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Who Will Win the Generic Drug Debate?

By May 13, 2011July 10th, 2019Uncategorized

These days, the courts are slowly being inundated with cases that involve generic drug manufacturers. Some of these cases involve the acid reflux drug Reglan.

The courts are hearing the case of two women whose cases have been consolidated, Gladys Mensing and Julie DeMahy. Both women have used metoclopramide for years between the years of 2001-2006 to treat sinus infections and acid reflux. Both women were diagnosed with tardive dyskinesia as a result of that prolonged use. The time periods that those women used generic Reglan are important since the brand name version of Reglan didn’t receive a proper black box warning against prolonged use until 2009.

In 2009, the FDA included warnings on the label of Reglan that stipulated Reglan use should be limited to a period no longer than 12 weeks because of the drug’s increased risk to patients developing TD. Before that, generic drug makers like Pliva Inc. (part of a lawsuit being heard by the Supreme Court) were prohibited by federal laws from including information from the name brand version on their labels — even though state laws required this information to be included in the generic labels.

This technicality of dueling laws may be just what the drug maker ordered in clearing Pliva and other generic drug manufacturers from liability. However, the debate is one that is long overdue in the court system and should prove to be a major turning point in the future on how drug manufacturers and pharmaceutical companies communicate drug risks.

Support for the plaintiffs is being expressed by the American Medical Association, 42 states and even President Obama’s Administration. The decision in the case of Mensing v. Pliva Inc. will be decided by the Supreme Court in June and there is no doubt that almost everyone will be listening. With so much popular support for the plaintiffs and legal technicalities favoring the drug makers, it is no wonder why the court is currently split.