Kellog v. Wyeth: A Groudbreaking Lawsuit

Vermont resident Ethel Kellog was first prescribed metoclopramide, under the prescription drug name Reglan, in 2000 as a remedy for gastroesophageal reflux disease (GERD). She continued to consume the medication for four straight years, at which point the severe side effects produced by Reglan overshadowed the symptoms from her gastrointestinal disease.
Kellog suffered uncontrollable movements in her limbs as well as facial grimacing and involuntary lip twisting and tongue thrashing. These are all symptoms of tardive dyskinesia, an incurable neurological condition that Kellog had developed, and a known side effect of the drug known as Reglan.
Kellog hired a Reglan lawyer in 2007, a full two years before the FDA mandated a “black box warning” for the medication. She filed a lawsuit against drugmaker Wyeth as well as other manufacturers of generic versions of metoclopramide.
In that lawsuit, Kellog alleged that Wyeth and other companies did with full knowledge include misleading information on the Reglan warning label. She asserted that the manufacturers led users to believe that the side effects were less serious than they are known to be. Specifically, the label warned only of side effects that come from short-term consumption of the drug, even though their own research had found that the medicine was frequently prescribed for long-term use.
In addition, her Reglan lawsuit alleged that metoclopramide is not just “believed” to increase the odds of developing tardive dyskinesia the longer it is taken. Scientific studies support a direct correlation between increased exposure to Reglan and increased risk of succumbing to the irreversible neurological disorder. The label failed to clearly state this fact.
Of course, Wyeth and the other responsible companies argued against her claims. Wyeth asserted that federal regulations made it impossible for the company to alter the warning label after it had originally been approved by the FDA. Generic makers of metoclopramide said that current laws prevented them from making changes to the label first issued to the brand-name version of the drug.
Judge William K. Sessions III of the U.S. District Court for the District of Vermont issued a precedent-making decision when he ruled in favor of the plaintiff, Ethel Kellog. Included in his official decision was this statement he wrote:
“There is no evidence that FDA has ever brought, or threatened to bring, an enforcement action against (or otherwise sanctioned) a drug manufacturer who sought to strengthen or add a warning to its label. Likewise, there is no evidence that FDA has proposed to withdraw approval for a generic drug because its manufacturer sought to strengthen a label warning.”
An appeal request from the drug manufacturers was denied, an act which paved the way for further successful lawsuits against the makers of Reglan and generic forms of metoclopramide. At this time there are hundreds of Reglan lawsuits underway across the nation. Within a year, we may even see a Reglan class-action lawsuit emerge.