Sandoz v. Amgen
Lynn C. Tyler, Barnes & Thornburg
The Supreme Court and the Federal Circuit hold that the innovator of a biologic cannot obtain injunctive relief to enforce a biosimilar applicant’s disclosure obligations under the Biologics Price Competition and Innovation Act.
Bristol-Myers Squibb v. Superior Court of California
Mark E. Haddad and Naomi A. Igra, Sidley & Austin
The Supreme Court limits a state’s jurisdiction over a non-resident drug company in a product liability case to claims brought by plaintiffs who either resided in the state or incurred injury in the state.
T.H. v. Novartis
Anand Agneshwar and Jocelyn Wiesner, Arnold & Porter
The Supreme Court of California finds that a brand-name manufacturer can be liable for failure to update a label even when the plaintiffs used a generic version of the product, years after the brand-name manufacturer last held rights to it.
Eike v. Allergan
William M. Janssen, Charleston Law School
The Seventh and Third Circuits go separate ways on whether eye drop patients, alleging the medicine bottles dispense drops in sizes that are too large, have the constitutional right to sue pharmaceutical companies.
In re Fosamax Product Liability Litigation
James M. Beck, Reed Smith
The Third Circuit rules that even FDA’s prior consideration of, and decision not to adopt, the safety warnings advocated by a plaintiff does not preempt the plaintiff’s suit under state law.
U.S. ex rel Campie v. Gilead
Anne K. Walsh and Andrew J. Hull, Hyman, Phelps & McNamara
The Ninth Circuit finds that in a False Claims Act action predicated on Food, Drug & Cosmetic Act violations, FDA’s decision not to take the product off the market does not preclude the violation being material.
LabMD v. FTC
Ginger Pigott and Richard Tabura, Greenberg Traurig
The Eleventh Circuit pondered whether the enforcement of reasonable data security practices falls within the FTC’s unfairness authority.
FTC v. Quincy Bioscience
Megan Olsen, Council for Responsible Nutrition
In the Southern District of New York, a District Court finds that the FTC failed to meet its burden to show that the cognitive benefits of a dietary supplement were falsely advertised.
Nicopure Labs v. FDA
Stacy L. Ehrlich and James William Woodlee, Kleinfeld Kaplan & Becker
The District Court for the District of Columbia rules that vaping products may be deemed subject to the Family Smoking Prevention and Tobacco Control Act even if they do not contain e-liquids or nicotine.
Singleton v. Fifth Generation
August T. Horvath, Foley Hoag and Rebecca Kirk Fair, Analysis Group
The District Court for the Northern District of New York elaborates the standard for a damages model to pass muster under the Rule 23(b)(3) predominance standard in the post-Comcast world.
Significant Settlements of 2017
Jacqueline J. Chan, Kleinfeld Kaplan & Becker
Regulatory, Compliance and Enforcement Developments of 2017
Jonathan A. Havens, Saul Ewing Arnstein & Lehr
Food and Drug Cases to Watch in 2018
The contributing authors