Included In This Update:
- United States Supreme Court Holds Food, Drug and Cosmetic Act Preempts State Law Claims Against Medical Device that Received Premarket Approval from Food and Drug Administration
- Massachusetts Appeals Court Decertifies Class of Mouthwash Purchasers Due to Differences Among Purchasers’ Exposure to, and Reliance on, Allegedly Deceptive Advertisements
- Massachusetts Superior Court Refuses to Certify Class of Buyers/Lessees of Vehicles that Included Twenty-Three Distinct Jacks, Finding Lack of Common Factual Issues, Predominance of Common Over Individual Issues and Superiority of Class Action Method of Adjudication Over Individual Claims
- Massachusetts Appeals Court Holds Alleged Failure to Warn Was Not Proximate Cause of Injury Because Plaintiff Did Not Read and Heed the Warnings that Were Provided
- Massachusetts Appeals Court Holds Failure to Move for Dismissal Within Reasonable Time Waives Pleaded Defense of Insufficient Service of Process
Excerpt:
United States Supreme Court Holds Food, Drug and Cosmetic Act Preempts State Law Claims Against Medical Devices that Received Premarket Approval from Food and Drug Administration
In Riegel v. Medtronic, Inc., --- U.S. --- , 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008), a balloon catheter ruptured in plaintiff’s coronary artery while he was undergoing a coronary angioplasty, requiring him to undergo emergency bypass surgery and be placed on life support. Plaintiff, his wife and - after his death - his wife as administrator of his estate sued the catheter’s manufacturer in United States District Court for the Northern District of New York, asserting various claims under New York common law including: strict liability; breach of implied warranty; negligence in the design, testing, inspection, distribution, labeling, marketing, sale, and manufacturing of the catheter; and loss of consortium. The district court dismissed these claims as preempted by the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 360k(a). The United States Court of Appeals for the Second Circuit affirmed and the United States Supreme Court granted certiorari.
The Court noted that the FDCA expressly preempts any state "requirement" purporting to apply to a medical device if the requirement is "different from, or in addition to, any requirement applicable... to the device" under the FDCA and "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device" under the FDCA. The Court first determined that federal law imposed "requirements" on the catheter because the premarket approval process through which the catheter was approved focuses on safety, requires a reasonable assurance of the device’s safety and effectiveness, is specific to the individual device and permits no deviations from the specifications contained in its application for approval. The Court contrasted the premarket approval process to the process under 21 U.S.C. § 510(k) by which many medical devices are cleared for marketing, which focuses on whether the device is "substantially equivalent" to an already marketed device.
The Court then determined that the catheter’s safety and effectiveness were the very subjects of plaintiff’s common law claims and that state common law duties, such as those invoked by plaintiff’s claims, are "requirements." The Court observed that a jury applying state tort law pursuant to a negligence or strict liability standard sees only the costs of a challenged device’s design, not the benefits, and therefore could readily disrupt the federal regulatory scheme by effectively requiring a device to be safer but less effective than FDA approval requires. The court noted that preemption applies only to state law requirements that are "different from, or in addition to," requirements imposed by the FDCA - and not to "parallel" state law requirements - but refused to address plaintiff’s argument that his lawsuit raised parallel state claims, as plaintiff had not made such an argument to the court of appeals.
The Court rejected plaintiff’s argument, based on a reading of a certain FDA regulation, 21 C.F.R. § 808.1.d(1), that state common law requirements cannot be preempted because they are not device-specific, noting that the plain language of the FDCA does not require a state law requirement to be device-specific to be preempted.
Download the Foley Hoag April 2008 Product Liability Update (.pdf)
For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.