ETHEX Corporation: How This Manufacturer's Practices Put Thousands At Risk
UPDATED: August 5, 2019
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The ETHEX Corporation, a subsidiary of KV Pharmaceuticals Company, put thousands of consumers at risk of serious injury or death by releasing oversized generic drugs such as narcotics, cardiac drugs, prenatal and iron supplement products into the marketplace. How could this have happened?
Company Acted with Gross Negligence
Dan Thornburgh, a Florida attorney whose firm represents those injured by dangerous or defective drugs, says that there are a number of possible causes for how this could have happened, including problems with the manufacturing compression machines and an overall failure on the part of the manufacturer to properly investigate problems and take corrective action to prevent defective drugs from being sold in the market – putting thousands of consumers at serious risk of injury or death. He explained:
"The FDA (U.S. Food & Drug Administration) consent decree laid out a number of violations that were committed by the manufacturers. Those included quality control issues that existed at the manufacturing plants."
Patients were put at risk of serious injury or illness associated with the manufacturers' quality control issues and a complete failure on the part of the manufacturer to address defects in its manufacturing process when such defects became known or should have been known by the companies. In my opinion, a review of the FDA documents shows the company acted with gross negligence and without regard for the safety and health of consumers.
Injuries & Deaths Due to Unintended Overdose
Plaintiffs who have filed lawsuits against the manufacturers are alleging that they were injured or their loved ones died as a result after receiving one of the products manufactured by KV Pharmaceuticals. Thornburgh explained:
"According to FDA alerts, overdoses for some of these drugs can include arrhythmias and low blood pressure with propafenone HDL and fainting and low blood pressure with isosorbide. Respiratory depression and low blood pressure can occur with morphine sulfate. Rapid heart rate and high blood pressure can occur with dextroamphetamine sulfate. Each of these serious side effects could result in death."
Manufacturer Shut Down
According to Thornburgh, until the manufacturers resolve the issues addressed in the consent decree and the FDA comes in and does another inspection, they're not able to manufacturer any of their products until the FDA is satisfied that they've met the requirements outlined in the consent decree. In the meantime, numerous product liability lawsuits are pending against the manufacturer.