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US District Court Holds that Strict Liability Not Applicable to Manufacturers of Prescription Medical Devices

In an opinion authored on May 17, 2012, by the Honorable Eduardo C. Robreno, Jr., the United States District Court for the Eastern District of Pennsylvania held that under Pennsylvania law, strict liability cannot be imposed on manufacturers of prescription medical devices.

The underlying case of Kee v. Zimmer, Inc.,
817 F. Supp. 2d 405, 89 A.L.R. 6th 785 (E.D. Pa. 2012)involved a plaintiff who underwent knee replacement surgery in both knees for treatment of arthritic pain. Integral to the surgeries was a medical implant device manufactured by defendant. Following the surgery, plaintiff experienced persisting knee pain secondary to a loosening of the implant’s component parts. As a result, plaintiff was forced to undergo a revision surgery to correct the implant.

Plaintiff subsequently brought suit against the defendant manufacturer, alleging defective design, failure to warn, negligent design and manufacture, and fraud. Pursuant to diversity jurisdiction, defendant removed the case from Pennsylvania state court to the Eastern District of Pennsylvania. Thereafter, defendant moved for dismissal of all non-negligence claims, including those sounding in strict liability, pursuant to comment k of the Restatement (Second) of Torts § 402A.

On review of defendant’s motion, the Court noted that while Section 402A imposes strict liability on sellers of “unreasonably dangerous products,” an exception is provided for those products which are designated as “unavoidably safe.” Specifically, the Court drew upon the articulation of this exception within Pennsylvania state law, in particular its application to prescription drugs, noting that “where the adequacy of warnings associated with prescription drugs is at issue . . . the manufacturer’s negligence is the only recognized basis of liability.” n v. Richter 3 A.2d 888 (Pa. 1996).

According to the District Court, while the Supreme Court of Pennsylvania had not yet extended the Section 402A exception to prescription medical devices, the Pennsylvania Superior Court, as well as many courts outside Pennsylvania, had already done so. The Court thereby found such precedent sufficient to conclude that “as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices.” Notably, in recognizing what it termed as a “blanket exception” within Section 402A, the Court refused to allow for a “case-by-case, product-by-product analysis” to determine whether the medical device at issue was unavoidably unsafe. Thus, defendant’s motion was granted and plaintiff’s claims for strict liability were dismissed.


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