A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval. The case is Vanda Pharmaceuticals, Inc. v. FDA, No. 22-cv-938, 2023 U.S. Dist. LEXIS 51853 (D.D.C. Mar. 27, 2023), and the plaintiff was a
Today’s guest post is by Jim Fraser of Greenberg Traurig. Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”). Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases. As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.
********
Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues. For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.
Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.
On this date 46 years ago, President Nixon and his aides had a conversation about the Watergate break-in and cover-up. What did they say? We do not fully know, because the tape of the conversation has an 18 and ½ minute gap. That gap was one of the more mysterious aspects of an ugly