Reglan named in federal product liability claim

Steve Gonzalez Jan. 9, 2008, 4:54am

A Missouri woman filed a strict product liability suit against Wyeth, A.H. Robins Company, Inc., and Schwarz Pharma in federal court Jan. 7, alleging the prescription medication Reglan or its generic, metoclopramide, was defective and unreasonably dangerous.

Shirley Brinkley claims that in June 1992, her physician prescribed Reglan to treat the motility of her stomach which she took until April 2007.

According to the complaint, Wyeth is the successor in interest to A.H. Robins, a Virginia corporation which first obtained approval by the Food and Drug Administration (FDA) to distribute metoclopramide, under the brand name of Reglan, in the U.S.

On Dec. 27, 2001, Wyeth sold the rights and liabilities associated with Reglan tablets and Reglan syrup to Schwarz Pharma, Inc., a Delaware corporation with its principal place of business in Wisconsin.

Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying and is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms.

Brinkley claims that in prescribing Reglan on a long-tern basis, her doctors relied upon information published in the package inserts and/or the Physician's Desk Reference (PDR) and was not aware of information different from or contrary to the inaccurate, misleading, materially incomplete, false and/or otherwise inadequate information disseminated in the PDR.

She claims her long term exposure to Reglan has caused her to suffer serious, permanent and disabling neurological injuries, including Tardive Dyskinesia.

According to the National Institute of Health, Tardive Dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs generally prescribed for psychiatric disorders, as well as for some gastrointestinal and neurological disorders. Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements including grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye-blinking.

Brinkley claims her long-term use of Reglan has caused her to experience and will continue to experience medical and related expenses, loss of ability to provide household services, disfigurement, disability, pain and suffering, psychological injury and other injuries and damages.

"Reglan was not approved by the United States Food and Drug Administration for long-term use," the complaint states.

"Because of the misleading information that the Defendants provided to physicians and the FDA about the true risks associated with the use of Reglan and because of the failure of the Defendants and each of them to adequately inform physicians generally, including Plaintiff's physicians, about the true risks associated with the use of Reglan, her physicians never informed her of any side effects associated with Reglan or that Reglan was only approved for short term use (up to 12 weeks)," the complaint also states.

Brinkley claims the Defendants are liable for acts and/or omissions amounting to negligence, gross negligence and/or malice including, but not limited to:

  • Failure to adequately warn her and her physicians of the known or reasonably foreseeable danger that she would suffer a serious injury or death by ingesting Reglan;

  • Failure to adequately warn her and her physicians of the known or reasonably foreseeable danger that plaintiff would suffer a serious injury by ingesting Reglan in unsafe doses;

  • Failure to use reasonable care in testing and inspecting Reglan so as to ascertain whether or not it was safe for the purpose for which it was designed, manufactured and sold;

  • Failure to use reasonable care in implementing and/or utilizing a reasonably safe design in the manufacture of Reglan;

  • Failure to use reasonable care in the process of manufacturing Reglan in a reasonably safe condition for the use for which it was intended; and

  • Failure to use reasonable care in the manner and method of warning her and her physicians as to the danger and risks of using Reglan in unsafe doses.

    She also claims the defendants committed fraud by making material representations that were false about the number of adverse events even though they had in their possession adverse drug event reports, drug studies, and other documentation about Reglan.

    "Defendants delivered goods that were unfit for Plaintiff's particular purpose, and thus breached their implied warranty of fitness," the complaint states. "Defendants' failure to select and sell a product which was reasonably safe for its intended use proximately caused Plaintiff's injuries and monetary losses."

    Represented by John Driscoll of Brown & Crouppen in St. Louis and Daniel McGlynn and P. Ann Trantham of Baton Rouge, La., Brinkley is seeking damages in excess of $600,000, plus costs.

    "Plaintiff will respectfully request the Court and Jury to determine the amount of the loss Plaintiff has incurred in the past and will incur in the future, not only from a financial standpoint, but also in terms of good health and freedom from pain and worry."

    The case has been assigned to District Judge William Stiehl.

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