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, March 30, 2015

High Court rejects request to reverse failure-to-update label ruling

By Susan Lasser, J.D.

A request by the manufacturer of a generic drug that the U.S. Supreme Court review a ruling by the Iowa Supreme Court which allowed an injured patient’s claims to move forward based on the generic drug manufacturer not updating its drug labels to match the brand name manufacturers’ updated labels was declined. The generic drug maker argued that the state supreme court took the wrong side in a split among the circuits and that the court should have ruled that the claim was preempted under federal law (PLIVA, Inc. v. Huck, Docket No. 14-544, filed November 10, 2014, cert. denied March 30, 2015).

Background. Theresa Huck was prescribed the brand name drug, Reglan, to treat acid reflux disease. When she was prescribed the drug, the label contained warnings that the drug was not approved for therapy longer than 12 weeks and addressed possible side effects, one of which being tardive dyskinesia, a severe neurological disorder that, among other symptoms, leads to involuntary body movement. Five months after Huck began taking the drug, the Food and Drug Administration (FDA) approved an update to the brand name drug label that included a boldface warning concerning the 12-week threshold. PLIVA, Inc., a manufacturer of the generic version of the drug, metoclopramide, did not update its label to match the brand name label. Huck only ingested generic metoclopramide tablets manufactured by PLIVA. Two years after the updated labeling, Huck stopped taking the prescription and was diagnosed with tardive dyskinesia. Two years after her diagnosis, Huck filed suit against PLIVA, the brand name manufacturers, and several physicians. Huck’s legal challenges asserted products liability, fraud, and warranty violations. All of the defendants eventually managed to obtain judgment in their favor. Through multiple challenges, Huck’s claims reached the Iowa high court.

Iowa Supreme Court ruling. The generic drug manufacturer argued that all of the patient’s claims were preempted because it was impossible for the manufacturer to comply with both federal law and the state law requirements of her claims. In other words, PLIVA argued that it was complying with FDA requirements and the patient could not impose additional regulatory requirements on a drug the FDA had already approved.

The Iowa Supreme Court held that was true for each of the patient’s claims, except for those which turned on her allegation that the generic drug manufacturer was obligated to update its label to match the changed brand name drug label. The state high court held that PLIVA was responsible for updating its label to match the brand name manufacturer’s label, and that the generic drug maker’s failure to do so could establish a failure-to-warn claim. Thus, the court held that the patient’s claims against PLIVA were not preempted because they were consistent with FDA labeling requirements for generic drugs.

Question presented. The generic drug manufacturer noted that it was presenting the same question to the court as did Teva Pharmaceuticals USA, Inc. in another petition, Teva Pharmaceuticals USA, Inc. v. Superior Court of Orange County (Pikerie) (Docket No. 13-956). The Supreme Court denied that petition on January 20, 2015 (see the Products Liability Law Daily, December 23, 2014, and January 21, 2015, analyses). In that case, the patient, Oleg Pikerie, was prescribed and took the brand-name drug, Fosamax® (manufactured and sold by Merck Sharp & Dohme Corp. and Merck & Co., Inc.) and/or its generic form, alendronate sodium (both, bisphosphonates for the treatment and prevention of osteoporosis), from 2006 to 2011. The patient complained that a bone fracture she suffered was caused by her use of the drugs. Her claims were preempted by federal law, except for her claim against the manufacturer of the generic drug that it failed to update its label to match the brand name drug label.

Here, PLIVA’s question to the Supreme Court was: Whether the Iowa Supreme Court erred when it deepened an acknowledged circuit split among the federal and state appellate courts and held—contrary to the Supreme Court’s decisions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); the Fifth Circuit’s decisions in Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605 (5th Cir. 2014), Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014), and Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013); the Sixth and Eleventh Circuits’ decisions in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378 (6th Cir. 2013), and Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013); and the plain language of the federal Food, Drug, and Cosmetic Act (FDCA)—that federal law does not bar state tort claims predicated on allegations that a generic drug manufacturer violated the FDCA by failing to immediately implement or otherwise disseminate notice of labeling changes that the U.S. Food and Drug Administration (FDA) approved for use on the generic drug product's brand-name equivalent?

The docket number is 14-544.

Attorneys: Jay P. Lefkowitz (Kirkland & Ellis LL) for PLIVA, Inc. Louis M. Bograd (Center for Constitutional Litigation, P.C.) for Theresa Huck.

Companies: PLIVA, Inc.

MainStory: TopStory SupremeCourtNews PreemptionNews WarningsNews DrugsNews

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.