Litigation partner and head of the firm’s Life Sciences group William Hoffman spoke with Law360 about a recent California federal court decision, which found that drugmakers were shielded from state law claims because the U.S. Food and Drug Administration would not have approved the changes to the product labels that the plaintiffs claimed were necessary.
In a multidistrict litigation against multiple drugmakers regarding their alleged failure to warn of their Type 2 diabetes drugs' potential to cause pancreas problems, Judge Anthony J. Battaglia found that defendants had met the so-called "clear evidence" standard established by the Supreme Court's landmark 2009 ruling in Wyeth v. Levine. The 2009 ruling mandated that branded-drug makers could be held liable to patients for potential labeling issues, finding that even though FDA oversees the pharmaceutical industry, manufacturers still have to maintain the adequacy of product labeling.
"This opinion gives a roadmap to other courts for the way they should handle this issue, and the way they should treat FDA regulatory actions as evidence bearing on the preemption questions," said Hoffman.
"There have been a range of decisions on this question since 2009, a range of decisions based on different records," he added. "This is probably the most thorough discussion of the question, and reflects what I think is the kind of considered analysis of a regulatory record that the Supreme Court contemplated in Levine."
Also of Interest
- And Now A Word From The Panel: 3 Alternatives To MDLs September 28, 2016 • Articles
- Kaye Scholer Represents Investors in Volkswagen Diesel Emissions Litigation September 28, 2016 • Client Successes
- NLJ Names Shores as Antitrust Trailblazer September 27, 2016 • Recognitions
- Shape of Things to Come: Protecting Product Configuration and Packaging Design September 26, 2016 • Articles
- On the Road to a Safe and Secure Internet of Things: What Companies Should Do September 19, 2016 • Articles
- Druckenbrodt Quoted in Bloomberg on Volkswagen Dieselgate September 14, 2016 • Media Mentions
- Arbisser Featured in The Recorder and Law360... September 7, 2016 • Media Mentions
- Consumer Products: Adapting to Innovation Fall 2016 • Reports / Newsletters
- ILS and Zinsser Analytic Shareholders Sell to Gardner Denver Medical September 2, 2016 • Client Successes