Reglan Lawsuits - Higher Court Decisions
Over the past 30 years or so as corporations have gained more and more power over government, consumers have suffered. Jury awards in product liability cases decided at the local or state level have frequently been reduced or overturned completely at the federal level. Most of this has been in the name of "tort reform;" the argument is that holding corporations liable for injuries caused by their products will somehow stifle innovation.
The questionable nature of this argument aside, recent Supreme Court decisions in cases involving metoclopramide, or Reglan as well as similar drugs strongly indicate that the tide is turning in favor of the consumer. Although the Supreme Court decisions were not unanimous, they are setting a precedent that has the large pharmaceutical companies concerned.
The Litigation Process
The first step in recovering for losses due to harm from a product (in this case, Reglan) is to consult with an attorney who is experienced in these issues. This lawyer will analyze your case, determine its chances for success, and if the lawyer feels your case is strong enough, will file suit with your local county court, or that of another county somewhere in the United States if they feel this is warranted (for example, you as the plaintiff are a resident of Multnomah County, Oregon, and the company being sued is headquartered in Knox County, Tennessee, and your lawyer has reason to believe it would be in your best interest to have the case heard in the company's home jurisdiction).
Civil trials at the county level are where plaintiffs in personal injury cases are awarded the large damage amounts that you frequently hear about in the media. However, these are invariably appealed to a higher court – first at the state level, then at the district level, the Circuit Courts of Appeals.
Cases rarely goes further than that. Occasionally however, an injury case may make it all the way to the Supreme Court.
Litigation related to Reglan specifically have just begun to get underway, and while early indications suggest that higher courts are more willing to side with plaintiffs in these cases, there is still relatively little precedent. However, upper court decisions in cases involving other kinds of neuroleptic drugs can give a good indication as to what to expect as the number of legal actions against drug companies that manufacture metoclopramide increase.
Current Upper Court Decisions
One of the most significant decisions regarding Reglan was handed down from a California Appellate Court in November 2008 in the case of Conte v. Wyeth. In her complaint, the plaintiff alleged that her tardive dyskinesia was the result of 48 months of taking a generic version of metoclopramide. The suit states that not only the companies who had made the generic version, but Wyeth, Inc. ( which manufactures and markets the drug under its trade name, Reglan) knew, or should have known that physicians were likely to over-prescribe the medication; while it is approved for no more than three months at a time, the warning labels minimized and misstated the facts. Her claims against Wyeth were based not only on the labeling that was provided, but the company's own entry in the Physician's Desk Reference as well. The court's opinion stated that it was
"...highly likely that a prescription for Reglan written in reliance on Wyeth’s product information will be filled with generic metoclopramide . . . it is also eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth’s representation about Reglan. In this context we have no difficulty concluding that Wyeth should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide."
It should be noted that the judge in this case is also a pharmacist.
In January 2009, Wyeth appealed the decision to the California Supreme Court, which refused to hear the case.
Illustrative of the difference a venue can make, a similar case which came before the U.S. District Court for the Western District of Oklahoma made an opposite ruling in Schrock v. Wyeth. Like Conte, Schrock took only the generic form of Reglan, and the judge in this case concluded that,
"the manufacturer bears responsibility for the content of its label at all times...regardless of the theory of recovery advanced, the responsibility for the defect must still be traced to the proper defendant."
The plaintiff in this case can still pursue a case against the company that manufactured the generic version that he actually ingested, however.
The difference here is that the California court held Wyeth liable because even though it had not actually manufactured the drugs that were used to treat Conte, they had issued the written guidelines regarding dosage and possible side effects, thus extending liability "beyond the chain of distribution." The Oklahoma Court (a federal jurisdiction) ruled on grounds of strict liability; Wyeth had not actually manufactured the drug, and thus could not be held responsible.
A Supreme Court Ruling
In March of 2009, a case involving another Wyeth drug, Phenergan (a weak dopamine antagonist, similar to neuroleptic medications but used to treat nausea) actually made it to the Supreme Court. A Vermont woman had been injected with the drug, which caused gangrene, resulting in her loss of an arm. The lower courts awarded the woman $6.7 million, which Wyeth appealed, arguing that while it had been aware of the potential gangrene complications since the 1960s, it was unable to update its labeling because doing so would have required approval from the FDA.
Writing the opinion for the majority, Justice John Paul Stevens acknowledged that,
"Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application"
but then pointed out that,
"There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency's approval."
© 2010 TardiveDyskinesia.com Last Modified Friday, April 23rd, 2010
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