legislature was forced to act because, in a long and awful opinion that ignored much of the law cited in this post, the Alabama Supreme Court made Alabama the only state in the union to allow innovator liability, under a “misrepresentation” (not products liability) theory.  Wyeth, Inc. v. Weeks, 159 So.3d 649, 670-77 (Ala. 2014).  We discussed that Weeks reasoning extensively at the time, so we won’t inflict that on you again.

Prior to Weeks, courts applying Alabama law had rejected other forms on non-manufacturer liability such as market share liability, Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060, at *5-6 (N.D. Ala. Feb. 13, 1986), and generally required product identification as an essential element in other product-related litigation involving prescription medical products.  Bloodsworth v. Smith & Nephew, 2005 WL 3470337, at *5 (M.D. Ala. Dec. 19, 2005).  None of that mattered to (or was even cited by) the Alabama Supreme Court in Weeks, except in the dissent.


Alaska hasn’t been cursed with much prescription medical product liability litigation, and we haven’t run across anything on Conte, market share liability, or product identification.  The general statement of strict liability in Alaska is that “a manufacturer is strictly liable . . . when an article he places on the market” is defective.  Clay v. Fifth Avenue Chrysler Center, Inc., 454 P.2d 244, 247 (Alaska 1969).


No Arizona court has directly passed on innovator liability, but the federal district court in the Darvocet litigation twice held that the theory was incompatible with Arizona law.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7-8 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014).  No Arizona plaintiffs appealed in Darvocet, so the Sixth Circuit’s opinion, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), doesn’t discuss Arizona law.

Otherwise, courts applying Arizona law have rejected market share liability, both as to prescription medical products, In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998) (applying Arizona law), and products generally.  White v. Celotex Corp., 907 F.2d 104, 105 (9th Cir. 1990) (asbestos) (applying Arizona law).  Product identification has been required in pain pump cases under Arizona law.  Placencia v. I-Flow Corp., 2011 WL 1361562, at *2, 3-4 (D. Ariz. April 11, 2011); Peterson v. Breg, Inc., 2010 WL 2044248, at *2 (D. Ariz. April 29, 2010).A ringing defense of the principle that liability runs with the manufacture of, and profit from, the product in found in the successor liability case, Windsor v. Glasswerks PPX, LLC, 63 P.3d 1040, 1049 (Ariz. App. 2003).


The Eighth Circuit has twice held that Arkansas law rejects innovator liability.  Fullington v. PLIVA, Inc., 720 F.3d 739, 744 (8th Cir. 2013); Bell v. Pfizer, Inc., 716 F.3d 1087, 1092-93 (8th Cir. 2013).  So did the Sixth Circuit in Darvocet.

Guided by our sister circuit, we likewise predict that the Arkansas Supreme Court would construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification under Arkansas law.

In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 941 (6th Cir. 2014).  See also Fields v. Wyeth, Inc., 613 F. Supp.2d 1056, 1060-61 (W.D. Ark. May 11, 2009); Neal v. Teva Pharmaceuticals USA, Inc., 2010 WL 2640170, at *2 (W.D. Ark. July 1, 2010).  ‘Nuff said for now.


California is now the home of innovator liability.  In T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. 2017), the California Supreme Court unanimously decided that a non-manufacturer branded drug company could be liable for negligent misrepresentations in its labeling (which by federal requirement, generic companies must use without change) because it is “foreseeable” that such misrepresentations could influence physicians prescribing generic drugs.  Even alleged off-label promotion and the passage of over six years since the defendant last gave a warning did not preclude a jury from finding “foreseeable” injury.  Id. at 30.  Other considerations − the greater control of actual generic sellers and manufacturers over their products, the lack of any economic benefit to branded companies from generic products, the imposition of liability for 100% of products on 10% of the actual market, and the simple common sense of product liability that liability follows profit, failed to move even a single member of the current California high court.  Indeed, even asbestos fares better than FDA-approved drugs now, since generic use of branded labels undergirded the foreseeability uber alles rationale that the same court rejected in asbestos cases.  See T.H., 407 P.3d at 30-31 (distinguishing O’Neil v. Crane Co., 266 P.3d 987, 1003 (Cal. 2012)).  The overwhelming weight of precedent against innovator liability is dismissed as mere “crowd” noise against which “the mere fact that the claim is novel will not of itself operate as a bar to the remedy.”  Id. at 47.

Even more extreme, a 4-3 majority of the court decided that innovator liability can effectively be perpetual.   The dissenters made nine points:  (1) predecessors cannot control a successor’s warnings or promotional activities; (2) assessing massive liability on alleged misreading of emerging scientific data encourages overwarning of scientifically questionable risks; (3) loss of liability’s deterrent effect against actual product manufacturers; (4) “destabilization” of the pharmaceutical industry by perpetual, unlimited liability; (5) liability spillover to other products; (6) basing liability on an unrealistic view of corporate transactions; (7) a former seller’s relative lack of moral blame; (8) unavailability of insurance for risks of competing products; and (9) the increase in the price of branded drugs that did not cause injury.  T.H., 407 P.3d at 54-59.  In reality T.H. imposes common-law liability as a way to hold branded drugs hostage to force federal action against generic preemption.  See Id. at 31 n.2 (majority), 48 (concurrence).


Colorado has a product liability statute that pretty explicitly defines “product liability action” as litigation brought against a “manufacturer” and the definition of manufacturer is not broad enough to include the manufacturer of a competing product that the plaintiff did not take.  Colo. Rev. Stat. §13-21-401.  Thus, a “plaintiff must establish that a particular defendant’s product was a substantial contributing cause of his injury.” Merkley v. Pittsburgh Corning Corp., 910 P.2d 58, 59 (Colo. App. 1995).  In Sheeks v. American Home Products Corp., 2004 WL 4056060, at *1-2 (Colo. Dist. Oct. 15, 2004), the court rejected innovator liability.


Connecticut was one of the states that the Sixth Circuit in In re Darvocet, Darvon, &  Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), held would reject innovator liability:

Because Plaintiffs bring a personal injury claim allegedly caused by a defective product, their claims are within the scope of the CPLA [Connecticut Product Liability Act] and require product identification. . . .  We predict that if the Connecticut Supreme Court were directly faced with this question under Connecticut Law, it would find that Plaintiffs’ claims are product liability claims within the scope of the CPLA that do not survive under CUTPA [Connecticut Unfair Trade Practices Act]. Accordingly, the district court did not err in dismissing Plaintiffs’ claims against the Brand Manufacturers arising under Connecticut law because Plaintiffs did not allege that they ingested a product manufactured by the Brand Manufacturers.

Id. at 942.  Accord In re Zofran (Ondansetron) Products Liability Litigation, 2018 WL 2317525, at *4-5 (D. Mass. May 21, 2018) (following Darvocet as to Connecticut law).

Connecticut law also rejects market share liability, even in the DES context.  Gullotta v. Eli Lilly & Co., 1985 WL 502793, at *9 (D. Conn. May 9, 1985).  Product identification has also been required in prescription medical product cases, Barbour v. Dow Corning Corp., 2002 WL 983346, at *3 (Conn. Super. April 19, 2002) (no liability for products made after sale of manufacturing subsidiary); and in product liability generally.  Bobryk v. Lincoln Amusements, Inc., 1996 WL 24566, at *3 (Conn. Super. Jan. 5, 1996) (“the plaintiff must plead and prove that the item which caused him harm was in fact the defendant’s ‘product’ within the meaning of the Act”).


In Delaware plaintiffs must prove “that there was a causal relationship between the defendant’s product and the plaintiff’s physical injury.”  Money v. Manville Corp. Asbestos Disease Compensation Trust Fund, 596 A.2d 1372, 1377 (Del. 1991).  Thus in Trower v. Janssen Pharmaceuticals, Inc., 2019 WL 1571834 (D. Del. April 11, 2019), the court directly rejected innovator liability, holding that “Delaware law does not support imposing liability on a brand name defendant for a generic manufacturer’s product.”  Id. at *4.   Similarly, Delaware rejects market share liability.  Nutt v. A.C. & S. Co., 517 A.2d 690, 694 (Del. Super. 1986) (asbestos); In re Asbestos Litigation, 509 A.2d 1116, 1118 (Del. Super. 1986), aff’d, 525 A.2d 146 (Del. 1987).

District of Columbia

In the District, “[i]t is, of course, incumbent on the plaintiff in any product liability action to show that the defendant’s product was the cause of his or her injuries.”  Claytor v. Owens-Corning Fiberglas Corp., 662 A.2d 1374, 1381 (D.C. 1995).  D.C. courts haven’t passed on innovator liability.  However D.C. law has rejected market share liability, even in the DES context.  Tidler v. Eli Lilly & Co., 851 F.2d 418, 424 (D.C. Cir. 1988).  Market share liability has also been rejected with respect to other products.  Bly v. Tri-Continental Industries, Inc., 663 A.2d 1232, 1244 (D.C. 1995) (gasoline); Claytor v. Owens-Corning Fiberglas Corp., 662 A.2d 1374, 1383 & n.10 (D.C. 1995) (asbestos); District of Columbia v. Beretta U.S.A. Corp., 2002 WL 31811717, at *55-56 (D.C. Super. Dec. 16, 2002), aff’d in part and rev’d in part on other grounds, 872 A.2d 633 (D.C. 2005) (firearms).


In Florida, tort claims “fail as a matter of law [when] the record is undisputed that [defendant] did not design, manufacture, or distribute the [product].”  Hall v. Sunjoy Indus. Grp., Inc., 764 F. Supp. 2d 1297, 1301 (M.D. Fla. 2011) (collecting cases).  Florida is one of the states where innovator liability has been rejected over and over again.  Florida state courts have done so.  Dietrich v. Wyeth, Inc., 2009 WL 4924722 (Fla. Cir. Dec. 21, 2009); Sharp v. Leichus, 2006 WL 515532, at *2-6 (Fla. Cir. Feb. 17, 2006), aff’d per curiam, 952 So.2d 555 (Fla. App. 2007).

The Eleventh Circuit threw out all such claims in Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013), in reliance upon a “mountain of authority.”  Id. at 1251-53.  So have the following federal district courts:  Tsavaris v. Pfizer, Inc., 154 F. Supp.3d 1327, 1339-41 (S.D. Fla. 2016); Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1293-95 (M.D. Fla. 2011), aff’d, 525 F. Appx. 893 (11th Cir. 2013); Levine v. Wyeth, Inc., 684 F. Supp.2d 1338, 1344-46 (M.D. Fla. 2010); Howe v. Wyeth Inc., 2010 WL 1708857, at *3-4 (M.D. Fla. Apr. 26, 2010).

Florida was also one of the states’ laws addressed in the Darvocet litigation.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 942-43 (6th Cir. 2014) (“We predict that the Florida Supreme Court would construe Plaintiffs’ misrepresentation claim as a product liability claim that fails for lack of product identification under Florida law”); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014).


The Georgia product liability statute limits liability to manufacturers.  OCGA §51-1-11(b)(1). Thus, [r]egardless of whether the plaintiff proceeds under a theory of negligence or strict liability, a plaintiff must prove as part of his case that the defendant’s product was the proximate cause of the injuries alleged.” Fouch v. Bicknell Supply Co., 756 S.E.2d 682, 687 (Ga. App. 2014).

In PLIVA, Inc. v. Dement, 780 S.E.2d 735 (Ga. App. 2015), cert. granted on other grounds (Ga. Sept. 6, 2016) (generic defendants), the court held:

Regarding liability of a name brand drug manufacturer to a consumer who used only a generic drug, the overwhelming national consensus is that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of the generic form of a product.  Because the name brand drug manufacturers owed no duty of care to [plaintiff], who never used their product, those defendants were entitled to judgment as a matter of law.

Id. at 743 (footnotes and quotation marks omitted).  See also Reynolds v. Anton, 2004 WL 5000272, at ??? (Ga. Super. Oct. 28, 2004) (“holding one manufacturer liable for the packaging/warnings of another is not based upon traditional Georgia tort law principles”) (no page numbering; last issue in opinion).

A couple of Georgia federal district courts have likewise rejected innovator liability.  Moore v. Mylan, Inc., 840 F. Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012); Swicegood v. Pliva, Inc., 543 F. Supp.2d 1351, 1354-59 (N.D. Ga. 2008).

The Sixth Circuit in Darvocet predicted that Georgia law would reject innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 943 (6th Cir. 2014) (“we predict that the Georgia Supreme Court would either construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification or that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Georgia law”); accord In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2013 WL 5184129, at *2 (E.D. Ky. July 29, 2013).

Similarly, the court in In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *9-10 (D. Mass. Aug. 4, 2017), relied on the above precedents to predict that Georgia would adopt the majority view and reject innovator liability.

Georgia law rejected market share liability even before it was prohibited by statute.  Blackston v. Shook & Fletcher Insulation Co., 764 F.2d 1480, 1483 (11th Cir. 1985) (applying Georgia law); Starling v. Seaboard Coast Line Railroad Co., 533 F. Supp. 183, 186 (S.D. Ga. 1982).  The Georgia product liability statute broadly prohibits “theories of market share or enterprise, or other theories of industry-wide liability.”  OCGA §51-1-11(d).  Innovator liability can be considered an “other” theory of “industry-wide liability.”

Product identification has also been required in other situations:

To survive summary judgment, Hoffman clearly needed to present evidence that she was exposed to defendants’ products. . . .  [U]nless the manufacturer’s defective product can be shown to be the proximate cause of the injuries there can be no recovery.  A manufacturer has the absolute right to have his strict liability for injuries adjudged on the basis of the design of his own marketed product and not that of someone else.

Hoffman v. AC&S, Inc., 548 S.E.2d 379, 382 (Ga .App. 2001) (citations and quotation marks omitted) (asbestos case).  See Thurmon v. A.W. Chesterton, Inc., 61 F. Supp.3d 1280, 1285-86 (N.D. Ga. 2014) (same).  Murphy v. Aventis Pasteur, Inc., 270 F. Supp.2d 1368, 1377 (N.D. Ga. 2003) (holder of expired patent for medical device owed no “duty to warn the purchasers and recipients of . . . copied products manufactured by other companies”).


There isn’t any law in Hawaii on innovator liability.  Hawaii did adopt market share liability in a blood products case over 20 years ago, but as far as we know hasn’t addressed product identification since then.  See Smith v. Cutter Biological, Inc., a Div. of Miles Inc., 823 P.2d 717, 719 (Haw. 1991) (“Traditional proof in a negligence case includes the factor of causation.”) (syllabus at 6).


In Stirling v. Novartis Pharmaceuticals Corp., 2019 WL 6456186 (Idaho Dist. Sept. 25, 2019), an Idaho trial court rejected innovator liability as to the same drug involved in the adverse T.H. case in California.  “It has long been the general law in Idaho that a company is not liable for the injuries caused by another company’s products.  This Court finds persuasive the reasoning of the Supreme Court of Iowa in Huck v. Wyeth,” rejecting innovator liability.  Id. at *5-6.  Along the same lines, in Doe v. Cutter Biological, 852 F. Supp. 909, 912-914 (D. Idaho 1994), the court rejected market share liability in the context of a blood product.  “Idaho would not allow recovery when it is not possible for plaintiff to prove which defendant caused his injury.”  Id. at 924.


Illinois has long required product identification for all product liability matters, as evinced by the Illinois Supreme Court’s rejection of industry-wide liability under both market share liability and public nuisance rubrics.  See Young v. Bryco Arms, 821 N.E.2d 1078, 1087-91 (2004) (public nuisance); Smith v. Eli Lilly & Co., 560 N.E.2d 324, 337-39, 344-45 (Ill. 1990) (market share liability); City of Chicago v. American Cyanamid Co., 823 N.E.2d 126, 134-35 (Ill. App. 2005) (market share liability in public nuisance); Lewis v. Lead Industries Ass’n. Inc., 793 N.E.2d 869, 874-76 (2003) (same) (all four cases finding no causation as a matter of law without product identification).  See also Leng v. Celotex Corp., 554 N.E.2d 468, 470-471 (Ill. App. 1990) (rejecting market share liability pre-Smith in asbestos case); York v. Lunkes, 545 N.E.2d 478, 480 (Ill. App. 1989) (rejecting market share liability pre-Smith in battery case); Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351, 353 (N.D. Ill. 1988) (rejecting market share liability pre-Smith in blood products case); Coerper v. Dayton-Walther, 1986 WL 4111, at *1 (N.D. Ill. March 27, 1986) (rejecting market share liability pre-Smith in tire rim case).

Moreover, in Illinois there is no duty to warn about the risks of a competing product:

[Defendant] is under no duty to provide information on other products in the marketplace.  Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies.  This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.

Pluto v. Searle Laboratories, 690 N.E.2d 619, 621 (Ill. App. 1997).  Recently, an Illinois appellate court recognized in dictum that an “overwhelming majority of courts have held that generic consumers may not sue the brand-name manufacturer.”  Guvenoz v. Target Corp., Guvenoz v. Target Corp., 30 N.E.3d 404, 409 n.1 (Ill. App. 2015).  See Id. at 416 (plaintiffs “cannot obtain relief from brand-name drug manufacturers whose products they did not ingest”).

Nonetheless, in the teeth of all this precedent, a federal court sitting in diversity improperly predicted an expansion of Illinois law to encompass innovator liability in Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, 718 (N.D. Ill. 2014) (“Taken out of context, language in product identification cases like Smith and Lewis may well appear to support [defendant’s] argument.  In truth, the principles for which that line of cases stands are inapposite here”).  In one paragraph, after agreeing that strict liability is precluded, Dolin decided that negligence was different:

This reasoning does not hold where a name-brand manufacturer is found, not strictly liable, but liable for negligence.  An injury (or at least liability for an injury) that occurs due to negligence can be avoided simply by satisfying one’s duty of care.  Significantly, this is so without regard to whether the name-brand or generic version of the drug was consumed.  Where a company’s negligence in connection with a product causes injury, it may naturally be held liable for having caused that injury.  Where there is no fault, however, the public policy rationale that justifies burdening the seller with the cost of injury rather than the consumer does not merit placing liability on an entity whose benefit from the sale is so remote, and whose ability to account for the cost is so limited.

Id. at 723 (no citations omitted; Dolin did not cite anything).  As we’ve said many times before, federal courts sitting in diversity should not do this – they have no authority to invent new forms of state-law liability.  Years later, after much litigation expense, Dolin was reversed on other grounds.  See Dolin v. GlaxoSmithKline LLC901 F.3d 803 (7th Cir. 2018) (all claims preempted as a matter of law; refusing to offer Erie prediction of Illinois law on innovator liability).

Another Illinois decision, Garner v. Johnson & Johnson, 2017 WL 6945335, at *6-9 (C.D. Ill. Sept. 6, 2017), followed Dolin prior to its Seventh Circuit reversal.  Garner never mentioned Erie standards for predicting federal law, but did distinguish some of the extensive adverse Illinois product identification precedent as involving “when it is unclear which manufacturer, in a sea of manufacturers working in an industry, has created the faulty product.”  Id. at *7.  That distinction fails to address the gun cases, Guvenoz, or Pluto.

However, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit was also called upon to construe Illinois law. The appellate court trashed Dolin thoroughly:

We disagree with the Dolin court’s holding.  While Illinois does not have a product liability statute, its case law indicates that Plaintiffs’ misrepresentation claims would be construed as product liability claims and fail for lack of product identification.  Under Illinois law, a plaintiff must identify the supplier of the product and establish a causal connection between the injury and the product.  [citing Smith and York].  But, even if Plaintiffs’ misrepresentation claims were not construed as product liability claims, applying the same factors, we predict that the Illinois Supreme Court would not recognize brand manufacturers owed generic consumers a duty that can give rise to liability.

First, the generic consumers’ injuries are not the foreseeable result of the brand manufacturers’ conduct, but of the laws over which the brand manufacturers have no control.  Congress made the public policy decisions to lower barriers of entry for generic drugs, as has the Illinois state legislature in enacting laws to require certain prescriptions be filled with available generics.  Using these laws as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Additionally, the Dolin court failed to properly account for the magnitude of brand manufacturers’ burden of guarding against the injury; and the consequences of placing that burden on the brand manufacturers.  Courts in the majority note the traditional reticence against imposing liability on a manufacturer for injuries caused by their competitor’s products.  Further, there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs.

As a federal court predicting state law . . ., given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.  The potential for wide-ranging ramifications on Illinoisans’ health and welfare should we recognize a duty in this case renders the narrower path the proper choice.

We predict that the Illinois Supreme Court would either construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification or that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Illinois law.

Darvocet, 756 F.3d at 944-45 (citations and quotation marks omitted).

Indiana’s statutory product liability law (Ind. Code §34-20-2-1) requires a plaintiff to “produce evidence to support a reasonable inference that the defendants’ products caused” the claimed injury.  Peerman v. Georgia-Pac. Corp., 35 F.3d 284, 287 (7th Cir. 1994) (applying Indiana law); accord Piltch v. Ford Motor Co., 11 F. Supp.3d 884, 888 (N.D. Ind. 2014) (the defendant’s product must have caused the plaintiff’s injuries); Thornburg v. Stryker Corp., 2006 WL 1843351, at *3–4 (S.D. Ind. June 29, 2006) (summary judgment where defendant neither sold nor manufactured product).
An Indiana trial court rejected Conte and innovator liability in Short v. Eli Lilly & Co., 2009 WL 9867531, at *4-9, slip op. (Ind. Super. Marion Co. March 25, 2009).  Indiana has a product liability statute, Ind. Code §34-20-1-1, et seq., that applies to all theories and limits liability to manufacturers.  Failure to identify the defendant’s product as being ingested by the plaintiff was fatal.  Id. at  *5-6.  Negligent misrepresentation was no away around the statute because the plaintiff never relied upon the defendant.  Id. at *6 (citing one of Bexis’ Bone Screw cases).  Conte was “inconsistent with Indiana law.”  Id. at *7-9.
Three federal courts applying Indiana law have relied on Short rejected innovator liability.  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the court recognized its role in diversity to tread softly on state law.  Id. at 945.  The court found no basis under Indiana law principles to hold a manufacturer liable for defects in a competing product:
[W]e take up the three factors in [used by the Indiana Supreme Court to evaluate duty claims].  First, the party’s relationship, we note that the generic consumers were injured by a product that the Brand Manufacturers did not manufacture, and, as already noted, courts are reluctant to impose “competitor liability.”  Second, the generic consumers’ injuries are not the foreseeable result of the Brand Manufacturers’ conduct, but of the laws over which the Brand Manufacturers have no control.  Using federal and Indiana state laws designed to increase the availability of generic drugs as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Further there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs. Taken together, we predict that the Indiana Supreme Court would decline to recognize that brand manufacturers owe generic consumers a duty of care that could give rise to liability.
Id. (citations and quotation marks omitted).
Similarly, the court in In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *10-11 (D. Mass. Aug. 4, 2017), relied largely on the “comprehensive” discussion of the issue in Darvocet to predict that Indiana would follow the majority rule and reject innovator liability.  Another prediction that Indiana law would reject innovator liability occurred in Stewart v. Sanofi Aventis U.S., LLC, 15 F. Supp.3d 1151 (N.D. Ala. 2014):
While the Indiana Supreme Court apparently has not yet addressed this specific issue, a plain reading of the IPLA [Indiana Product Liability Act] as well as several IPLA-related opinions from other Indiana courts persuade this court that a plaintiff . . . who allegedly was injured by a prescription drug cannot state a claim for failure to warn under the IPLA against the manufacturer of a brand name prescription drug . . . when the allegations show that the plaintiff ingested solely a generic form of the drug.
Id. at 1153.  Most recently, in In re Mirapex Products Liability Litigation, 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016), adopted, 2016 WL 4203422 (D. Minn. Aug. 9, 2016), the court again rejected innovator liability under Indiana law.
[M]anufacturers of a brand-name product are generally not liable for injuries caused to users of a generic equivalent (i.e., “innovator liability”). . . .  The plain language of the [Indiana statute] does not support a theory of innovator liability in Indiana. The opening clause of §34-20-2-1 requires that the defendant must have sold, leased, or otherwise put into the stream of commerce the product that caused the user or consumer’s physical harm.  Defendants cannot be held liable under the [statute] because they did not sell, lease, or put the generic drug into commerce. . . .  Based on the overwhelming authority that has declined to recognize a theory of innovator liability, the Court agrees with the Stewart and In re Darvocet courts that the Indiana Supreme Court would decline to recognize a theory of innovator liability.  Plaintiffs cannot hold Defendants liable for generic drugs manufactured by different pharmaceutical companies.
Id. at *5.
Indiana has also rejected market share liability.  City of Gary v. Smith & Wesson, Corp., 801 N.E.2d 1222, 1245 (Ind. 2003).  It requires product identification in asbestos cases.  Asbestos Corp. Ltd. v. Akaiwa, 872 N.E.2d 1095, 1098 (Ind. App. 2007).
In Iowa we have Huck v. Wyeth, Inc., 850 N.W.2d 353 (Iowa 2014).  In Huck the Iowa Supreme Court does a number on innovator liability.  Id. at 369-81.  Although it appears to be a plurality opinion (3-1-3), it’s firmly based in Iowa precedent, which mandates product identification.  See  Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 75-76 (Iowa 1986) (rejecting market share liability in DES cases); Doe v. Baxter Healthcare Corp., 380 F.3d 399, 410-11 (8th Cir. 2004) (evidence insufficient to exclude other products as possible causes) (applying Iowa law).  You can read more about Huck here.

In Kansas, “[the plaintiff] still has the burden of establishing that the particular defendant has sold a product . . . and that it caused his injury.”  Mays v. Ciba–Geigy Corp., 661 P.2d 348, 357 (Kans. 1983).  Kansas has as product liability statute, K.S.A. §60-3301, et seq., which merges all common-law theories and requires that the defendant be in the chain of sale.  In Anselmo v. Sanofi-Aventis, Inc. USA, 2014 WL 8849464, slip op. (Kan. Dist. Oct. 13, 2014), the court rejected innovator liability, holding that Conte was an outlier that was incompatible with the Kansas statute.

Plaintiffs’ generic liability theory has been overwhelmingly rejected by over forty courts in more than twenty states. . . .  These courts have reached a common conclusion: a brand name manufacturer cannot be held liable for injuries allegedly caused by a generic manufacturer’s product.  Based upon the similarities between the KPLA and these majority states’ statutes, this Court feels compelled to reach a similar conclusion.

Anselmo, 2014 WL 8849464, at *2.  The court also rejected a “negligent design” variant for similar reasons.  Id. at *3.


The Sixth Circuit has twice held that Kentucky’s product liability statute precludes innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 945-46 (6th Cir. 2014); Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011) (applying Kentucky law).  In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *11 (D. Mass. Aug. 4, 2017), relied on these two Sixth Circuit decisions likewise to reject innovator liability under Kentucky law.
So have Missouri courts, which rampant litigation tourism has placed in the odd position of interpreting Kentucky law.  Franzman v. Wyeth, Inc., 451 S.W.3d 676, 689-92 (Mo. App. 2014) (applying Kentucky law); Nicely v. Wyeth, Inc., 451 S.W.3d 694, 697 (Mo. App. 2014) (applying Kentucky law); Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059, at *20-24 (E.D. Mo. July 29, 2013) (applying Kentucky law).  Back in Kentucky, the same plaintiff struck out again.  Neeley v. Wolters Kluwer Health, Inc., 2015 WL 8967931, at *5 (E.D. Ky. Dec. 15, 2015) (Darvocet and Smith control; Kentucky law not “unsettled”).
That’s probably enough, but every Kentucky case to consider market share liability has also rejected that dodge of product identification. Collins v. Ansell Inc., 2003 WL 22769266, at *2 (W.D. Ky. Nov. 19, 2003) (rejecting market share liability in latex gloves case); Dawson v. Bristol Laboratories, 658 F. Supp. 1036, 1040-41 (W.D. Ky. 1987) (rejecting market share liability in antibiotic case).
Louisiana, with its statutory product liability regime (La. Rev. Stat. §9:2800.52), is another of these states with lots of precedent rejecting innovator liability, every which way but loose.  The Fifth Circuit has rejected the theory twice.  Johnson, 758 F.3d 605, 614-16; Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 183-84 (5th Cir. 2012). The Sixth Circuit followed Demahy in reaching an identical holding in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 917 F.3d 917, 946 (6th Cir. 2014).
A Louisiana appellate court agreed.  Stanley v. Wyeth, Inc., 991 So.2d 31, 34-35 (La. App. 2008) (“a name brand drug manufacturer owes no legal duty to the consumer of a generic equivalent of its drug”).
Given all this appellate authority, Louisiana federal district courts have for years been playing wac-a-mole with plaintiffs asserting innovator liability.  Tillman v. Woldenberg Village, Inc., 2013 WL 6198864, at *5 (E.D. La. Nov. 27, 2013); Morris v. Wyeth, Inc., 2011 WL 4975317, at *3-4 (W.D. La. Oct. 19, 2011); Cooper v. Wyeth, Inc., 2010 WL 4318816, at *2-3, (M.D. La. Oct. 26, 2010); Craig v. Pfizer, Inc., 2010 WL 2649545, at *2-4 (Mag. E.D. La. May 26, 2010), adopted, 2010 WL 2649544 (W.D. La. June 29, 2010); Morris v. Wyeth, Inc., 2009 WL 4064103, at *4-6 (W.D. La. Nov. 23, 2009); LeBlanc v. Wyeth, Inc., 2006 WL 2883030, at *5-6 (W.D. La. Oct. 5, 2006); Possa v. Eli Lilly & Co., 2006 WL 6393160, at *1 (M.D. La. May 10, 2006); Tarver v. Wyeth, Inc., 2005 WL 4052382, at *2 (Mag. W.D. La. June 7, 2005), adopted, 2006 WL 1517546, at *2-3 (W.D. La. Jan. 26, 2006).
No court applying Maine law has addressed innovator liability, but in Maine there is “no authority for . . . a duty to warn against another supplier’s dangerous product.”  Bouchard v. American Orthodontics, 661 A.2d 1143, 1145 (Me. 1995).  Such claims “failed to establish any causal link between defendant’s product and plaintiffs’ harm.”  Id.  In Kinnett v. Mass Gas & Electric Supply Co., 716 F. Supp. 695, 697 n.7 (D.N.H. 1989) (applying Maine law), the court suggested that Maine would reject market share liability.  Defendant-specific product identification has also been required in Maine asbestos cases.  E.g., Elderkin-Graham v. New England Insulation Co., Inc., 2011 WL 6424838, at 1 n.1 (E.D. Pa. Nov. 28, 2011) (applying Maine law); Rumery v. Garlock Sealing Technologies, Inc., 2009 WL 1747854 (Me. Super. April 24, 2009).
Maryland law produced the first decision rejecting innovator liability in a generic drug case.  Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) (applying Maryland law).
Although actions for negligent misrepresentation arise in many contexts other than products liability, in this case the allegations of negligent misrepresentation are an effort to recover for injuries caused by a product without meeting the requirements the law imposes in products liability actions.  Maryland law requires a plaintiff seeking to recover for an injury by a product to demonstrate that the defendant manufactured the product at issue.
Id. at 168; accord id. at 171 (plaintiffs “offer no authority for their assertion that one manufacturer can be held liable for injuries stemming from another manufacturer’s product”).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 946 (6th Cir. 2014), the Sixth Circuit was “guided” by Foster and reiterated that Maryland would reject innovator liability.  Accord Gross v. Pfizer, Inc., 2010 WL 4485774, at *2-3 (D. Md. Nov. 9, 2010) (following Foster; rejecting Conte), reconsideration denied, 2011 WL 4005266 (D. Md. Sept. 7, 2011).
As discussed in Foster, Maryland has rejected market share liability, even in the DES context.  Tidler v. Eli Lilly & Co., 851 F.2d 418, 424 (D.C. Cir. 1988) (applying Maryland law).
A fortiori Maryland has also retained its product identification requirement and refused to apply market share liability outside of DES.  Reiter v. AC&S, Inc., 947 A.2d 570, 573 (Md. App. 2008) (asbestos), aff’d, 8 A.3d 725 (Md. 2010); Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 93-94 (D. Md. 1989) (breast implant), aff’d without op., 898 F.2d 146 (4th Cir. 1990); Herlihy v. Ply-Gem Industries, Inc., 752 F. Supp. 1282, 1291 (D. Md. 1990) (fire retardants).See Miller v. Bristol-Myers Squibb Co., 121 F. Supp.2d 831, 836-837 (D. Md. 2000) (granting summary judgment where “Plaintiff will not have testimonial, documentary, or real evidence available at trial to confirm the identity of the manufacturer”).
Massachusetts recognized a limited form of innovator liability in Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018), as we discussed in detail here.  Recognizing that [“if consumers of generic drugs were allowed to recover damages for a brand-name manufacturer’s negligent failure to warn, it would be far more difficult for the manufacturer to shoulder these costs,” id. at 1216, Rafferty, created innovator liability for “reckless” conduct.  Id. at *1218.

Under this standard, a brand-name manufacturer that intentionally fails to update the label on its drug to warn of an unreasonable risk of death or grave bodily injury, where the manufacturer knows of this risk or knows of facts that would disclose this risk to any reasonable person, will be held responsible for the resulting harm.

Id. at 1220.  By making “intentional[] fail[ure] to update” part of the cause of action, Rafferty, at least seems to rule out liability after a New Drug Application (and thus an ability to update) has been sold or withdrawn.  No innovator liability can lie in strict liability, negligence, on under the Massachusetts consumer protection statute.  Id. at 1212, 1222-23.

Other courts applying Massachusetts law have considered, and rejected, innovator liability under theories other than the intentional tort basis allowed in RaffertySee In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *12-13 (D. Mass. Aug. 4, 2017); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *3 (E.D. Ky. Oct. 10, 2012), aff’d on other grounds, 917 F.3d 917 (6th Cir. 2014).
In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit concluded that Michigan law was incompatible with innovator liability:
[W]e take up the three [duty] factors in [Michigan law].  First, regarding the party’s relationship, the generic consumers were injured by a product that the Brand Manufacturers did not manufacture, and as already noted, courts are reluctant to impose competitor liability.  Second, the generic consumers’ injuries are not the foreseeable result of the brand manufacturers’ conduct, but of the laws over which the brand manufacturers have no control. Using federal and Michigan state laws designed to increase the availability of generic drugs as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Finally, there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations, including higher priced brand name drugs and fewer innovative drugs.  Taken together, we predict that the Michigan Supreme Court would decline to recognize that brand manufacturers owe generic consumers a duty of care that could give rise to liability.
Id. at 946-47 (citations and quotation marks omitted).
There hasn’t been much prescription drug litigation in Michigan since the state enacted its FDA compliance presumption.  Market share liability under the state’s peculiar Abel v. Eli Lilly & Co., 343 N.W.2d 164 (Mich 1984), DES theory has not extended beyond that drug, with product identification being maintained in both breast implants, In re Dow Corning Corp., 2010 WL 750200, at *2-3 (E.D. Mich. March 3, 2010) (“threshold requirement of any products liability action is identification of the injury-causing product and its manufacturer”); In re Dow Corning Corp., 250 B.R. 298, 362-63 (Bankr. E.D. Mich. 2000), and in asbestos.  Marshall v. Celotex Corp., 651 F. Supp. 389, 392-94 (E.D. Mich. 1987).  In Michigan there is no “duty to warn of the hazards of using products manufactured by someone else.”  Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 515 (Mich. App. 1995).
An appellate court in Minnesota rejected innovator liability in Flynn v. American Home Products Corp., 627 N.W.2d 342 (Minn. App. 2001).
Appellant argues that respondents intended all consumers rely on their representations to the FDA and owed all consumers a duty to disclose material facts, but that contention conflicts with Minnesota common law, which requires a stronger relationship and a direct communication.  Appellant did not purchase or use respondents’ product, and therefore, there was no direct relationship between them, let alone a fiduciary relationship that gave rise to a duty.
Id. at 350.
Applying Minnesota law, the Eighth Circuit rejected innovator liability in Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009) (relying on Flynn and Foster), rev’d in part on other grounds, 131 S.Ct. 2567 (2011), reaffirmed in pertinent part and vacated in part on other grounds, 658 F.3d 867 (8th Cir. 2011).
In Zandi v. Wyeth, 2009 WL 2151141, at *3-4 (Minn. App. July 21, 2009) (unpublished), the court affirmed summary judgment for an innovator drug manufacturer and one generic company where the plaintiff failed to introduce evidence that she ever ingested those defendant’s drugs, as opposed to a different generic brand.
Minnesota has rejected market share liability as a way around product identification.  Bixler v. Avondale Mills, 405 N.W.2d 428, 430 (Minn. App. 1987) (cotton cloth); Mason v. Spiegel, Inc., 610 F. Supp. 401, 406 & n.7 (D. Minn. 1985) (same).
Mississippi is another state with an abundance of law concerning innovator liability.  In Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014), the Fifth Circuit affirmed that Mississippi rejects this theory:
The Mississippi Products Liability Act (“MPLA”) applies “in any action for damages caused by a product” and requires a plaintiff to prove that it was the defendant’s product that caused the injury.  [Plaintiff] argues that the . . . brand defendants are not “manufacturers or sellers” of the product, relying on a Mississippi case holding that “the MPLA does not preclude claims against defendants who are neither manufacturers nor sellers” of a defective product.  Lawson v. Honeywell International, Inc., 75 So.3d 1024, 1030 (Miss. 2011).  This argument fails because brand defendants are, indeed, manufacturers − and were they not, there would be no relationship on which to presume liability (since they did not design the drug).  In any event, because [plaintiff] did not ingest the . . . brand defendants’ products, he has not established a duty.
Id. at 476-77 (other citations omitted).  The district court opinion that was affirmed, Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 471-76, 480 (S.D. Miss. 2012), contained a lengthy discussion of why innovator liability was incompatible with Mississippi law.  Other Mississippi trial courts agree.  Truddle v. Wyeth LLC, 2015 WL 160696, at *4 (N.D. Miss. Jan. 12, 2015); Gardley-Starks v. Pfizer, Inc., 917 F. Supp.2d 597, 601-04 (N.D. Miss. 2013), reconsideration denied, 2013 WL 12379417 (N.D. Miss. May 23, 2013); Washington v. Medicis Pharmaceuticals Corp., 2013 WL 496063, at *3-4 (S.D. Miss. Feb. 7, 2013).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 947-48 (6th Cir. 2014), the Sixth Circuit followed Lashley in holding that Mississippi rejects innovator liability.
Chatman v. Pfizer, Inc., 960 F. Supp.2d 641 (S.D. Miss. 2013), allowed innovator liability based on a misrepresentation theory (recognizing that product liability theories were invalid).  However, Chatman relied (id. at 652-55) on the same Lawson v. Honeywell rationale specifically rejected by the Fifth Circuit in Lashley. The Chatman court recognized that Lashley invalidated its misrepresentation theory in Chatman v. Pfizer, Inc., 2015 WL 160696, at *4 (S.D. Miss. Sept. 11, 2014), and vacated that part of its prior decision, entering summary judgment for the innovator defendant on all claims.
In Gorman–Rupp Co. v. Hall, 908 So.2d 749, 757 (Miss. 2005), the court enforced the product identification requirement in an asbestos case.
In Missouri, a plaintiff must “establish that the particular defendant actually caused the problem.  Absent product identification evidence, [plaintiff] simply cannot prove actual causation.”  City of St. Louis v. Benjamin Moore & Co., 226 S.W.3d 110, 116 (Mo. 2007).  The only Missouri precedent specifically on innovator liability is, In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *2 & n.7 (E.D. Ky. Aug. 21, 2012) (“There is no theory of product liability under which a defendant can be held liable for an injury caused by a product it did not sell, manufacture, or otherwise supply to the plaintiff.”), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014) (no Missouri plaintiff appealed).  This Darvocet opinion cited, inter aliaSt. Louis v. Benjamin Moore, 226 S.W.3d at 112–15, in which the Missouri Supreme Court rejected market share liability.  Indeed, Missouri rejected market share liability as a way around product identification, even in the DES context.  Zafft v. Eli Lilly & Co., 676 S.W.2d 241, 246-47 (Mo. 1984) (discourages safety innovations since defendants liable for competitors’ conduct).  In all “product liability claims,” a Missouri statute requires that the defendant have “transferred” the product that injured the plaintiff.  VAMS §537.760(1).
There is no law in Montana on either innovator liability.  The general causation rule for product liability actions in Montana requires that a “defect existed when the product left the hands of the particular defendant.’  Duncan v. Rockwell Manufacturing Co., 567 P.2d 936, 939 (1977) (quoting Prosser).

“[U]nder Nebraska law, a plaintiff must show, inter alia, the defendant’s product caused injury to a plaintiff.”  Barrett v. Rhodia, Inc., 2009 WL 2477560, at *8 (D. Neb. Aug. 11, 2009), aff’d, 606 F.3d 975 (8th Cir. 2010).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 948-49 (6th Cir. 2014), the Sixth Circuit predicted that Nebraska would reject innovator liability:

We predict that the Nebraska Supreme Court would either construe Plaintiffs’ misrepresentation claims as product liability claims under the Nebraska statute defining product liability actions that fail for lack of product identification, or that the Brand Manufacturers did not owe the Plaintiffs a duty that could give rise to liability under Nebraska law.

Id. at *28 (noting that Nebraska, like a number of other states, has a comprehensive product liability statute).  The Tenth Circuit has also indicated that Nebraska would adhere to product identification and reject market share liability.  Menne v. Celotex Corp., 861 F.2d 1453, 1468 n.22 (10th Cir. 1988) (applying Nebraska law).

In Nevada, “the injured party must prove that exposure to the products made or sold by that particular defendant was a substantial factor in causing the injury.”  Holcomb v. Georgia Pac., LLC, 289 P.3d 188, 197 (Nev. 2012) (citations omitted).  In Moretti v. Wyeth, Inc., 579 F. Appx. 563 (9th Cir. 2009) (affirming Moretti v. Wyeth, Inc., 2009 WL 749532, at *3-4 (D. Nev. March 20, 2009)), the court held:
The district court properly concluded that Nevada law does not recognize [plaintiff’s] claims.  Under Nevada law, a misrepresentation by omission is actionable only if the defendant was under a duty to disclose the relevant information.  The duty to disclose requires, at a minimum, some form of relationship between the parties.  [The Nevada Supreme Court] explicitly rejected concealment claims against [a defendant], stating that: “[it] had no duty to disclose to the [plaintiffs] any superior knowledge it may have had regarding the safety of [its] products, however, because it was not directly involved in the transaction from which this lawsuit arose, or any other transaction with the [plaintiffs].
Id. at 564 (following Dow Chemical Co. v. Mahlum, 970 P.2d 98 (Nev. 1998)).  Accord Baymiller v. Ranbaxy Pharmaceuticals Inc., 894 F. Supp.2d 1302, 1307-11 (D. Nev. 2012) (also rejecting innovator liability and Conte).
New Hampshire
In Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. Sept. 30, 2009), the court, in the course of rejecting a (pre-Mensing) preemption argument, noted:
The vast majority of courts have rejected the notion that the manufacturer of the brand-name drug may be liable for defects in its generic equivalent on a theory of “innovator liability.”
Id. at 309 n.40.  Bartlett did not decide the issue under New Hampshire law.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014), the court held that New Hampshire would reject innovator liability.  Darvocet cited University System of New Hampshire v. U.S. Gypsum Co., 756 F. Supp. 640, 653-56 (D.N.H. 1991), rejecting market share liability in an asbestos case, and MacCleery v. T.S.S. Retail Corp., 882 F. Supp. 13, 15-16 (D.N.H. 1994), a corporate succession dispute holding that “imposition of liability depends upon the plaintiff proving that the defendant manufacturer made the product that caused the plaintiff’s injury.”
New Jersey
New Jersey has a product liability statute that subsumes all other claims and requires product identification.  N.J.S.A. §§2A:58C-l, et seq.  Four New Jersey trial court opinions have rejected innovator liability in generic drug cases, most recently Condouris v. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012):
Having concluded that the Plaintiffs’ claims are governed by the [Product Liability Act], the Court finds that Plaintiffs’ action must fail because they did not ingest a product made or sold by the Brand Defendants.  In New Jersey, it is well-settled that in products-liability litigation, [a plaintiff] must demonstrate that his or her injuries were caused by defendant’s product.
Id. (citation and quotation marks omitted).  Condouris followed the prior three cases, Rossi v. Hoffmann-LaRoche, 2007 WL 7632318 (N.J. Super. L.D. Jan. 3, 2007); Westerlund v. Wyeth, Inc., 2008 WL 5592753, at *3 (N.J. Super. Law Div. Oct. 20, 2008); Sloan v. Wyeth, 2004 WL 5767103 (N.J. Super Law. Div. Oct. 13, 2004).
Federal courts agree.  Three different Darvocet opinions have rejected innovator liability under New Jersey law.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 856 F. Supp.2d 904, 911 (E.D. Ky. 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir.  2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595, at *2 n.5 (E.D. Ky. March 7, 2012), aff’d on other grounds, 756 F.3d 917 (6th Cir. 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *1-3 (E.D. Ky. Oct. 10, 2012), aff’d and rev’d on other grounds, 917 F.3d 756 (6th Cir. 2014).  None of the New Jersey plaintiffs appealed, so the Sixth Circuit did not address New Jersey law.  Also, in Adamson v. Ortho-McNeil Pharmaceutical, Inc., 463 F. Supp.2d 496, 505 (D.N.J. Nov. 16, 2006), reconsideration denied, 2007 WL 604790 (D.N.J. Feb. 20, 2007), the court rejected innovator liability under New Jersey law when advanced as a claim for unjust enrichment.  Finally, In re Zofran (Ondansetron) Products Liability Litigation, 2018 WL 2317525, at *5-6 (D. Mass. May 21, 2018), relied on this precedent also to reject innovator liability under New Jersey law.  “[T]he five courts to have addressed the issue have concluded that under New Jersey law a plaintiff may not hold a brand-name manufacturer liable for injuries allegedly caused by ingestion of a generic version of a drug” and “there is no New Jersey authority to the contrary.”  Id. at *6.
Product identification has repeatedly been required in cases rejecting market share liability, both with respect to DES and other products, including prescription medical products.  Shackil v. Lederle Laboratories, 561 A.2d 511, 517, 526 (N.J. 1989); (no market share liability in vaccine cases); Namm v. Charles E. Frosst & Co., 427 A.2d 1121, 1125 (N.J. Super. App. Div. 1981) (same, DES); Lyons v. Premo Pharmaceutical Labs, Inc., 406 A.2d 185, 190 (N.J. Super. App. Div. 1979) (same, DES); Johnston v. Aventis, 2007 WL 954017 (N.J. Super. Law Div. March 9, 2007) (same, vaccine); Pipon v. Burroughs-Wellcome Co., 532 F. Supp. 637, 639 (D.N.J. 1982) (same, asbestos), aff’d without op., 696 F.2d 984 (3d Cir. 1982) (applying New Jersey law); Gianvito v. Premo Pharmaceutical Laboratories Inc., 940 N.Y.S.2d 272, 273-74 (N.Y. App. Div. March 20, 2012) (same, DES) (applying New Jersey law).
New Mexico
There is no New Mexico precedent either on innovator liability or market share liability.  The general New Mexico causation standard is that “[a] defendant can only be liable for damages that the particular defendant caused.”  Westbrook v. Lea General Hospital, 510 P.2d 515, 518 (N.M. App. 1973).  In asbestos cases, New Mexico law requires “product identification” so “that defendants’ products actually caused the [injuries].”  Huber v. Armstrong World Industries, Inc., 930 F. Supp. 1463, 1465 (D.N.M. 1996).
New York
Courts applying New York law have repeatedly rejected innovator liability.  In Coleson v. Janssen Pharmaceutical, Inc., 251 F. Supp.3d 716 (S.D.N.Y. 2017), the court rejected the theory even in the wake of New York’s recent asbestos bare metal decision:
Defendants had no oversight in the manufacturing of the generic drugs.  They earned no profit from the sale of the generic drugs.  Given the length of time generic drugs can sell following a patent’s expiration, to find a new duty would unforeseeably expand the cost of liability on brand name drug manufacturers.  With this judicial landscape, it is concluded that the New York authorities are consistent with the majority of other courts around the country in rejecting liability for a company that itself did not manufacture, sell, or distribute generic versions of its name-brand drug.
Id. at 721-22.  Another New York case doing so is Montero v. Teva Pharmaceuticals United States,  2019 WL 6907467 (S.D.N.Y. Dec. 4, 2019):
Plaintiff attempts to proceed on a theory of “innovator liability,” arguing that the manufacturer of a name-brand drug can be liable for injuries caused by the generic version, particularly where the generic drug’s manufacturer uses the warning label from the brand-name product. Courts applying New York law have consistently rejected this theory.  Plaintiff has not sufficiently alleged that [the branded manufacturer] owed her a duty or that [its drug] was the cause of her injuries.
Id. at *1.  Here’s another:
Although the New York Court of Appeals has not addressed whether a name-brand drug manufacturer may be held liable for injuries resulting from a generic drug manufacturer’s equivalent products, the majority of courts to consider the issue, including at least two courts in this Circuit, have answered no to the question.  I agree.  Because, by Plaintiff’s own admission, Defendant . . .  did not manufacture the drug that Plaintiff alleges he took,  Plaintiff’s product liability claims against Defendant . . . are dismissed.
Rosser v. Sanofi-Aventis, 2018 WL 4080351, at *4 (S.D.N.Y. Aug. 26, 2018)
In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014), the Sixth Circuit held that innovator liability did not exist under New York law:
[A]ny duty a brand defendant has in connection with its own products and labels does not extend to products and labeling over which it has no control, even if those products and labels mirror its own, because it has done nothing toward putting them in the hands of consumers.  We predict that the New York Court of Appeals would construe Plaintiffs’ misrepresentation claims as a product liability claim that fails for lack of product identification, or alternatively that the Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability.
Id. at 949 (citations and quotation marks omitted).  Darvocet relied upon prior New York precedent rejecting innovator liability.  Id. (citing Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  These decisions were followed in In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *13-14 (D. Mass. Aug. 4, 2017), also predicting that New York would reject innovator liability.
New York has allowed market share liability for DES, and only DES, distinguishing both the characteristics of the product and the circumstances of DES-specific legislative action.  With respect to all other products, medical or otherwise, the product identification requirement remains.  See Hamilton v. Beretta U.S.A. Corp., 750 N.E.2d 1055, 1067-68 (N.Y. 2001) (no market share liability for handguns); Brenner v. American Cyanamid Co., 699 N.Y.S.2d 848, 851-52 (N.Y. App. Div. 1999) (same, lead paint); In re New York State Silicone Breast Implant Litigation, 631 N.Y.S.2d 491, 494 (N.Y. Sup. 1995) (same, breast implants), aff’d mem., 650 N.Y.S.2d 558 (N.Y. App. Div. 1996); Catherwood v. American Sterilizer Co., 532 N.Y.S.2d 216, 220 (N.Y. Sup. 1988) (same, toxic chemical); 210 E. 86th St. Corp. v. Combustion Engineering, 821 F. Supp. 125, 145-46 (S.D.N.Y. 1993) (same, asbestos).
Nor does New York impose a duty to warn about other manufacturer’s similar products:
[W]e decline to hold that one manufacturer has a duty to warn about another manufacturer’s product when the first manufacturer . . . had no control over the production of the subject [product], had no role in placing that [product] in the stream of commerce, and derived no benefit from its sale.
Rastelli v. Goodyear Tire & Rubber Co., 591 N.E.2d 222, 225-26 (N.Y. 1992).
North Carolina
North Carolina federal district courts, applying the state’s product liability statute, N.C. Gen. Stat. §§99B–1, et seq., have rejected innovator liability twice.  Couick v. Wyeth, Inc., 691 F. Supp.2d 643, 645 (W.D.N.C. 2010) (“no North Carolina authority allow[s] a name-brand drug manufacturer to be held liable for injuries caused by a generic competitor’s drug”); Stoddard v. Wyeth, Inc., 630 F. Supp.2d 631, 633-34 (E.D.N.C. 2009) (“under North Carolina law a manufacturer of a brand name pharmaceutical may not be held liable for injuries stemming from the use of another manufacturer’s generic bioequivalent”).
This authority convinced the Sixth Circuit in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), that North Carolina would not embrace the theory:
Guided by these decisions, we predict that the North Carolina Supreme Court would construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification, or alternatively that the Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability.
Id. at 950.   See also Bennett v. Hoffmann-LaRoche Inc., 2013 WL 1191899, at *3-6 (E.D.N.C. March 22, 2013) (rejecting innovator liability; finding sufficient product identification evidence to survive summary judgment); John & Jane Doe 2 v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 628-29 (M.D.N.C. 2004) (defendant’s “duty to Plaintiffs would not extend to warning Plaintiffs or other manufacturers who copied [defendant’s contrast agent]”).
North Carolina also rejects market share liability.  Griffin v. Tenneco Resins, Inc., 648 F. Supp. 964, 966 (W.D.N.C. 1986) (applying North Carolina law) (“the defendant manufacturer must be identified with the specific instrumentality allegedly causing the injury”).
North Dakota
North Dakota law has not addressed innovator liability.  However, the state has not allowed market share liability.  Black v. Abex Corp., 603 N.W.2d 182, 189 (N.D. 1999) (asbestos).  Other asbestos cases under North Dakota law also impose a product identification requirement.  E.g., Various Plaintiffs v. Various Defendants, 847 F. Supp. 2d 722, 732 (E.D. Pa. 2012) (applying North Dakota law).
Product identification is incorporated into the Ohio Product Liability Act (“OPLA”).  A plaintiff must prove that the defendant “designed, formulated, produced, constructed, created, assembled, or rebuilt the actual product that was the cause of harm for which the claimant seeks to recover.”  Ohio Rev. Code §2307.73(A)(3).  The statute expressly bans innovator (“the type of product”), as well as market share liability:
Proof that a manufacturer designed, formulated, produced, constructed, created, assembled, or rebuilt the type of product in question is not proof that the manufacturer designed, formulated, produced, constructed, created, assembled, or rebuilt the actual defective product. . . .  A manufacturer may not be held liable in a product liability action based on market share, enterprise, or industrywide liability.
Ohio Rev. Code Ann. §2307.73(C).  Cf. Sutowski v. Eli Lilly & Co., 696 N.E.2d 187, 192-93 (Ohio 1998) (rejecting market share liability in DES cases); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (same) (applying Ohio law).
Ohio courts have twice rejected innovator liability under OPLA.  Hendricks v. Pharmacia Corp., 2014 WL 2515478, at *5-6 (Mag. S.D. Ohio June 4, 2014) (§2307.73(C) “readily dispose[s]” of innovator liability), adopted, 2014 WL 4961550 (S.D. Ohio Oct. 2, 2014); Hogue v. Pfizer, Inc., 893 F. Supp.2d 914, 918-19 (S.D. Ohio 2012) (“OPLA precludes [plaintiff’s] argument that the Brand Manufacturers are subject to liability as inventors or primary manufacturers of [the drug] as neither theory is an exception to the rule that a plaintiff must prove [his or] her injuries were caused by the actual product the defendant manufactured”).  This precedent “guided” the Sixth Circuit’s conclusion that Ohio would not permit innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 950 (6th Cir. 2014) (“we predict that the Ohio Supreme Court would construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification”).
The Tenth Circuit held that innovator liability was incompatible with Oklahoma law in Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir. 2013), rejecting:  strict liability, negligence, fraud/misrepresentation, a “duty to speak,” and warranty.  Id. at 1281-84.  Plaintiffs “fail[ed] to cite Oklahoma case law suggesting that these general tort principles impose liability with respect to a defendant that did not sell, distribute, manufacture, or otherwise have contact with the allegedly harmful product.”  Id. at 1284 (affirming 601 F. Supp.2d 1262, 1266 (W.D. Okla. 2009)).
In reliance on these precedents, the Sixth Circuit agreed that Oklahoma law did not recognize innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 950-51 (6th Cir. 2014) (“Guided by our sister circuit’s analysis of Oklahoma tort law, we predict that the Oklahoma Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Oklahoma law”).  A similar result occurred in In re Zofran (Ondansetron) Products Liability Litigation, 2017 WL 3448548, at *14 (D. Mass. Aug. 4, 2017), rejecting innovator liability under any of numerous theories.  See In re Zofran (Ondansetron) Products Liability Litigation, 2018 WL 2317525, at *4 (D. Mass. May 21, 2018) (second ruling under Oklahoma law).  Likewise, a Massachusetts state trial court, called upon to opine on Oklahoma law, followed Schrock and rejected innovator liability.  Cardinal v. Elsevier Inc., 2014 WL 10937406, at *2-3 (Mass. Super. Aug. 11, 2014).
If all that were not enough, Oklahoma has also rejected market share liability, both in the DES context and elsewhere.  Case v. Fibreboard Corp., 743 P.2d 1062, 1067 (Okla. 1987) (asbestos); Wood v. Eli Lilly & Co., 38 F.3d 510, 513-514 (10th Cir. 1994) (applying Oklahoma law) (DES).
The Oregon Supreme Court determined in Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 233 (Or. 1988), that any tort theory that eliminated a plaintiff’s obligation to prove product identification “requires a profound change in fundamental tort principles of causation,” and “cannot [be] . . . consistent with common law principles of tort liability.”  Id. at 223 (rejecting alternative liability).
Three Oregon trial courts have rejected innovator liability.  In Phelps v. Wyeth, Inc., 857 F. Supp.2d 1114 (D. Or. 2012), the court, following the Mensing generic preemption decision, reaffirmed this position:
Under Oregon’s product liability law, the name-brand defendants cannot be found liable for plaintiffs’ injuries because plaintiffs cannot show that their injuries resulted from the use of the name-brand manufacturers’ product . . . .  I decline to stretch the duty of care for name-brand defendants to cover injuries caused by generic manufacturers’ products, given that their argument directly contradicts Oregon law.  [discussion rejecting Conte and Kellog omitted]  Oregon product liability law is controlling here, and it does not allow for name-brand manufacturer liability unless [plaintiff] can demonstrate that the name-brand manufacturers’ products caused her injury.
Id. at 1120-21. See Phelps v. Wyeth, Inc., 2010 WL 2553619, at *2 (Mag. D. Or. May 28, 2010) (“I cannot find that a decision to hold a manufacturer liable for injury caused by its competitor’s product is rooted in common sense”), adopted, 2010 WL 2553614 (D. Or. June 21, 2010).  Accord DaCosta v. Novartis AG, 2002 WL 31957424, at *8-9 (D. Or. March 1, 2002) (no liability where plaintiff never took defendant’s “chemically identical drugs”; “the allegedly defective product or form of [the drug], that [defendant] sold was not consumed by [plaintiff] and could not have caused [her] injuries”); Lukas-Werner v. Novo Nordisk, A/S, No. 1009-13177, transcript at 26 (Or. Cir. May 11, 2012) (“I do not think the Oregon Supreme Court would conclude that the innovator, the original manufacturer of a drug responsible for its labeling, has a duty arising out of the FDA regulations to the consumers or prescribers of all generic versions of its drug”).
“Pennsylvania . . . follows the general rule that a plaintiff, in order to recover, must establish that a particular defendant’s negligence was the proximate cause of her injuries.”  Skipworth v. Lead Industries Ass’n, 690 A.2d 169, 172 (Pa. 1997) (rejecting market share liability) (lead paint case).  Thus, “[a] plaintiff must also establish that the injuries were caused by a product of a particular manufacturer.”  DeWeese v. Anchor Hocking Consumer & Industrial Products Group, 628 A.2d 421, 423 (Pa. Super. 1993).
[A] defendant must be identified as the manufacturer, distributor, or seller of the offending product before the injuries suffered by the plaintiff may be found to be proximately caused by some negligent act or omission of the defendant.  Absent such identification, there can be no allegations of duty, breach of duty, or legal causation, and hence there can be no liability.
Mellon v. Barre-National Drug Co., 636 A.2d 187, 191-91 (Pa. Super. 1993) (citations and quotation marks omitted) (rejecting market share liability for OTC drug).
The first Pennsylvania court to consider innovator liability was Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. May 25, 2006), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009).  Finding Foster “persuasive,” the court held:
[W]e agree that to impose a duty in this case would be to stretch the concept of foreseeability too far, as [an innovator manufacturer] cannot reasonably expect that consumers will rely on information they provide when actually ingesting another company’s drug.  Also, we agree that unfair consequences would result if we were to impose a duty upon [an innovator], when it obtained no benefit from the sale of [the] generic equivalent and had no control over the manufacturing or labeling of [the generic drug], yet it bore the expense of developing [the innovator drug] from which [the generic manufacturer] materially benefits.
*          *          *          *
Plaintiff in this case invites this Court to drastically expand the boundaries of Pennsylvania tort law without precedent or policy to support his position.  We believe the Supreme Court of Pennsylvania would not accept this invitation, and accordingly, we decline to do so as well.  Thus, this Court holds that under Pennsylvania law, there is no duty of care owed by a brand-name prescription drug manufacturer to a plaintiff allegedly injured by a generic equivalent drug manufactured by another company.
432 F. Supp.2d at 541 (footnote, citations and quotation marks omitted).
Based largely on Colacicco, the Sixth Circuit in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 951 (6th Cir. 2014) (“Guided by the Eastern District’s analysis of Pennsylvania tort law, we predict that the Pennsylvania Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Pennsylvania law”).
Taking a contrary view in an economic loss case, the court in Clark v. Pfizer, Inc., 2008 WL 7668730 (Pa. C.P. Phila. Co. March 17, 2008), held that an innovator manufacturer that allegedly promoted its product off-label could be liable for the “foreseeable” effect that its promotion would also increase off-label prescriptions of generic equivalents.  Id. (applying Restatement (Second) of Torts §§ 552 & 531 (1965)).
In addition to Skipworth and Mellon, numerous appellate courts have reaffirmed the product identification requirement under Pennsylvania law by rejecting market share liability or similar theories in litigation involving a wide variety of products.  Pennfield Corp. v. Meadow Valley Electric, Inc., 604 A.2d 1082, 1088 (Pa. Super. 1992) (electrical cable); Cummins v. Firestone Tire & Rubber Co., 495 A.2d 963, 972 (Pa. Super. 1985) (tires); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 127 (3d Cir. 1993) (lead paint) (applying Pennsylvania law); Robertson v. Allied Signal, Inc., 914 F.2d 360, 379-81 (3d Cir. 1990) (asbestos; rejecting “fiber drift” theory) (applying Pennsylvania law); see also Bortell v. Eli Lilly & Co., 406 F. Supp.2d 1, 6-7 (D.D.C. 2005) (DES) (applying Pennsylvania law).
Rhode Island
In Rhode Island, “[i]t is axiomatic that a plaintiff must prove that the proximate cause of his or her injuries was the defendant’s product.”  Clift v. Vose Hardware, Inc., 848 A.2d 1130, 1132 (R.I. 2004).  While there isn’t any Rhode Island law on innovator liability, product identification is strongly supported by the Rhode Island Supreme Court’s firm rejection of market share liability non-manufacturer liability in Gorman v. Abbott Laboratories, 599 A.2d 1364, 1364 (R.I. 1991), refusing to allow market share liability even in DES cases.
South Carolina
“It is a fundamental principle of the law of products liability that a product manufacturer is not an insurer of its product, and a plaintiff may recover against a manufacturer only upon a showing that the product was in a defective condition unreasonably dangerous at the time it left the manufacturer’s control.”  Baughman v. General Motors Corp., 627 F. Supp. 871, 874 (D.S.C. 1985).
In Fisher v. Pelstring, 2010 WL 2998474 (D.S.C. July 28, 2010), after a lengthy discussion of the Fourth Circuit’s Foster decision and its progeny, the court “conclude[d] that South Carolina law does not support an action against the name-brand drug manufacturers . . .  for injuries allegedly caused by a generic drug manufactured by another company.  Id. at *8.  The same cases cited in Fisher led the Sixth Circuit to agree that South Carolina would not adopt innovator liability:
[P]laintiffs could not establish that the brand manufacturers owed them a duty because they did not manufacture or sell the products allegedly responsible for their injuries.  Guided by the Fisher court’s analysis of South Carolina law, we predict that the South Carolina Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under South Carolina law.
In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 951-52 (6th Cir. 2014).
Among the cases relied upon in Fisher were those holding that South Carolina would rejected market share liability, even in DES cases.  Mizell v. Eli Lilly & Co., 526 F. Supp. 589, 596 (D.S.C. 1981) (applying South Carolina law); Ryan v. Eli Lilly & Co., 514 F. Supp. 1004, 1007 (D.S.C. 1981) (applying South Carolina law).
South Dakota
“It is a fundamental principle that a plaintiff must prove, as an essential element of his case, that the defendant manufacturer actually made the particular product in question.”  Bradley v. Firestone Tire and Rubber Co., 590 F. Supp. 1177, 1179 (D.S.D. 1984) (refusing to expand market share liability beyond DES).  There are no innovator liability decisions from South Dakota.  No innovator liability case has yet been decided under South Dakota law.
The Sixth Circuit has twice determined that innovator liability is contrary to the law of Tennessee.  In Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 378 (6th Cir. 2013), the court held:
The Tennessee Product Liability Act] . . . applies to all of the plaintiffs’ claims against the Brand-Name Manufacturers.  Unfortunately for the plaintiffs, however, these defendants were not the manufacturers or sellers of the generic drugs that injured the plaintiffs.  Yet “in order to recover under the TPLA, a plaintiff must show that the product manufactured and sold by the defendant caused the injuries he alleges to have sustained. . . .  [S]imply because a particular harm is foreseeable “is not dispositive in determining the existence of a legal duty. . . .  [W]e have no basis to conclude in this diversity case that the Tennessee Supreme Court would overrule its prior decisions holding that a manufacturer owes no duty of care to consumers of products made by others.  Tennessee law instead requires manufacturers to warn of hidden and unknown dangers in their products.

Id. at 403-05 (citations and quotation marks omitted) (affirming 882 F. Supp.2d 1020, 1028-31 (W.D. Tenn. Aug. 8, 2012)).  See In re Darvocet,Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 952 (6th Cir. 2014) (“[t]his Court has already determined that claims by consumers of generic drugs against brand manufacturers cannot stand under Tennessee law”).

Tennessee law also rejects market share liability.  Barnes v. Kerr Corp., 418 F.3d 583, 589 (6th Cir. 2005) (applying Tennessee law) (dental amalgam).  Nor is there any duty to warn about other manufacturer’s products.  Id. at 591 (“a product manufacturer generally has a duty to warn of the dangers of its own products, it does not have a duty to warn of the dangers of another manufacturer’s products”); McConkey v. McGhan Medical Corp., 144 F. Supp. 2d 958, 964 (E.D. Tenn. 2000) (“Plaintiffs cannot establish that [defendant] owed a duty . . . to warn about dangers of breast implants it did not produce”); Kellar v. Inductotherm Corp., 498 F. Supp. 172, 175 (E.D. Tenn. 1978) (“[i]f a manufacturer could be held liable for injury merely because it foresaw a danger created by another party, there would literally be no end of potential liability,” and manufacturers would become “insurers of products manufactured by others”).


Texas is another state with abundant precedent rejecting innovator liability.  In Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674 (5th Cir. 2014), the court relied on extensive contrary precedent, in Texas and elsewhere:

Although [plaintiff] concedes that he has never used a product manufactured by the Brand Defendants, he argues that given the structure of the pharmaceutical industry as a result of federal law, the Brand Defendants owe a duty to eventual consumers of the drugs they design, even if those consumers use a generic version of the drug.  Several courts have faced this question.  Every circuit court has held (under the laws of several different states) that a brand-name manufacturer does not owe a duty to consumers who use a generic version of the drug.

Id. at 681 (citations omitted) (affirming 889 F. Supp.2d 901, 905-10 (S.D. Tex. 2012)).  The court in Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014), the court reached the same conclusion.

Under Texas law, meanwhile, a products liability action is broadly defined as “any action against a manufacturer or seller for recovery of damages arising out of personal injury . . . allegedly caused by a defective product whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.”  Tex. Civ. Prac. & Rem. Code Ann. §82.001(2).  The Texas Supreme Court has determined that under this statute, entities are “‘manufacturers’ . . . only with respect to their own products.”  It has also found that “[a] fundamental principle of traditional products liability law is that the plaintiff must prove that the defendants supplied the product which caused the injury.”

Id. at 477-78 (quoting Owens & Minor, Inc. v. Ansell Healthcare Products, Inc., 251 S.W.3d 481, 485 (Tex. 2008) (no duty to indemnify for competing products)); Gaulding v. Celotex Corp., 772 S.W.2d 66, 68 (Tex. 1989) (rejecting market share liability in asbestos cases)).  The Sixth Circuit concurred in this conclusion.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 952-53 (6th Cir. 2014).

A raft of Texas trial courts also reject innovator liability.  Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, at *1 (Tex. Dist. May 7, 2010); Phares v. Actavis-Elizabeth LLC, 2015 WL 12780637, at *4-5 (S.D. Tex. March 19, 2015) (fraud claims); Willis v. Schwarz-Pharma, Inc., 62 F. Supp.3d 560, 564-66 (E.D. Tex. 2014); Phares v. Actavis-Elizabeth LLC, 892 F. Supp.2d 835, 844-46 (S.D. Tex. 2012), reconsideration denied, 2015 WL 12780637, at *4-5 (S.D. Tex. March 19, 2015); Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. March 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003).

Wells v. Wyeth Pharmaceuticals, Inc., 2016 WL 8849935, at *4 (Mag. W.D. Tex. Dec. 16, 2016), adopted, 2017 WL 1826295 (W.D. Tex. Jan. 11, 2017), rejected a claim that an innovator’s alleged off-label promotion allowed it to be sued by a user of solely generic products.


In Utah, there must be “causation between [a plaintiff’s injuries] and the breach of any particular defendant.”  Highland Construction Co. v. Union Pacific Railroad Co., 683 P.2d 1042, 1047 (Utah 1984).

Innovator liability was rejected in Beutella v. A.H. Robins Co., 2001 WL 35669202, at *2-3 (Utah Dist. Dec. 10, 2001).


In Vermont, “in a products liability action, a plaintiff must show that the defendant’s product . . . caused injury to the consumer.”  Farnham v. Bombardier, Inc., 640 A.2d 47, 48 (Vt. 1994); see Haskins v. Zimmer Holdings Inc., 2010 WL 342552, at *2 (D. Vt. Jan. 29, 2010) (“Plaintiffs must at least allege in their complaint that [defendant’s] product was administered”).  Nonetheless, a federal district court, in the absence of any Vermont precedent, chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010), because it was “fair” and “[t]here is no reason, under Vermont law, to limit [defendant’s] duty of care to physicians by the pharmacist’s choice of a generic bioequivalent.”  Id. at 706, 709.  Cf. Lyman v. Pfizer, Inc., 2012 WL 2970627, at *17-18 (D. Vt. July 20, 2012) (dismissing innovator liability case where warnings have changed because any reliance on older warnings would
not have been justifiable as a matter of law).


In Virginia, a duty to warn “has no application in this case because [defendant] was not the manufacturer of the [product] or any of its component parts.”  Baker v. Poolservice Co., 636 S.E.2d 360 (Va. 2006).

In Colas v. Abbvie, Inc., 2014 WL 2699756 (N.D. Ill. June 13, 2014), the court, predicting Virginia law, held that Virginia would not recognize innovator liability.

Plaintiff admits that defendants were not the “suppliers” of the [drug] he took.  Thus, plaintiff cannot, as a matter of Virginia law, state a failure to warn claim against defendants. . . . Apparently, no Virginia court has decided whether a company that makes a brand name drug owes a duty to consumers of a generic drug made by another company.  However, the Virginia failure to warn decisions, and the weight of authority from other jurisdictions, suggest that the Virginia Supreme Court would not recognize such a duty.

Id. at *2 (citations omitted).


In Washington, “[i]n order to have a cause of action, the plaintiff must identify the particular manufacturer of the product that caused the injury.”  Lockwood v. AC & S, Inc., 744 P.2d 605, 612 (Wash. 1987).  Further, a “manufacturer’s  duty to warn is restricted to warnings based on the characteristics of the manufacturer’s own products, the law generally does not require a manufacturer to study and analyze the products of others and warn users of the risks of those products.”  Braaten v. Saberhagen Holdings, 198 P.3d 493, 498 (Wash. 2008) (citations and quotation marks omitted).

In Madden v. Teva Pharmaceuticals, USA, Inc., 2012 WL 4757253. (Pa. C.P. Phila. Co. Oct. 1, 2012), the court applied Washington law (where the plaintiff was domiciled and the prescription written) and concluded that innovator liability was not proper:

[T]he Court properly dismissed Plaintiff’s claims . . . because [defendant] was not the manufacturer or seller of the product ingested by the Plaintiff.  Here, it is undisputed that the Plaintiff purchased and ingested the generic drug . . ., not the brand-name drug . . . manufactured by [defendant].  Moreover, courts across the country have overwhelmingly refused to allow claims against the manufacturer of a name-brand medication for damages allegedly caused by the use of another manufacturer’s generic-equivalent medication on both legal and policy grounds.

Id. at ?? (near end of opinion) (footnote omitted).  In reliance on Madden, the Sixth Circuit also concluded that Washington would not recognize innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 953 (6th Cir. 2014).

West Virginia

In McNair v. Johnson & Johnson, 818 S.E.2d 852 (W. Va. 2018), the West Virginia Supreme Court of Appeals rejected innovator liability:

There is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug ingested was produced by a generic drug manufacturer.

818 S.E.2d at 854, syllabus, point 4.

Innovator liability “would sever the connection between risk and reward . . . that forms the basis of products liability law.”  Id. at 866.

[S]trict liability has only been applied to a manufacturer, seller, or distributor of the product in question.  In other words, a plaintiff cannot recover damages in a strict liability action against the defendant, in the absence of showing that the defendant either manufactured or sold the product that allegedly injured the plaintiff.

Id. at 860 (citation, footnote, and quotation marks omitted). There’s very good reason for this limitation:

[T]his Court, as well as other courts, adopted products liability to place responsibility for the harm caused by a product on the party who profits from its manufacture and sale.  Because the brand manufacturer did not place the generic product on the market, it cannot spread the cost of compensating generic consumers by including the cost of insurance or judgments as part of the product’s price tag.

Id. at 866 (citations and quotation marks omitted). Particularly in the case of prescription drugs,

If brand manufacturers become liable for injuries allegedly caused by generic drugs, significant litigation costs would be added to the price of new drugs to the disadvantage of consumers.  Further, the increase in litigation against brand manufacturers could stifle the development of new drugs, which would have negative health consequences for society.

Id. (citation omitted).  See McNair v. Johnson & Johnson, ___ F. Appx. ___, 2019 WL 3238907, at *1 (4th Cir. July 18, 2019) (affirming dismissal after remand from West Virginia Supreme Court of Appeals).  This logic applied to all theories by which a product manufacturer could be held liable.  Negligent misrepresentation likewise failed, for the reasons stated in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 954 (6th Cir. 2014) (applying West Virginia law), and Huck v. Wyeth (see Iowa). McNair, 2018 WL 2186550 at *7-8.  As to general negligence, “all federal circuit courts that have considered the question have held, under the laws of different states, that a brand manufacturer does not owe a duty to a consumer who uses a generic drug.”  Id. at *8 (string citation omitted; see our scorecard for these cases).  “Any recognition of an outlier theory of liability permitting a generic drug consumer to bring an action against the brand manufacturer for an injury allegedly arising from the use of the generic drug would be plainly at odds with this public policy.”  Id. at *10.

See also Meade v. Parsley, 2009 WL 3806716, at *2-3 (S.D.W. Va. Nov. 13, 2009) (“[I]nnovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff’s injuries.”).


There are no innovator liability decisions in Wisconsin.  Wisconsin’s new product liability statute, however, subsumes all common-law claims (W.S.A. §895.046(2)) and mandates product identification.

[T]he manufacturer, distributor, seller, or promoter of a product may be held liable in an action under sub. (2) only if the claimant proves, in addition to any other elements required to prove his or her claim, that the manufacturer, distributor, seller, or promoter of a product manufactured, distributed, sold, or promoted the specific product alleged to have caused the claimant’s injury or harm.

W.S.A. §895.046(3).

A very limited exception is provided to the statutory product identification requirement, but it cannot be applicable to prescription drugs.  An essential element of that exception requires that the product “[w]as distributed or sold without labeling or any distinctive characteristic that identified the manufacturer, distributor, seller, or promoter.”  W.S.A. §895.046(4)(a)(3)(c).


There are no Wyoming decisions on innovator liability or market share liability.  The general Wyoming causation standard “require[s] the plaintiff to show the defendant’s product or negligence was a ‘substantial factor’ in bringing about the plaintiff’s harm.”  Johnson v. Allis-Chalmers Corp. Products Liability Trust, 11 F. Supp.3d 1119, 1125 (D. Wyo. 2014).


Innovator liability has also been raised, and rejected, by two Canadian (Ontario) courts.  In Goodridge v. Pfizer Canada Inc., 2010 ONSC 1095 (Ont. Super. Feb. 18, 2010), the court comprehensively took down the concept of innovator liability under Canadian law.  Id. at ¶¶65-100. The court concluded:

Would it be fair to make the Defendants, as innovators, liable simply for releasing an idea that is copied? I think not, because once again this would be to impose strict liability and because the harm in releasing the idea is caused by releasing the idea without appropriate warnings about how the associated product may be used, but the innovator is not in a position to give any warnings about the uses being made by consumers of a copied version of the innovator’s product. A drug innovator cannot issue warnings about the hazards of a drug manufactured and sold by another pharmaceutical company, particularly when the hazards may be associated with off-label uses. Although the drug innovator can control the manufacture of its own product, monitor for adverse reactions to its product and give warnings about its own product, the innovator is not in a position to stop the generic manufacturer from releasing the generic drug or to stop physicians from prescribing the generic drug for off label uses. This conduct is not the innovator’s conduct, and, in my opinion, it would be unfair to impose a duty of care on the innovator for another’s conduct when the innovator cannot control, qualify, or stop that conduct. In my opinion, it would not be fair or just to make the innovator liable for failing to do something that should and can only be done by others.

Put differently, normally, an innovator of a prescription drug may discharge its duty of care by giving a warning about the risks associated with its own drug, but imposing a duty of care on the innovator for simply releasing the idea of the drug into the stream of commerce is to impose strict liability on the innovator and also to deny the innovator the defence of having given an adequate warning to a learned intermediary. In my opinion, such an imposition of liability would be unfair.

I, therefore, conclude that it is plain and obvious that the Defendants do not have a duty of care to the consumers of generic [drugs].

Id. at ¶¶98-100.  In an order as terse as Goodridge was extensive, the court in Brown v. Janssen, Inc., 2016 CarswellOnt 12959, slip op. (Ont. Super. April 7, 2016), the court struck all generic references from the complaint, finding that Goodridge “is directly on point and was correctly decided.”  Id. at 1. “No Canadian court has ever held that a brand name manufacturer owes a duty of care to the consumers of the generic version manufactured by a competitor.”  Id.


Ever since innovator liability burst onto our consciousness a decade ago with the horrific decision in Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), we have had nightmares about the potential impact of this theory.  After all: (1) over 90% of all prescriptions these days are for generic drugs, and (2) plaintiffs claiming injury from generic drugs are largely prevented from suing their actual manufacturers due to preemption.  Even if generic drugs, by and large, generate less litigation per prescription than innovator drugs, due to their risks being better known over longer periods of use, imposing 100% of potential liability on less than 10% of the market, as innovator liability theories permit, would pose a massive threat to the innovator drug industry, and would send innovator drug prices skyrocketing.

Thus, we’ve manned the barricades against innovator liability since its inception.  The Blog maintains a comprehensive innovator liability scorecard, as well as an updated 50-state survey of innovator liability.  Appellate decisions on innovator liability – pro or con (thankfully, mostly con) have ranked highly on our annual top- and bottom-ten lists of the most significant cases of the year.  See 2018+1; 2018-1; 2017-1A; 2016-5; 2014+1; 2014+3; 2014-1; 2013+2; 2013-5; 2008-1.

But now we’re saying “woah,” at least a bit.  Two state high courts:  California in T.H. v. Novartis Pharmaceuticals Corp., 407 P.3d 18 (Cal. 2017), and Massachusetts in Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018), have allowed some form of innovator liability for a year or more, now.  We follow the legal press pretty closely on prescription medical product liability litigation issues, and we haven’t read anything about a flood of additional innovator liability cases – or even one − being filed in those states.  Indeed, we haven’t heard a peep out of the T.H. case itself since it was remanded after the California Supreme Court’s decision.  We checked with defense counsel, and no, T.H. hasn’t settled, but rather is proceeding towards trial in orderly fashion.

So what’s going on?  Has the existential threat of innovator liability turned into a paper tiger in practice?

We think the answer is, “hopefully.”  And that’s very good news for manufacturers of innovator drugs.  In retrospect, one of the reasons we experienced such a rash of innovator liability litigation after Mensing/Bartlett was that these preemption rulings left high and dry a lot of existing cases involving generic drugs.  In particular, the other side had been actively soliciting metoclopramide cases, so when the Supreme Court lowered the preemption boom, those lawyers were left like fish in a barrel – and innovator liability was one of the few tools at their disposal.  By now, in 2019, those metoclopramide cases have pretty much worked their way through the system.  We ran “metoclopramide” on Westlaw, and there hasn’t been a single trial court level metoclopramide decision of any sort on any topic since Raskas v. Teva Pharmaceuticals USA, Inc., 2018 WL 351820 (E.D. Mo. Jan. 8, 2018), over a year ago.

Nor has anything else significant taken the place of metoclopramide litigation.  Our innovator liability scorecard reflects only four decisions for all of 2018.  All four involved different drugs, and none was a metoclopramide case.  Entries into our generic preemption scorecard have also slowed dramatically.  Only eight cases involving generic preemption (that we’re aware of) were decided in all of 2018.  Every prior year, going back to Mensing in 2011, was well into double figures.  Nor are there really any targeted generic products any longer.  The eight generic preemption cases in 2018 involved seven drugs, with only amiodarone generating more than one judicial opinion.  Since our scorecards include every decision we find, both good and bad, they’re a pretty good indicator of what’s out there.

What we think this means is that preemption has been an excellent deterrent.  The other side doesn’t seem to be taking on many cases involving alleged injury from ingestion of generic drugs.  Seen any “bad drug” lawyer ads lately about generic drugs?  We haven’t either.  The post-Mensing onslaught of innovator liability claims wasn’t a portent, but was more of a last gasp.  That makes sense to us, too.  Innovator liability is another of these unusual theories of liability, like failure to update and failure to report adverse events to the FDA, that essentially didn’t exist in the absence of preemption.  Innovator liability lacks the simplicity and jury appeal of “they made it, they should pay” theories of strict liability and negligence.  All of the policy arguments that we’ve made against innovator liability have their jury-accessible equivalents, so this theory is another of these “bad” causes of action that plaintiffs pursue only when they have no other option.  It’s hard to prove liability, and harder to prove causation, so our opponents aren’t likely to bring innovator liability cases unless there’s some other significant incentive – usually in the form of big damages.

Thus, in terms of how innovator liability seems to be doing in practice, as opposed to theory, it’s looking more like a paper tiger than something that will actually pose an existential threat to our clients.  First of all, it remains an extreme minority theory.  As far as we know, not a single penny has ever been paid on a verdict based on innovator liability.  There are lots of other, less problematic, ways for our opponents to earn a living.  Short of some DES-like surprise latent injury from a popular generic drug, our best guess now is for innovator liability to be a one-off sort of claim asserted only in big damages/poor liability situations such as SJS/TENS cases.

Here’s another guest post on the Dormant Commerce Clause by our guest guru on that subject, Dick Dean over at Tucker Ellis.  He reports on another possible use for the Dormant Commerce Clause that could provide a win for the our side in an innovator liability situation.  As always our guest bloggers deserve 100% of the credit, and any blame, for their postings.


On April 25, 2018 this blog advised “Don’t Sleep on the Dormant Commerce Clause.”  It was right.  That post discussed a Fourth Circuit case involving a drug pricing regulation attempt by the State of Maryland.  Since then, two other Circuit court decisions have followed; it’s the Dormant Commerce Clause gone wild.  And both decisions involve subject matter areas of direct interest to readers of this blog.

In Daniels Sharpsmart, Inc. v. Smith, 889 F.3d 608 (9th Cir. 2018), the Ninth Circuit upheld a District Court decision which invoked the Dormant Commerce Clause to strike down the enforcement of a California regulation beyond the state’s border.  Daniels was an Illinois-based corporation that made systems for the disposal of biohazardous medical products including waste syringes and blood collection devices.  It also transported and treated medical waste.  It had a medical waste treatment facility in Fresno, as well as others in several different states.  California’s Medical Waste Management Act (CMWMA) required that California-generated medical waste must be incinerated.  And if medical waste was transported out-of-state, it was required to be “consigned” to a waste treatment facility “permitted” in the “recovery state.”  As of 2014, there were no incinerators within California to treat Daniels’ biohazardous medical waste (why that is the case is not discussed in the decision), and so Daniels transported that waste to other states to have it incinerated.  Eventually, Daniels shipped that waste to Kentucky and Indiana, where that waste was treated by methods other than incineration consistent with the regulations in those states.  In Kentucky, the waste was treated by a method called autoclave; in Indiana, the method was “thermal deactivation.”  Both treatment methods are less expensive than incineration.

California regulators took the position that biohazardous medical waste originating in California had to be incinerated in Indiana and Kentucky, even though the regulations and laws of other states permitted an alternative method.  To that end, the regulators proposed daily fines against Daniels for failure to do so.  Daniels filed a complaint in the Eastern District of California arguing that state officials had violated the Dormant Commerce Clause by its extraterritorial application of the MWMA.  The District Court granted Daniels’ motion for a preliminary injunction and in a short, focused decision, the Ninth Circuit affirmed. It characterized the regulation as “an attempt to reach beyond the borders of California and control transactions that occur wholly outside of the State after the material in question . . . has been removed from the State.”  Id. at *4.  Attempts at direct regulation of out-of-state conduct have generally been struck down without further inquiry.  See Brown-Forman Distillers Corp. v. N.Y. State Liquor Auth., 476 U.S. 573, 579 (1986); and Healy v. Beer Inst., 491 U.S. 324, 336 (1989).  Laws neutral on their face, but which have an impermissible protectionist purpose and effect, have also been struck down.  But where there is no obvious protectionist purpose and a state law has only incidental impact on interstate commerce, such laws are subject to a more lenient standard of review.  They are usually upheld unless the burden they impose on interstate commerce exceeds their local benefits. Pike v. Bruce Church, Inc., 397 U.S. 137, 144–46 (1970).

Such a standard was employed in Garber v. Menendez, 888 F.3d 839 (6th Cir. 2018).  The case involved Ohio’s tolling statute, which stops the statute of limitations from running when the defendant is out-of-state.  O.R.C. 2305.15.  This statute had been construed by the Supreme Court in Bendix Autolite Corp. v. Midwesco Enterprises, Inc., 486 U.S. 888 (1988).  There, in a commercial dispute between corporations, the Supreme Court struck down the tolling statute noting:

The State may not withdraw such defenses [i.e., statutes of limitation] on conditions repugnant to the Commerce Clause.  Where a State denies ordinary legal defenses or like privileges to out-of-state persons or corporations engaged in commerce, the state law will be reviewed under the Commerce Clause to determine where the denial is discriminatory on its face or an impermissible burden on commerce.

Id. at 893.

Innovator liability, like the tolling statute, withdraws the legal defense of lack of product exposure so it neatly fits the language of Bendix (more later on that issue). In Bendix, the Supreme Court struck down the tolling statute under the Commerce Clause because Ohio could not justify its statute as a means of protecting its residents given the provisions of the Ohio long-arm statute.  It did not engage in any detailed discussion of the impact on commerce—almost assuming one from the statute.  Concurring in the result only, Justice Scalia noted that applying the Pike balancing factors “is more like judging whether a particular line is longer than a particular rock is heavy.”  Id. at 897 (Scalia, J., concurring).  He wrote that he would not know how to do such a balancing.

In Garber, the District Court and the Sixth Circuit took very different views of Bendix. The District Court, confronted with same statute held to violate the Dormant Commerce Clause in Bendix, not surprisingly reached the same result.  But the Sixth Circuit distinguished Bendix, finding that the statute forced out-of-state companies like Midwesco to face liability forever as a cost of doing business across state lines and noting the Supreme Court’s application of the Pike test in that context.  It viewed the transaction in Garber, which involved one patient suing one doctor (who had left the state), as yielding a different result under the Commerce Clause with there being no demonstrable effect on the same.  In the absence of a record establishing such an effect—there was no such record apparent in Bendix—the challenge failed.

Putting the facts of Garber aside, Bendix clearly remains good law.  Defenses cannot be withdrawn in a way “repugnant” to the commerce clause.  Is there an impact on commerce from the largest state in the country (population wise) radically changing product exposure rules?  At an elementary level, if drug companies are going to have to defend and pay settlements and judgments on products made by other companies in California, that will have a dramatic impact on drug pricing throughout the country.  The difference between the District Court and the Sixth Circuit here is one of what is in the record.  It would not take a particularly high powered economist to establish such a record in regard to the impact of innovator liability.

The Dormant Commerce Clause has been used to invalidate state registration statutes.  See here and here.  So it is not surprising that in addition to the argument that innovator liability may be precluded by lack of personal jurisdiction (see here and here), there is also a Dormant Commerce Clause argument in regard to innovator liability.  Once again—don’t sleep on the Dormant Commerce Clause.

Since Conte in 2008, we have not made a secret of our view that innovator liability is a bad idea, contrary to traditional tort law principles and to sound public policy.  We, especially Bexis, may even be accused of being somewhat obsessed with chronicling the decisions, big and small, on this issue over close to a decade.  We have kept a scorecard of the decisions and commemorated the one-hundredth decision.  We tracked when the Alabama legislature got sick of the turbulent expansion by the courts and kept product liability limited to the product designed, manufactured, or sold/leased by the defendant.  We have peppered our top and bottom ten lists with these decisions and we expect they will find places on our august enumerations for the eleventh year in a row this December.

The decision in In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2018 WL 2317525 (D. Mass. May 21, 2018), has familiar ring to it.  Among the claims presented in this MDL are those against the branded manufacturer from the offspring of women who received generic versions of a prescription antiemetic.  These plaintiffs sought to impose innovator liability on the theory that the branded manufacturer had made misrepresentations to unspecified doctors that somehow encouraged the off-label prescription to pregnant women for morning sickness without disclosing a purported risk of birth defects.  (As an aside, while not in the decision, this is considered an essential medication by WHO and the current labeling suggests that FDA rejects that any birth defect risk has been established.)  Last year, the court ruled on a motion to dismiss this version of innovator liability under Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma law.  We discussed it here  and it took on honorable mention on last year’s top ten list.  Other plaintiffs persisted with these claims and the branded manufacturer defendant filed a motion for judgment on the pleadings.  After some voluntary dismissals, the court considered the issue under the law of Oklahoma (again), Connecticut, and New Jersey.

Why is this worth a post instead of just an update to our scorecard? Well, there have been two really big, bad decisions on innovator liability since the court’s prior decision and we like to make sure the majority position continues to hold after such dreck.  The first innovator abomination was T.H. v. Novartis Pharm. Co., which we railed about here and took over the spot of worst case of 2017 in a rare supplemental shuffling of the list.  We have said quite a bit about why this decision, and the Court of Appeals decision before it, were especially bad, extending innovator liability into perpetual liability under the guise of foreseeability.  A few months later, the Massachusetts Supreme Judicial Court a mile away from the Zofran MDL issued its own stinker in Rafferty v. Merck & Co., Inc., reversing a lower court rejection of innovator liability.   Even with the “limitation” that innovator liability would only for “reckless” conduct in failing to update the branded drug’s label, there is a good chance that this will find a place on the list of 2018’s worst come December.  There was also a good decision a few weeks ago from the West Virginia Supreme Court soundly rejecting innovator liability in McNair v. Johnson & Johnson, which may end up with a place on 2018’s best list.  More important than our lists—breathe, Bexis, breathe—is that the Zofran court reviewed and considered these decisions before addressing the merits.

The Oklahoma plaintiff’s claim was easy, given the court’s evaluation of Oklahoma law less than a year ago. “While it is true that the minority view has gained ground in the last year with the California and Massachusetts opinions, that is not sufficient under the circumstances to tip the balance.”  2018 WL 2317525, *4.

The court had not previously considered Connecticut law and the Connecticut state courts had not previously considered the issue. The Sixth Circuit had, though.  Connecticut was one of the 22 states at issue in In re Darvocet, which we lauded here before giving it the top spot in our 2014 list.  The Darvocet analysis was that the Connecticut Product Liability Act provided the sole remedy for misrepresentation claims asserted and it required the product at issue to be the defendant’s to impose liability.  While not binding, “In re Darvocet is a 2014 decision by a federal appellate court that addresses the issue in comprehensive terms, and there appears to be no Connecticut authority suggesting a contrary result.” Id. at *5.

Predictably, In re Darvocet (in the district court) had addressed New Jersey law and New Jersey lower courts have addressed the issue a few times, even if the New Jersey Supreme Court has not.  They all came out against innovator liability, with pre-Conte cases followed post-Conte.  (See here and the New Jersey part of this.)  The New Jersey PLA also limits liability to the manufacturer or seller of the product that allegedly hurt the plaintiff and misrepresentation claims like the plaintiffs assert against the branded manufacturer are subsumed by the NJPLA. Id. Thus, there is no innovator liability under New Jersey law.

Despite our retrospective here, we do not see this decision making this year’s top ten list. However, the First Circuit could certainly take high honors by affirming this or the prior Zofran MDL decision.  Just saying.

Once again we find ourselves in the position of creating new defenses to a novel, plaintiff-side cause of action.  This time, we’ve been doing a lot of thinking about innovator liability – the theory that would hold branded manufacturers liable for injuries allegedly caused by the ingestion of (preemption-immune) generic drugs on some kind of attenuated inadequate warning theory – since even before the California Supreme Court’s T.H. v. Novartis, Inc., 407 P.3d 18 (Cal. 2017), decision late last year.  If your company or your clients are concerned about being a target of such theories, here are some ideas we’ve come up with that might help.

Direct Preemption

In T.H., the “major, and ultimately most important, consideration under California law is the foreseeability of physical harm.”  407 P.3d at 29 (citations and quotation marks omitted).  What did T.H. have to say about “foreseeability” in deciding to create a new negligence duty on non-manufacturing branded manufacturers?  The manner in which T.H. construed “foreseeability” was much different than in the normal negligence case:

[A branded drug manufacturer] could reasonably have foreseen that deficiencies in its [product’s] label could mislead physicians about the safety of [the drug’s] generic bioequivalent, which was legally required to bear an identical label.

A brand-name pharmaceutical manufacturer has a duty under federal law to draft, update, and maintain the warning label so that it provides adequate warning of the drug’s potentially dangerous effects. . . .  [T]his category of manufacturers may use the “changes being effected” . . . regulation to “add or strengthen a contraindication, warning, precaution, or adverse reaction” immediately upon filing a supplemental application, without waiting for FDA approval.

The duty for a manufacturer of generic drugs, on the other hand, is to ensure that its warning label is identical to the label of the brand-name drug. . . .

What a brand-name manufacturer thus knows to a legal certainty is that any deficiencies in the label for its drug will be perpetuated in the label for its generic bioequivalent.

Id. (numerous regulatory citations omitted) (emphasis added).

T.H. thus grounded its duty (to be distinguished from breach) analysis, not on the likelihood that the defendant would have violated some common-law obligation, which is the usual way foreseeability is analyzed – but on the likelihood that the defendant would be compliant with its federal obligations under the FDCA.  Indeed, T.H. suggests that, but for this federal overlay, it would not have recognized a new duty at all.  Id. at 31 n.2 (were there “parity between NDA [branded] holders and ANDA [generic] holders with respect to submission of . . . safety-related labeling changes based on newly acquired information,” that could “justify reweighing of the [duty] factors and some reconsideration of the brand-name manufacturer’s duty in this category of cases”).

There is a second element to T.H.’s foreseeability analysis, and that also involves compliance (as opposed to violation) with legal obligations:

A brand-name manufacturer will also be aware that although the warnings communicated in its drug label are designed for physicians . . . it is often the pharmacist who actually decides whether the patient receives the brand-name drug or its generic bioequivalent.  Moreover, many insurance companies require the substitution of a generic drug for the brand-name drug as a matter of course. . . .  Accordingly, it is entirely foreseeable that the warnings included (or not included) on the brand-name drug label would influence the dispensing of the generic drug, either because the generic is substituted by the pharmacist or the insurance company after the physician has prescribed the brand-name drug, or because the warning label on the generic drug is legally required to be identical to the label on the brand-name drug.

Id. at 29-30.

The same unusual reliance on compliance with – rather than violation of – federal and other legal requirements governing the marketing of prescription drugs occurred in Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018):

[I]n the vast majority of such cases, the duty to warn would be limited to the manufacturer of the product − even if the plaintiff were to bring a general negligence claim − because the risk of harm arising from an inadequate warning would be foreseeable to a manufacturer only with respect to users of its own product, not the users of another product. . . .  Moreover, apart from any duty arising from the risk of foreseeable injury, only in rare cases could a plaintiff contend that his or her injury was caused by the inadequate warning given for another product.

But this case presents an exception to the usual pattern. Because the Hatch–Waxman amendments to the act require that the warning label of a generic drug be identical to the warning label of its brand-name counterpart . . . duty to warn claims involving generic drugs are potentially viable as general negligence claims, although not as products liability claims.  With generic drugs, it is not merely foreseeable but certain that the warning label provided by the brand-name manufacturer will be identical to the warning label provided by the generic manufacturer, and moreover that it will be relied on, not only by users of its own product, but also by users of the generic product.

92 N.E.3d at 1214-15 (once again omitting a passel of regulatory citations) (emphasis original).  And again the branded defendant’s compliance with the FDCA was the basis for this unique extension of duty to a non-manufacturer:

Federal labeling requirements for generic drugs present precisely the kind of “special circumstance” where a consumer would rely on the warnings created by someone other than the manufacturer of the product causing the injury. . . .  Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product.  Consequently, this is the rare (perhaps the only) type of case involving a manufactured product where the requirements of general negligence may be satisfied even where the requirements of products liability are not.

Id. at 1215 (emphasis added).

Plainly, innovator liability amounts to the imposition of a singular and burdensome form of non-manufacturing negligence liability predicated on the branded defendant’s compliance with its obligations under the FDCA – specifically the Hatch-Waxman requirement that it allow generic manufacturers to copy its labeling word-for-word.

Basing liability expressly on a branded manufacturer’s compliance with federal law should give rise to impossibility preemption.  This observation goes back to the oldest FDCA preemption case on the books, McDermott v. Wisconsin, 228 U.S. 115 (1913), where a state’s attempt to prohibit a product because its label complied with the FDCA, rather than with state law, was held preempted.  Even in 1913, it was “well settled that the state may not, under the guise of exercising its police power or otherwise, . . . enact legislation in conflict with the statutes of Congress passed for the regulation of the subject, and if it does, to the extent that the state law interferes with or frustrates the operation of the acts of Congress, its provisions must yield to the superior Federal power given to Congress by the Constitution.” Id. at 131-32 (citations omitted) (emphasis added).

The modern way of expressing the proposition recognized in McDermott is that “state and federal law conflict where it is ‘impossible for a private party to comply with both state and federal requirements.’” PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011) (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)).  “Even in the absence of an express pre-emption provision, the Court has found state law to be impliedly pre-empted where it is ‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (quoting English v. General Electric Co., 496 U.S. 72, 79 (1990)).

That’s, frankly, pretty blatant here, since (as just demonstrated) compliance with federal law is the sine qua non of extending a warning-related duty to the non-manufacturing, branded-drug defendant in both T.H. and Rafferty.  Since innovator liability is explicitly based on the fact of the branded manufacturer’s compliance with what Hatch-Waxman requires, it cannot avoid being preempted, because the entire theory flows from the premise that meeting FDCA requirements about allowing generic use of its labels equals foreseeability, indeed “certainty.”

There are undoubtedly numerous other precedents expressing the same concept, but even the most anti-preemption courts recognize that tort law cannot penalize compliance with federal law.  Take the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), one of the most virulently anti-preemption decisions we can think of.  Bausch was adamant that preemption (express, in that case) precludes “claims that the [product] at issue ‘violated state tort law notwithstanding compliance with the relevant federal requirements.”  Id. at 552 (quoting Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008)) (emphasis original in Bausch).  Innovator liability, which equates “foreseeability” with the branded defendant’s “compliance with the relevant federal requirements,” is worse than even the claims Bausch recognized would be preempted, because state-law innovator liability exists because of, not merely “notwithstanding,” a defendant’s FDCA compliance.

Lack of Personal Jurisdiction

Next, we invite you to consider personal jurisdiction in innovator liability cases in light of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”).  In a prescription drug product liability case, BMS held that there was no specific jurisdiction over a plaintiff’s claim just because the same defendant allegedly sold the same drug to other, in-state residents, causing similar injuries:

The mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug] in California − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.  As we have explained, “a defendant’s relationship with a . . . third party, standing alone, is an insufficient basis for jurisdiction.”

BMS, 137 S. Ct. at 1781 (quoting Walden v. Fiore, 134 S.Ct. 1115, 1123 (2014)).  Rather, “case-linked” personal jurisdiction requires case-linked conduct by the defendant within the jurisdiction.  “Nor is it sufficient − or even relevant − that [the defendant] conducted [activities] in California on matters unrelated to [its product].  What is needed − and what is missing here − is a connection between the forum and the specific claims at issue.”  Id.  It was dispositive in BMS that “all the conduct giving rise to the [plaintiffs’] claims occurred elsewhere.”  Id.

Now, consider the conduct alleged to give rise to innovator liability.  It is not the sale of any product, let alone sale of the product that allegedly injured the plaintiff in the jurisdiction where the plaintiff brings suit.  Rather:

Plaintiffs further allege that [the branded defendant] knew or should have known that [the drug] was of questionable efficacy . . ., that [the drug] carried serious risks of side effects for [persons such as plaintiff], and that federal law required [defendant] to report this information to the FDA and to update the warning label − something [it] could have done unilaterally.  Instead, [the branded defendant] falsely represented that [the drug] was safe and effective and would not cause serious side effects in newborns, and it intended for pregnant mothers and their physicians to rely on these representations.

T.H., 407 P.3d at 26.  See Rafferty, 92 N.E.3d at 1212 (similar allegations that the branded defendant “not changed its label” to include a relevant risk that it was warning about overseas).

Under BMS, where does the “case-linked” conduct of branded defendant take place in an innovator liability case?  That conduct does not include sale of a product.  The defendant did not sell the allegedly injurious product, but only a different bioequivalent product with the same risks.  Sale of a different product to different people, even if those other people are in-state residents, can’t support specific, “case linked” personal jurisdiction.  That’s what BMS was all about, only BMS involved the same product, not a bioequivalent generic.  Further, since a branded defendant did not sell the injurious product, there’s not even an arguable basis for “stream of commerce” jurisdiction in innovator liability cases.

Rather, the alleged failure to warn, the alleged knowledge of undisclosed risks, and the alleged failure to bring this information to the attention of the FDA (or to consumers) occurred, if at all, at the principal place of business of the defendant.  Unless the branded defendant in an innovator liability case has the misfortune of being “at home” in the state permitting that theory, there is no basis for “case linked” personal jurisdiction under BMS, because no case-linked conduct occurred that also constituted the necessary “purposeful availment” of the jurisdiction where the plaintiff was allegedly injured by ingesting a generic drug resided.  Further, Daimler AG v. Bauman, 571 U.S. 117 (2014), teaches that there can be no general personal jurisdiction under the same facts, unless the branded defendant was either incorporated or had its principal place of business in the state where suit is brought.

No case-linked jurisdiction due to lack of case-related in-state conduct, combined with the defendant not being “at home” for general jurisdiction purposes, means that there can’t be personal jurisdiction over a branded defendant sued for no reason other than the plaintiff being injured in a state recognizing innovator liability.  Branded defendants should raise personal jurisdiction as a defense – remember, personal jurisdiction is waivable.

This jurisdictional insight is the reason we invited the guest post a few weeks ago by Blank Rome’s Terry Henry.  He was the first person (other than Bexis) whom we saw articulate this argument – and he got around to writing about it before we did.

The second act of the personal jurisdiction defense to innovator liability occurs when the plaintiff is forced to bring suit in the state where the defendant is “at home.”  That sets up choice of law as another hoop for plaintiff to jump through. Historically, almost all states have limited product liability (even under fraud-based theories) to the manufacturer of the product that allegedly produced the plaintiff’s harm.  Fewer, but still quite a few, states have product liability statutes that expressly impose this requirement (sometimes referred to as “product identification”).  Think back to how plaintiffs, during the brief period that West Virginia rejected the learned intermediary rule, attempted (with some success) to claim that West Virginia “public policy” overrode any other choice of law principles and precluded reliance on the differing law of a plaintiff’s home state?   We described that situation here.  Well, that same “public policy” exception to choice of law analysis, see Restatement (Second) of Conflict of Laws §187(2)(b) (1971) (discussing this aspect of the law), can be utilized by branded defendants to argue that allowing innovator liability would offend the law of the defendant’s “home” state, thus rendering the theory entirely unavailable.  If there’s a statutory basis for this home state public policy, then so much the better, but even states without such statutes (Pennsylvania is one of those) probably have long-established precedent saying something like this:

The underlying purpose of [strict liability] is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves. . . .  [T]he burden of injuries caused by defects in such products should fall upon those who make and market the products and the consuming public is entitled to the maximum of protection.

Miller v. Preitz, 221 A.2d 320, 334-35 (Pa. 1966).  That’s a pretty solid iteration of state “public policy” that product liability is intended to be borne by manufacturers of injurious products.

So consider raising personal jurisdiction as an issue against plaintiffs making innovator liability claims. There’s more than one way to skin a cat.

Setting up a Prophylactic Preemption Defense

The potential scope of innovator liability is so massive that it may require branded companies to reconsider how they carry out certain aspects of their business.  We’re sure most such companies review their warnings in strict compliance with FDA requirements and guidance concerning analysis of signals from medical literature and adverse events, with full recognition that, first, overwarning is a bad thing and, second, voluntarily reported adverse events, by themselves aren’t proof of causation.

If innovator liability catches on, then potential defendants might want to consider changing those time-honored practices at two critical moments:  (1) when entry of generic products into the market is imminent, and (2) when a decision is made to sell the new drug application of a drug having generic counterparts.  When #1 happens, the commercial considerations that reinforce strict compliance with FDA warning standards weaken, because a significant loss of market share is inevitable.  When #2 happens, the potential defendant is about to lose any control over drug labeling, since only NDA holders can file NDA supplements.  Number 2 would, of course, be in addition to any indemnification or similar provisions in the contract selling the NDA.

In those situations, companies that fear being targeted by innovator liability might want to pull every possible “signal” or statistical anomaly they can find in their data and submit these purported “risks” to the FDA for its independent evaluation − even if, objectively, the company does not believe that the data otherwise justify a “changes being effected” labeling change of the sort mentioned in T.H. or Rafferty.  Let the FDA be the one to say “no.”  If the FDA doesn’t like this, let the agency take regulatory steps to prohibit innovator liability.


The FDA saying “no” – that the scientific data at the time the supplement was submitted was insufficient to justify a warning change – sets up a “clear evidence” preemption defense.  In Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017), which we discussed here, the court held:

We conclude that the rejection of a [submission to the FDA] may constitute clear evidence that the FDA would have rejected a manufacturer-initiated change to a drug label. Our case provides a perfect example. . . .  Under the standard that would have applied to a change proposed by [the manufacturer], the FDA concluded that warnings were unjustified for risks [at issue in this case].  That conclusion controls here, and the FDA’s denial constitutes clear evidence that the FDA would not have approved the [plaintiffs’] desired warning.

Id. at 1105.  Indeed, the big preemption fight in Cerveny wasn’t even about whether an FDA rejection was preemptive “clear evidence,” but rather focused on whether an FDA citizen’s petition filed by a non-NDA holder should be given the same effect as an FDA rejection of a manufacturer’s NDA supplement.  The scientific standards for both are the same, and Cerveny said that’s enough for preemption.  Id.

Some states disagree, and only give preemptive effect to FDA rejection of manufacturer-filed submissions.  Notably, Massachusetts is in this category.  See Reckis v. Johnson & Johnson, 28 N.E.3d 445, 459-60 (Mass. 2015) (holding that FDA decision rejecting additional warning language proposed by defendant would preempt claims, but not FDA rejection of a third-party citizen’s petition).  California trial court decisions provide a solid basis for a Cerveny-like preemption argument.  See In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108, 1122-23 (S.D. Cal. 2015), rev’d on other grounds, ___ F. Appx. ___, 2017 WL 6030735 (9th Cir. Dec. 6, 2017) (as to Buckman preemption); Risperdal & Invega Product Liability Cases, 2017 WL 4100102, at *10-11 (Cal. Super. March 16, 2017), reconsideration denied, 2017 WL 4479317 (Cal. Super. July 24, 2017); In re Byetta Cases, 2015 WL 7184655, at *13-14 (Cal. Super. Nov. 13, 2015).  Since the strategy we’re recommending that branded manufacturers consider involves manufacturer-submitted supplements, the distinction drawn in Reckis would be irrelevant.

Thus, if a branded company is staring down the barrel of extensive innovator liability for injuries caused by products it did not make, and thus received no profit from manufacturing, it may be time to reconsider, at certain critical periods, whether to err on side of extreme caution concerning possible emergent risks, and let the FDA decide.  If the FDA says no warning is justified at those times, then the company can assert a “clear evidence” preemption defense against future plaintiffs (innovator liability or otherwise) claiming the opposite.

*          *          *          *

To our in-house readers:

Do these arguments interest you?  Well, Bexis has put together a detailed presentation on these – and several other − ideas for combatting/ameliorating innovator liability.  The dog and pony show takes about an hour, and if you’d like Bexis to pay you a visit and discuss innovator liability with your in-house legal team (invite your outside counsel, too, if you’d like) send an email and we’ll try to set something up.

This guest post, by long-time friend of the blog, Terry Henry of Blank Rome, is a little different than most.  It was invited.  We read an article Terry wrote, which, at the end (it was mostly about other stuff), advised “[a] brand manufacturer defending itself [against innovator liability] should consider, at the appropriate time, a motion to dismiss any potential claims related to innovator liability on lack of jurisdiction.”  It just so happens that we (well, Bexis) had been thinking about precisely that – the “suit-related conduct” in innovator liability cases does not take place in the plaintiff’s forum state (MA or CA) because the branded defendant didn’t sell the injurious product, so unless that defendant is unfortunate enough to be “at home” in those states, there shouldn’t be case-specific personal jurisdiction either.  Without a product sale there’s not even a stream of commerce argument.  Wishing to encourage innovative thinking by defense counsel, we reached out to Terry and invited him to write a full blogpost devoted solely to personal jurisdiction in innovator liability cases.  Here it is.  As always our guest posters deserve 100% of the credit, and any blame, for their posts.


Friday evening this writer and his son were to catch a flight from Philadelphia to Denver so that the boy could attend his scheduled tour of University of Colorado, Boulder.  As the time to board our 6:00 pm flight approached, the gate agent announced a delay. The aircraft coming in from Boston had a mechanical problem and our flight was now pushed back to 10:45!  We quickly investigated other options, but the two remaining flights were booked solid.  The situation looked bleak.  Experience told me that our flight was probably going to cancel and that our weekend in Boulder would not happen.  But how can you look your hopeful teenager in the eyes and dash his expectations?  So we decided to be optimistic and set up camp for the long wait.  When my Flight Aware app updated to let us know our incoming aircraft had finally taken off from Boston, we could see a ray of hope.  And so too, should branded drug manufacturers facing innovator liability claims.

Readers of this blog are familiar with the bleak prospects for branded manufacturers facing innovator liability claims in California; that distorted theory that holds a branded manufacturer liable for an allegedly inadequate label on the generic version of the branded manufacturer’s drug.  Innovator liability has hit the headlines again because the Massachusetts Supreme Court recently adopted it in Rafferty v. Merck . Innovator liability also snuck past the district court and is pending before the Seventh Circuit in Dolin v. GSK.  What seemed like an aberration when Conte v. Wyeth first gave life to the theory in 2008 may be gaining ground with courts looking to provide a remedy to plaintiffs that took the generic form of a drug. The blog warned us this could happen.

So where can a brand drug manufacturer find a little ray of hope in what appears to be expanding exposure from innovator liability?  Two words – specific jurisdiction.  In addition to the usual substantive arguments for why innovator liability is not a valid claim, a brand manufacturer should also assert lack of jurisdiction.

If the brand manufacturer defendant is not “at home” in the jurisdiction where the case is pending, the court cannot exercise general jurisdiction over the brand manufacturer.  “At-home” status is determined by where the manufacturer is incorporated or where it has its principal place of business.  Daimler AG v. Bauman, 134 S. Ct. 746 (2014). State of incorporation is usually a pretty straight forward determination, but principal place of business can be a bit murky.  The reality of today’s business organizations mean that companies may have operations in many states and employ senior officers in a variety of locations. Hertz Corp. v. Friend, 599 U.S. 77 (2010), explains how to determine a corporation’s nerve center, which is how Hertz defines principal place of business.  If a branded manufacturer is facing potential innovator liability, it should establish early, by affidavit or declaration, the facts showing that the defendant is not at-home in any innovator liability state. This will limit the Court’s jurisdiction over the brand manufacturer to specific jurisdiction.

Specific jurisdiction depends on an affiliation between the forum and the underlying controversy.  Goodyear Dunlop Tires Operations, S.A. v. Brown, 131 S. Ct. 2846, 2851 (2011).  A defendant’s suit-related conduct must create a substantial connection with the forum State.  Walden v. Fiore, 134 S. Ct. 1115, 1121 (2014).  For a court to exercise specific jurisdiction over a branded manufacturer, there must be a relationship between the branded manufacturer, the forum, and the litigation, and it must be the branded manufacturer, not the plaintiff or generic manufacturer, who creates the suit-related contact with the forum state.  Id. at 1126.   See also Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County, 137 S. Ct. 1773, 1783 (2017).  That the brand manufacturer may generally sell its branded version of the drug in the forum state is irrelevant for purposes of specific jurisdiction, because there is no connection between general in-state sales and some other manufacturer’s competing generic version of the drug taken by plaintiff.  See generally Bristol-Myers Squibb Co., 137 S. Ct. at 1773.  Similarly, the fact that a plaintiff may have been injured in the forum is irrelevant because there must be a connection between the injury and the branded manufacturer’s in-state conduct.  Walden, 134 S. Ct. at 1121.

In the context of innovator liability, the brand manufacturer’s case-linked conduct will be its internal decision making with respect to its drug label and its communications with FDA about the label.  That conduct likely took place at the manufacturer’s headquarters or in its dealings with FDA, not in the forum state.  Under BMS, a court cannot exercise specific jurisdiction over that out-of-state conduct.  Plaintiffs argue. and courts have speculated, that a brand manufacturer should have known that generic manufacturers were required to adopt its label, and should have foreseen that the information in their branded label would be communicated to plaintiffs by way of the generic drug being sold in-state.  If at all, that knowledge exists at corporate headquarters.  Using foreseeability to analyze minimum contacts impermissibly allows plaintiff’s contacts (or the generic manufacturer’s contacts) to drive the jurisdictional analysis.  Walden 134 S. Ct. at 1125.  Foreseeability attributes another person’s forum connections to the branded manufacturer “and makes those connections ‘decisive’ in the jurisdictional analysis,” obscuring the reality that none of the branded manufacturer’s challenged conduct (related to the label) took place in the forum state.  Id.

This jurisdictional analysis addresses innovator liability claims filed in a state where the branded manufacturer is not at-home, but not claims filed in the branded manufacturer’s home state.  In such a situation, the court would be able to exercise general jurisdiction over the branded manufacturer, but would have to undertake a choice of law analysis – including application of “public policy,” see Restatement (Second) of Conflict of Laws §187(2)(b) − to determine if the plaintiff would get the benefit of innovator liability imported from his or her home state (presumably Massachusetts or California).  That is a discussion for another blog.

The end of our story is all good. Our flight finally pushed back at 11:00 pm and we were pretty exhausted arriving in Boulder at 3:00 am (5:00 am east coast time).  But when the sun crested over Folsom Field just a few hours later, with the majestic cloud capped Rockies towering over campus, we were glad that we remained optimistic.  And so, as we fly back east with the sun setting behind us, it is good to know that the requirements of due process can provide that light of hope for branded manufacturers by precluding courts from exercising jurisdiction over allegations of innovator liability.

We recently read a news story about a man who was imprisoned for 39 years for a crime he did not commit. The crime was grisly and resulted in the violent deaths of a 24-year-old woman and a small child, leaving a community outraged and law enforcement officials determined to hold someone responsible.  So, burdens of proof be damned, the defendant was convicted despite the fact that relevant DNA recovered from the victims was not his.  Eventually, a crusading retired policeman succeeded in winning exoneration and freedom for the prisoner.   Now, we went to law school.  We know all about the differences between criminal law and civil law.  And we know we should be circumspect about fragile visceral analogies when we are well aware of the relevant distinctions.  Nevertheless, when we read a bad “innovator liability” decision – a decision holding an innovator drug manufacturer liable for injuries caused by a generic version of the drug – a drug manufactured by someone else – there is a simplistic part of us that fails to see how this is so different from imprisoning someone for a crime he did not commit

Today’s case, Garner v. Johnson & Johnson, et al., 2017 WL 6945335 (C.D. Ill. Sept. 06, 2017) (just surfacing though several months old), is just such a bad decision.  In Garner, the plaintiff alleged that a generic fluoroquinolone antibiotic caused her to suffer serious injuries.  She sued the generic drug manufacturer that actually made her drug along with the innovator drug company that manufactured the name-brand version of the drug.  The defendants moved to dismiss for failure to state a claim.

The court first considered the plaintiff’s claims against the generic drug manufacturer, and correctly concluded that, under Mensing, the claims, all rooted in alleged inadequacies of the generic drug’s warning label, were preempted.  But the court wanted to hold someone responsible.  So, noting that the Seventh Circuit had not yet addressed innovator liability, it undertook to circumvent Illinois law.

As we discussed in our “Innovator Liability at 100” post, Illinois has long required product identification for all product liability matters, as evinced by the Illinois Supreme Court’s rejection of industry-wide liability under both market share liability and public nuisance rubrics. See Young v. Bryco Arms, 821 N.E.2d 1078, 1087-91 (2004) (public nuisance); Smith v. Eli Lilly & Co., 560 N.E.2d 324, 337-39, 344-45 (Ill. 1990) (market share liability); City of Chicago v. American Cyanamid Co., 823 N.E.2d 126, 134-35 (Ill. App. 2005) (market share liability in public nuisance); Lewis v. Lead Industries Ass’n. Inc., 793 N.E.2d 869, 874-76 (2003) (same) (all four cases finding no causation as a matter of law without product identification). See also Leng v. Celotex Corp., 554 N.E.2d 468, 470-471 (Ill. App. 1990) (rejecting market share liability pre-Smith in asbestos case); York v. Lunkes, 545 N.E.2d 478, 480 (Ill. App. 1989) (rejecting market share liability pre-Smith in battery case); Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351, 353 (N.D. Ill. 1988) (rejecting market share liability pre-Smith in blood products case); Coerper v. Dayton-Walther, 1986 WL 4111, at *1 (N.D. Ill. March 27, 1986) (rejecting market share liability pre-Smith in tire rim case).

Moreover, Illinois does not recognize a duty to warn about the risks of a competing product:

[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies.  This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.

Pluto v. Searle Laboratories, 690 N.E.2d 619, 621 (Ill. App. 1997).  Recently, an Illinois appellate court recognized in dictum that an “overwhelming majority of courts have held that generic consumers may not sue the brand-name manufacturer.” Guvenoz v. Target Corp., 30 N.E.3d 404, 409 n.1 (Ill. App. 2015). See id. at 416 (plaintiffs “cannot obtain relief from brand-name drug manufacturers whose products they did not ingest”).

But the Garner court disregarded all of this. The court acknowledged that, to state a claim for negligence, the plaintiff was required to establish that the defendants owed her a duty of care, and that the existence of such a duty turned on the reasonable foreseeability of the injury.  But it  held, “In the well-regulated pharmaceutical industry, . . . a brand-name manufacturer . . . is surely not blindsided to find out that the equivalent of its . . . [label] as imposed on generic versions of [its drug],” and that doctors and patients would rely on that label when prescribing and using the generic drug.   Garner, 2017 WL 6945335 at *7.  Further, the court held, it was “a common practice, and therefore foreseeable, for a doctor to prescribe a name brand drug and the pharmacy to fill it with the generic version.” Id. And so, though “other courts have expressed trepidation about the consequences of holding brand-name manufacturers liable for injury caused by generics,” id. (citations omitted), the court concluded that finding that the brand-name manufacturer had a duty of care to a plaintiff taking someone else’s drug “simply allows [the plaintiff] to attempt to recover from the one entity, under federal law, that has the unilateral ability to strengthen the label.” Id.  Even though that entity did not manufacture the product that allegedly injured her.

The court next addressed the issue of causation, acknowledging that “liability for negligence may not be imposed based merely on a breach of duty, without causation being established. Id. (citation omitted).  The plaintiff alleged that she would not have taken the generic drug if its label contained adequate warnings.  (Although the generic drug was a prescription drug, the court failed to analyze warnings causation from the perspective of the prescribing physician.) And the court held that “an extra link in the causal chain (here, the transfer of the identical label from the branded drug to the generic drug) does not break it.  It is possible for a plaintiff to show that injuries caused by mislabeling on a generic medication can be directly traced back to the brand name manufacturer’s creation of the label.” Id. (citations omitted).  As such, the court found that the plaintiff had “adequately alleged causation,” id., and, in derogation of its Erie duty to apply Illinois law, denied the innovator company’s motion to dismiss the plaintiff’s negligence claims.  Similar analysis allowed the plaintiff’s related claims to proceed.

We get the issue. We understand that the United States Supreme Court has limited the remedies of plaintiffs injured by generic drugs, even assuming they can prove a product defect, an injury, and causation in between.  But “someone’s gotta pay” cannot justify a decision that starts from a desired result and works backward, hurdling any doctrine or jurisprudence that gets in the way.  We defend innovator drug companies for a living, and we will continue to speak out against decisions like Garner. And we’ll keep you posted on what comes next.

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week.  One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like surprises, and it is helpful to them to know information about potential litigation possibilities (read:  threats), even if they are not current targets.

So that’s what we’re doing here today – about a topic that wasn’t even the topic of a separate presentation at this year’s ACI Conference. That threat is innovator liability.  For those of you not familiar with litigation jargon, this is the term that litigators, particularly those on our side of the “v.,” use for plaintiff-side litigation theories seeking to hold manufacturers of branded drug products liable for injuries caused by competing generic products that our clients didn’t make.

Yes, innovator liability is an inherently absurd theory that contravenes the most foundational principle of strict liability – that the manufacturer of a defective product should be responsible for injuries caused by that product.  That’s why innovator liability is usually brought on a misrepresentation/fraud theory, rather than under “traditional” product liability theories.  Because branded manufacturers are required by federal law to allow generic products to take (for free) their labels and use them verbatim, innovator liability theories posit that it is “foreseeable” that “fraud” or “misrepresentation” purportedly occurring with respect to branded labels could lead physicians to prescribe generic drugs bearing the same labeling at some unknown future date.  It also lets the actual manufacturer of the allegedly “defective” product that actually caused harm off the hook, even though the manufacturer controls everything else about how the product is manufactured and promoted.

Since 90% or so of the current prescription drug market is generic, innovator liability is a very dangerous – indeed existential – threat to the branded drug industry.  Potentially 10% of the prescription drug market share would be forced to shoulder 100% of possible liability, not only with that additional liability bailing out current business competitors, but also being effectively uninsurable because it does not arise from a defendant’s own products and is potentially unlimited in both amount and time.

Plaintiffs pursue innovator liability currently for one reason only – the deterrent effect of preemption on claims brought against the manufacturers of generic products.  Such preemption is now likely to continue in full effect for the foreseeable future, with the FDA’s regulatory attempt to change the rules to eliminate generic preemption now effectively over, and with the threat of additional appointments of anti-preemption Supreme Court justices very likely minimal as well, for the time being.

Innovator liability was not even a separate topic at this year’s ACI conference.  With good reason.  As detailed in our innovator liability scorecard and in our 50 state survey, the defense side has been winning the overwhelming majority of the decisions that have addressed such theories.

Here’s the big however.

Most of this litigation so far has been decided in federal court, and in federal court, with jurisdiction based on diversity of citizenship, the Erie principle favoring conservative applications of state law over radical changes has worked strongly to the defense’s advantage in federal cases.  No federal circuit court has ever recognized innovator liability, and given the state of Illinois law (see our 50 state survey), we don’t see the Seventh Circuit becoming the first.

No, the problem is with state courts of last resort, which are not constrained by Erie.  So far there have been two high court decisions on innovator liability – and our side’s success rate there is only 50%.  We lost in Wyeth, Inc. v. Weeks, 159 So.3d 649, 656-76 (Ala. 2014).  Weeks was overturned by the legislature almost before the ink was dry, so it looks like a hiccup, but we have to wonder, if it could happen in Alabama, could it happen anywhere?  The answer was “no” in Iowa, the only other high court decision so far. See Huck v. Wyeth, Inc., 850 N.W.2d 353, 369-81 (Iowa 2014).  Huck, however, was actually a 4-4 split decision that operated as an affirmance only because the defendant had won below, and the Huck justices who saw things our way did so in part (how much a part is unclear) because of the pendency of the FDA’s now-dead rule on generic labeling.  Id. at 380-81 (“the FDA’s proposed rule . . . would abrogate the Mensing holding, permitting consumers of generic drugs to bring a claim against generic manufacturers”).

Plaintiffs are aware of this.  We’re not giving anything away here.  They have thus been trying to move the innovator liability theater of litigation operations to state-court appeals for years.  And they have finally been able to do so.  Right now, the issue is pending in three high courts:  California, T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768, 774-82 (Cal. App. 2016), review granted & depublished, 371 P.3d 241 (Cal. June 8, 2016) (discussed here); Massachusetts, Rafferty v. Merck & Co., 33 Mass. L. Rptr. 464, 2016 WL 3064255, at *5-7 (Mass. Super. May 23, 2016) (discussed here), appeal granted, No. SJC-12347 (Mass. 2017); and West Virginia, McNair v. Johnson & Johnson, 694 Fed. Appx. 115, 120 (4th Cir. 2017) (discussed here), certified question accepted, No. 17-0519 (W. Va. Sept. 1, 2017).

The California and Massachusetts appeals have been argued, and we wish we had better news to report.  As we discussed, the California argument was mostly about the “perpetual liability” aspects of the case (that the defendant branded company had left the market years before the plaintiff was exposed to a generic product), so there is a distinct possibility that the California Supreme Court will either bypass the basic innovator liability question or worse allow it.  In Massachusetts – another notoriously liberal tort jurisdiction – too many members of the Supreme Judicial Court for our liking were asking questions about under what conditions (such as scienter) innovator liability could be permitted.  The West Virginia Supreme Court of Appeals is not as radically pro-plaintiff as it was back when it rejected the learned intermediary rule, see Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007).  However, one judge remains from the Karl majority, and the situation of generic drug using plaintiffs without anyone they can sue is certainly present.  After all, if it could happen in Alabama, it could happen anywhere.

So what happens if the tide starts to turn in 2018 on innovator liability?  It certainly could, and because of the magnitude of the potential threat, we can’t ignore it.  As stated at ACI, our clients don’t like surprises, particularly surprise threats, so we’re letting you know that from our perspective, the threat is real.  Moreover, particularly in California and Massachusetts, we can’t expect a legislative fix of the sort that came through in Alabama.

And if state high courts start what the other side could argue to be a “trend,” what does that do to the current monolith of federal court decisions?

So what’s Plan B?

Congress appears right well paralyzed on any issue like this.  Aside from cutting their donors’ taxes, we don’t expect much there.

That leaves the FDA.  Could it be persuaded to issue a regulation preempting innovator liability?  There is that 1962 uncodified “direct conflict” preemption clause, and a lot of FDA statements about how its regulatory scheme is not supposed to change the standards of common-law liability.  That is one plausible outcome, but plaintiffs would be active, too, demanding an end to preemption of generic products.  Does a regulatory fix for innovator liability thus degenerate into a three-way fight between branded, generic, and plaintiffs?  That’s a recipe for paralysis, as well.

How does one litigate an innovator liability case?  Unlike a product liability case, the defendant isn’t a manufacturer, so it doesn’t have access to design, manufacturing, warning, and adverse report information about the product that actually caused (allegedly) the plaintiff’s harm.  At minimum that’s a serious discovery problem.  Will the solution be joining generic drug manufacturers as third-party defendants?  That would be a fine finger-pointing mess, and what would the consequences be for preemption?  Even the DDLaw Blog might be forced to take sides, which for eleven years we have been able to avoid doing.  Who knows, depending on where a plaintiff chose to sue, it might be difficult under BMS to obtain personal jurisdiction over the generic manufacturer.  These are just a few of the questions that broader adoption of innovator liability would pose.

We don’t like being the ones to point out the dark clouds on the horizon.  We’d much rather celebrate defense wins – and we hope we do in T.H., Rafferty, and McNair.  But our clients don’t like surprises, and given the size of the threat posed by innovator liability, we’d be remiss not to point out what we know/fear is out there.  After all, innovator liability is not even on the ACI’s own agenda (although it was mentioned) this year.  So a word to the wise.  Don’t be caught napping.  Think about Plan B.

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws that branded drug manufacturers could not be liable for injuries suffered by plaintiffs who never used their products, but only took competing generic drugs.  Twenty-something states in one opinion.  If that had ever happened before, we remain unaware of it.

Well, it recently happened again, albeit on a smaller scale. See In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2017 WL 3448548 (D. Mass. Aug. 4, 2017).  The Zofran MDL is like Darvon in that it involves a relatively old drug, approved back in 1991, for prevention of nausea and vomiting in cancer patients undergoing difficult treatments such as chemotherapy. Id. at *1.  Since Bendectin was driven off the market by bogus birth defect litigation, drug companies have been loathe to pursue anything for treating morning sickness (we know of only one), which leaves off-label use.  Id. at *2.  Thus, Zofran and its generic equivalents are frequently used off-label by women (and their physicians) seeking some kind of relief from pregnancy-related morning sickness.

The Zofran litigation is a consequence of this off-label use – anything used during pregnancy becomes the target of birth defect lawsuits.  Plaintiffs make a rather extreme claim, that defendants should be liable for not researching the risks of off-label uses for which they never sought FDA labeling approval.  Id. at *3 (“The crux of all of the claims is that defendants failed to perform an adequate study of the safety of ingesting Zofran during pregnancy”).

When generic drugs get involved, things get even worse. Plaintiffs using generic drugs are barred by preemption from suing those manufacturers (absent unusual situations like failure to update warnings with FDA-ordered changes), id. at *4, but they still want money, so they try to sue the branded manufacturers – innovator liability, in these cases for off-label uses.  Such claims seek to hold manufacturers liable for the risks of someone else’s product used in a manner for which that product was never labeled.

In Zofran, the court was having none of it.  It ordered all generic plaintiffs – 35 plaintiffs from 19 states − alleging innovator liability to justify those allegations.  Id.  Challenged to put up or shut up, most of the generic plaintiffs dropped out, leaving six plaintiffs suing under the laws of six states, those being Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma. Id.

Examining the laws of those six states, the court in Zofran, like the court in Darvocet, concluded that none of them would take the radical step of holding branded drug manufacturers liable for injuries caused by competing generic drugs.  Such liability ran contrary to “the long-settled principle that a manufacturer of a product cannot be held liable for injuries caused by another company’s product.”  Id. at *4.  Instead, plaintiffs alleged that:

As the holders of the New Drug Application (NDA) for Zofran and the patents for Zofran, [innovator] Defendants knew that any generic drug manufacturer would be required by law to use the same labeling as Zofran’s, and that any inadequacies in the labeling of generic ondansetron could be corrected by Defendants only.

Id. at *5.  Thus, the innovator defendants were being held liable not for what they chose to do, but rather for what was “required by law” – how Congress, in amending the FDCA, had chosen to structure the generic drug market.  While plaintiffs claimed this was not “novel,” id., to paraphrase Yogi Berra, “half the lies they tell about [the law] aren’t true.”

The overwhelming majority of courts—including all seven federal circuits to have addressed the issue—have held that the manufacturer of a brand-name drug may not be held liable for injuries caused by ingestion its generic equivalent, regardless of the theory of liability.

Id. at *6 (citations omitted).  The omitted citations, of just the federal appellate decisions, take up half a page of the opinion.  But don’t fret about that.  Our “Innovator Liability at 100” post, which discusses all these decisions, is closing in on 14,000 words.  The precedent rejecting innovator liability is truly “overwhelming.”

The “minority view,” on the other hand, consists of exactly four cases, one of which was “superseded by statute” “within a year” of being decided.  Id. at *8-9 & n. 6.  As for the relevant states in Zofran:

Georgia:  An intermediate state appellate court, the Sixth Circuit in Darvocet, and a federal district court, have all rejected innovator liability.  See PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Darvocet, 756 F.3d at 943; Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351, 1353-54 (N.D. Ga. 2008). Zofran, 2017 WL 3448548, at *8-9.  On the other side – zilch.  Actually, Georgia precedent rejecting innovator liability is more extensive than what was mentioned in Zofran.  See our “at 100” post for details.

Indiana:  The Sixth Circuit Darvocet case also rejected innovator liability under Indiana law.  756 F.3d at 845. Zofran, 2017 WL 3448548, at *10-11.  Again, there are several more Indiana law cases also rejecting innovator liability that aren’t mentioned in Zofran – but are in our post.

Kentucky:  Not only is Darvocet again on point, but the Sixth Circuit likewise rejected innovator liability in another Kentucky law case.  Darvocet, 756 F.3d at 945-46; Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011).  Zofran, 2017 WL 3448548, at *11.  As our post adds, a couple of Kentucky litigation tourists also got kicked out of court in Missouri on innovator liability grounds.

Massachusetts:  Two Massachusetts trial courts have rejected innovator liability. Rafferty v. Merck & Co., 2016 WL 3064255, at *4-5 (Mass. Super. May 23, 2016); Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).  Zofran, 2017 WL 3448548, at *12-13.  We provide some more on-point Massachusetts precedent in our post, which never has to cite to a non-Westlaw slip opinion, because Bexis gets all the good ones added.

New York:  Darvocet, again, plus federal and state trial court decisions, all rejecting innovator liability under New York law.  Darvocet, 756 F.3d at 949; Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).  Zofran, 2017 WL 3448548, at *13-14.  Actually, there’s another recent federal district court decision that agrees, as our post discusses.

Oklahoma:  Not only Darvocet, but another federal appellate decision both reject innovator liability under Oklahoma law. Darvocet, 756 F.3d at 950-51; Schrock v. Wyeth, Inc., 727 F.3d 1273, 1281-84 (10th Cir. 2013).  Zofran, 2017 WL 3448548, at *14.  Our post adds another state trial court opinion applying Oklahoma law in a similar manner (a toughie, but we found it).

Thus, the Zofran decision concludes, as to the merits of innovator liability, that there aren’t any merits, and that contorting state law to impose liability for liability’s sake, without any basis in precedent or policy, isn’t a good idea:

In summary, none of the state supreme courts in any of the six relevant states have ruled on precisely the issues presented here.  Nonetheless, for each of the jurisdictions, there is case law suggesting, often strongly so, that dismissal is appropriate. . . .

It is true that dismissal would appear to leave consumers injured by generic drugs without any form of remedy.  But it is by no means obvious that the minority viewpoint is correct or fair, or even that it is the outcome that best protects consumers.  Just as it may be unfair to leave some injured consumers without a remedy, so too it may be unfair or unwise to require brand-name manufacturers to bear 100% of the liability, when they may have only 10%, or less, of the relevant market.

Id., 2017 WL 3448548, at *14 (citations omitted).

Finally, Zofran rejects what appears to be the new overall strategy of generic plaintiffs peddling innovator liability theories – try to shift the battle from federal to state courts.  Zofran refused to certify the issue to the high courts of the six states in question.  Id. at *15-17.  New York doesn’t even allow certification (an “oops” for plaintiffs).  Id. at *16.  “Clear and recent” appellate authority in every state but Massachusetts, leaves little doubt what the relevant law is.  Id.  As for Massachusetts (and indeed all the states), the question proposed to be certified “involve[d] alleged misrepresentations, none of which are identified by the plaintiff,” leaving the basis for those claims “unclear.”  Id. at *17.  Certification of such a “hypothetical” question would thus be “inadvisable”:

It is therefore entirely possible that the Court could wind up certifying a purely hypothetical question that has no actual relationship to the evidence.  It would be an enormous waste of judicial resources to certify a fact-bound question to the [state high court], only to find that the facts as ultimately proved are different. . . .  Any answer . . . to the proposed question might therefore prove to be entirely advisory.

Id. (footnote omitted).  Courts faced with innovator-liability-related certification requests in the future are likely to be facing similar situations, given how loosely our opponents throw around misrepresentation allegations.  Kudos to Zofran for not taking the easy way out, and declining to kick the decisional can down the road.

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when the one-hundredth judicial opinion on this topic was decided.  Well, not too long ago the Fourth Circuit, in McNair v. Johnson & Johnson, ___ F. Appx. ___, 2017 WL 2333843 (4th Cir. May 30, 2017), did what no court of appeals had done since the innovator liability first reared its ugly head in 1994 – it certified the question to the relevant state high court – in this case, the West Virginia Supreme Court of Appeals:

Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.

2017 WL 2333843, at *1.

At least a dozen federal court of appeals decisions have rejected innovator liability under the laws of some two dozen states. Ironically, the first to do so was the Fourth Circuit itself, in Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. 1994), under Maryland law.  Plaintiffs did not begin resorting to the delaying tactic of requesting state court certification until relatively late in the game.  Courts of appeals were not accommodating, refusing to certify what they saw as an outlier issue in Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014); Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 387, 406-07 (6th Cir. Dec. 2, 2013). See also In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *3 (E.D. Ky. Aug. 21, 2012), aff’d, 756 F.3d 917 (6th Cir. 2014); Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1351 n.9 (S.D. Ala. 2010) (district courts refusing certification motions).  But plaintiffs got lucky (for a few months) in Wyeth, Inc. v. Weeks, 159 So. 3d 649, 653 (Ala. 2014), with a certified question, and with nothing left to lose they’ve been trying it ever since.

McNair is not only an outlier procedurally, but is troubling substantively.  First, the Fourth Circuit’s certification opinion seems more concerned with preemption rather than state law – addressing preemption before even bothering with state-law causation principles, and finishing that section with the observation, “while a state law failure-to-warn claim against a generic manufacturer is preempted, such claims are not preempted as to the warnings on a brand-name drug distributed by a brand-name manufacturer.”  2017 WL 2333843, at *3 (emphasis original).  Ordinarily, the existence of a recognized state law claim precedes any decision on whether that claim is preempted.  We always find it troubling when a federal court views principles of state law more through the lens of a preemption dodge than on their merits.

Although pointing out (as could hardly be denied) that even in the current preemption environment, “overwhelming” precedent rejects innovator liability, McNair, 2017 WL 2333843, at *4, the certification order makes it appear as if there is no prior West Virginia law on this subject.  That is simply not so.  As we state in our Innovator Liability at 100 post:

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit concluded that West Virginia “has rejected claims attempting to impose liability on brand manufacturers where plaintiffs ingested only generic drugs.”  Id. at 953.  Darvocet relied upon Meade v. Parsley, 2009 WL 3806716 (S.D.W. Va. Nov. 13, 2009).

[Innovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff’s injuries.”  Because neither [innovator defendant] manufactured the product that injured plaintiffs, there is no proximate cause.

Id. at *2-3 (quoting Dunn v. Kanawha County Board of Education, 459 S.E.2d 151, 157 (W. Va. 1995)).

That the Fourth Circuit would decide to omit all of the most directly on-point West Virginia law-based precedent – including a published court of appeals decision − from its certification order is simply inexplicable.  Certainly, ignorance cannot be claimed, as both the Darvocet and Meade decisions were relied upon by the district court in McNair itself.  McNair v. Johnson & Johnson, 2015 WL 3935787, at *6 (S.D.W. Va. June 26, 2015).  We can only hope that the West Virginia high court (docket available here) will not be misled by these omissions.