Recently, in the context of an IVC filter case, the Third Circuit Court of Appeals certified two questions to the Pennsylvania Supreme Court:

1. Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate?

2. Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?

Petition for Certification of Questions of State Law, Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).

The first question concerns the scope of the novel “negligent design” claim allowed in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), see our post here about Lance.  The Third Circuit asks whether the Lance cause of action is limited to the relatively unusual unsafe-for-any-class-of-patients claim that the Pennsylvania Supreme Court actually allowed in Lance (as bad as that was), or if will it metastasize into a general negligent design claim.  This assumes – something that is not at issue in either Lance or Ebert – that design defect claims of this sort are not impliedly preempted by the need for prior FDA approval of design changes under the Mensing independence principle (see our post here).

The second question is whether Pennsylvania will adhere to 75 years of Pennsylvania Supreme Court precedent rejecting strict liability in drug and medical device product liability litigation.  See Lance, 85 A.3d at 452-53; Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996); Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385-86 (Pa. 1991); Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971); DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965); Henderson v. National Drug Co., 23 A.2d 743, 748 (Pa. 1942).

We discussed that precedent (and much more) at length in response to the first federal district court case to claim that a non-prescription medical product case, Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow changed that rule, although it was never before the Tincher court.  We have since chronicled additional precedent, almost all of it federal, good and bad, over the last couple of years.  That includes the district court decision in Ebert.  Now the issue is finally before the court that under our federal system, is supposed decide it.

Some background on this second issue.  The Tincher decision, which we discussed here and here, overturned Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), and with it – we hoped – 35 years of pro-plaintiff Pennsylvania idiosyncrasy that had removed the issue of whether a product defect was “unreasonably dangerous” under Restatement §402A from the jury’s purview on the now-discredited proposition that negligence and strict liability were absolutely separate and that evidence of negligence was improper in a case raising only strict liability.  This led to an appalling “manufacturer as guarantor” jury instruction, refusal to charge the jury on risk/utility principles, abolition of the state-of-the-art defense so that liability could be based on scientifically unknown risks, as well as depriving the jury of relevant evidence, such as concerning compliance with governmental and industry standards, plaintiff comparative fault, and exclusion “reasonableness” and “foreseeability” generally (at least when these would have benefited a defendant).

The effect of the existing no-strict liability rule in the Hahn/Incollingo line of cases was to insulate our sandbox – prescription medical product liability litigation in Pennsylvania – from the jurisprudential depredations of the Azzarello era of super-strict liability.  We were never faced with arguments by plaintiffs that any dichotomy between negligence and strict liability meant that, say, the compliance of a drug or device with FDA requirements was “irrelevant” in strict liability and could not be made known to the jury.  Nor were our clients subjected to strict liability-based arguments that they could be liable for alleged product risks that were not scientifically discovered until much later.

But at the same time that the Ebert action was pending in the Third Circuit, the Pennsylvania Superior Court – in a non-prescription medical product decision − decided to reinsert some of the worst of the Azzarello-era product liability restrictions on admissible evidence into the new Tincher regime.  See Sullivan v. Werner Co., ___ A.3d ___, 2021 WL 1419480 (Pa. Super. April 15, 2021), reargument denied (June 23, 2021):

Under the above-quoted provision [Restatement (Second) of Torts §402A(2)(a) (1965)], it is irrelevant if a product is designed with all possible care, including whether it has complied with all industry and governmental standards, because the manufacturer is still liable if the product is unsafe.

Id. at *12.  Denial of reargument in Sullivan occurred the day before the Third Circuit’s Ebert certification of the strict liability question to the Pennsylvania Supreme Court.  Assuming Sullivan is appealed, that means that both questions will simultaneously be before the Pennsylvania Supreme Court.

To us, the potential synergy between Ebert, on the strict liability question, and Sullivan, on the inadmissibility of government and industry standards in strict liability, raises the stakes in both appeals considerably.  Anyone involved in pelvic mesh litigation knows how exclusion of FDA compliance evidence there has created an FDA-free fantasy world that misleads juries and has allowed plaintiffs free reign to make arguments at odds with what the FDA required.  Imagine having to deal with a similar situation in every future drug and device case in Pennsylvania.

That’s what is now at stake.