Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, December 16, 2013

Violations of FDA-approved labeling are solely federal claims

By Harold M. Bishop, JD

A remaining state failure to warn claim against generic manufacturers of an acid reflux drug was found to be preempted by federal law and dismissed with prejudice. The federal district court, which previously allowed the Louisiana state claim to stand, reversed its ruling based on a subsequent decision of the Fifth Circuit, which held that (1) failure to warn claims alleging violation of FDA labeling laws are solely federal claims, and (2) generic manufacturers cannot take any unilateral action to warn physicians of potential dangers (Cooper v Wyeth, Inc., December 11, 2013, Dick, S).

Background. Robert Cooper (Cooper) was prescribed and ingested the generic drug metoclopramide (brand name Reglan) from 1998 to 2009 to treat acid reflux. Sue Ann Cooper did not ingest the drug. Her claims are derivative of her husband’s claims. The generic metoclopramide ingested by Cooper was allegedly manufactured by PLIVA, Inc. (PLIVA), Teva Pharmaceuticals USA, Inc. (Teva), and Watson Laboratories (Watson). Cooper’s claims against Teva have been previously dismissed.

Neither Cooper nor his physicians were aware of any information about the drug that was contrary to the information disseminated in the Physician’s Desk Reference (PDR) or package inserts provided by PLIVA and Watson. Importantly, the brand manufacturers, beginning in 2004, changed their labeling to include warnings when the drug is used beyond 12 weeks. In 2009, Cooper began to show signs of central nervous system and extrapyramidal motor system injury, including tardive dyskinesia, a severe and often permanent disfiguring neurological movement disorder. As a result, Cooper filed suit alleging his injuries were the result of the metoclopramide ingestion.

In 2011, PLIVA, Teva, and Watson filed a motion to dismiss alleging preemption. On March 6, 2012, the court found that all of Cooper’s claims were preempted except one arising out the Louisiana Products Liability Act (LPLA). The LPLA claim, based on a failure to warn, alleged that both the brand and generic manufacturers failed to update their labeling to reflect FDA approved labeling changes from 2003 and 2004, which prohibited long-term use of the drug. The court based its decision on PLIVA v. Mensing (June 23, 2011), where the U.S. Supreme Court held that generic labeling must be the same as brand drug labeling at all times.

Analysis. PLIVA and Watson filed a motion asking the court to reconsider its decision allowing the LPLA claim to stand due to the Fifth Circuit’s subsequent decision in Morris v PLIVA, Inc. (February 14, 2013), which interpreted the Supreme Court’s decision in PLIVA v Mensing.

In allowing the LPLA claim to stand, the court believed that the generic manufacturer could have sent out “Dear Doctor” letters or other forms of communication warning physicians of new brand drug labeling changes without running afoul of any federal law. The Fifth Circuit decision in Morris, however, found that generic manufacturers must follow the lead of the brand manufacturer and cannot take any unilateral action, such as “Dear Doctor” letters or other communication. In addition, the court’s earlier conclusion, that Cooper’s failure to update labeling claim was a state claim, is also contrary to Morris, where the Fifth Circuit clearly explained that all claims for violation of FDA labeling laws are solely federal claims.

As a result, the court granted reconsideration and dismissed Cooper’s remaining LPLA claim with prejudice. The court’s ruling has no bearing on Cooper’s claims against Wyeth LLC.

The case number is 09-929-SDD-SCR.

Attorneys: Steven Courtney Gill (Law Offices of Steven Gill Attorney At Law) for Robert S. Cooper. David Michael Melancon (Irwin, Fritchie, Urquhart & Moore, LLC) for Wyeth, Inc.

Companies: Wyeth, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicalNews GenericDrugNews LabelingNews PLDrugNews PreemptionNews PrescriptionDrugNews

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.