ETHEX Corporation Oversized Drug Recalls Prompt Lawsuits

ETHEX, one of the largest US generic drug manufacturers of narcotics, cardiac drugs, prenatal and iron supplement products, is defending numerous personal injury and wrongful death lawsuits after it recalled so many oversized drugs that the U.S. Food & Drug Administration (FDA) finally had to shut down the company. What happened to prompt these lawsuits? Our legal experts explains.

Recall After Recall – After Recall

Dan Thornburgh, a Florida attorney whose firm represents those injured by dangerous or defective drugs, says that KV Pharmaceuticals Company, a generic pharmaceutical manufacturer and parent corporation to ETHEX Corporation and Ther-Rx (the promotion, marketing and distribution arms of drugs manufactured by KV Pharmaceuticals), put thousands of people at risk of serious injury or death by manufacturing and releasing oversized drugs before issuing recall after recall – after recall. Thornburgh provided us with the following timeline of the circumstances surrounding the recalls:

  • 6/2008: Between June 9th and June 12th of 2008, ETHEX issued a recall one lot of morphine sulfate, 60 milligrams, extended release tablets. In the FDA press release that was issued, the company was fearful that there was a possibility that oversized tablets were released at both the wholesale and retail levels. More specifically, they believed they had a problem with the manufacturing of the morphine sulfate tablest in June of 2008 that put patients at risk of receiving more than the intended dose of the morphine sulfate than they expected.
  • 6/13/08: The FDA announced that ETHEX and KV Pharmaceuticals had expanded their earlier recall to include more than just one lot. They now believed that numerous lots were defectively manufactured between the dates of June 2006 and May of 2008.
  • 12/08: The FDA did an inspection of the manufacturer's plant located in Missouri.
  • 12/23/08: The manufacturers announced the recall of their hydromorphine product two-milligram tablets.
  • 1/8/09: The manufacturers expanded their recall yet again. This time, it included generic products such as propafenone, isosorbide, additional morphine extended and immediate release tablets and dextroamphetamine sulfites.
  • 2/09: The manufacturers again expanded their recall. This time, it included prescription iron and prenatal supplements.
  • 3/09: The FDA shut down the ETHEX Corporation and KV Pharmaceuticals. They entered into a consent decree with the FDA which essentially stopped or suspended the manufacturing of every drug made by those manufacturers or distributors.

Product Liability Lawsuits Filed

Numerous product liability lawsuits have been filed against the manufacturers by those who were injured, or by the families of those who died, after unknowingly overdosing on drugs made by ETHEX and KV Pharmaceuticals. Product liability attorneys will likely say that the manufacturers' blatant disregard for consumer safety was simply inexcusable and play a part in the outcome of those lawsuits.