For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k. Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor. A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims. On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.
Subject: Medical Devices
FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”
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Remembering Stengel and Celebrating the Arizona Supreme Court
Those familiar with his legend know that Hall of famer Casey Stengel managed the New York Yankees in their mid-century heyday and, for a short time at their inception, the New York Mets. But he also is remembered as one of baseball’s great characters.
One story about Stengel was told by the great broadcaster Curt Gowdy. He was having a beer with Stengel at a bar in Cleveland. Stengel received his beer and quickly downed it in one long gulp, leading Gowdy to ask why he drank it so fast. Stengel said he drank beer that way ever since “the accident.”
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§ 510(k) Safety and Effectiveness – A Changing Landscape for Punitive Damages?
The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence process for Class II medical devices involves an FDA finding of safety and effectiveness. It is part of a trend of recent federal cases giving credence to the § 510(k) process, which could have significant implications for punitive damages claims brought against manufacturers of Class II devices.
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