Our firm has filed a wrongful death lawsuit in an Alabama state court, against Ethex Corporation and KV Pharmaceutical Company, manufacturers of Isosorbide Mononitrate. As you may know, Isosorbide Mononitrate is used in the prevention and treatment of angina, or chest pain, caused by coronary artery disease. Isosorbide Mononitrate is one of many products subject to a recall by Ethex and KV Pharmaceutical on January 28, 2009. The recall was the result of manufacturing defects which caused the drugs to be double the appropriate strength, which made these drugs defective and unreasonably dangerous. But sadly, this recall comes too little and too late for Robert Jones, a resident of Barbour County, who died as a result of taking the defective Isosorbide Mononitrate tablets.
We have learned that the Food and Drug Administration has repeatedly warned Ethex Corporation and KV Pharmaceutical Company about violations of good manufacturing practices. On March 9, 2000, the FDA issued a Warning Letter to KV Pharmaceutical Company identifying numerous current good manufacturing practice violations and providing that a failure to correct the violations could lead to regulatory action, including seizure and/or injunction. FDA inspections continued to reveal violations of good manufacturing practices in inspections in April 2003, January 2004, January 2005, March 2006, April 2007, March 2008, August 2008, and February 2009.
Ethex Corporation and KV Pharmaceutical Company officials were notified of the results of these inspections and were given opportunities to correct the ongoing violations, but failed to do so. Finally, on March 2, 2009, the United States District Court, Eastern District of Missouri, issued a Consent Decree ordering Ethex Corporation and KV Pharmaceutical Company to destroy:
• all drugs in their possession, custody, and/or control that are the subject of recalls announced by KV Pharmaceutical Company from May 2008 through February 3, 2009; and
• all other drugs in their possession, custody, and/or control, including all in-process drugs and drug components, as well as finished drugs.
The Consent Decree was the result of a history of continuing violations of current good manufacturing practices discovered through the Food and Drug Administration inspections of Ethex Corporation and KV Pharmaceutical Company’s manufacturing facilities. Roger Smith, Andy Birchfield and I will try this case for the Jones family.
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