Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Product Liability Law & StrategyLJN NewslettersNewsSections

Colacicco v. Apotex: A New Era in Prescription Drug Pre-emption

By Donald C. Le Gower

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

  • 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

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.

Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers Image

There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.

Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

Transfer Tax Implications on Real Property Leases Image

The real property transfer tax does not apply to all leases, and understanding the tax rules of the applicable jurisdiction can allow parties to plan ahead to avoid unnecessary tax liability.

When Is a Repair Structural or Nonstructural Under a Commercial Lease? Image

A common question that commercial landlords and tenants face is which of them is responsible for a repair to the subject premises. These disputes often center on whether the repair is "structural" or "nonstructural."