Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, April 3, 2017

High Court rejects generic drug makers’ request to review failure-to-warn claim exception to preemption

By Susan Lasser, J.D.

The U.S. Supreme Court has declined review of a petition by manufacturers of a generic version of a brand name drug used for the treatment of gastroesophageal reflux and diabetic gastroparesis who had sought review of a decision by the New Jersey Supreme Court which held that failure-to-warn claims brought against a generic drug manufacturer under state law is not preempted by federal law if the generic manufacturer used outdated and inferior labeling warnings compared with the brand-name manufacturer’s Food and Drug Administration (FDA)-approved warnings. The state supreme court had stated that although generic drug manufacturers have a duty of "sameness" to not alter their labels to meet state-law duties, failure to alter their labels to align with brand-name labeling can remove their protections under the federal Food, Drug and Cosmetic Act (FDCA) preemption doctrine (PLIVA, Inc. v. Kohles, Docket No. 16-684, filed November 21, 2016; cert. denied April 3, 2017).

Reglan® is a metoclopramide tablet prescription drug used for the treatment of gastroesophageal reflux and diabetic gastroparesis. The FDA approved Reglan for marketing in 1980, and since then has issued stronger warning labels warning of the possibility of developing tardive dyskinesia, a severe neurological disorder, as a result of taking metoclopramide for more than 12 weeks. Stronger labeling changes were issued in 1985, 2004, and 2009. In 2011, the U.S. Supreme Court ruled in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) (Mensing), that generic drug manufacturers are obligated to provide the same warning labels as those provided by the brand-name drug manufacturer and, therefore, state laws that would require generic manufacturers to give warnings exceeding those approved by the FDA are preempted by the FDCA. As a result, manufacturers of generic metoclopramide tablets generally cannot be held liable for failure to warn consumers of the dangers associated with the drug [see Products Liability Law Daily’s July 14, 2014 analysis].

Nearly 1,000 individuals in New Jersey filed lawsuits against more than 50 brand-name and generic manufacturers of metoclopramide for alleged injuries caused by taking the drug. The lawsuits were consolidated into a master complaint. Of the defendant manufacturers, PLIVA, Inc.; Barr Pharmaceuticals, LLC; Barr Laboratories, Inc.; Watson Laboratories, Inc.; Actavis-Elizabeth LLC; Teva Pharmaceuticals USA, Inc.; Mutual Pharmaceutical Company, Inc.; and United Research Laboratories, Inc. did not change their labeling to match the 2004 and 2009 FDA-approved brand-name label warnings. The plaintiffs—consumers who were prescribed and used metoclopramide tablets after the FDA approved the 2004 label warnings—alleged that the generic manufacturers did not update their labeling and packaging inserts to match the FDA warnings until long after the warnings were issued. The generic manufacturers argued that the claims were preempted under Mensing.

New Jersey Supreme Court ruling. The New Jersey Supreme Court determined that Mensing was inapplicable to this situation because the plaintiffs were not seeking to impose a duty beyond that of federal law onto the generic defendants. Rather, they were arguing that the generic manufacturers could have given stronger warnings and, in fact, were required to do so under federal law. In this case, it was possible for the manufacturers to comply both with the FDA "sameness" requirement and the state-law duty to warn. Because the generic manufacturers failed to comply with the sameness requirement when they did not promptly update their warning labels to match that of Reglan, the plaintiffs were imposing a parallel duty to that of the FDCA, not one in excess of it. The court remanded the consolidated suit to the trial court for further proceedings.

Petition. The generic drug makers asked the High Court whether the prohibition on private enforcement of the FDCA precluded state-law tort claims predicated on allegations that a generic drug manufacturer violated the FDCA by failing to implement FDA-approved labeling changes in a manner considered timely under state law. The manufacturers argued in support of the High Court’s granting their petition that the New Jersey decision: implicated "an entrenched division of authority in the lower courts"; conflicted with prior U.S. Supreme Court precedent in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001); and undermined federal policy. The Court, however, denied their petition.

The case is Docket No. 16-684.

Attorneys: Jay P. Lefkowitz (Kirkland & Ellis LLP) for PLIVA, Inc.; Barr Pharmaceuticals, LLC; Barr Laboratories, Inc.; Watson Laboratories, Inc.; and Teva Pharmaceuticals USA, Inc. Louis M. Bograd (Motley Rice, LLC) for Phyllis Kohles.

Companies: PLIVA, Inc.; Barr Pharmaceuticals, LLC; Barr Laboratories, Inc.; Watson Laboratories, Inc.; Teva Pharmaceuticals USA, Inc.

MainStory: TopStory SupremeCtNews PreemptionNews WarningsNews DrugsNews NewJerseyNews

Back to Top

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability 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.