In our initial post about Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), we stated up front that we didn’t think that Tincher changed Pennsylvania law applicable to prescription medical products much, if at all.
We wrote:
For prescription products, the short answer is “not much..” . . . Largely as a result of concerns over liability for scientifically undiscovered risks . . . in Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (another case Bexis briefed) the Court excluded prescription medical products entirely from Azzarello strict liability using Restatement §402A, comment k . . . . Thus Tincher’s reworking of strict liability doesn’t affect prescription medical products because that theory wasn’t applicable in the first place. Indeed, one of Bexis’ worries about the Third Restatement was that eventually it might call the Hahn strict liability exemption into question. Without the Third Restatement, that doesn’t happen.
Just because we said so, however, doesn’t make it so. We’ve learned recently that at least one plaintiff’s lawyer has created an argument for the opposite position – that Tincher supposedly opens up wide vistas of strict liability in prescription medical product cases – and has asserted it in certain medical device litigation in which none of your bloggers are participants. One of our readers sent us that brief (a publicly filed document) and asked us to comment.
So we will, but we’re not identifying either the case or the plaintiff’s lawyer – if you’re reading, you know who you are.
To us, the plaintiff’s proposition is, in one word, absurd. It makes no sense that Tincher, which was primarily devoted to moving strict liability design defect cases closer to negligence, would somehow expand strict liability sub silentio (that’s legal Latin for “without explicitly saying so”) in the prescription medical product area, while simultaneously reining it in everywhere else. There are three fundamental reasons why Tincher cannot be read in that fashion.
First, to do so would mean that the Pennsylvania Supreme Court, in a non-drug case, purported to overrule over 70 years of Pennsylvania precedent barring strict liability (or its equivalents) in prescription medical product liability litigation.
Second, controlling Pennsylvania law prevents such a radical change in existing law from being made by implication in a case not directly presenting the question.
Third, in federal court, where this brief was filed – as we’ve said many times – a diversity based action cannot be a forum for predicting novel expansions of tort liability not already adopted by the relevant state courts.
We’ll address this trio first before turning to some other Tincher– related arguments that those plaintiffs have asserted.
Number one: Since the dawn of product liability litigation in Pennsylvania, the Pennsylvania Supreme Court has always, whenever the issue was raised (and it’s been raised a fair amount), treated product liability cases involving prescription medical products differently, and has rejected any form of strict liability. How long has this been going on? It started in 1942 and was most recently mentioned in Tincher itself (albeit only in passing).
Refusal to apply strict liability began with Henderson v. National Drug Co., 23 A.2d 743 (Pa. 1942), long before the concept of §402A strict liability in tort was even a gleam in a plaintiff’s lawyer’s eye. In Henderson, the plaintiff failed to prove negligence but claimed that “‘even if the Drug Company was not negligent . . . its product was not safe and therefore on the proof of breach of warranty alone the plaintiff would be entitled to a verdict.’” Id. at 748-49 (quoting from plaintiff’s brief). The Pennsylvania Supreme Court unanimously replied: “[t]his action is not founded on a breach of warranty. An action against a druggist to recover for personal injuries should be ex delicto and not ex contractu.” Id. at 749 (citation and quotation marks omitted).
Thus, the “warranty” predicate for the “consumer expectation” prong of the “composite” strict liability design defect test announced in Tincher, 104 A.3d at 401-02, has not existed in Pennsylvania prescription medical product cases since 1942. As stated in Henderson, pharmaceutical companies are held “to a high degree of responsibility under both the criminal and the civil law for any failure to exercise vigilance commensurate with the harm.” 23 A.2d at 748. That responsibility remains a negligence duty of care, as eliminating the traditional negligence standard of proof would “ill-serve” the public:
This consideration, however, does not justify the courts in lowering the standards of proof in tort cases of this kind. If we did so the public interest would be ill served. If those who make and compound drugs and medicines in packages or bottles, under the strict conditions prescribed by the [forerunner of the Food, Drug & Cosmetics Act], can be mulcted in damages every time some person uses such drugs or medicines with harmful results, the making and selling of such products would be a most peculiarly hazardous enterprise.
Id. (citations omitted) (emphasis added).
Henderson involved what today would be called a warranty of “merchantability.” More than 20 years later, plaintiffs tried again to impose warranty style strict liability – asserting a “warranty of fitness for use” − against a prescription drug manufacturer in DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965). The court reiterated what it had said in Henderson:
[I]n Henderson, disposing of a contention that the drug company would be liable, even if not negligent, if the drug was not safe on theory of a breach of warranty, this Court held that, unless the action is based upon an express warranty, an action against a drug company must be ex delicto and not ex contractu, the action being based upon a breach of duty imposed by law. Under Henderson, . . .[plaintiff], relying on a breach of implied warranty, would be restricted to an action in trespass rather than an action in assumpsit.
Id. at 585, 208 A.2d at 285-86 (footnote and other citations omitted). To these Supreme Court cases, we append the more recent Superior Court case of Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374 (Pa. Super. 1987), also emphatically rejecting applicability of implied warranty to prescription drugs. “[T]he very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for ‘ordinary purposes.’” Id. at 376-77.
The first modern – that is, post-§402A – prescription medical product liability case in Pennsylvania was Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971). Incollingo, in light of the policies expressed by Restatement (Second) of Torts §402A, comment k (1965), reaffirmed Henderson’s holding that negligence was the only viable cause of action in cases involving prescription-only products:
The Restatement reaches the same conclusion as to a product which is incapable of being made safe for its intended use, such as new or experimental drugs, as to which, because of lack of time and opportunity for sufficient medical experience there can be no assurance of safety, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.
“The seller of such products”, concludes this comment (Comment k), “again with the qualification that they are properly prepared and marketed and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product attended with a known but apparently reasonable risk.”
282 A.2d at 219-20 (emphasis original). The only proper theory was negligence:
Since the strict liability rule of §402A is not applicable, the standard of care required is that set forth in §388 of the Restatement dealing with the liability of a supplier of a chattel known to be dangerous for its intended use. Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.
The next Pennsylvania Supreme Court holding rejecting strict liability in a prescription medical product case was Baldino v. Castagna, 478 A.2d 807 (Pa. 1984). It essentially reiterated what the court had already said about the absence of negligence claims in Incollingo.
In Incollingo we held that, assuming proper preparation and warning, a manufacturer of drugs is not strictly liable for the unfortunate consequences attending the use of otherwise useful and desirable products which are attended with a known but apparently reasonable risk. Rather, such a manufacturer is liable only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.
Id. at 810 (citations omitted).
Next up was Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383 (Pa. 1991), rejecting a claim of “strict liability independent of the issue of inadequate warning” brought against a pharmacist who had sold a prescription drug. Id. at 1384. The Court once again reiterated the explicit exception” id. at 1385, provided in comment k for prescription medical products:
[Plaintiffs] also argue . . . that [a pharmacist] may be subject to strict liability as a supplier of a defective product. . . . It is unclear in what sense the appellants contend that the drug was defective beyond that it allegedly carried a risk, of which no warning was given. . . . It is not alleged that [the drug] was useless for the purpose it was prescribed for, or that it invariably caused the adverse consequences complained of. It would thus seem that [the drug] is necessarily the type of product covered by comment k of Section 402A, “an apparently useful and desirable product, attended...
