Law.com Subscribers SAVE 30%

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

KickerFeaturesSectionsNewsLJN NewslettersProduct Liability Law & Strategy

Preemption and Generic Drug Liability

BY Alan Minsk
August 29, 2013

To quote Michael Corleone from the forgettable The Godfather: Part III, “Just when I thought I was out, they pull me back in.” In 2011, we thought we had heard the last from the courts on whether preemption prevented generic drug manufacturers from being held liable under state failure-to-warn statutes. The answer was yes ' preemption exists because manufacturers cannot comply simultaneously with their state duty to adequately warn on the labels and their federal obligation to have the same label as their branded drug counterpart. See PLIVA v. Mensing, 131 S. Ct. 2567 (2011).

The 2011 decision followed the Court's 2009 holding that, regarding branded drug manufacturers, state failure-to-warn lawsuits were not preempted by federal law because branded manufacturers may strengthen the warnings in labels on their own initiative. See Wyeth v. Levine, 555 U.S. 555 (2009). Now, the trilogy continues with Fulgenzi v. PLIVA (6th Cir. No. 12-3504, March 13, 2013). While this case has not reached the Supreme Court, it attempts to further define preemption and potential product liability claims against generic drug companies. In short, preemption might not apply in certain cases, as discussed below. The Sixth Circuit pulls us back in. (One month before the Sixth Circuit decision, the Fifth Circuit ruled in a strikingly similar case (same generic drug manufacturer and drug product, but slightly different state-law claims) and rejected the argument that a generic manufacturer could be held liable for failing to update the generic drug label to match a revised brand-name label. Morris v. PLIVA, (5th Cir. No. 12-30319, Feb. 14, 2013). This article focuses on the Fulgenzi ruling.)

Background

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
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models Image

Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.

Hyperlinked Documents: The Latest e-Discovery Challenge Image

As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.

Identifying Your Practice's Differentiator Image

How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.

Risks and Ad Fraud Protection In Digital Advertising Image

The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.

Turning Business Development Plans Into Reality Image

This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.