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:
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:
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 LLC, 901 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).
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.
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.
“[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).
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.
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.
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).
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.
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.