Judge Says Pharmacy Not Liable for Failure to Warn of Reglan Risks
A Montana district judge has recently ruled against the plaintiffs in a Reglan lawsuit involving a 91 year-old U.S. navy veteran who was prescribed the generic version of the drug. According to documents submitted to the Billings, Montana federal court, Harold and Kathy Holtshouser filed a complaint against the Department of Veterans pharmacy, hoping to recover damages for Harold, who was prescribed metoclopramide (the generic equivalent of Reglan), which was dispensed to him by the VA from 2001 to 2008.
In May 2008, Harold was exhibiting early signs of Parkinson’s disease and was taken off metoclopramide pending a neurologist’s evaluation, but was later diagnosed with a severe movement disorder known as tardive dyskinesia. The claimants alleged that the Veterans pharmacy “violated the standard of care for pharmacists in filling prescriptions for metoclopramide in excess of the manufacturer’s recommendation for duration of treatment, without warning the plaintiffs or contacting Harold’s treating provider.”
The plaintiffs further claim that given the patient’s known renal impairment, the medication dosage was too much. The Holtshousers and their Reglan lawyer argue that pharmacists employed at the VA pharmacy did not meet the appropriate standards of care.
Reglan lawsuit alleges VA pharmacy failed in its medical duties
The U.S. district judge appointed to the case decided that the Veterans pharmacy is not liable to the plaintiff, who developed tardive dyskinesia after ingesting generic Reglan for seven years. Judge Richard Cebull offered the following jurisdictional ruling when rendering his verdict: “a pharmacist has no duty to warn a patient, or to contact the prescribing health care provider regarding a prescription, unless the pharmacist has knowledge of a patient-specific risk associated with the medication.”
The judge also pointed out that the bulk of jurisdictions have refused to apply liability on pharmacists because they, unlike physicians, have a non-existent relationship with the patient and are therefore unable to “relate the propensities of the drug to the physical idiosyncrasies of the patient.” The judge noted that doctors are “in the best position to decide when to use and how and when to inform his patient of the risks and benefits pertaining to drug therapy.”
Harold suffered a host of medical complications and was on more than 20 prescription medications, which he took daily. The Reglan lawsuit plaintiffs say that the VA pharmacy failed to warn Harold of the latent risks associated with generic Reglan, but the defendant’s expert witness, Arthur Lipman, Parm.D., testified that a drug maker’s warning label does not prohibit use for a longer period, or in any other manner not described in the labeling.
Judge Cebull states that “Courts have found that the duty to warn customers about potential side effects of medication falls with the physician, not the pharmacist.”
Reglan and tardive dyskinesia
The U.S. Food and Drug Administration (FDA) issued a black box warning regarding long-term or high-dose use of Reglan and its generic versions because of the high risk of developing tardive dyskinesia. Metoclopramide is typically indicated to treat patients with heartburn, gastroesophageal reflux disease, and gastroparesis.
In a news release published on February 26, 2009, the FDA says that tardive dyskinesia is “directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.”