Did you ever wish there was a way to get a definitive answer to those age-old issues that have been plaguing humans since the beginning of time?  Like — is it worse to fail at something or never attempt it in the first place?  Or — does nature shape our personalities more than nurture?  What about the questions the only plague us when we are stuck in traffic or at three in the morning.  Why is it said that an alarm clock is going off when really it’s coming on?  At a movie theater which arm rest is yours?  When does it stop being partly cloudy and start being partly sunny?  Why are there no “B” batteries?

Alas, even in the age of asking Siri, certain answers remain elusive.  But, long before Alexa was searching Google, courts had a system in place for getting to the bottom of an issue – the certified question.  A neat little device whereby one court asks another court, usually of higher authority, for an opinion on a question of law.  That’s just what the Eastern District of Pennsylvania did in Rosenberg v. C.R. Bard, Inc., __ F. Supp. 3d __, 2019 WL 2596358 (E.D. Pa. Jun. 25, 2019).  Faced with competing decisions on an issue of Pennsylvania law, the district court rendered its decision, but is certifying a question to the Third Circuit for an immediate interlocutory appeal.  The question is:

[D]oes Pennsylvania law recognize a strict liability claim for a manufacturing defect of a prescription medical device?

Id. at *7.  It may not be a question as old as why doesn’t glue stick to the inside of the bottle?  But, it has been open to debate for several years.

Pennsylvania has long applied comment k of §402A of the Restatement (Second) of Torts across the board to bar strict liability design and warning claims.  Comment k exempts “unavoidably unsafe products” from strict liability when they are properly prepared and accompanied by proper warnings.  If §402A “defines the general scope of strict liability,” comment k “sets the perimeter beyond which Section 402A many not encroach.”  Rosenberg, at *3.

Rosenberg walks through Pennsylvania’s history with comment k.  The Pennsylvania Supreme Court has held that comment k applies to prescription drugs.  Hahn v. Richter, 673 A.2d 888 (Pa. 1996).  But Rosenberg involves a prescription medical device and the applicability of comment k to medical devices has not been answered by Pennsylvania’s highest court.  Both Pennsylvania Superior Courts and federal courts applying Pennsylvania law, however, have held that Pennsylvania would extend comment k to prescription medical devices as well.  Rosenberg does too.  Rosenberg at *3-4.  But that’s the easy part of the issue.

Going back to Hahn, Pennsylvania has said the comment k bars strict liability claims for design defect and failure to warn.  Id. at *5.  But the plaintiff in Rosenberg also alleged a strict liability manufacturing defect claim.  Whether that claim is permissible is less certain and federal courts interpreting Pennsylvania law have come out differently.  That’s because the trend in Pennsylvania courts has gone back and forth with no definitive answer.

First, there was Lance v. Wyeth, 4 A.3d 160, 164-65 (Pa. Super. Ct. 2010) (Lance I), in which the Pennsylvania Superior Court in dismissing a claim for negligent marketing said that a strict liability manufacturing defect claim was possible in a prescription drug case.  But, the Pennsylvania Supreme Court reversed Lance I finding the court’s reasoning “deeply flawed” and that it erroneously equated “products liability” with “strict liability.”  Lance v. Wyeth, 85 A.3d 434, 453 (Pa. 2014) (Lance II).  So, many courts, including Rosenberg, find that Lance I “is entitled to no weight.”  Rosenberg at *6.

Lance II also held that the Pennsylvania Supreme Court “ha[d] declined to extend strict liability into the prescription drug arena” but had not immunized drug manufacturers from other types of liability.  Id.  Which courts have come to interpret as Pennsylvania recognizes negligence claims for prescription drugs, but not strict liability claims.  Id.

Then came Tincher v. Omega Flex, Inc., 104 A.3d 328, 382 (Pa. 2014) in which the Pennsylvania Supreme Court said that “[n]o product is expressly exempt” from strict liability.  Which plaintiffs tried to use, mostly unsuccessfully, to open the door to strict liability in drug and device cases in Pennsylvania.  But Tincher is actually quite clear because that quoted language is followed by:  “but see Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (Pa. 1996) (manufacturer immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warnings.”  Tincher, 104 A.2d at 382 (emphasis added).  “Therefore, nothing in Tincher reopens the door to strict liability claims for prescription drug or prescription medical devices, a door Hahn had firmly closed.”  Rosenberg, at *6.

Based on its analysis, the Rosenberg court dismissed plaintiffs’ strict liability claims, including for manufacturing defect, with prejudice.  Id. at *8.  However, it also concluded that the issue met the requirements for certification for interlocutory appeal.  The issue is a controlling question of law on which there is “substantial ground for difference of opinion,” and deciding the issue now will conserve resources and avoid protracted litigation.  Id. at *7.      There is a chance the Third Circuit will in turn certify the question to the Pennsylvania Supreme Court (federal district courts can’t do this) and we’ll finally have an answer as to comment k and both medical devices and manufacturing defects in Pennsylvania.  Now, if only someone could answer whether the “s” or the “c” is silent in scent?