A Landmark Reglan Decision: Kellog vs. Wyeth
In 2000, Ethel Kellog of Vermont was prescribed metoclopramide, trade name Reglan, to treat gastroesophageal reflux disease (GERD). She took the medicine for more than four years before the Reglan side effects became worse than the ailment it was developed to treat.
Uncontrollable facial grimacing, lip twisting, tongue thrashing and difficulty controlling her limbs, Kellog was told she had developed tardive dyskinesia, an irreversible neurological disorder that was known for years to be a Reglan side effect.
In 2007, two years before a “black box” warning was imposed on Reglan, Kellog obtained a Reglan lawyer and filed a lawsuit against Wyeth and other drugmakers that manufacture generic metoclopramide.
In her Reglan lawsuit, Kellog alleged the companies knowingly included misleading information on the drug’s label. The companies downplayed Reglan’s side effects, she asserted. They warned of only side effect related to short-term use of Reglan when they knew, through their own investigations, the drug was regularly administered long-term.
Kellog’s Reglan lawsuit also asserted that the drug wasn’t just “believed” to increase risk of tardive dyskinesia with increased exposure, as the label asserted; the longer Reglan is administered, the more likely a user is to develop the disorder. The correlation was supported by scientific fact, not belief, and the label should have reflected this fact.
Wyeth and the other defendants fought the claim. Wyeth argued that federal regulations preempted the company from altering the warning label from that which was originally cleared by the FDA. The generic makers argued laws prevented them from altering the label initially issued to the brand name drug.
In a landmark decision, Judge William K. Sessions III of the US District Court for the District of Vermont ruled in Kellog’s favor. In the official decision, the Judge 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.
The drugmakers’ appeal request was denied, setting the stage for a wave of future successful litigation against the makers of Reglan. Today, hundreds of Reglan lawsuits are being processed across the country. A Reglan class action lawsuit could take shape within a year.