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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

What follows is a rather involved guest post by Reed Smith‘s Kevin Hara.  Actually, Kevin has contributed enough to the Blog over the last couple of years that he’s more of a crypto-blogger than a guest.  Instead of the more common case-specific post, Kevin has put together his own 50-state survey on state statutes of repose.  A lot of states have a variety of different statutes of repose.  Some of these statutes (such as those based on useful life) can be useful in prescription medical product liability litigation, others (like those involving fixtures to real property) – not so much.  Anyway, in this guest post Kevin endeavors to sort things out on a nationwide basis.  As always our guest bloggers deserve 100% of the credit, and any blame, for their work.

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Although this relatively recent Law360 article discussed statutes of repose, this powerful affirmative defense remains underutilized, so this post revisits it and digs a little deeper.  This defense, where applicable, provides a potentially swift conclusion to an action with accompanying cost savings for the client.  Further, defense counsel may move to dismiss at the pleading stage, where the applicability of the defense is apparent from the complaint.  Many courts view statutes of repose as substantive, rather than procedural, unlike statutes of limitation – so the plaintiff cannot escape by becoming a litigation tourist.

The state of Tennessee’s statute of repose serves as a perfect example of a bright line application in a prescription product liability action, regardless of a plaintiff’s knowledge wherein “a delay, even without knowledge of the hazard involved in the delay, may preclude the bringing of an otherwise meritorious claim.”  Montgomery v. Wyeth, 580 F.3d 455, 463, 466 (6th Cir. 2009) (applying Tennessee law).  Tennessee courts have explained this rule succinctly:

A statute of limitations governs the time within which suit may be brought once a cause of action accrued. A statute of repose limits the time within which an action may be brought, but it is entirely unrelated to the accrual of a cause of action and can, in fact, bar a cause of action before it has accrued.

Jones v. Methodist Healthcare, 83 S.W. 3d 739, 744 (Tenn. App. 2001) (emphasis added).

The Texas Supreme Court provided a thoughtful analysis of that state’s clear-cut statute of repose:

Indeed, the key purpose of a repose statute is to eliminate uncertainties under the related statute of limitations and to create a final deadline for filing suit that is not subject to any exceptions, except perhaps those clear exceptions in the statute itself.  In recognizing the absolute nature of a statute of repose, we have explained that while statutes of limitations operate procedurally to bar the enforcement of a right, a statute of repose takes away the right altogether, creating a substantive right to be free of liability after a specified time.  The whole point of layering a statute of repose over the statute of limitations is to fix an outer limit beyond which no action can be maintained.  One practical upside of curbing open-ended exposure is to prevent defendants from answering claims where evidence may prove elusive due to unavailable witnesses (perhaps deceased), faded memories, lost or destroyed records, and institutions that no longer exist.

Methodist Healthcare Sys. of San Antonio v. Rankin, 307 S.W.3d 283, 286-87  (Tex. 2010 ) (internal citations and marks omitted) (emphasis added)

The Tennessee and Texas statutes of repose are elegant in their simplicity:  you are either in, or you’re out.  Period.  No ifs, ands, or buts.  Iowa, Connecticut, and North Carolina are a few of the states with similarly straightforward statutes of repose.  However, perhaps because they are so unyielding – and unlike statutes of limitation, the vast majority of which are subject to the discovery rule – statutes of repose are often more limited in scope, and therefore not uniformly applicable to manufacturers of prescription medical products.

That said, statutes of repose add a significant item to any defense practitioner’s toolbox because they can take a case, and simply “nip it in the bud,” a common expression that is illustrative here.  Indeed, it is a phrase that sometimes gets mixed up, such as with the malapropism “nip it in the butt,” which got us to thinking about something else that often leads to confusion: music.  All too often, people misapprehend the words to a song, and there are a multitude of websites with compilations of some of the more notable – and incidentally, most humorous – misheard song lyrics, including Mentalfloss , Huffington Post, and New Musical Express, but here are some of the best.  Perhaps the most famous example is the Jimi Hendrix classic “Purple Haze,” with famous phrase “Excuse me while I kiss the sky,” interpreted erroneously as: “Excuse me while I kiss this guy.”

Who can forget the San Francisco Bay Area’s own all-time great rock band Creedence Clearwater Revival’s song “Bad Moon Rising,” with part of the chorus, “There’s a bad moon on the rise,” replaced with “There’s a bathroom on the right.”  (In fact, this error became prominent that front man John Fogerty was known to purposefully sing that rendition and gesture to the proverbial restroom.)  Another prime example is the upbeat Johnny Nash song “I Can See Clearly Now,” with the line from the refrain “I can see clearly now, the rain is gone,” somehow thought to be: “I can see clearly now, Lorraine is gone.”  It would be remiss not to mention The Monkees, and their hit “I’m A Believer,” with the eternally ecstatic line, “Then I saw her face, now I’m a believer!” instead substituted with the diametrically opposed – and frankly cruel, but evocative – “Then I saw her face, now I’m gonna leave her!”

Bexis pointed out that one could interpret the chorus of British band ELO’s chart topper “Evil Woman,” “Evil woman,” as “You need a woman.”  He also misunderstood for years (until the advent of lyrics services on the Internet) the line in Steppenwolf’sFrom Here To There Eventually” as “cause benign, rather than “caused by man.”

These faux pas are fitting metaphors for failing to comprehend the importance of statutes of repose.  While it is easy enough to have a chuckle when a friend butchers a line in a favorite song, failing to seize an opportunity to secure a dismissal with prejudice is no laughing matter.  Defense counsel should thoroughly consider and explore all possible options for resolving a case quickly in the name of expediency and client satisfaction.

To assist with those aims, here is a rundown of the applicable statutes of repose for all 50 jurisdictions, including discussions of which states apply the discovery rule, which utilize presumptions rather than complete defenses, and other subtle variations, beginning with those states whose statutes are most likely to apply to prescription product claims.

States With Statutes That Are Applicable To Prescription Product Liability Claims

 Alabama – Alabama applies a unique, common law, 20 year rule of repose which “arose within the context of property disputes,” but according to the Alabama Supreme Court “the rationale underlying the rule is not so limited and, accordingly, the rule has been applied in other contexts, including those alleging tort claims.”  Ex parte Liberty National Life Insurance Co., 825 So. 2d 758, 763-64 (Ala. 2002); see also Owens-Illinois, Inc. v. Wells, 50 So.3d 413, 420 (Ala. 2010) (ruling that “Alabama’s 20-year common-law rule of repose does not begin to run on a claim until all the essential elements of that claim, including an injury, coexist so that the plaintiff could validly file an action”).

Colorado – Col. Rev. Stat. § 13-21-403(3).  Applies a presumption of non-defectiveness more than “[t]en years after a product is first sold.”  See Mile Hi Concrete, Inc. v. Matz, 842 P.2d 198, 205 (Colo. 1992).

Connecticut – Conn. Gen. Stat. § 52-577a.  An action is foreclosed “more than 10 years after the manufacturer relinquished “possession or control of the product,” absent fraud or express warranty.

Florida – Fla. Stat. § 95.031(b).  A products liability action is barred “more than 12 years after delivery of the product,” with exceptions for latent disease or injury, and fraudulent concealment.

Georgia – O.C.G.A. § 51-1-11(b)(2).  Precludes any action “after ten years from the date of the first sale for use or consumption” of a product that causes injury.

Idaho – Idaho Code § 6-1403(b).  Rebuttable presumption that injury “caused more than ten (10) years after time of delivery” occurred after product’s safe life, rebuttable “by clear and convincing evidence.”

Illinois – 735 ILCS 5/13-213(b).  Forbids any “product liability action” on any theory after 12 years from the first sale or 10 years after the purchase by an initial consumer, unless brought within two years of discovery of alleged injuries.   Davis v. Toshiba Mach. Co., 710 N.E. 2d 399, 401 (Ill. 1999) (weakening statute of repose by allowing discovery rule in cases not involving latent injuries).

Indiana – Ind. Code § 34-20-3-1(b).  Action must commence within “10 years after delivery of the product to initial user,” but may be brought within two years after accrual. See, e.g., Land v. Yamaha Motor Corp., 272 F.3d 514, 515-516 (7th Cir.2001) (ruling that where it was “undisputed” that injury and filing suit occurred more than 10 years after product purchase by initial user, statute of repose barred product liability action.) (emphasis added).

Iowa – Iowa Code § 614.1(b). Bars product liability action on any theory 15 years after purchase of a product absent express warranty or concealment. See Albrecht v. GMC, 648 N.W.2d 87, 95 (Iowa 2002) (the “allegations of the petition establish[ed] that the present suit falls with the scope of section 614.1(2A)(a) and was brought more than fifteen years after the product in question was first purchased,” precluding plaintiff’s action); Cf. Merner v. Deere & Co., 176 F. Supp.2d 882, (E.D. Wis. December 18, 2001) (under Wisconsin’s borrowing statute that 15 year Iowa statute of repose barred plaintiff’s claims).

Kansas – Kan. Stat. Ann. § 60-3303(a)(b)(1).  A presumption arises that a product’s “useful safe life,” expires 10 years after delivery, rebuttable by “clear and convincing” evidence; see also Kan. Stat. Ann. § 60-513(b), barring claims more than 10 years old.  The useful safe life statute of repose applies to prescription drugs.  Baughn v. Eli Lilly & Co., 356 F. Supp. 2d 1166, 1172 (D. Kan. 2005).  In Ehrenfelt v. Janssen Pharms., ___ F. Appx. ___, 2018 WL 2945911 (6th Cir. June 11, 2018), a prescription drug product liability case, the Court of Appeals for the Sixth Circuit held “that the exceptions in Kan. Stat. Ann. § 60-3303(b)(2)(D) [for latent injuries] appl[ied] even when the harm was caused less than ten years after delivery.”   Id. at *2.  Therefore, the plaintiff’s claims for alleged injuries from use of a drug was not barred under the general 10 year statute of repose, § 60-513(b).

Kentucky –  K.R.S § 411.310(1).  Presumption that a product was not defective for injury “more than five (5) years after the date of sale . . . or more than eight” years after manufacture, rebuttable by a preponderance of evidence.

Michigan – Mich. Comp. Laws § 600.5805(13).  Technically not a statute of repose, but after a product has “been in use for not less than 10 years,” the plaintiff is not entitled to any presumption improving his case.  But see Hall v. GMC, 582 N.W.2d 866, 867 (Mich. App. 1998) (“claim could be pursued under Michigan law, which has no statute of repose,” and where statute of limitations did not prevent claim).

Minnesota – Minn. Stat. § 604.03.  Provides an affirmative defense for injuries occurring after “the expiration of the ordinary useful life of the product,” which is a jury issue.   Hodder v. Goodyear Tire & Rubber Co., 426 N.W.2d 826, 830 (Minn. 1988) (“We hold, therefore, that … [product’s useful life] is a factor to be weighed by the jury in determining the fault of the manufacturer and the fault of the user.”).

Nebraska – Neb. Rev. Stat. § 25-225.  Bars claims filed more than 10 years after product manufactured in Nebraska, otherwise the statute of repose of the state of manufacture applies, not to exceed 10 years, or 4 years from date of injury if no statute exists, applicable to prescription products.  King v. Pfizer, Inc., 2016 U.S. Dist. Lexis 111456, 17-18 (D. Neb. Aug. 19, 2016) (fraud based claims for injuries allegedly resulting from prescription drug are “grounded in product liability,” such that the substantive right of the statute of repose cannot be removed “by court action,” whereby passage of the 10-year period, following  plaintiff’s first prescription “vested the Defendants with a substantive right under § 25-224(2),” barring the action).

North Carolina – N.C. Gen. Stat. § 1-46.1.  Prohibits product liability claims “more than 12 years after . . . initial purchase for use or consumption.”  See Willoughby v. Johnston Memorial Hosp. Authority, 2016 WL 4091370, at * 13-14, 791 S.E.2d 283 (table) (N.C. App. Aug. 2, 2016) (affirming summary judgment for manufacturer of surgical table, including indemnity claim, notwithstanding that alleged injuries occurred in 2009, and actual loss in 2015); In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2016 WL 4385846, at *3 (M.D. Ga. Aug. 15, 2016) (applying North Carolina law) (plaintiff suffered alleged injuries when she experienced mesh erosion, which foreclosed claims per statute of repose).

Ohio – Ohio Rev. Code § 2305.10(C)(1).  Precludes claims more than 10 years after product delivery to first consumer, but applies discovery rule to prescription drugs, which reduces the provision’s utility.

Oregon – Or. Rev. Stat. § 30.905(2).  An action “must be commenced before the later of 10 years after” product’s purchase, or the expiration of the statute of repose in state of manufacture.  Wrongful death actions must be brought within 3 years after death or 10 years after product purchased, whichever occurs sooner.  O.R.S. § 30.905(3)-(4).  Dortch v. A. H. Robins Co., 650 P.2d 1046, 1052-53 (Or. App. 1982), overruled on other grounds, (IUD manufacturer properly dismissed; statute of repose limited “manufacturer’s liability to ten years and [gave] each plaintiff a full two years to commence an action after the cause of action accrue[d],” and finding that the claim was barred.); Philpott v. A.H. Robins Co., 710 F.2d 1422, 1425 (9th Cir. 1983) (plaintiff’s claims “barred by ORS 30.905,” where “she did not learn of a causal connection between her pelvic disorders and the Dalkon Shield until . . . nine years and eight months after she purchased and began using” the product).

Tennessee – Tenn. Code Ann. § 29-28-103(a).  An action must be brought “within ten (10) years” from purchase, or “one (1) year after the expiration” of product life. See, e.g., Jenkins v. Novartis Pharmaceutical Corp., 2013 WL 1760762, at *3 (E.D. Tenn. Apr. 24, 2013) (implied warranty claim against prescription drug manufacturer was prohibited by statute of repose where motion to amend was filed more than 10 years post injury “by both the six-years-from-injury provision of § 29-28-103(a) and the ten-years-from-purchase provision of § 29-28-103(a)).” Tennessee case law bars any discovery rule or fraudulent concealment exception to the statute. Greene v. Brown & Williamson Tobacco Corp., 72 F. Supp.2d 882, 886 (W.D. Tenn. 1999) ( “[a]n equitable ‘discovery rule’ is not available to toll the statute of repose” and holding that “the Tennessee Supreme Court would decline to create an equitable exception for fraudulent concealment”).

Texas – Tex. Code Ann. § 16.102(b) cuts off actions 15 years “after the date of the sale of the product” with exceptions for latent disease and express warranty, but is not subject to tolling.  See Methodist Healthcare System v. Rankin, 307 S.W.3d 283, 290 (Tex. 2010) (“the essential function of all statutes of repose is to abrogate the discovery rule and similar exceptions to the statute of limitations” and a “statute of repose, by design, creates a right to repose where the applicable statute of limitations would be tolled or deferred”); Salgado v. Great Dane Trailers, 2012 WL 401484, at *2 (S.D. Tex. Feb. 6, 2012) (“[a] statute of repose … does not run from the time a cause of action arises, but from some other date or event selected by the Legislature,” and is “not subject to judicially crafted rules of tolling or deferral”) (internal citations and quotations omitted).

Washington – Wash. Rev. Code Ann. § 7.72.060(1)(b)(i-iii).  Rebuttable presumption that an injury “more than twelve years after . . . delivery,” occurred after expiration of a product’s useful life, with exceptions for express warranty, concealment, and latent injuries.

Wisconsin – Wis. Stat. § 895.047(5-6).  Precludes action for products manufactured “15 years . . . or more” before a claim with exceptions for negligence, latent disease, and express warranty, and asbestos actions).

States With Statutes That Are Not Applicable To Prescription Product Claims

By contrast, the following states have statutes of repose that are inapplicable to prescription product liability actions, generally because they have statutes that pertain only to real property improvements or the statutes contain exclusions for defective products.

Alaska – Alaska Stat. § 09.10.055(2).  Actions must be brought “within 10 years,” of the “last act alleged to have caused the personal injury,” property damage, or death, but expressly excludes defective products.

Arkansas – Ark. C. Ann. § 16-56-112.  Applicable to property actions only; Brown v. Overhead Door Corp., 843 F. Supp. 482, 490 (W.D. Ark. 1994) (ruling that statute of repose was limited to real property improvements, holding that “Arkansas courts when called upon to do so will hold that the manufacturers of mass produced fungible goods do not fall within the protection of the statute, particularly when the defendant manufacturer is not involved in the installation of the product and had nothing to do with the design of the improvement within which it is installed”).

California – Cal. Civ. Proc. Code § 337.15 (10 years for latent deficiencies).  See McCann v. Foster Wheeler LLC, 225 P.3d 516, 529 (Cal. 2010) (finding that California’s statute of repose was applicable to latent deficiencies in real property improvement, “not to personal injury actions.”).

Delaware – 10 Del. C. § 8127.  Applicable only to claims pertaining to real property improvements, within six years of substantial completion.

District of Columbia – D.C. Code § 12-310.  Real property claims only, within 10 years of substantial completion of project.

Hawaii – Haw. Rev. Stat. § 657-8.  Available only for claims within 10 years of substantial completion of improvement to real property, and two years after accrual.

Maine – 14 M.R.S.A. § 752-A.  Statute applicable only to real property, within 10 years of the project or services rendered, but no more than 4 years after discovery.

Maryland – Md. Code Ann. § 5-108.  Does not apply to product liability, but for property improvements within 20 years and 10 years against architect or engineer.

Massachusetts – Mass. Ann. Laws Ch. 260 § 2B.  Allows claims within 6 years of substantial completion of improvement, and owner taking possession.

Mississippi – M.C.A. § 15-1-41.  Claims must be brought within 6 years of acceptance or actual occupancy for real property improvement.

Missouri – Mo. Rev. Stat. § 516.097.  Applicable to real property improvement claims within 10 years of substantial completion.

Montana – Mont. Stat. § 27-2-208.  Statute allows claims within 10 years of improvement, including to damage caused by a defective product related to the improvement.

Nevada – N.R.S. § AB 125, § 2.  Applies to real property improvements, six-year statute of repose.

New Jersey – N.J.S.A. § 2A: 14-1.1.  Real property improvements only, within 10 years of substantial completion.

New Mexico – N.M.S.A. § 37-1-27.  Repose only for improvements to real property, 10 years of substantial completion.

New York – While New York has no true statute of repose, courts require notice of an action to any party responsible for professional performance, such as architects and engineers, after 10 years have elapsed.  Six year statute of limitations for construction defects, N.Y. C.P.L.R. § 214-d.

Oklahoma – 12 Okla. Stat. Ann. Tit. 12 § 109.  Claims for real property improvements must be brought within 10 years of substantial improvement.

Pennsylvania – Although the statute of repose, 42 Pa. C.S.A. § 5536(a), is generally applicable only to real property improvements, it may apply to product manufacturers in certain cases, such as to manufacturers of asbestos.  See, e.g., Graver v. Foster Wheeler Corp., 96 A.3d 383, 386-87 (Pa. Super. 2014) (granting j.n.o.v., applying the 12 year statute of repose relating to real property improvements to 13 story boiler in asbestos action because statutes of repose are substantive, and may bar actions before they accrue).

South Carolina – S.C. Code Ann. § 15-3-640.  Must be brought within 8 years of substantial completion of improvement to real property.

South Dakota – S.D.C.L. § 15-2A-3.  Applicable to real property improvements only, within 10 years of substantial completion.

Utah – U.C.A. § 78B-2-225.  Actions for real property improvements may not be brought later than nine years after completion.

Vermont – Vt. Stat. Ann. Tit. 27A, § 4-116(a).  Applicable only to Common Interest Ownership claims within six years after the cause of action arose.

Virginia – Va. St. § 8.01-250.  Claims must be brought within five years for injuries resulting from improvements to real property, but does not apply to manufacturers of equipment.

West Virginia – W. Va. Code § 55-2-6a.  Applies to claims related to real property, construction or design within 10 years of occupancy or acceptance, but excludes product manufacturers.

Wyoming – Wyo. Stat. § 1-3-111.  Applicable only to real property improvements, if a claim is brought within 10 years of substantial improvement.

States In Which Courts Ruled That Statutes Of Repose Were Unconstitutional

New HampshireHeath v. Sears, Roebuck & Co., 464 A.2d 288, 296 (N.H. 1983) (statute of repose unconstitutional where plaintiffs were “deprived arbitrarily of a right” to sue).

North DakotaDickie v. Farmers Union Oil Co., 611 N.W. 2d 168, 173 (N.D. 2000) (product liability statute of repose violated equal protection clause).

Rhode IslandKennedy v. Cumberland Eng’g Co., 471 A.2d 195, 201 (R.I. 1984) (holding that state “Constitution forbids absolute bars to recovery” prior to accrual).

ArizonaHazine v. Montgomery Elevator Co., 861 P. 2d 625, 630 (Ariz. 1993) (holding statute of repose unconstitutional, ruling “A.R.S. § 12-551 abrogated that constitutional right [to bring action] by barring the action even before the injury occurred,” and that “the attempted statutory abrogation of their claim fails.”).

 

Statutes of repose can be a defense counsel’s best friend by providing an inexpensive and decisive avenue for disposal of an action, even before the claims have accrued in certain jurisdictions. However, each state is different, and practitioners need to research potentially relevant provisions thoroughly.  After all, a missed opportunity to end the case before it begins is no song and dance.

We’ve seen stories lately that an increasing trend towards online sales of prescription drugs could become as much of a threat to retail drugstores as online shopping generally has become to department stores.  For non-prescription drugs, that future is already here – just Google “OTC Drugs Online” and check out the results.  Or you can go to your favorite general online marketplace and search for the name of a commonly used OTC drug.

When we see something like this, we immediately wonder, “what are the product liability implications?”  We thought we’d take a look.

For this thought experiment, assume that plaintiff X purchased a generic drug online through a large internet marketplace, and now claims to have suffered injury. We’re using generic drugs as an example because preemption would preclude product liability claims against the manufacturer – but if it’s a foreign manufacturer, as is often the case online, well….  But put that aside for the moment, too.

What happens when a plaintiff sues the operator of an online marketplace for injuries caused by a product purchased through that market place?

The plaintiff almost always loses.

Why?  Two reasons.  First, unless the operator actually buys the product and resells it (which happens sometimes, but not a lot), the marketplace isn’t considered a product “seller.”  It’s more like the shopping mall than like any individual store.  Second, a federal statute, the Communications Decency Act, precludes a website operator from being liable for content on its site that is created and uploaded by others.

Both prongs of this defense were recently on display in Oberdorf v. Amazon.com, Inc., 295 F. Supp.3d 496 (M.D. Pa. 2017), which dismissed a non-drug/device product-related personal injury claim brought by plaintiffs who were allegedly injured by a product allegedly bought on the “Amazon Marketplace.”  This “marketplace” is described as:

a vehicle through which third parties may independently offer products for sale.  This service . . . is currently utilized by more than one million third-party vendors.  These third-party vendors decide which products they wish to sell, obtain their stock from manufacturers or upstream distributors, and set their own sales price.  They provide a description (including, perhaps, a photograph) of the product to [the marketplace], which [it] uses to create a listing on its website.

Id. at 497-98 (footnote omitted).  Notably, this is one of the sites where one can currently purchase OTC drugs.

According to Oberdorf, marketplace users “are informed that they are purchasing from an identified third party, and not from [the marketplace] itself.”  Id. at 498.  Except is special cases, the marketplace itself “has no interaction with the third-party vendor’s product at any time.”  Id.  The site’s supervision over its third-party marketers is limited to:  (1) collecting payments, from which it deducts its fee; (2) its platform being the exclusive means of communicating with customers; (3) editorial rights over the contents and appearance of product listings; and (4) imposing rule governing shipping and returns.  Id.

Plaintiffs purchased the product in Oberdorf from a third-party vendor that, once suit was brought, they were “unable to make contact” or serve with process.  Id.  They sued the marketplace  instead

Plaintiffs lost, on the two above-mentioned grounds.  Under Pennsylvania common law, an online retailer was not a “seller” of such products, as that term was used in Restatement (Second) of Torts §402A (1965).  It did not design, manufacture, or sell the product.  Instead of being a store, the online marketplace acted more like “a sort of newspaper classified ad section.”  295 F. Supp.3d  at 501.  Oberdorf compared the marketplace to a product auctioneer that, in Musser v. Vilsmeier Auction Co., 562 A.2d 279 (Pa. 1989), was held not to have attributes of a “seller” that could be subject to §402A strict liability:

Like an auctioneer, [the marketplace] is merely a third-party vendor’s “means of marketing,” since third-party vendors − not [the marketplace] − “cho[o]se the products and expose[ ] them for sale by means of” the Marketplace.  Because of the enormous number of third-party vendors (and, presumably, the correspondingly enormous number of goods sold by those vendors) [the marketplace] is similarly “not equipped to pass upon the quality of the myriad of products” available on its Marketplace.  And because [the marketplace] has “no role in the selection of the goods to be sold,” it also cannot have any “direct impact upon the manufacture of the products” sold by the third-party vendors.

Oberdorf, 295 F. Supp.3d 501 (quoting Musser).

In holding online websites displaying goods sold by others not to be product “sellers” subject to strict liability, Oberdorf appears squarely in the legal mainstream.  In the only state court decision we’ve seen that’s on point, an Ohio trial court held:

[The internet platform] did not in any way modify the [product] purchased by [plaintiff’s decedent].  Nor did [it] distribute the product as the packaging, handling and shipping were performed by [another defendant] and shipped directly to [still another defendant].  {the platform’s] services − allowing the product to be uploaded to its marketplace − were not connected to any aspect of the product which ultimately resulted in the decedent’s death.  Any issues with labeling, concentration, instructions, warnings, etc., were aspects of the product are unconnected to the services [the platform] performed.

Stiner v. Amazon.com, Inc., 2017 WL 9751163, at *6, slip op. (Ohio C.P. Sept. 20, 2017).  That the actual sellers were “a Chinese company . . . not subject to process” or “insolvent” did not justify imposing liability on someone who was not a seller at all.  Id. at *5. See id. at *7-9 (not a seller under state Little FDCA Act or Uniform Commercial Code either).

Similar federal decisions include:  Milo & Gabby LLC v. Amazon.com, Inc., 693 F. Appx. 879, 885 (Fed. Cir. 2017) (online marketer not a product “seller” for purposes of copyright infringement); Fox v. Amazon.com, Inc., 2018 WL 2431628, at *2, 7 (M.D. Tenn. May 30, 2018) (online “information service and system designed so multiple users across the world can access its servers and browse its marketplace at the same time” not a “seller” as defined by Tennessee product liability statute); Erie Insurance Co. v. Amazon.com, Inc., 2018 WL 3046243, at *2 (D. Md. Jan. 22, 2018) (website operator not a “seller” under Uniform Commercial Code”) (fire subrogation case); McDonald v. LG Electronics., USA, Inc., 219 F. Supp.3d 533, 542 (D. Md. 2016), reconsideration denied, 2017 WL 4163348, at *1-2 (D. Md. May 8, 2017) (online marketer not a product “seller” under strict liability or the UCC); Inman v. Technicolor USA, Inc., 2011 WL 5829024, at *6 (W.D. Pa. Nov. 18, 2011) (online auctioneer not a “seller” for §402A purposes); Stoner v. eBay, Inc., 2000 WL 1705637, at *2 (Cal. Super. Nov. 1, 2000) (online auctioneer not “an active participant in the sale of the auctioned goods and services” so as to be liable for copyright infringement).

The second basis for immunity of an Internet website from liability for online sales made by those advertising on the site was federal preemption.  Oberdorf held that all the plaintiff’s tort claims were barred by 47 U.S.C. §230 (the “Communications Decency Act” or “CDA”), which provides that “[n]o provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.”

[I]t is clear from [plaintiffs’] papers that they are, in fact, attempting to hold [defendant] liable for its role in publishing an advertisement for [the seller’s] product.  In other words, [plaintiffs] are attempting to “treat[ defendant] as the publisher or speaker of … information provided by” the seller.  Therefore, these claims are barred by §230 of the CDA.

Oberdorf, 295 F. Supp. at 502-03 (footnote omitted) (quoting statute).  See also Id. at 503 n.52 (CDA would bar product liability claims had they not already been dismissed).

Once again, Oberdorf appears to be in the strong majority of courts holding that product liability actions brought against non-seller online entities are barred by the CDA.  In general, the CDA “provides immunity to [any] publisher or speaker of information originating from another information content provider.”  Green v. America Online, 318 F.3d 465, 471 (3d Cir. 2003).  The CDA has repeatedly been held to preempt product liability claims against website owners.  See Erie Insurance, 2018 WL 3046243, at *3 (“even if I am incorrect with respect to my conclusion that [defendant] is not a seller . . ., I conclude that the CDA would preclude the claims in any event”); McDonald, 219 F. Supp.3d at 538 (CDA immunized online retailer from warning-based claims); Hinton v. Amazon.com.DEDC, LLC, 72 F. Supp.3d 685, 691-92 (S.D. Miss. 2014) (CDA immunized online retailer from product liability suit over product obtained from third-party through interactive internet site); Inman, 2011 WL 5829024, at *6-7 (CDA precluded all claims against internet retailers for injury from allegedly toxic products purchased online); Doe v. MySpace, Inc., 629 F. Supp.2d 663, 665-66 (E.D. Tex. 2009) (CDA barred strict liability claim); Reyes v. LA VaporWorks, 2017 WL 1717406, at *1-2 (Cal. Super. Feb. 16, 2017) (CDA prevents “plaintiffs in product liability cases [from] seeking to hold interactive computer service providers liable for the failure to prevent or screen” “defective product[s] from allegedly being sold” online); Stoner, 2000 WL 1705637, at *3 (in enacting the CDA “Congress intended to remove any legal obligation of interactive computer service providers to attempt to identify or monitor the sale of such products”); Stiner, 2017 WL 9751163, at *11-14 (“to the extent that §230 is applicable to the instant case, the immunity provided thereunder would further support the finding already made by the court that [defendant] is not a supplier or seller of the [product] and that it cannot be held liable under the specific facts of this case”); cf. Gentry v. eBay, Inc., 121 Cal. Rptr.2d 703, 712-16 (Cal. App. 2002) (CDA precludes action against online auctioneer for allegedly counterfeit products); Gibson v. Craigslist, Inc., 2009 WL 1704355, at *4 (S.D.N.Y. June 15, 2009) (CDA immunizes online website from liability for facilitating sales of “inherently hazardous objects, such as handguns”).

The practical reason why we’re seeing a proliferation of attempts to sue internet platforms was alluded to in both Oberdorf and Stiner – online sales platforms are allowing a plethora of products to be sold by a myriad of manufacturers who, before such technologies, had no way of selling worldwide.  The proliferation of online product retailing is leading to more and more situations where product liability plaintiffs are left with nobody, as a practical matter, for them to sue.  It will be very interesting to see what happens when some plaintiff claims SJS-TENS from some drug purchased online.

Particularly after Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), and Daimler AG v. Bauman, 134 S. Ct. 746 (2014), how many of the “more than one million third-party vendors,” Oberdorf, 295 F. Supp.3d at 498, on that particular website, and uncounted others utilizing similar websites worldwide, are likely even to be subject to personal jurisdiction anywhere in the United States?  Moreover, as we have discussed before, the expansive “stream of commerce” jurisdiction theory, which purports to allow suit anywhere that a product happened to injure someone has never commanded a majority on the Supreme Court, and is falling further out of favor after BMS.  With traditional defendants disappearing, it is not surprising to see plaintiffs attempt to sue non-traditional entities, but for now the law is not letting them get away with it.

Your Reed Smith bloggers are part of their firm’s Life Sciences Health Industry Group — a collective that includes not only your bloggers’ compatriots in drug/device product liability defense, but esteemed colleagues assisting health and life sciences companies with issues and opportunities related to regulatory compliance, IP, tech, transactions, and many other areas.

We mention this because we recently received an invitation to a free CLE webinar that two of our regulatory colleagues – Celeste Letourneau and Katie Pawlitz – will be presenting on Wednesday, July 11. It’s on “Clinical Trial Contracts and Investigator-Initiated Study Grant Contracts.”

Typically, we try not to be overly shameless with our shameless plugs. We usually restrict ourselves to just letting our loyal readers know about their bloggers’ upcoming speaking engagements or key drug/device defense industry events.

But we found ourselves just so personally interested in this webinar that we couldn’t help but share it with you. Here’s the webinar description:

Understanding the regulatory underpinnings related to the conduct of clinical trials serves to support compliance with applicable laws and promote efficient negotiation. This program is intended to describe the standards, regulations and requirements that are, or should be, addressed in contracts for the conduct of clinical trials to support FDA applications. The speakers will also address the various FDA and health care laws commonly referenced in clinical trials contracts and discuss fraud and abuse considerations related to clinical trial contracts and investigator-initiated study grant contracts, including the Anti-Kickback Statute, as well as transparency laws related to the same, such as the federal Sunshine Act.

The webinar (and CLE credit) are free, but you do have to register, which you can do here.

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.

We were reading the appallingly bad personal jurisdiction (and other things, but those aren’t what we’re interested in today) decision in Hammons v. Ethicon, Inc., ___ A.3d ___, 2018 WL 3030754 (Pa. Super. June 19, 2018).  While many of the jurisdictional issues in Hammons are factually limited to the particular defendant and the particular product, one holding made us drop what we were doing and turn to research.

That question is very simple – who has the burden of proof where the issue is whether a plaintiff’s assertion of personal jurisdiction violates Due Process.

Hammons held:

A defendant making a challenge to the court’s personal jurisdiction has, as the moving party, the burden of supporting its objection to jurisdiction.

2018 WL 3030754, at *6 (quoting De Lage Landen Services, Inc. v. Urban Partnership, LLC, 903 A.2d 586, 589 (Pa. Super. 2006)) (emphasis added).

This holding − that the defendant, not the plaintiff who asserted jurisdiction in the first place, has the burden of proof when a constitutional challenge to personal jurisdiction is raised – is virtually unprecedented and contrary to practically all the cases we have seen addressing this issue. It also seems intuitively wrong, since analogous issues, such as subject matter jurisdiction, standing, and the admissibility of evidence, impose the ultimate burden of proof on the party advocating jurisdiction or admissibility of evidence, even though the opposing party usually makes the motion to have the issue decided.

Moreover, in Hammons we think that the burden of proof question matters.  Much of Hammons revolves around the same third-party contractor issue that we recently discussed in this post about another adverse jurisdictional decision from the same Philadelphia mass tort.  Although Hammons tries harder to disguise the lack of causal relationship between what the third party did (knitting the mesh together) and any design or manufacturing claim actually asserted by the plaintiff (see 2018 WL 3030754, at *9 (defendant “worked together” with the third-party “in Pennsylvania to design, test and manufacture the” product), the problem we identified in the prior post still exists – Hammons never states how this third-party’s activities contributed to the particular defect/injuries alleged by this plaintiff.  None of the “specifications” for the knitting originated with the Pennsylvania entity, but rather with the defendant. Id. (“knitted . . ., and tested samples for, compliance with [defendant’s] specifications”).

Ultimately, we don’t think that the Superior Court’s proposition – that any allegation of “design” or “manufacturing” defect allows jurisdiction to rest on any arguably in-state “design” or “manufacturing”-related activities where those activities don’t have anything to do with what allegedly injured the plaintiff – flies under Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”).

But there’s a second set of allegations in Hammons, that the defendant “relied heavily on an Allentown, Pennsylvania gynecologist . . . for the development, study, and marketing of [the product].”  Id.

Those facts, whether significant or wildly overblown, were nonetheless “trial evidence,” id. − meaning that plaintiff did not assert them in opposition to the defendant’s previous jurisdictional motion.  The court’s excuse for considering them was:

We may affirm on any ground.  Thus, we need not confine our reasons for affirming to evidence adduced during proceedings on [defendant’s] preliminary objections to jurisdiction.

Id. at 9 n.6 (citation and quotation marks omitted).

That’s fine if the defendant bears the burden of proof, and is thus responsible for ensuring a complete jurisdictional record.  But if the plaintiff bore the burden of proof in Hammons, then the plaintiff had the obligation to complete the jurisdictional record in a timely fashion, and it would not be proper for an appellate court to decide the jurisdictional issue on facts that the trial court did not have before it because the plaintiff failed to present them.  Reliance on such after-the-fact facts is called “sandbagging,” and is generally frowned upon. E.g., Com. v. Johnson, 456 A.2d 988, 996 (Pa. Super. 1983).  We can’t evaluate whether the extent of this Pennsylvania consulting was enough for this litigation tourist to remain in a Pennsylvania court under BMS, but we do believe that it was procedurally improper for an appellate court to consider it if the party being benefited bore (and thus failed to meet) the burden of proof on personal jurisdiction.

All this being said, we can’t say with 100% certainty that the Hammons burden of proof ruling is erroneous – because neither the United States Supreme Court nor the Pennsylvania Supreme Court appears to have decided the burden-of-proof question in the specific context of personal jurisdiction.  No controlling decision of a higher court was ignored – at least that we could find.

In researching this question, we (of course) looked at to United States Supreme Court and found very little.  In Burger King Corp. v. Rudzewicz, the Court phrased the inquiry in the passive voice, “[o]nce it has been decided that a defendant purposefully established minimum contacts within the forum State, these contacts may be considered.”  471 U.S. 462, 476 (1985).  So did Asahi Metal Industries Co. v. Superior Court, 480 U.S. 102, 114, (1987) (“[w]hen minimum contacts have been established”).  Such language neatly avoids the burden of proof question, and presumably arises because the Supreme Court is usually dealing with undisputed factual records.

We found even less precedent in the Pennsylvania Supreme Court – not even passive voice holdings.

However, review of Superior Court precedents shows that the Hammons position was not even the majority rule.  A majority of Pennsylvania Superior Court decisions hold something like this:

Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.

Schiavone v. Aveta, 41 A.3d 861, 865 (Pa. Super. 2012) (quoting Gaboury v. Gaboury, 988 A.2d 672, 675 (Pa. Super. 2009) (emphasis added), aff’d, 91 A.3d 1235 (Pa. 2014) (per curiam).  See N.T. v. F.F., 118 A.3d 1130, 1134 (Pa. Super. 2015) (also quoting Gaboury); Sulkava v. Glaston Finland Oy, 54 A.3d 884, 889 (Pa. Super. 2012) (“Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.”); Mendel v. Williams, 53 A.3d 810, 816 (Pa. Super. 2012) (quoting Schiavone); Taylor v. Fedra International, Ltd., 828 A.2d 378, 381 (Pa. Super. 2003) (“Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.”); Barr v. Barr, 749 A.2d 992, 994 (Pa. Super. 2000) (same); Grimes v. Wetzler, 749 A.2d 535, 540 (Pa. Super. 2000) (“Once the [defendants] supported their jurisdictional objection, the burden shifted to [plaintiff] to prove that there is statutory and constitutional support for the trial court’s exercise of jurisdiction.”); General Motors Acceptance Corp. v. Keller, 737 A.2d 279, 281 (Pa. Super. 1999) (”Once the movant has supported its jurisdictional objection, however, the burden shifts to the party asserting jurisdiction to prove that there is statutory and constitutional support for the court’s exercise of in personam jurisdiction.”); McCall v. Formu-3 International, Inc., 650 A.2d 903, 904 (Pa. Super. 1994) (“once the moving party has supported his objection to jurisdiction, the burden of proof shifts to the party asserting jurisdiction”); Rivello v. New Jersey Automobile Full Insurance Underwriting Ass’n, 615 A.2d 342, 343 (Pa. Super. 1994) (“once the defendant properly raises the issue of jurisdiction, the plaintiff has the burden of proving that jurisdiction is proper”); Derman v. Wilair Services, Inc., 590 A.2d 317, 319 (Pa. Super. 1991) (same); (“When, as here, a defendant properly raises an objection on the ground of a lack of in personam jurisdiction, the plaintiff has the burden of proving that the exercise of jurisdiction is permissible.”); Babich v. Karsnak, 528 A.2d 649, 654 (Pa. Super. 1987) (same); Bergere v. Bergere, 527 A.2d 171, 173 (Pa. Super. 1987) (“When a defendant raises lack of personal jurisdiction, it becomes the plaintiff’s burden to prove that the exercise of jurisdiction is permissible.”).  There are older cases, but you get the point….

We tried following the line of cases Hammons quoted to see how a contrary position originated.  That wasn’t hard.  We started with the De Lage case, which Hammons quoted.  The burden of proof didn’t really matter in De Lage, since that case affirmed dismissal for lack of personal jurisdiction.  903 A.2d at 592.  On the burden issue, De Lage in turn quoted (id. at 589-90) two cases: King v. Detroit Tool Co., 682 A.2d 313, 314 (Pa. Super. 1996) (for the proposition, “A defendant making a challenge to the court’s personal jurisdiction has, as the moving party, the burden of supporting its objection to jurisdiction”), and Gall v. Hammer, 617 A.2d 23, 24 (Pa. Super. 1992).  King cited Scoggins v. Scoggins, 555 A.2d 1314, 1317 (Pa. Super. 1989).

Taking Gall first, it’s not any different in content from the string cite we have above – only in organization and placement.  In the body of the opinion, Gall did indeed state, “When a defendant challenges the court’s assertion of personal jurisdiction, that defendant bears the burden of supporting such objections to jurisdiction by presenting evidence.”  617 A.2d at 24.  That may involve a burden of production, but not the ultimate burden of proof.  The “then what” proposition in Gall was dropped to a footnote.  “The burden of proof only shifts to the plaintiff after the defendant has presented affidavits or other evidence in support of its preliminary objections challenging jurisdiction.”  Id. at 24 n.2.  So Gall is not authority for holding that a defendant, alone, bears the burden of proof when personal jurisdiction is at issue.  Nor is Scroggins.  In that case, the court simply separated “if X” from “then Y.”  Here is the complete discussion in Scroggins, with the two propositions highlighted:

When a defendant wishes to challenge the court’s exercise of in personam jurisdiction, he may do so by filing preliminary objections.  As the moving party, the defendant, has the burden of supporting its objections to the court’s jurisdiction.

Once the plaintiff has produced some evidence to support jurisdiction, the defendant must come forward with some evidence of his own to dispel or rebut the plaintiff’s evidence.  The moving party may not sit back and, by the bare allegations as set forth in the preliminary objections, place the burden upon the plaintiff to negate those allegations.  Only when the moving party has properly raised the jurisdictional issue does the burden of proving jurisdiction fall upon the party asserting it.  Where an essential factual issue arises from the pleadings as to the scope of a defendant’s activities within the Commonwealth, the plaintiff has the right to depose defendant as to his activities within the Commonwealth.

555 A.2d at 1317-18 (multiple citations omitted) (emphasis added as described above).

Thus the Hammons holding that the defendant has the burden of proof − period – on personal jurisdiction is unwarranted even by Superior Court precedent.  It confuses the initial burden of production of evidence with the ultimate burden of proof.  Hammons, along with the case it quotes, misstates the burden of proof by omitting the holding of numerous prior Superior Court panels that, once the defendant puts on some evidence to support its jurisdictional position (which we’re sure was done), then the burden switches to the plaintiff to establish jurisdiction as “the party asserting it.”  That makes practical sense as well.  If plaintiffs didn’t bear the burden of proof, why would they need jurisdictional discovery?

The majority Pennsylvania rule, that the plaintiff bears the ultimate burden of proof on personal jurisdiction, is also the federal rule.  While the United States Supreme Court hasn’t decided the issue, the Courts of Appeals have done so many times, and appear to be unanimous in imposing the ultimate burden of proving personal jurisdiction on the plaintiff asserting it.  Here are a few of the many decisions (the search pulled up 881 cases):

To survive a motion to dismiss for lack of personal jurisdiction, a plaintiff must plead sufficient facts to support a reasonable inference that the defendant can be subjected to jurisdiction within the state.  But where, as here, the parties submit affidavits to bolster their positions on the motion, and the district court relies on the evidence, the motion is in substance one for summary judgment.  The plaintiff bears the burden of proof on the issue of personal jurisdiction, and must establish jurisdiction by a preponderance of the evidence at trial or when the court holds an evidentiary hearing.

Creative Calling Solutions, Inc. v. LF Beauty Ltd., 799 F.3d 975, 979 (8th Cir. 2015) (citations and quotation marks omitted).

It was [plaintiff’s] burden to convince the district court that it had jurisdiction over the persons of the defendants.  That is, [plaintiff] had to satisfy a threshold requirement, the prima facie establishment of jurisdiction.  The plaintiff bears the burden of establishing a prima facie case of jurisdiction over the movant, non-resident defendant.

PVC Windoors, Inc. v. Babbitbay Beach Construction, N.V., 598 F.3d 802, 810 (11th Cir. 2010) (citations and quotation marks omitted).

The plaintiff bears the burden of establishing” personal jurisdiction, and though he need only make a prima facie case at the Rule 12(b)(2) stage, his burden escalates to preponderance of the evidence by the end of trial.

In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 778 (5th Cir. 2018) (citations and quotation marks omitted).

See also, e.g., John Crane, Inc. v. Shein Law Center, Ltd., 891 F.3d 692, 695 (7th Cir. 2018) (“When challenged, the plaintiff has the burden of proving personal jurisdiction.”) (citation omitted); Scottsdale Capital Advisors Corp. v. The Deal, LLC, 887 F.3d 17, 20 (1st Cir. 2018) (“a plaintiff must proffer evidence which, if credited, is sufficient to support findings of all facts essential to personal jurisdiction and may not rely on unsupported allegations”) (citation and quotation marks omitted); Friedman v. Bloomberg L.P., 884 F.3d 83, 90 (2d Cir. 2017) (“The plaintiff bears the burden of demonstrating that the court has personal jurisdiction over each defendant.”) (citation omitted); Anwar v. Dow Chemical Co., 876 F.3d 841, 847 (6th Cir. 2017) (“Plaintiffs have the burden of establishing that a district court can exercise jurisdiction over the defendant”); Morrill v. Scott Financial Corp., 873 F.3d 1136, 1141 (9th Cir. 2017) (“When a defendant moves to dismiss for lack of personal jurisdiction, the plaintiff bears the burden of demonstrating that jurisdiction is appropriate.”); Polar Electro Oy v. Suunto Oy, 829 F.3d 1343, 1348 (Fed. Cir. 2016) (“The plaintiff bears the burden of establishing minimum contacts”); Grayson v. Anderson, 816 F.3d 262, 268 (4th Cir. 2016) (“a plaintiff must establish facts supporting jurisdiction over the defendant by a preponderance of the evidence”) (citation omitted); Niemi v. Lasshofer, 770 F.3d 1331, 1347 (10th Cir. 2014) (“the plaintiff generally must establish, by a preponderance of the evidence, that personal jurisdiction exists”) (citation and quotation marks omitted); Williams v. Romarm, SA, 756 F.3d 777, 785 (D.C. Cir. 2014) (”[plaintiffs] have the burden of establishing a factual basis for the court’s exercise of personal jurisdiction over [defendant]”); Control Screening LLC v. Technological Application & Production Co., 687 F.3d 163, 167 (3d Cir. 2012) (“The plaintiff bears the burden to prove, by a preponderance of the evidence, facts sufficient to establish personal jurisdiction.”) (citation and quotation marks omitted).  That’s a clean sweep.  Every federal court of appeals imposes the ultimate burden of proof on plaintiffs in personal jurisdiction matters.

Finally, because of what personal jurisdiction represents, we think that the burden of proof should be on the plaintiff as a matter of policy.  Personal jurisdiction is an essential element of due process of law.  “Because ‘[a] state court’s assertion of jurisdiction exposes defendants to the State’s coercive power,’ it is ‘subject to review for compatibility with the Fourteenth Amendment’s Due Process Clause.”  BMS, 137 S. Ct. at 1779 (quoting Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 918 (2011)).  “The Due Process Clause protects an individual’s liberty interest in not being subject to the binding judgments of a forum with which he has established no meaningful contacts, ties, or relations.” Burger King, 471 U.S. at 471-72.  The constitution “operates as a limitation on the jurisdiction of state courts to enter judgments affecting rights or interests of nonresident defendants.”  Kulko v. Superior Court, 436 U.S. 84, 91 (1978).  Restrictions on personal jurisdiction “are more than a guarantee of immunity from inconvenient or distant litigation.  They are a consequence of territorial limitations on the power of the respective States.”  Hanson v. Denckla, 357 U.S. 235, 251 (1958).  Given the interests at stake, even if there were no precedent, we think that Due Process considerations mandate that plaintiffs demonstrate that their assertion of personal jurisdiction over defendants is constitutional.

In any event, the peculiar burden of proof ruling in Hammons seems to us to cry out for additional review, which should begin with the en banc Superior Court being given the opportunity to sort out the discrepancies in that court’s panel decisions on this issue.

Today, on the last day of the United States Supreme Court’s 2018 Term, the Court issued an order granting review (“certiorari”) in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 – which is the Supreme Court docket name for the defendant’s appeal from the horrible preemption decision (our worst case of the year for 2017) in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  The brief Supreme Court order did not alter the question presented in the petition for review, which is:

Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?

That’s a nice, broad question that should encompass all of the subsidiary issues – burden of proof, judge vs. jury, and clear evidence, to name three – implicated by the Fosamax decision.

Here at the Blog, we had repeatedly supported Supreme Court review.  We do note one unfortunate aspect of the order granting review:  “Justice Alito took no part in the consideration or decision of this  petition.”  Since Justice Alito has historically supported preemption – he wrote the dissent in Wyeth v. Levine, 555 U.S. 555 (2009) – that means we’re short a vote.  Conversely, the anti-preemption side might lose the vote of Justice Kennedy’s replacement (Justice Kennedy was in the Levine majority).  But even with Justice Thomas (who supports only “impossibility” preemption), a combination of Roberts, Gorsuch, Thomas, and ______ would only get us to a 4-4 tie.  However, we think that the Fosamax decision is bad enough that we should be able to draw a vote from one of the others (most likely Kagan or Breyer), at least on the procedural issues.

We’ve seen Griffith v. Blatt, 51 P.3d 1256 (Or. 2002), cited – and not just by plaintiffs – for broad propositions, like Oregon abolished the learned intermediary rule in strict liability cases, or that strict liability, generally, is strait-jacketed by legislative adoption of Restatement (Second) of Torts §402A (1965) and its comments.

We don’t think that’s so.

First, let’s start with the Oregon product liability statute that the Oregon Supreme Court applied in Griffith.  There is, indeed, a provision that does exactly what Griffith held – Or. Rev. Stat. §30.920.  This section of the product liability statute provides:

(1) One who sells or leases any product in a defective condition unreasonably dangerous to the user or consumer or to the property of the user or consumer is subject to liability for physical harm or damage to property caused by that condition, if:

(a) The seller or lessor is engaged in the business of selling or leasing such a product; and

(b) The product is expected to and does reach the user or consumer without substantial change in the condition in which it is sold or leased.

(2) The rule stated in subsection (1) of this section shall apply, even though:

(a) The seller or lessor has exercised all possible care in the preparation and sale or lease of the product; and

(b) The user, consumer or injured party has not purchased or leased the product from or entered into any contractual relations with the seller or lessor.

(3) It is the intent of the Legislative Assembly that the rule stated in subsections (1) and (2) of this section shall be construed in accordance with the Restatement (Second) of Torts sec. 402A, Comments a to m (1965). All references in these comments to sale, sell, selling or seller shall be construed to include lease, leases, leasing and lessor.

(4) Nothing in this section shall be construed to limit the rights and liabilities of sellers and lessors under principles of common law negligence or under ORS chapter 72.

In addressing the learned intermediary rule, the Griffith court interpreted Section 30.920(3) strictly to apply only §402A and its comments – which do not reference (they date from 1965) the learned intermediary rule:

Pursuant to ORS 30.920(3), we must construe ORS 30.920(1) and (2) “in accordance with” the cited comments to Restatement (Second) of Torts §402A. . . . , [which] indicate that a seller of a drug may be required to give an adequate warning of the product’s danger to a consumer when the seller has knowledge or should have knowledge of the danger. . . .  It is sufficient for present purposes to conclude that, contrary to Stout’s argument, Oregon’s product liability statute does not create a defense to strict liability based on the learned intermediary doctrine.

51 P.3d at 1262.

Some of our more long-term (and sharp-eyed) readers might notice something unusual about this last quote.  Normally, we don’t leave party names in quotations.  But that’s critical here.  Who are the defendants?

Rugby manufactured the lotion and Stout, a pharmacist, filled the prescription.

Id. at 1258 (emphasis added).  The actual manufacturer was dismissed on the statute of limitations, and that dismissal was affirmed in Griffith.  Id. at 1261.  Thus, the pharmacist, Stout, was the only defendant left in the case.

That’s critical, because the statute distinguishes throughout between four classes of entities in the chain of sale of a product – the “manufacturer,” “distributor,” “seller,” and “lessor” of the product at issue.  See Or. Rev. Stat. §§30.900, 30.902; 30.905(5); 30.907(3)(b); 30.908(4-5); 30.910, 30.915(1,3); 30.927(1,3).

Now look back at the language of §30.920, the provision construed in Griffith.  It is entitled “Liability of seller or lessor of product.”  Neither the title, nor the body of this section is in any way applicable to the “manufacturer” of a product.

This is the key to the widely misunderstood Griffith decision.  The only defendant at issue in Griffith was a pharmacist – a non-manufacturing seller of a prescription drug.  Likewise, the statutory section construed in Griffith is applicable solely to product “sellers” or “lessors” – and by its terms is not applicable to manufacturers.

Griffith’s recognition of a §402A strait-jacket forbidding the adoption of the learned intermediary rule thus only applies to strict liability cases brought against pharmacists (sellers) and should not displace the learned intermediary rule in cases involving manufacturers – to which §30.920 expressly does not apply – where the rule is well-established under Oregon law.  See Oksenholt v. Lederle Laboratories, 656 P.2d 293, 296-97 (Or. 1982); Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1247-48 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).

So manufacturing defendants in cases under Oregon law should be careful not to fall for overly expansive arguments based on Griffith.  There is no statutory §402A strait-jacket in cases involving manufacturers (as opposed to “sellers” or “lessors”), whether involving the learned intermediary rule or anything else.  Any decision or commentary to the contrary is ignoring the manner in which the Oregon legislature structured its product liability statute.  It expressly adopted §402A and its comments only to define the liability of product sellers and lessors – not manufacturers.

Today we have a guest post from Reed Smith associate Curtis Waldo.  It describes a farce of a Daubert decision where a plaintiff’s expert opinion was allowed to proceed even though the court conceded the evidence was inconclusive.  We don’t like that, and neither does Curt.  As always our guest posters are responsible for their writings, deserving 100% of the credit, and any blame.  Tee time, Curt.

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Even the casual golf fan is likely familiar with gaudy stories involving John Daly.  On his way to winning the 1995 British Open at St. Andrews, John Daly wolfed down Otis Spunkmeyer chocolate chip muffins to offset sugar cravings induced by alcohol withdrawal.  Upon finishing second place at the World Golf Championship, Daly lost $1.65 million in Vegas, mostly at slots.  Suffering a collapsed lung in the middle of a tournament, Daly quipped, “I only smoke two packs of cigarettes a day, not three, so I’ll be alright.”  Daly self-diagnosed:  “Everyone has addictions and my problem is that I have 5,000 of them.  If it’s not drinking, it’s gambling; if it’s not gambling, it’s eating anything from burgers, doughnuts to M&Ms. The only addiction I don’t suffer from is chasing women.”

To that, Tiger Woods might say, “Hold my beer and watch this.”  Two years after Daly’s last major win at the 1995 British, young gun Tiger Woods burst on the scene and won the Master’s by 12 strokes.  In contrast to Daly, through his years atop the PGA Tour, Tiger projected nothing but the utmost discipline and confidence.  Tiger was manic about his fitness, and you would certainly never see him smoking or drinking on a golf course.  Of course, the façade came crumbling down, and Tiger was eventually exposed as a “sex addict,” subject to the same demons that haunted Daly.

Enter the Abilify MDL, where plaintiffs argue Abilify causes patients to develop “impulsive and irrepressible urges to engage in certain harmful behaviors, including gambling, eating, shopping, and sex.”  Op. (infra) at *1.  This author is not aware if John Daly or Tiger Woods ever took Abilify, but if so, based on a March 15, 2018 opinion out of the Northern District Florida, they could conceivably attempt to blame their respective struggles with impulse control on the drug.

To the court’s opinion, In re Abilify (Aripiprazole) Products Liability Litigation, 2018 WL 1357914 (N.D. Fla. March 15, 2018).  Before diving into the law, the opinion spends several paragraphs describing the brain as a “tremendously complex biochemical system.” I d. at *3.  The brain contains billions of neurons, sending and receiving information to other neurons.  Id.  Electrical impulses are constantly being sent from neuron to neuron across gaps called synapses.  Id.  The impulses are housed by molecules called neurotransmitters. Id. Dopamine is an “integral” neurotransmitter, constantly telling the brain what it likes and doesn’t like and thus playing a critical role in “pleasure, reward processing and motivation.”  Id.  This becomes important later when the decision addresses plaintiffs’ biological plausibility expert’s argument that Abilify prevents the activation of dopamine molecules, causing the brain to increase the number of dopamine receptors. Id. When dopamine activates these receptors, a “potentiated” physiological response is triggered, resulting in the complained of impulsive behavior.  Id.

Back to the law.  Most notable in the legal discussion, after discussing the types of general causation evidence the Eleventh Circuit normally requires (epidemiology, dose-response, accounting for background risk), the decision stated that “in practice” any expert must also consider the “weight of the evidence” in coming to his conclusion. Id. at *9.  Of course, “in practice,” this may lead to an expert throwing any number of theories against the wall, seeing what sticks, and saying that he is considering the “weight of the evidence.”  Where the science stops and the weighing begins is not entirely clear.  But what is clear is Eleventh Circuit law.  The sort of vague, seat of the pants expert opinions allowed in Abilify should not have been.  See Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245, 1253-57 (11th Cir. 2010) (affirming exclusion of unreliable differential diagnosis); McClain v. Metabolife International, Inc., 401 F.3d 1233, 1239-51 (11th Cir. 2005) (excluding various expert machinations ultimately based on the “post hoc ergo prompter hoc fallacy”).  This precedent strongly indicates that the Eleventh Circuit has not, and would not, embrace the “weight of the evidence” approach taken in Abilify.  Notably, Abilify cited only district courts from within the Eleventh Circuit, as well as cases from other, less rigorous courts of appeals.  2018 WL 1357914, at *9.

Moving to plaintiffs’ evidence, purportedly the most persuasive was the “Etminan Study,” a so-called epidemiological study drawn from an insurance claims database of millions of patients.  Id. at *11-12.  It just so happened that the author of the study, Dr. Etminan (an ophthalmologist from Canada) reached out to plaintiffs’ counsel before he developed the research protocol for his study.  Id. at *19.  How fortunate plaintiffs’ counsel must have felt when after they brought their Abilify cases; a doctor called to say he was about to conduct a study going to the central issue in the case, and imagine further the smile on face of plaintiffs’ counsel when the study turned out to say exactly what plaintiffs wanted it to say.  Imagine the smile on Dr. Etminan’s face when those expert fee checks started rolling in.

Anyway, Dr. Etminan examined the claims database to identify patients with diagnostic codes for a gambling or impulse control disorder. Id. at *11-12.  He identified a separate group of patients with neither diagnosis. Id. Dr. Etminan compared the two groups and found the former more likely to have been prescribed Abilify in the year prior to their gambling or impulse control diagnosis—so much more likely, according to plaintiffs’ experts, that an inference of causation could be drawn. Id. This study, and plaintiffs’ experts’ statistical analysis of the study, was plaintiffs’ primary evidence of general causation.

The court acknowledged several flaws in the study, including that Dr. Etminan never actually looked at any medical records for any of these people. Id. at *13.  Dr. Etminan didn’t know if any of the patients even ingested Abilify (as opposed to merely filling the prescription). Id. at *14.  If they did ingest the drug, Dr. Etminan didn’t know how much they took. Id. At least one of the Abilify-taking patients in the database reported a compulsive gambling disorder only after seeing a lawyer advertisement saying Abilify caused compulsive gambling, suggesting his “diagnosis” (and likely that of other patients in the database) was colored by reporting bias.  Id. at *20.

The study also appears to treat a gambling diagnosis like a flu virus—something one contracts and is “diagnosed” with.  A small problem—the DSM says a gambling disorder takes up to 12 months to develop into a disease. Id. at *15.  And as many readers are likely aware from personal experience or the experience of loved ones, one does not buy a lotto ticket and then seek out treatment for a gambling disorder.  A likelier course is to wallow undiagnosed in heady indulgences for years, perhaps at a casino, golf course, seedy bar, or in the case of shopping addiction, perhaps the mall, until one hits the proverbial rock bottom (such as Tiger Woods’ infamous single-car accident), at which time it becomes apparent that a trip to the psychiatrist is in order.  Once one is on the psychiatrist’s couch, recounting tales that would make John Daly look like a model of discipline and rationality, then maybe also comes an Abilify prescription.

This gets to the most critical flaw of the Etminan study, which is that the very disorders that may lead to impulse control issues—depressive disorders, anxiety disorders, and personality disorders—are often the disorders that Abilify attempts to treat.  Claiming the same disorder being treated as a “adverse effect” of the drug used in treatment is a common plaintiff ploy. See, e.g. Colacicco v. Apotex Inc., 521 F.3d 253, 256 (3d Cir. 2008) (observing that suicide was also “inherent in depression,” the condition the drug at issue treated), vacated on other grounds, 556 U.S. 1101 (2009) (preemption).

The Abilify opinion conceded problem with causation, but found no actual evidence that anxiety and personality disorders were related to increased exposure to Abilify.  2018 WL 1357914, at *18.  While this may be true, the logical implications that follow are, well, hard to follow.  One could imagine that of all the humans in the world with anxiety and personality disorders, a very small percentage are taking Abilify.  But one could also imagine that of all those who take Abilify, a high percentage have anxiety and personality disorders, and as such, may be more inclined to have impulse control issues.  After all, that is one of the reasons the drug was likely prescribed in the first place.  Ultimately, the opinion found the medical literature to be “inconclusive on the question of whether depressive, anxiety and personality disorders are causal risk factors for pathological gambling.”  Id.  This lack of evidence of a causal relationship between these disorders and impulse control was decisive; not merely the fact that as the DSM notes, “individuals with gambling disorder have high rates of comorbidity with [depressive, anxiety and personality disorders].”  Id.  Plaintiffs received a mulligan.  One wonders where the burden of proof on the party offering the expert opinion went.

Next up was, plaintiffs’ non-epidemiological evidence of causation, including evidence of a dose-response relationship and of biological plausibility.  The analysis of this evidence is best summarized as, “maybe.”  Maybe it’s plausible; maybe there is a dose-response relationship; maybe the case studies and adverse event reports show causation.  Because the epidemiological evidence is sufficient, this is all gravy for plaintiffs, and defendants’ arguments don’t carry much weight.  None of these “bolstering” studies were sufficient proof of general causation under Daubert by themselves, but because the epidemiological evidence was sufficient to meet plaintiffs’ burden, the “bolstering” studies could come in, too.  Why rake the sand trap when you’re already on the green?  Of course, whether a future jury will draw this distinction is another matter.  One could certainly imagine a jury finding a single case study more persuasive than an epidemiological study of 6 million insurance claims.

After describing the general causation evidence, the Abilify opinion proceeded one-by-one through plaintiffs’ experts, finding faults with many, though ultimately allowing the key epidemiology testimony, based on the serendipitously timed Etminan study.  Id. at *36, et seq.  Defendants’ experts largely passed through, too.

Past the gatekeeper, and on to the jury. Good luck to each side in the second round.  As John Daly said, “The first tournament is not the hardest one to win.  It’s always the second one.”

You’ll have to excuse us a bit today.  This post is about product liability – specifically Pennsylvania product liability.  However, it is not really focused on prescription medical products.  But what can we say?  We were provoked.

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“The dark side of the Force is a pathway to many abilities some consider to be unnatural.”   – Darth Sidious (a/k/a Sheev Palpatine).

Money and the dark side share many of the same attributes.

The first footnote of a new law review article, Wertheimer & Rahdert, “The Force Awakens:  Tincher, Section 402A, & the Third Restatement in Pennsylvania,” 27 Widener Com. L.R. 157 (2018), reveals that “[t]he preparation of this article was supported in part by a research grant from the Pennsylvania Association for Justice.”  Id. at 157 n.1.  So we were not surprised in the least that “Force Awakens” read like a plaintiff litigation expert’s opinion on Pennsylvania product liability law.  The scholarship was bought and paid for, after all.

Another conclusion we reached by the end of that article was more surprising.

The Pennsylvania Association for Justice wuz robbed.  Whatever they paid, they didn’t get what they paid for.

To explain. “Force Awakens” was an obvious response to our own Bexis’ 2017 91-page opus, J. Beck, “Rebooting Pennsylvania Product Liability Law: Tincher v. Omega Flex & the End of Azzarello Super-Strict Liability,” 26(2) Widener L.J. 91 (2017).  As the PAJ engagement no doubt required, Bexis article and the propositions it contains come in for criticism.  “Rebooting,” 26(2) Widener L.J. at 204-05.  Heck, “Force Awakens” was even published in the same law review (albeit with an intervening name change) as Bexis’ article.  The point-counterpoint can hardly be more obvious.

Except Bexis didn’t get any research grants.

The first way that “Force Awakens” doesn’t stack up is simply size.  Size matters if an article is going to cover all the bases.  If the 91 pages of Bexis’ article were kilos, it would weigh in as a heavyweight.  This 57-page counter-punch is, comparatively, a featherweight.

Of course, in scholarship, length is something, but not everything.

So what else?  We think “Force Awakens” wastes precious pages discussing non-Pennsylvania law.  Granted that, given Tincher’s discussion of California precedent, see “Rebooting,” 26(2) Widener L.J. at 144-45, 163-64, 169-70, reference to California law makes sense, but the extended discussion of New Jersey law, “Force Awakens,” 27 Widener Com. L.R. at 164-65, seems odd and tangential, at best.

But most of “Force Awakens” was predictable – intended to provide something that plaintiffs could cite for arguments that Tincher didn’t change much, and (probably more importantly) in support of the embattled post-Tincher suggested jury instructions critiqued in “Rebooting.”  Thus, much of “Force Awakens” is an apologia for the SSJI and (like an expert report) reflects the position of those who purchased the scholarship:

  • “The Tincher court chose to maintain strict liability, and once again it crystallized that choice by reaffirming Section 402A, while at the same time refusing to adopt the directives of the Third Restatement.”  27 Widener Com. L.R. at 193.
  • “[P]roduct liability in Pennsylvania remains a form of strict liability.”  Id. at 194.
  • “Under Tincher the ‘blackletter’ principles of section 402A clearly remain the baseline for Pennsylvania product liability law.”  Id. at 196-97.
  • “[W]here a plaintiff succeeds in proving that a product’s dangers exceed ascertainable consumer expectations, social cost-benefit balancing of risks and utilities is not required.”  Id. at 198.
  • “Pennsylvania courts can and should utilize Barker’s fairly detailed discussion of the relevant evidentiary considerations as a guide.”  Id. at 200.
  • Tincher’s explication of risk-utility analysis carefully avoids dependence on proof of a reasonable or feasible alternative design.”  Id. at 201.
  • “The [SSJI] Subcommittee sought to change instructions that were directly in conflict with Tincher, but to leave in place all other instructions. . . . This approach strikes us as essentially correct.”  Id. at 204.
  • “[T]hirteen of fifteen distinct charges or parts of [the PDI] charges employ the phrase “unreasonably dangerous” at least once”; “its ubiquity in the proposed PDI instructions strikes us as revealing overkill.”  Id. at 204 n.165.
  • “[W]e believe that the fundamental doctrinal assumption on which these [defense side] criticisms rest is incorrect.”  Id. at 206.
  • “By reaffirming Pennsylvania’s commitment to . . . Section 402A, [Tincher] clearly signaled that product liability is and should remain . . . a doctrine firmly founded on strict liability.”  Id.
  • “Because Tincher reaffirmed the strict liability character of product liability, it remains necessary to keep product liability separate from negligence.”  Id. at 206-07.
  • “As the [SSJI] properly recognized, courts must continue to draw that dividing line in their jury instructions.”  Id. at 207.
  • “For purposes of product liability under Section 402A, a product contains relevant dangers if it ‘lacks any element that is necessary to make it safe’ for an intended or foreseeable use, or if it ‘contains a condition that makes it unsafe’ for such use.”  Id. at 208.
  • “[W]e agree with the [SSJI] Subcommittee that it would be both premature and inconsistent with Tincher’s overarching perspective to draft new warning instructions based on dicta in the opinion regarding that subject.”  Id. at 208-09.
  • “The critics’ argument that the standard jury instructions should embrace a ‘state of the art’ defense is in our opinion entirely incorrect. . . .  This is a due care defense, pure and simple, and it sounds in negligence.”  Id. at 210.
  • “The Subcommittee used Barker’s revised list on the ground that it enabled more streamlined and efficient instructions.  As a practical matter we agree with this assessment. More importantly, we think the charge that the Subcommittee ignored the relevance of the Wade factors is incorrect.”  Id. at 211.

Overall, we found “Force Awakens” recitation of these (and other) pro-plaintiff talking points quite superficial.  To take just one example, the state-of-the-art discussion utterly ignores prior Pennsylvania appellate authority recognizing that such a defense exists as to risk/utility analysis, Hicks v. Dana Cos., 984 A.2d 943, 966 (Pa. Super. 2009), and never comes to grips with the black letter of the consumer expectation test requiring plaintiffs to prove that relevant product risks are “unknowable.  Bexis covered all that in some detail.  See “Rebooting,” 26(2) Widener L.J. at 164-72 (discussing state of the art issues).

Also inexplicably absent from “Force Awakens” is the Pennsylvania Supreme Court’s treatment of the “unreasonably dangerous” of Restatement §402A in Tincher.  “[T]he notion of ‘defective condition unreasonably dangerous’ is the normative principle of the strict liability cause of action.”  Tincher v. Omega Flex, Inc., 104 A.3d 328, 400 (Pa. 2014).

[I]n a jurisdiction following the Second Restatement formulation of strict liability in tort, the critical inquiry in affixing liability is whether a product is “defective”; in the context of a strict liability claim, whether a product is defective depends upon whether that product is “unreasonably dangerous.”

Id. at 380.  The “normative” nature of the unreasonably dangerous element is nowhere found in “Force Awakens” (the word never appears), and its status as “the critical inquiry” is buried in a footnote, 27 Widener Com. L.R. at 183 n.94, while the article describes other issues as “critical.”  Id. at 183 (“defective condition”), 193 (same), 194 (failure to satisfy defect tests).  Unreasonably dangerous as “overkill”?  We don’t think so.

Assuming that “Force Awakens” is used as intended to counter defense-side arguments about Tincher, we’ve found that, on a close read, the article includes some useful concessions, should defendants need to reply:

  • “Trial courts clearly may no longer rely on the jury instructions that had emanated from Azzarello.”  27 Widener Com. L.R. at 193.
  • “The fact that a product may be dangerous . . . does not automatically mean that it is also defective.”  Id. at 195.
  • “The Tincher court acknowledged that Third Restatement materials sometimes may be helpful.”  Id. at 197.
  • Tincher recognized a negligence strand that contributed to product liability law’s formation and continues to play a role in its development.”  Id. at 206.
  • “[T]he ‘unreasonably dangerous’ language of Section 402A need not be excised in its entirety from product liability jury instructions,” id. at 207 − precisely what the pro-plaintiff SSJI did.
  • “[T]he general [SSJI] statement that ‘[a] product is defective’ if it lacks a necessary safety feature or contains an unsafe condition qualifies as an overstatement.”  Id. at 208.
  • Tincher “reaffirmed the default position that plaintiffs typically bear the burden of persuasion in civil matters.”  Id. at 212.
  • “The [SSJI] Subcommittee’s minimalist approach, while comporting with Tincher’s appeals to modesty and caution, ends up offering little by way of guidance on a range of potentially vexing product liability issues.”  Id. at 212-13.

We think that last quote is a particularly important point of departure. The SSJI subcommittee has always been slow, particularly when the law shifts in favor of defendants.  It took over 40 years, for example, for the Pennsylvania SSJIs to incorporate learned intermediary rule instructions.  As “Force Awakens” concedes, after Tincher the subcommittee’s tendency hardened to the point of Azzarello-based ossification “offering little by way of guidance.”  Id. at 213.

We on the defense side take the opposite view − recognizing the need of the bench and bar to fill in some of these post-Tincher blanks.  In sharp contrast to the retrograde approach endorsed by “Force Awakens,” the defense side’s jury instructions are being expanded and updated.  The 2018 second edition, which has just been released to the public, not only incorporates the most recent post-Tincher precedent – including the Superior Court’s 2018 holding that giving an Azzarello strict liability instruction is now “a paradigm example of fundamental error,” Tincher v. Omega Flex, Inc., 180 A.3d 386, 399 (Pa. Super. 2018) – but also has expanded beyond strictly Tincher issues to include instructions on causation (3 different situations), component parts, and post-sale duty to warn.  Suggested instructions are just that, suggestions; only the defense believes in more, not less.

Finally, our mention of post-Tincher precedent in the preceding paragraph is at the heart of why we believe that PAJ didn’t get value for whatever it paid.  Tincher was decided in late 2014.  “Force Awakens” came out halfway through 2018 – 3 ½ years later.  Bexis’ “Rebooting” article collected and reviewed every post-Tincher decision right up until that article couldn’t be edited any longer.  “Force Awakens” is just the opposite.  Remarkably, it doesn’t cite a single post-Tincher Pennsylvania decision.  Not one.  That omission, we’re pleased (but surprised) to say, leaves our opponents without any precedential support – just a law review article ex cathedra.

If we had to speculate on the reason why “Force Awakens” went radio silent on Pennsylvania precedent, we would again analogize to a litigation expert report. The available data – here post-Tincher precedent – was not supportive of the positions that the authors were being paid to advocate.  So they did what other paid experts do:  ignore it.

So, where the other side goes silent, that’s a signal for us to pour it on.  Here’s our support for our contention that almost all post-Tincher decisions disagree with the positions being asserted in “Force Awakens.”

Rejecting argument that Tincher was a narrow decision that did not change anything

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Plaxe v. Fiegura, 2018 WL 2010025, at *6 (E.D. Pa. April 27, 2018)

After Tincher an Azzarello-“any element”/”guarantor” jury charge is reversible error

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

After Tincher courts need not be bound by Azzarello-era decisions

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *7 (C.P. Clarion Co. Oct. 19, 2015)

Tincher requires that the product be “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

High v. Pennsy Supply, Inc., 154 A.3d 341, 347 (Pa. Super. 2017)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Roudabush v. Rondo, Inc., 2017 WL 3912370, at *2 (W.D. Pa. Sept. 5, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6-7 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2 (W.D. Pa. July 14, 2016)

Stellar v. Allied Signal, Inc., 98 F. Supp.3d 790, 807 (E.D. Pa. 2015)

Nathan v. Techtronic Industries North America, Inc., 92 F. Supp.3d 264, 272 (M.D. Pa. 2015)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *3 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *8 (Pa. C.P. Mercer Co. April 14, 2015)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 & n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Explicitly applying Wade factors/cost-benefit balancing

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 695 (M.D. Pa. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *8 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 451 (E.D. Pa. 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13-14 & n.16 (W.D. Pa. March 15, 2016)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.2, 7 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *2 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *5 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Summary judgment for lack of viable alternative design in risk/utility case

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *4 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Tincher does not shift risk/utility burden of proof

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.1 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *1 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Tincher rejects blanket exclusion of “negligence concepts” in strict liability

Roverano v. John Crane, 177 A.3d 892, 907 n.9 (Pa. Super. 2017)

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13 n.15 (W.D. Pa. March 15, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *7 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Risk/utility test is similar to, and derived from, negligence

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482 (Pa. Super. 2016)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *7 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8 (Pa. C.P. Clarion Co. April 17, 2015)

Risk/utility test requires expert testimony

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 724-25 (E.D. Pa. 2016)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016) (risks of alternative design)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *4 (Pa. C.P. Clarion Co. April 17, 2015)

Tincher requires jury instruction on “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620-21 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Rejecting Azzarello guarantor/any element jury instruction

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *3-4 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Consumer expectation test held inappropriate

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (known risk)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016) (complexity)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *8-9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798 (M.D. Pa. March 20, 2015) (conceded inappropriate to mechanical equipment – concrete block maker)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017) (known risk)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015) (obvious risk)

Consumer expectation test based on objective, reasonable consumer (not plaintiff)

High v. Pennsy Supply, Inc., 154 A.3d 341, 348-49 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Yazdani v. BMW of North America, LLC, 188 F. Supp.3d 486, 493 (E.D. Pa. 2016)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450-52 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *7 (E.D. Pa. Sept. 8, 2016)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Strict liability only applies to a manufacturer’s own products

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 712 (M.D. Pa. 2017)

McLaud v. Industrial Resources, Inc., 2016 WL 7048987, at *7 (M.D. Pa. Dec. 5, 2016), aff’d, 715 F. Appx. 115 (3d Cir. 2017)

Schwartz v. Abex Corp., 106 F. Supp.3d 626, 653-54 (E.D. Pa. 2015)

Tincher principles apply to warning claims

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Igwe v. Skaggs, 258 F. Supp.3d 596, 609-10 (W.D. Pa. 2017)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Trask v. Olin Corp., 2016 WL 1255302, at *9 n.20 (W.D. Pa. March 31, 2016)

Williams v. U-Haul International, Inc., 2015 WL 171846, at *3 n.6 (E.D. Pa. Jan. 14, 2015) (subsequently vacated in part on other grounds having to do with negligence, 2015 WL 790142)

Horst v. Union Carbide Corp., 2016 WL 1670272, at *16 (Pa. C.P. Lackawanna Co. April 27, 2016)

Product must be “unreasonably dangerous” without a warning

High v. Pennsy Supply, Inc., 154 A.3d 341, 351 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 612, 614-15 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 453-54 (E.D. Pa. 2016)

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 725, 727 (E.D. Pa. 2016)

Inman v. General Electric Co., 2016 WL 5106939, at *7 (W.D. Pa. Sept. 20, 2016)

Post-sale duty to warn continues to require defect at sale

Trask v. Olin Corp., 2016 WL 1255302, at *9 (W.D. Pa. March 31, 2016)

Evidence of product user’s negligent conduct admissible as relevant to risk/utility

Punch v. Dollar Tree Stores, 2017 WL 752396, at *11 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Evidence of third-party’s negligent conduct admissible as relevant to risk/utility

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5-6 (Mag. M.D. Pa. Sept. 27, 2017)

Evidence of product user’s knowledge admissible as relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 611-12 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452 (E.D. Pa. 2016)

Evidence of product warnings relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 610-11 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016)

Evidence of product user’s negligent conduct admissible as relevant to causation

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5 (Mag. M.D. Pa. Sept. 27, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

Evidence of a product’s compliance with industry standards is relevant/admissible

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016) (maybe, but issue was not properly preserved)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *1-2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *6-7 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of compliance with government standards is relevant/admissible

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017) (OSHA)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of technological infeasibility under current state of the art is relevant/admissible

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (on summary judgment)

And finally, to provide at least something that is specific to prescription medical products:

Existing exclusion of prescription medical products from strict liability applies after Tincher

Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237, at *3 (W.D. Pa. Feb. 15, 2018)

Krammes v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015)

In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35 (N.D. Ill. June 12, 2015)

*          *          *          *

Is there any contrary Pennsylvania product liability precedent?  Well, we’re a defense-side blog and we don’t do the other side’s research for them.  That’s what plaintiffs’ side presumably paid for with the “research grant” that produced “Force Awakens” – and they didn’t get it.  PAJ should demand its money back.

Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in Aged Tau Transgenic Mice Are Dependent on Leukotrienes Biosynthesis: Role of the cdk5 Kinase Pathway,” in the scientific journal Molecular Neurobiology.  That sounds pretty dense, but what the article concludes is that the generic drug zileuton (branded name Zyflo) has been shown – in a transgenic mouse study – to reduce both physical evidence of Alzheimer’s disease, and its mental symptoms.  To wit:

[A]ged tau transgenic mice were randomized to receive zileuton . . . starting at 12 months of age for 16 weeks and then assessed in their functional and pathological phenotype.  Compared with baseline, we observed that untreated tau mice had a worsening of their memory and spatial learning.  By contrast, tau mice treated with zileuton had a reversal of these deficits and behaved in an undistinguishable manner from wild-type mice.

“Learning Impairments” Article, at Abstract (emphasis added).  In lay terms, it might just successfully treat (we hesitate to throw the “c” word around) Alzheimer’s disease.

Nothing else works very well at treating Alzheimer’s disease.

Zileuton/Zyflo has been on the market since 1996, indicated for treatment of asthma, and is thus available for generic production under Hatch-Waxman.

Since this drug has already been FDA approved, it may also be used off-label, right now, to treat Alzheimer’s patients under the therapeutic rationale explained in the “Learning Impairments” article.  With the drug’s basic safety profile already established by FDA approval and twenty-something years of clinical use, the primary issue in any such off-label use is effectiveness – does it actually benefit Alzheimer’s patients – rather than safety.

Let’s assume, for the moment, that zileuton/Zyflo actually has therapeutic value for treating Alzheimer’s in humans.  This is a drug that can be produced generically, so who is going to finance the Phase III human studies necessary to provide the “substantial evidence” that the FDA requires for a label change adding a new indication?  If any generic manufacturer can take a “free ride” on studies sponsored – at great expense – by someone else, then there is not much incentive for anyone to spend that money.  Thus, this extremely consequential new indication may become a regulatory orphan.  Of course, if the drug shows sufficient promise, other sources of funding could become available – third party payers who pay for the medical needs of Alzheimer’s patients, or even the research fund that is supported by the recently issued Alzheimer’s semipostal stamp.

If this off-label use is truly beneficial, then it would (in the absence of any better treatment option) likely become the medical standard of care despite being off-label.  Eventually, the FDA would be forced to engage in some ad hoc, retrospective approach in order to reconcile the label with clinical practice.  That’s how the FDA finally resolved the regulatory conundrum of so-called “pedicle screws,” where regulation fell behind clinical practice – a retrospective study supported the safety and effectiveness of off-label spinal use, but only after manufacturers endured a decade of meritless product liability litigation.  See 63 Fed. Reg. 40025-41 (FDA Jul. 27, 1998).

While further studies are being performed, however, what happens to scientific communication?  This could be (or it could not be – too early to tell for sure) an historic breakthrough in treatment of Alzheimer’s.  If it is, does the FDA continue to prohibit any manufacturer of zileuton/Zyflo from informing the medical community of information on the effectiveness of the off-label treatment, such as optimal dosage and administration practices?  We’ve frequently decried the unconstitutionality of such speaker- and topic-based restrictions on manufacturer scientific communications under the First Amendment.  However, for the most part the FDA’s refusal to conform to current First Amendment norms has flown under the public’s radar, allowing the agency to get away with dilatoriness, and the rest of the government to monetize the FDA’s unconstitutional stance with through “false” claims litigation that isn’t really about falsity.

Alzheimer’s, however, is the elephant in the room.  Without some sort of effective treatment, our health care system cannot indefinitely support the cost of palliative Alzheimer’s care.  Almost everybody knows somebody suffering from dementia, or else someone suffering through the heartbreak of caring for someone with dementia.  The FDA will run into a political and medical buzz saw if its retrograde attitude towards truthful off-label promotion gets in the way of making information about an effective (we hope) treatment for Alzheimer’s available to the public.

And now – but probably not coincidentally – it looks like the FDA is finally getting off the regulatory schneid.  A couple of days ago, the agency issued a “statement” from the commissioner about what was billed as a “new effort” “to advance medical product communications to support drug competition and value-based health care.”  The big news in the statement is rather buried in regulatory-speak, but it is legitimate big news:

Additionally, it’s our [FDA’s] belief that giving companies clear guidelines for providing payors with truthful and non-misleading information about unapproved products and unapproved uses of approved or cleared products will help facilitate communications that can allow payors to provide coverage for these new products and new uses more quickly after FDA approval or clearance.  And our hope is that these communications can also help companies and payors establish pricing structures that benefit patients as well as health plans.

(Emphasis added).  That’s a reference to (among other things) off-label use.  Specifically, the FDA is now approving “truthful and non-misleading” off-label promotion when directed to an audience of third party payors.

The details of this regulatory retreat from Moscow are found in the FDA’s new final guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, & Similar Entities − Questions & Answers, available here.  That’s another mouthful, so we’ll call it the “Off-Label Promotion (OLP) Guidance,” since that’s really what it is.

The FDA is now allowing those who market prescription drugs and medical devices (see id. at 16 explaining the identical treatment of all classes of medical devices) to provide information about off-label uses of these products to “payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis.”  OLP Guidance at 1 (footnote omitted)

This audience includes public and private sector payors, formulary committees (e.g., pharmacy and therapeutics committees), drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators, and other multidisciplinary entities that, on behalf of health care organizations, review scientific and/or technology assessments to make drug or device selection or acquisition, formulary management, and/or coverage and reimbursement decisions on a population basis.

OLP Guidance at 5 (footnotes omitted).

That’s the who.

The “what” is just about everything.  The kind of information that regulated drug and device manufacturers can now provide to third-party payors about off-label uses is defined as:

“any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug.  Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention. . . .  [Off-label promotion] may include comparative analyses of the economic consequences of a drug’s clinical outcomes to alternative options (including the use of another drug) or to no intervention.

[The information] can be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with a user manual, a budget-impact model, a slide presentation, or a payor brochure.

OLP Guidance at 4-5.

The “when” varies a bit depending on whether what kind of off-label use is at issue.  The FDA has drawn what we believe to be a new distinction between “material differences” from the labeling that “relate[] to an approved indication” and so-called “unapproved indications.”  Id. at 7.  In our experience, the FDA has always considered any variance from labeling limitations to be off-label use.  But now, as to approved indications, “material differences from the FDA-approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations)” are treated differently, and somewhat less stringently.  Id. at 6.  A presentation “should include an accurate overview of the design of the economic analysis, including a statement of the study objectives.”  Id. at 11 (going into considerable detail).

As to promotion of uses involving such “material differences” from labeling, a basis in “competent and reliable scientific evidence” is sufficient.  Id. at 10.  In determining the sufficiency of the scientific basis, the FDA will be deferring to “existing current good research practices for substantiation developed by authoritative bodies.”  Id.  The prior FDA requirements of “substantial evidence” is nowhere mentioned.  It appears to be gone as a restriction on off-label promotion under the OLP Guidance.  Promotion of “material differences” must include a “conspicuous and prominent statement describing” those differences.  Id. at 14.

However, off-label promotion “regarding unapproved products and unapproved uses of approved/cleared products” is also now allowed by the FDA.  Id. at 18-20.  As to this type of what might be considered “true” off-label uses, distribution of the following information to third-party payers is now OK with the FDA:

  • “Product information (e.g., drug class, device description and features).”
  • “Information about the indication(s) sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics).”
  • “Anticipated timeline for possible FDA approval/clearance/licensure of the product or of the new use.”
  • “Product pricing information.”
  • “Patient utilization projections (e.g., epidemiological data projection on incidence and prevalence).”
  • “Product-related programs or services (e.g., patient support programs).”
  • “Factual presentations of results from studies, including clinical studies of drugs or devices or bench tests that describe device performance (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the unapproved product or the unapproved use).”

Id. at 18-19.

This kind of off-label promotion should be accompanied by a variety of disclaimers and other information to ensure that the off-label nature of the uses involved is understood:

  • “A clear statement that the product or use is not approved/cleared/licensed, and that the safety or effectiveness of the product or use has not been established.”
  • “Information related to the stage of product development” and “whether a marketing application for the product or new use has been submitted to FDA or when such a submission is planned.”
  • “[M]aterial aspects of study design and methodology and . . . material limitations related to the study design, methodology, and results. Firms should also ensure that results are not selectively presented.”
  • “A prominent statement disclosing the indication(s) for which FDA has approved, cleared, or licensed the product and a copy of the most current FDA-required labeling.”

Id. at 19.  Significantly, there is no prerequisite that an FDA application for marketing be either pending or contemplated, although if this is the case, it should be disclosed.

As to off-label promotion of these so-called “unapproved uses” (and also drugs and devices that have not yet received any FDA regulatory OK), the FDA tries to salvage what it can of the justifications it used to advance in opposition to our side’s First Amendment arguments about truthful off-label promotion:

FDA believes that the categories of information . . . are, on the one hand, broad enough to encompass the information that payors may need to make informed coverage and reimbursement decisions and, on the other hand, limited enough to maintain appropriate incentives for firms to conduct robust studies to evaluate the safety and efficacy of unapproved products and unapproved uses of approved/cleared/licensed medical products. . . .  FDA believes that the risk that payors will be misled is relatively low.  Payors are a sophisticated audience with established procedures to carefully consider the full range of relevant evidence about new uses of medical products.

OLP Guidance 21-22.

Finally, the OLP Guidance reminds us that “[f]irms’ communications to other audiences about unapproved products or unapproved uses of approved/cleared/licensed products could raise additional or different considerations and are beyond the scope of this guidance.” Id. at 22.

In conclusion, let’s look at that last point a bit. The OLP Guidance punches another huge hole in the FDA’s previous attempts to ban regulated entities from distributing truthful information about off-label uses to anybody.  As discussed at some length in Greater New Orleans Broadcasting Ass’n, Inc. v. United States, 527 U.S. 173, 192-94 (1999), the number and nature of exceptions to a speech prohibition adversely affect both the prohibition’s rationality and its ability to advance the governmental interest that motivates it.  We fail to see how any constitutionally valid distinction can exist between providing the identical information, with identical disclaimers and limitations, to one “sophisticated” audience (third-party payors) while prohibiting that information’s distribution to another “sophisticated” audience – that being medical doctors that directly prescribe these drugs and devices.

And that’s just within the rubric of commercial speech.  Greater New Orleans also cautioned, “decisions that select among speakers conveying virtually identical messages are in serious tension with the principles undergirding the First Amendment.”  Id. at 194.  We now have Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011), for the proposition that, with respect to pharmaceutical detailing, we’re not just dealing with commercial speech.

Thus, we believe that, as a practical matter, the OLP Guidance effectively dooms any First Amendment defensibility of an FDA ban on the same truthful information being distributed, in the same fashion, to the rest of the medical community beyond third-party payors.  Conversely, to those regulated entities that seek to inform physicians of truthful scientific information about their products, we believe that the OLP Guidance can serve as a roadmap to success in an Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), situation by establishing that off-label promotion is “truthful,” “not misleading,” and therefore protected against governmental enforcement activity.  After all, just as third-party payers are sophisticated professionals interested in possible effective treatments for Alzheimer’s disease, so are the doctors directly involved in treating Alzheimer’s patients.