August 26, 2008
Cornell Law Review Symposium - U.S. Food and Drug Regulation in Its First Century and Beyond
The recently published Cornell Law Review Symposium, "U.S. Food and Drug Regulation in Its First Century and Beyond," includes the following articles: James T. O'Reilly, Losing Deference in the FDA's Second Century: Judicial Review, Politics & a Diminished Legacy of Expertise, 93 Cornell L. Rev. 939 (2008); Carl Tobias, FDA Regulatory Compliance Reconsidered, 93 Cornell L. Rev. 1003 (2008); Catherine T. Struve, Greater and Lesser Powers of Tort Reform: The Primary Jurisdiction Doctrine and State-Law Claims Concerning FDA-Approved Products, 93 Cornell L. Rev. 1039 (2008).
August 25, 2008
The Tobacco Law Consortium's Newsletter, Legal Update, Is Now Online
The new issue of Legal Update, the Tobacco Control Legal Consortium's newsletter, is now available online. It features the Consortium's most recent publication, “Workplace Smoking: Options for Employees and Legal Rights for Employers.”
August 22, 2008
The FDA and Risk Communication
The FDA This Week: Andy's Take, is written by Randall Lutter, Ph.D., Deputy Commissioner for Policy of the Food and Drug Administration. His focus is on the importance of risk communication, and his take is that that activity is as important as any other undertaken by the FDA, but that the FDA can better take advantage of the science of risk communication to promote better decision-making by consumers. The FDA's recently created Risk Communication Advisory Committee met last Friday for the last time this year. The Committee made several recommendations that will help enhance FDA's risk communication activities. The recommendations advised the FDA us to treat risk communication as a core activity and to plan and provide resources to support it, as well as to take advantage of outside expertise to obtain the research necessary to ensure that risk communications are grounded in scientific standards. They also advised development of a process to involve both the public and healthcare professionals in deciding how we communicate with the public. The FDA has created an internal Communications Council to act on the Advisory Committee's advice.
August 21, 2008
Medical Devices - Pleading to Avoid Preemption
An Illinois federal district court suggested two possible ways to get around a federal preemption ruling even as it dismissed a medical device product liability complaint on preemption grounds (Heisner v. Genzyme Corp., N.D. Ill., No. 08-C-593, 7/25/08), The court noted that the U.S. Supreme Court's ruled in Riegel v. Medtronic, 128 S.Ct. 999 (2008) that the preemption provision in the Medical Device Amendments to the Food, Drug and Cosmetic Act applicable to Class III medical devices that have satisfied the Food & Drug Adminstration's premarket approval process, precludes state common-law tort claims against device manufacturers if those claims would impose requirements that are "different from, or in addition to" federal requirements for the device. But, the court said, the Riegel opinion specifically declined to address whether claims based on state requirements that are "parallel to" federal requirements are preempted.
The parallel exception applied when resolution of a plaintiff's state law claims would impose requirements that are "substantially identical" to the applicable federal requirements. For example, a state-law-based claim for failure to comply with federal requirements (such as a manufacturing defect claim) would not, if successful, impose a requirement different from or in addition to a federal requirement. The complaint in Heisner referred only to a "defect" in the device, making it impossible for the court to determine whether a failure to comply with federal requirements was alleged therefore allowing the claim to proceed. If the claim was simply that the alleged defect was intrinsic to the device, then it would be preempted. The court gave the plaintiff leave to amend to clarify the nature of the defect claim.
Similarly, the court gave Heisner leave to amend his complaint to state a claim that Genzyme had failed to comply with post-approval reporting requirements. The complaint contained a "vague suggestion" that Genzyme may have violated these reporting requirements, but was insufficient to put Genzyme on notice of such a claim.
August 12, 2008
Texas Plaintiffs' Claims Preempted by Buckman
The judge overseeing multidistrict litigation regarding the bone-building drugs Aredia and Zometa dismissed plaintiffs' claims finding that a Texas law shields manufacturers of Food & Drug Administration-approved drugs from liability for failure to warn. In re: Aredia and Zometa Products Liability Litigation, M.D. Texas, No. 06-1760, 7/25/08. A separate provision of the Texas shield law provides that a plaintiff may rebut the presumption of non-liability by showing that the defendant withheld from or misrepresented to the FDA, the required information that was material to the drug's performance and was causally related to the plaintiff's injury. The Texas law's rebuttal standard, however, amounts to a "fraud on the FDA" claim of the kind that is preempted by federal law for the reasons expressed in the U.S. Supreme Court's ruling in Buckman v. Plaintiffs' Legal Committee, 121 S.Ct. 1012 (2001).
August 11, 2008
Consumer Expectation Test Applied to Airbag Defect Claim
The U.S. Court of Appeals for the Sixth Circuit overturned a summary judgment ruling in favor of Honda Motor Company in a case involving a non-deploying airbag. The court said that since the plaintiff stated her expectation about the airbag and Honda's own brochure regarding the car's safety features created an expectation about the airbag's deployment, the consumer expectation test applied under Tennessee law. The plaintiff's circumstantial evidence regarding the vehicle's speed at the time it collided with a tree was enough from which a jury could find that the airbag should have deployed and was, therefore, adequate to survive summary judgment. See the report on Sigler v. American Honda Motor Co., 6th Cir., No. 07-5471, 7/8/08) in Product Liability Daily.
August 7, 2008
When is a Product Seller a "Seller" for Strict Liability Purposes?
The U.S. Court of Appeals for the Second Circuit has certified an important question of state product sliability law to the New York Court of Appeals. A worker suffered a serious hand injury while working for Glenville Universal Packaging and operating a machine used to manufacture cardboard boxes. The machine had been purchased second-hand in 1971 by Weyerhaeuser and used by them for 15 years before it was sold to Glenville. The federal district court trial judge dismissed the worker's suit, agreeing with Weyerhaeuser's position that, having sold only 19 of these machines over a 25-year period, it was only a "casual" or "occasional" seller of the product and not a "regular" or "ordinary" seller. However, other evidence showed that Weyerhaeuser owned patents on technology used in the machine and had consulted with the manufacturer on safety issues related to the machine's design. The case is Jaramillo v. Weyerhaeuser, 07-0507-cv.