Reglan Defense Lawyers Argue Generic Manufacturers Didn’t Update Warning Labels

By April 22, 2011 July 10th, 2019 Uncategorized

A Reglan lawsuit that is being heard by the U.S. Supreme Court is gaining some attention lately as Julie DeMahy from Louisiana has had her case consolidated with Mensing v. Pliva Inc.

Like Mensing, Julie DeMahy has been diagnosed with the facial movement disorder tardive dyskinesia resulting from prolonged use of metoclopramide, which is a generic version of Reglan. DeMahy took the drug for 4 years starting in 2002 as a treatment for acid reflux. When she started the medication, the warning label claimed that the TD was a rare side effect; since then, newer information has been produced that proves that TD is a common side effect of Reglan and metoclopramide.

One study produced data that showed that 20 percent of patients that used Reglan over a long period of time would eventually contract TD. It is for this reason that the FDA only approved the drug for use of a period of no more than 12 weeks. This lawsuit will help to bring about answers to the question of how liable generic drug makers will be in promoting the side effects associate with the drugs they reproduce. Generic manufacturers like Pliva Inc. and Actavis Inc. who make generic Reglan (including the pills that DeMahy used) may end up being responsible for not updating their warning labels to include information that the brand name manufacturers include in theirs even though federal laws didn’t let them include the warnings.

This is what the defense lawyers are arguing in the case and the argument certainly has merits. However, state laws enforce drug companies to warn the public about the risks in taking drugs regardless of whether the drug is generic. One thing is for certain in this case that has gotten a lot of attention: There is a lot of support for the plaintiff’s cases. Support is flowing in from the American Medical Association, 42 states and even President Obama’s administration. DeMahy’s case of TD is so bad that she needs $6,000 a month to cover the cost of her medication for her spasms. In fact, she had a spasm that was so bad once that it actually tore her rotator cuff. The Supreme Court hasn’t made its decision yet and is still torn. The case is expected to be decided on in the summer.