We have significant experience litigating pharmaceutical drug and medical device preemption issues throughout the state and federal court systems, including in the United States Supreme Court, and across a broad range of industries. Our practice spans a variety of statutory regimes, including statutes regulating prescription drugs, biological products, and medical devices. In this arena, we draw collaboratively on the combined experience of lawyers in our products liability, appellate, healthcare, and food and drug law practices. We routinely advise clients about how regulatory actions may affect later preemption arguments, brief critical preemption motions at the trial level, and handle appeals.
We represented the party or amici curiae in three recent, high-profile, cases involving federal preemption in the pharmaceutical context:
- Warner-Lambert v. Kent (United States Supreme Court) (scope of the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, as it relates to a Michigan product liability statute) (representing petitioner)
- Riegel v. Medtronic, Inc. (United States Supreme Court) (preemption of state-law claims regarding premarket approved medical devices) (Advanced Medical Technology Association (AdvaMed), DRI, Medmarc and the Medical Device Manufacturers Association (MDMA) as amici curiae in support of respondent)
- Wyeth v. Levine (United States Supreme Court) (preemption of state-law claims regarding prescription drug Phenergan) (DRI as amicus curiae in support of petitioner)
A few recent examples of our work in preemption cases across the country on behalf of pharmaceutical clients include the following:
- In re Trasylol Prods. Liab. Litig., No. 08-md-1028, slip op. at 25-30 (S.D. Fla. May 10, 2010) (excluding purported evidence of fraud on the FDA, including testimony by plaintiffs’ proposed regulatory expert witness, as preempted by Buckman)
- Pennsylvania Employee Benefit Trust Fund v. Zeneca, Inc., -- F.3d --, 2007 WL 2376312 (3d Cir. 2007) (preemption of claims of false advertising of a prescription drug)
- Biotechnology Industry Organization v. District of Columbia, 496 F.3d 1362 (Fed. Cir. 2007) (representing the Biotechnology Industry Organization as amicus curiae in a successful preemption challenge to the District of Columbia’s Prescription Drug Excessive Pricing Act of 2005)
- In re Bextra & Celebrex Mktg. Sales Pracs. & Prods. Liab. Litig., No. MDL-1699, 2006 WL 2374742 (N.D. Cal. 2006) (preemption of failure to warn claims involving prescription drugs)