Because it is impossible to design a prescription drug that provides the desired health benefits with zero risk of harm, courts have long held that manufacturers of prescription drugs are not strictly liable for injuries these drugs cause. In recent years, courts around the country have begun to determine whether prescription medical-device makers merit the same treatment when confronted with strict liability claims.

The United States District Court for the Eastern District of Pennsylvania recently asked the U.S. Court of Appeals for the Third Circuit to answer whether Pennsylvania recognizes a strict liability claim for a manufacturing defect of a prescription medical device. Rosenberg v. C.R. Bard, Inc., — F. Supp. 3d —, 2019 WL 2596358 (E.D. Pa. 2019). This case is similar to one currently pending in the Utah Supreme Court, Burningham v. Wright Medical Group, which will answer a Certified Question from the United States District Court for the District of Utah of whether implanted medical devices fall under the “unavoidably unsafe” exception to strict products liability in design defect claims recognized in comment k to Section 402A of the Restatement (Second) of Torts. (Washington Legal Foundation filed an amicus curiae brief in that case, urging the court to apply comment k categorically to prescription medical devices.)

Section 402A of the Restatement as adopted by many state courts imposes strict liability on one “who sells any product in a defective condition unreasonably dangerous to the user or consumer, or to his property” regardless whether the seller “exercised all possible care in the preparation and sale of his product.” Restatement (Second) of Torts § 402A (1965). Comment k, however, creates an exception to strict liability for “unavoidably unsafe” products. Products are deemed unavoidably unsafe if they “provide an exceptionally important benefit” yet pose a “substantial and unavoidable” risk to their users. Grundberg v. Upjohn Co., 813 P.2d 89, 93 (Utah 1991).

Both the Pennsylvania Superior Court and the Pennsylvania Supreme Court have barred strict liability claims in prescription drug cases for design defect and failure-to-warn claims based on the policies directly expressed in comment k. See Hahn v. Richter, 543 Pa. 558, 560-63 (1996). The Superior Court determined that comment k excludes prescription drugs from strict liability claims because prescription drugs are “inherently dangerous products which benefit society.” Hahn v. Richter, 427 Pa. Super. 130, 151 (1993) aff’d, 543 Pa. 558 (1996).

In Rosenberg, Judge Robreno relied on the language of comment k and Pennsylvania case law to support the prediction that Pennsylvania would extend its comment k jurisprudence to strict liability manufacturing-defect claims.

Comment k specifically “contemplates its application to prescription” drugs that a doctor must prescribe. “[C]omment k’s plain language appears to include prescription medical devices because ‘prescription’ medical devices, by definition … require a physician’s prescription.” Rosenberg, 2019 WL 2596358, at *3. The court therefore found “no meaningful distinction” between prescription drugs and prescription medical devices. Id.

Pennsylvania state courts have also concluded that the reasons for applying comment k to prescription drugs apply equally to medical devices. See, e.g., Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006). In Creazzo, the Superior Court expanded comment k’s reach categorically to implanted medical devices. It agreed with the trial court’s finding that, given the utility and unavoidably unsafe nature of implanted medical devices, there was no significant difference between such devices and prescription drugs from the Hahn decision. Creazzo, 903 A.2d at 31.

Based on those considerations, the court concluded that there is “no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Id. But notably, Pennsylvania has not specifically prohibited strict liability claims for manufacturing defects in the prescription-product context. So the Pennsylvania district court needed to predict whether Pennsylvania law would extend to bar such claims.

The court noted that a split has developed among the lower Pennsylvania courts regarding the applicability of strict liability to manufacturing-defect claims. But it concluded that the Pennsylvania Supreme Court has determined that “strict liability claims are not cognizable in the prescription drug context.” Rosenberg, 2019 WL 2596358, at *6 (citing Lance v. Wyeth, 624 Pa. 231, 242-43 (2014)). Based on case law and “the lack of a meaningful distinction between the legal treatment of prescription drugs and prescription medical devices,” Judge Robreno predicted that the “Pennsylvania Supreme Court would not recognize a strict liability claim for a manufacturing defect of a prescription medical device.” Id.

Acknowledging that the availability of a strict liability claim in the manufacturing-defect context is open to debate and is a controlling question of law in Rosenberg, the court certified the question to the Third Circuit for interlocutory appeal.

It is likely the Third Circuit will certify the question to the Pennsylvania Supreme Court, rather than itself also guessing what that court would hold. But if it chooses to answer the question itself, the Third Circuit should follow Judge Robreno’s lead and “extend comment k’s mantle of protection both to prescription drugs and prescription medical devices” to preclude strict liability claims based on manufacturing defects. Id. at *7. The Food and Drug Administration (FDA) thoroughly analyzes prescription medical devices’ risks and benefits when clearing such products for public release. Further, doctors prescribe devices on an individual, case-by-case basis. If courts refuse to consider prescription medical devices as “unavoidably unsafe,” juries will step into the shoes of FDA and patients’ physicians.

Strict products liability litigation alleging defective design could force manufacturers to cease production or alternatively to increase prices and pass those costs on to consumers. The public suffers when medical devices become unavailable or unaffordable.

Also published by on WLF’s contributor page.