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Today s post discusses a recent implied-preemption decision
that is relevant beyond the generic-drug context in which it
arose.
A bit of background first.
In
Buckman Company v. Plaintiffs Legal Committee,
531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. §
337(a)-which declares that all actions to enforce the FDCA shall be by and in the name of the United
States -impliedly preempts any private suit seeking to enforce
the FDCA. Thus, under
Buckman, a state-law tort claim is
barred by federal law if it exist[s] solely by virtue of the
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It may be tempting to dismiss as boilerplate the choice of
law discussion that precedes the standard of
review in a typical brief. But while choice of law may not
always be challenging or pivotal, just as often it is both.
Today s case,
Peterson v. C.R. Bard Incorporated, 2021
WL 799305 (D. Or. Mar. 2, 2021), is a good example.
In
Peterson, the plaintiff, then a resident of
Pennsylvania, received the defendant s IVC (inferior vena cava)
filter at a Pennsylvania hospital. He moved to Oregon, where he
The Life Sciences industry can be particularly challenging for companies to navigate, often requiring careful navigation through rigorous testing and regulatory compliance.
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On February 26, 2021, Judge LaShann DeArcy Hall, of the United
States District Court for the Eastern District of New York,
dismissed with prejudice a putative class action asserting claims
under the Securities Exchange Act of 1934 against a pharmaceutical
company and certain of its officers.
In re Alkermes
Public Ltd. Co. Sec. Litig., No. 18-CV-7410 (LDH) (RML), slip
op. (E.D.N.Y. Feb 26, 2021). Plaintiff alleged defendants
made misstatements concerning clinical trials for a drug that
ultimately did not secure FDA approval. The Court held that
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Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA practices,.