Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Colacicco v. Apotex: A New Era in Prescription Drug Pre-emption
Prescription drug manufacturers have unsuccessfully asserted pre-emption as a defense to product liability claims for decades. A new FDA final rule and the first federal case interpreting that rule indicate that the tide may be turning. On May 25, 2006, Judge Baylson of the U.S. District Court for the Eastern District of Pennsylvania issued his opinion in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006). The decision is the first federal court opinion discussing the pre-emptive effect of the preamble to the FDA's final rule on prescription drug labeling (the 'preamble'). See 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006). See Lasker article infra at 5.
In Colacicco, the court dismissed the plaintiff's failure-to-warn claims against generic and brand name drug companies, based on its determination that it was required to defer to the FDA's statements on pre-emption in the preamble and in an amicus brief filed in the case. In a notable alternative holding, the court also found that a brand name drug manufacturer owes no duty to a plaintiff who took only the generic version of a prescription drug. The lengthy, detailed opinion, which is currently on appeal to the Third Circuit, has been labeled 'profoundly wrong' by members of plaintiffs' bar and is certain to be widely cited in prescription drug cases around the country. See Brief of Amicus Curiae the Pennsylvania Trial Lawyers Association in Opposition to Defendant's Motion for Summary Judgment (Pre-emption), Woodward v. Pfizer, Inc., No. 05-CV-3764, at 3 (E.D. Pa. filed June 8, 2006). To understand the court's reasoning and the scope of the opinion, it is necessary to discuss the FDA preamble and history of the case.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Blockchain Domains: New Developments for Brand Owners
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.