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From Products Liability Law Daily, August 29, 2013

Consumer could not hold brand-name drug manufacturers liable for injuries caused by generic counterparts

By Kathryn S. Beard, J.D.

A woman whose use of generic metoclopramide caused her to develop a neurological disorder could not hold the manufacturers of the brand-name drug, Reglan®, liable for her injuries (Schrock v Wyeth, Inc., August 28, 2013, Lucero, C). Her claims against the generic manufacturers also were dismissed. The liability claims violated the two-year statute of limitations, and the warranty claims were preempted by federal law.

Background. Metoclopramide, a drug used to treat gastrointestinal disorders, was first approved by the FDA under the brand name Reglan®. Generic manufacturers began production of metoclopramide in 1985. Since 1985, all versions of metoclopramide have had FDA-mandated labeling warning that tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements, may develop in patients treated with the drug. In 2009, the FDA ordered a “black box warning” on metoclopramide labels with regards to treatment lasting over 12 weeks and tardive dyskinesia.

On three occasions between 2000 and 2005, Susan Schrock (Schrock) was prescribed Reglan®. Each time, she purchased generic metoclopramide. In May 2005, Schrock visited a neurologist with “neck drawing and arm weakness” symptoms. The neurologist diagnosed her with a form of neurological movement disorder, and told her it was possibly related to metoclopramide. On the neurologist’s recommendation, Schrock discontinued use of metoclopramide and her symptoms abated. Later, she reported uncontrollable neck twisting, and was formally diagnosed with tardive dyskinesia in July 2007. Schrock filed suit against manufacturers of both generic and brand-name metoclopramide.

Claims against brand-name manufacturers. The court determined that brand-name manufacturers did not owe a duty to Schrock because she did not take brand-name metoclopramide. The Oklahoma Supreme Court has not yet spoken on the issue, so the court predicted that Oklahoma would follow a national trend and general Oklahoma tort law to refuse to recognize a duty flowing from brand-name manufacturers to consumers of generic drugs. Oklahoma courts generally require that a defendant have some relationship with the product alleged to have caused a plaintiff’s injuries, either through manufacturing, selling, or distributing the product. Schrock’s claims against the brand-name manufacturers, including strict liability, negligence, duty to warn, and concealed defect, all failed for lack of the requisite relationship. The court concluded that because the brand-name manufacturers were never in control or possession of the drug Schrock took, she could not establish the requisite relationship and the brand-name drug makers could not be held liable for injuries caused by their generic counterparts.

Non-warranty claims against generic manufacturers. The appellate court also held that Oklahoma’s two-year statute of limitations barred Schrock’s non-warranty claims against the manufacturers of generic metoclopramide (Okla. Stat. tit. 12 sec. 95). Oklahoma follows the “discovery rule,” under which the statute of limitations begins to run when the plaintiff knows or should know that she has the condition for which her action is brought and that the defendant caused it. Plaintiffs need not know the extent of the injury, nor whether it is permanent. When Schrock’s doctor informed her that metoclopramide was possibly responsible for her symptoms in May 2005, the limitations period began. The period did not toll until Schrock received a final diagnosis. Her claims were for involuntary muscle movements caused by metoclopramide (which she was aware of in May 2005). Therefore, the court determined that her claims were barred because she filed suit almost three years after she discovered her injury and its cause.

Warranty claims against generic manufacturers. The court began its analysis of Schrock’s warranty claims by identifying the state law duties Schrock’s claims would impose against the generic manufacturers. The breach of warranty claim contained duties regarding the packaging and labeling of goods (Okla. Stat. tit. 12A sec. 2-314) and the complaint referred to the manner in which the product was labeled, packaged, and otherwise described. The court held that these warranty claims were based on the theory of improper descriptions or warnings in the labeling and packaging of metoclopramide, and, therefore, were preempted by the FDA’s labeling regulations.

In addition, Schrock’s claim that the generic drug was not merchantable, unfit for its intended use, and was unreasonably dangerous was similarly preempted. The court determined that this claim was based on allegations of dangerousness or ineffectiveness, which would impose a duty to alter the composition of the drug (Mutual Pharmaceutical Co. v Bartlett, 133 S. Ct. 2466, 2474-75 (2013)). Federal law requires generic drugs to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based (21 U.S.C. secs. 355(j)(2)(A)(ii)-(v)). The court ruled that because the generic manufacturers could not alter the drug’s composition without violating federal law, Schrock’s merchantability claim was preempted.

Potential injustice. The court closed its opinion by recognizing that Schrock and similarly-situated consumers of generic drugs are in a “catch-22 situation.” Such consumers are unable to obtain relief from brand-name drug manufacturers due to lack of the necessary relationship, but also are unable to obtain relief from generic drug manufacturers because of federal preemption law. The court stated that it has limited authority to correct the “potential injustice” of such situations. Rather, state courts must engage in the policy considerations predicate to expanding the scope of state tort law, and Congress must act to provide consumers of generic drugs with federal relief, according to the court.

The case number is 12-6078.

Attorneys: William Burton Curtis (Curtis Law Group), Terrence J. Donahue, Jr. (McGlynn Glisson & Mouton), and Bryce Johnson (Bryce Johnson & Associates) for Susan Schrock. Kannon K. Schanmugam (Williams & Connolly LLP) for Wyeth, Inc. and Schwarz Pharma, Inc.; Jeffrey Francis Peck (Ulmer & Berne LLP) for Pliva USA, Inc.; Richard H. Nakamura Jr. (Morris Polich & Purdy, LLP) for Qualitest Pharmaceuticals, Inc.

Companies: Wyeth, Inc; Schwarz Pharma, Inc; Pliva USA, Inc.; Qualitest Pharmaceuticals, Inc.

MainStory: TopStory PreemptionNews DrugsNews ColoradoNews KansasNews NewMexicoNews OklahomaNews UtahNews WyomingNews

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