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, August 27, 2014

Revival of action against generic drug makers based on failure to update labels

By Susan Lasser, J.D.

A patient’s failure-to-warn claim against the manufacturers of the prescription drug metoclopramide was given new life by the Missouri Court of Appeals which ruled that the portion of the patient’s failure-to-warn claim against the manufacturers of the generic form of the drug concerning those manufacturers’ failure to update their warning labels to match the revised brand name drug label survived the manufacturers’ assertion of a preemption defense. The court found that it was not impossible for the generic manufacturers to comply with their duties both under the applicable Kentucky state law and under the Federal Food, Drug, and Cosmetic Act (FDCA) by updating their labels to conform to the 2004 revision of the label for Reglan®, the brand name version of the drug. Other portions of the patient’s failure-to-warn claim were preempted, the court held, affirming the trial court in part. The appellate court also affirmed the lower court’s finding that the brand name manufacturers were not liable for the patient’s injuries because the patient only ingested the generic version of the drug. Finally, the court of appeals panel reversed the trial court’s dismissal of the patient’s claims against a company that provided prescription drug information services to pharmacists and physicians and that disseminated information about metoclopramide (Franzman v. Wyeth, Inc., August 26, 2014, Odenwald, K.).

Background. The patient and a Kentucky resident, Helen Franzman, brought suit under Kentucky law in Missouri state court. Franzman was diagnosed with tardive dyskinesia, a movement disorder characterized by involuntary and repetitive movements, following her prolonged use of metoclopramide, a prescription drug used to treat digestive problems including diabetic gastroparesis and gastroesophageal reflex disorder. Metoclopramide is also sold under the brand name Reglan. Persons who ingest metoclopramide for extended periods of time have an elevated risk of developing tardive dyskinesia, which is often irreversible and permanent.

In March 2002, Franzman was prescribed a regimen of Reglan/metoclopramide to treat gastroparesis, an intestinal disorder. Under Kentucky‘s generic-substitution law, Franzman‘s pharmacy filled the prescription with generic metoclopramide. She continued to use metoclopramide until October 2005, when she sought treatment for certain involuntary movements. At that time, she discontinued her use of metoclopramide, and in March 2006, she was diagnosed with the illness. On June 28, 2012, the patient filed a 12-count amended petition against the defendants.

Even though the patient ingested only the generic form of the drug, she sought damages from all parties responsible for disseminating information about the risks associated with long-term use of both Reglan and the generic metoclopramide. In general, she alleged that the manufacturers and sellers of the generic metoclopramide she ingested (generic manufacturers), as well as the manufacturers and sellers of Reglan (brand manufacturers), failed to reasonably and adequately warn of the risks and dangers associated with long-term use of the drugs. Watson Laboratories, Inc. and Watson Pharma, Inc. were the manufacturers of generic metoclopramide sued by the patient; and Wyeth LLC, Wyeth Pharmaceuticals Inc., and Schwarz Pharma Inc. n/k/a UCB Inc. were the manufacturers of brand-name Reglan in her suit. Lastly, the patient sought damages for her injuries from First Databank, Inc.—a company that provided prescription drug information services to pharmacists and physicians and that disseminated information about metoclopramide.

The generic manufacturers argued that the patient’s claims against them should be dismissed because they were preempted by the FDCA, pursuant to the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). First Databank argued the patient’s claims were barred by the Kentucky statute of limitations, while the brand manufacturers contended that the patient’s claims against them lacked the required legal causation because she never ingested brand-name Reglan manufactured by them. The trial court agreed with all three and entered final judgment in the defendants’ favor on all claims.

Points on appeal. The patient posited three issues for appeal. First, she argued that the trial court erred in finding that federal law preempted all of her claims against the generic manufacturers. She asserted that preemption did not apply to all of her claims against those manufacturers—i.e., that not all involved state law duties that conflicted with federal law. Thus, the lower court should not have dismissed her case against the generic manufacturers in its entirety. Second, the patient argued that the trial court erred by characterizing her claims against the brand manufacturers as product liability claims, and consequently finding that her claims failed as a matter of law for lack of legal causation. The patient argued that Kentucky law allowed her to pursue non-product liability theories of negligence and fraud against the brand manufacturers and that she was not limited to bringing her claims against them under the Kentucky Product Liability Act (KPLA). Third, the patient contended trial court error in its finding that her claim against the information services provider was barred by the statute of limitations. She maintained that under Kentucky‘s discovery rule, her cause of action did not accrue until February 26, 2009, when the Food and Drug Administration (FDA) issued its black box warning advising of the increased risk of developing tardive dyskinesia with long-term use of metoclopramide. Because she filed her petition within one year of the issuance of the black box warning, she argued that her claims were filed in a timely manner.

Scope of immunity under Mensing as to generic drug manufacturers. The patient objected to the trial court’s finding that Mensing provided blanket immunity to manufacturers of generic drugs. She had asserted a variety of claims against the generic manufacturers, alleging different theories of recovery, and the trial court had agreed with the generic manufacturers that the patient’s claims, no matter how they were characterized, were based on a failure to provide adequate warnings, and, as such, were preempted under Mensing’s holding that federal drug regulations applicable to generic drug manufacturers directly conflicted with, and, thus, preempted, state law failure-to-warn claims. The patient argued that the trial court failed to conduct an impossibility preemption analysis as set forth in Mensing to determine whether federal law preempted her state law claims. She claimed that she pleaded several duties based on Kentucky law that the generic manufacturers could have performed without violating federal law, and that the trial court should not have dismissed all her claims against the generic manufacturers because at least some of her state law claims were not preempted by federal law.

The court of appeals agreed with the generic manufacturers that the core allegation of each of the patient’s claims against them was that they failed to adequately warn of the risks associated with long-term use of metoclopramide. The court said that under Kentucky law, all of the patient’s claims were subsumed by the KPLA, and that the Kentucky Supreme Court has held that the KPLA “applies to all damage claims arising from the use of products, regardless of the legal theory advanced.” Thus, the appellate court stated that it would treat all of the patient’s claims as product liability claims based on a theory of failure to adequately warn.

However, the court rejected the contention that all state law failure-to-warn suits brought against manufacturers of generic drugs should be summarily dismissed without a Mensing analysis. The patient alleged that the generic manufacturers failed to adequately warn of the dangers of long-term use of metoclopramide by failing to update their label to conform to the Reglan label revision approved by the FDA in 2004. Therefore, the warning label on the generic metoclopramide ingested by the patient did not include the same bold-face language that was featured on the brand-name label, including the warning: “Therapy should not exceed 12 weeks in duration.” According to the appellate court, while the generic manufacturers were limited as to the warnings they could provide by their “federal duty of sameness,” federal law did not prohibit the generic manufacturers from updating their label to conform to the 2004 Reglan label revision. It was not impossible for the generic drug makers to comply with their duties under Kentucky state law and fulfill their duty under the FDCA and its accompanying regulations by updating their label to conform to the brand name drug label revision of 2004. Therefore, the court of appeals concluded that the patient’s state law failure-to-warn claim was not preempted by federal law to the extent that her claim was limited to the generic manufacturers’ failure to adopt the additional warning language approved in 2004.

In response, the generic drug makers argued that the patient’s suit should be dismissed because there is no state law duty for generic drug manufacturers to conform their labeling to that of the brand-name manufacturer. They maintained that the duty alleged by the patient arose solely under the FDCA which expressly prohibits private causes of action to enforce its provisions. As such, the patient’s suit was premised on violations of federal law and, therefore, was impliedly preempted, according to the generic manufacturers.

However, the appellate court, citing the U.S. Court of Appeals for the Sixth Circuit in Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), ruled that the patient’s claims were not premised on federal law and did not exist solely by virtue of the federal regulatory scheme, but rather stemmed from an independent state law duty. Kentucky law required manufacturers to adequately warn of the foreseeable risks associated with their product, and this duty existed independent and separate of any duty imposed on the generic manufacturers by the FDCA. According to the court, the patient alleged that the generic manufacturers breached their state law duty by failing to update their warning labels to match the 2004 brand-name Reglan revision. Although the generic drug makers’ failure to update their labels also could be a violation of federal law, the court determined that the legal basis for the patient’s claim was Kentucky product liability law, not federal law. Therefore, the court concluded that the patient’s claim was not impliedly preempted. Further, the court said that while it recognized that Mensingwill preclude many state law failure-to-warn claims against generic drug manufacturers, Mensing did not offer blanket immunity to the generic drug market. In reversing the trial court’s dismissal, the court cautioned that the patient was limited to arguing that the generic manufacturers’ label was inadequate to the extent that it did not include the language contained in the revised 2004 brand name drug label. The appellate court affirmed the lower court relating to the generic manufacturers in all other respects.

Claims against brand name drug manufacturers. The court of appeals upheld the trial court’s entry of summary judgment in favor of the brand name manufacturers. The court held that the patient’s claims against the brand name manufacturers fell within the broad scope of the KPLA. Kentucky law required that a plaintiff show that the defendant’s product is the legal cause of the injury. Thus, because the patient admitted that she ingested only generic metoclopramide, she could not prove that the brand name manufacturers’ product was the legal cause of her injury and her claims failed as a matter of Kentucky law.

Statute of limitations defense. The court determined that Kentucky’s statute of limitations applied in the case because the patient’s claim originated in Kentucky. One- and two-year statutes of limitations governed her claims, and Kentucky courts held that an action may not accrue until a plaintiff has knowledge of sufficient facts to state a cause of action. Moreover, under Kentucky law, the discovery rule applied such that the date of actual or constructive knowledge of an injury triggered the running of the statute of limitations.

The court of appeals agreed with the patient that the date of her diagnosis was not determinative of when her cause of action accrued. Although it was clear from her allegations that she discovered the harm by March 2006, she alleged that she did not discover the information services provider’s wrongful conduct—their failure to adequately warn—until the FDA issued its black box warning on February 26, 2009. The court of appeals would not decide when the patient acquired knowledge of her legal injury because it said that that was a question of fact to be decided by a jury. Thus, the court held that the trial court erred in finding the patient’s claim was barred by the statute of limitations, and ruled that the patient was entitled to present evidence to support her claim as to when she acquired the requisite notice of her legal injury.

The case number is ED100312.

Attorneys: Kristine Kraft (Schlichter, Bogard & Denton) for Helen Franzman. Larry E. Hepler (HeplerBroom LLC), Henninger S. Bullock (Mayer Brown LLP), and Kevin C. Newsom (Bradley Arant Boult Cummings LLP) for Wyeth Inc. Aahren R. DePalma (Pitzer Snodgrass, PC) and Ravi V. Sitwala (Hearst Corp.) for First Databank, Inc. Sandra J. Wunderlich (Stinson Leonard Street) and Linda E. Maichl (Ulmer & Berne LLP) for Watson Laboratories.

Companies: Wyeth Inc.; First Databank, Inc.; Watson Laboratories

MainStory: TopStory PreemptionNews WarningsNews DrugsNews MissouriNews KentuckyNews

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.