Can You Have a Negligent Design Claim in a Pharmaceutical Product Liability Case? One Court Thinks So.
Every once in a while you encounter an opinion that surprises you enough that you say: "Wh-wh-what did they just say?" I read one this morning: Lance v. Wyeth, 2010 Pa. Super. 137 (Aug. 2, 2010).
Lance arises out of diet drug litigation. Plaintiff's decedent had taken Redux for a period of time while it was approved by the FDA and still on the market. She was diagnosed with primary pulmonary hypertension seven years later and subsequently died. Plaintiff filed suit alleging that Redux caused her decedent's death.
Interestingly, plaintiff did not plead a failure to warn claim, per se -- presumably because she could not allege that plaintiff or her doctor were unaware of the risks or relied on anything that the manufacturer said in prescribing the drug. The complaint explicitly stated that plaintiff "was making 'No Inadequate Labeling Claims.'" Slip op. at 7. She also did not allege a manufacturing defect claim.
Plaintiff did, however, allege the following four "claims": (1) that defendant unreasonably put Redux on the market prior to January 1997, (2) that defendant unreasonably refused to withdraw Redux from the market once its testing revealed risks of PPH, (3) that defendant breached the standard of care in failing to adequately test Redux, (4) and that it negligently designed the medicine.
The defendant moved for summary judgment in the trial court, noting that there are three types of product defect: design defect, manufacturing defect, and failure to warn. Plaintiff had excluded two, and (defendant argued) there is no cause of action for design defect in the field of pharmaceutical products. The trial court agreed and granted summary judgment.
The intermediate appellate court, however, partially disagreed, reaching the stunning conclusion that there is such a thing as a cause of action under Pennsylvania law for negligent product design -- but not strict liability design defect -- in pharmaceutical cases. The court properly cited Hahn v. Richter, 673 A.2d 888 (Pa. 1996) for the proposition that there is no strict liability design defect claim for pharmaceutical products. See Slip op. at 14. Hahn had cited Restatement (Second) of Torts Section 402A, comment k as a justification for the rule. Medicines are "unavoidably unsafe products" that present risks to some people despite their benefits for others, and comment k explains that the seller of such a product that is properly prepared and marketed cannot be held to strict liability for the unfortunate consequences attending use of the product.
But the court in Lance decided that this rule only applies to strict liability, and that it would still be possible for a plaintiff to state a cause of action for design defect in negligence. Of course, the policy justifications articulated in comment k -- that manufacturers should not be liable for the unavoidable consequences of a medicine so long as they prepare it right and warn about it -- are the same regardless of whether liability sounds in strict liability or negligence. Indeed, many scholars and, it would appear, the American Law Institute, have concluded that there is no real difference between the tests for design liability in negligence or strict liability. See Restatement (Third) of Torts, Section 2. The Lance court, citing decades-old opinions from Idaho and California, reached the opposite conclusion that there is some sort of meaningful difference between strict liability and negligent design claims. Slip op. at 18-21.
Moreover, saying that a medicine is improperly designed fundamentally implies a feasible alternative design. And yet if a medicine were designed differently, it would cease to be the same medicine; it would be something completely different. The design defect construct simply does not work in the pharmaceutical context. But now there is an intermediate appellate court opinion in Pennsylvania suggesting that such a cause of action exists.
This fact is even more surprising when one considers the rest of the opinion. The Lance court held that plaintiff's "failure to recall" claim was not cognizable under Pennsylvania law because the state does not recognize a common law duty to recall or retrofit, in large part because the cost of such a duty would be passed on to consumers and have significant economic impact. But if that's true for a duty to retrofit, what about a duty arising in negligence to design a medicine differently?
Moreover, the court relied on the FDA and its approval of the drug in refusing to recognize a duty to recall. Slip op. at 24-25. But once again, if the FDA has approved a medicine and that's good enough to preclude a common law duty to recall, why not defer to the FDA's judgment on the issue of the medicine's design, too?
The court also rejected plaintiffs' other causes of action. The claim for putting Redux on the market was tantamount to a disallowed strict liability design defect claim, the court held. And the claim for failure to adequately test Redux was not cognizable under Pennsylvania law, the court explained, because it was simply a design claim repackaged. Pennsylvania has never recognized an independent tort for failure to adequately test. Citing Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517 (D. Minn. 1989), the court explained that a "failure to test" claim is really a "failure to discover the defect" claim. Once a manufacturer discovers a defect, it has a duty either to change the product's design or to adequately warn and instruct about the danger associated with it, the court said, so the "failure to test" claim is really subsumed in the design defect or inadequate warnings claim. Slip op. at 30.
Given the Lance court's clear-headed reasoning on the remaining legal theories, it is doubly nonplussing how the court concluded that the only cause of action that should survive in this pharmaceutical case is a cause of action for negligent design, when admittedly there can be no strict liability design defect claim and the medicine was at the time approved for sale by the FDA. Let's hope the Pennsylvania Supreme Court quickly resolves the issue of whether a negligent design claim can be asserted in a pharmaceutical case.
