Product liability lawsuits continue to be filed against KV Pharmaceuticals and its subsidiaries Ethex Corporation and Ther-Rx Corporation well after the U.S. Food & Drug Administration (FDA) shut down the companies earlier this year for repeatedly manufacturing oversized drugs which contained more active ingredients than were appropriate, including narcotics such as morphine and oxycodone, cardiac drugs and prenatal and iron supplement products. The companies recalled over 60 products and put thousands of consumers in grave danger of serious injury and death.

Negligent & beyond irresponsible

That's what drug litigation attorneys are calling the drug manufacturers' behavior. Here's a summary of what the companies recalled and why:

• June 9, 2008: The companies recalled a single lot of morphine sulfate 60mg extended release tablets due to the possibility that oversized tablets may have been released at the wholesale and retail levels. Some of those tablets may have contained double the amount of morphine listed which the companies said could have “life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure.”
• June 13, 2008: Less than a week later, the companies expanded the above recall to include numerous lots of morphine which were manufactured from June 2006 to May 2008 due to oversized tablet production.
• December 23, 2008: The companies recalled a single lot of Hydromorphine Hcl 2mg tablets.
• January 28, 2009: The companies expanded the above recall to include Propafenone Hcl, Isosorbide Mononitrate extended release tablets, Morphine extended and immediate release tablets and Dextroamphetamine sulfite.

  Again, the reason for the recall was that the drugs may have been manufactured with more than the indicated dosage. The companies' announcement stated that, “overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate” – all of which could result in death.

• January 28, 2009: On the same day, the companies also announced that they were recalling Oxycodone – once again due to oversized tablet production which, in this case, could result in respiratory depression, low blood pressure and death.
• February 2009: The companies recalled their prescription iron and prenatal supplements.

FDA shuts manufactures down

Shortly afterward, the companies suspended shipments for all FDA-approved drugs – over 60 in total. In March 2009, the FDA initiated a permanent injunction against the drug manufacturers prohibiting them from manufacturing and distributing adulterated and unapproved drugs and for violating FDA regulations – including Good Manufacturing Practices – until they prove to the FDA that they've cleaned up their acts.

Numerous lawsuits have been filed against the companies alleging that they, 1) negligently designed, manufactured, marketed, advertised, promoted, sold and/or distributed defective drugs, and 2) failed to adequately warn users of the defective drugs unreasonably dangerous characteristics. If you've been injured due to the negligence of KV Pharmaceuticals, Ethex Corporation or Ther-Rx Corporation from one of their recalled drugs, contact an experienced drug litigation lawyer to discuss your situation. You may be entitled to compensation for your injuries.