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Drug Manufacturer Admits It Ignored Duty to Warn FDA of Its Defective Products

By April 9, 2010July 17th, 2019Dangerous Drugs

As a dangerous prescription drug attorney, I was interested in this story about a St. Louis drug manufacturer’s guilty plea to two felony counts of criminal fraud. Ethex Corp, a wholly owned subsidiary of KV Pharmaceutical, admitted that it had failed to report to the FDA that it had been producing generic prescription medications that contained up to double the dose they should have had. Company leaders admit that they knew about the problem in the spring of 2008, but kept quiet about most of the drugs until an FDA order shut down production in January of 2009. They blame the problem on bad managers who have since been pushed out. Despite 15 months of no production or sales, KV faces at least 30 lawsuits, 15 of which are wrongful death claims.
In May 2008, pharmacists in California and Canada discovered that morphine sulfate tablets produced by Ethex were much larger than they should have been. Overdoses of morphine, an opiate, can cause a person to stop breathing and go into a coma. KV Pharmaceuticals recalled the defective morphine tablets the next month. However, they decided not to do anything in response to reports of similarly oversized tablets of other drugs like propafenone, a medication for irregular heartbeat, and dextroamphetamine sulfate, a component of Adderall, the attention-deficit disorder drug. Propafenone overdose can lead to coma and seizures, and dextroamphetamine sulfate overdose can, in extreme cases, lead to amphetamine psychosis, in which a person experiences hallucinations and goes for long periods of time without sleep.
Assistant U.S. Attorney Andrew Lay wrote in court papers that a KV executive knew about these problems and decided that since there was low probability that more oversize tablets would be found, the company should do nothing, even though other employees objected to this approach. This executive told employees to avoid discussing the problem in writing as much as possible, and to limit the number of people who would find out about it. In other words, the executive orchestrated a cover-up. KV employees said that they were encouraged regularly to falsify records so that the FDA would think that KV was in compliance with FDA standards on chemical tests and cleanliness of the equipment used to produce the drugs.
In the end, the company’s emphasis on production over safety has already severely affected its bottom line — industry watchers say KV could be bankrupt within the year. It is no surprise to me, as a drug defect attorney, KV is facing so many lawsuits over defects in its drugs. Over 200 more pending claims have not yet made it to court, and 26 of those involve a patient’s death. CVS Pharmacies is also suing KV for $100 million for allegedly breaking a supply contract.

As a defective prescription drug lawyer, I am disturbed by the disregard for patients’ well-being shown by KV’s decision-makers. Covering up known problems for the sake of expediency and profits at the potential cost of patients’ lives is inexcusable, as well as illegal. Like all manufacturers, the company has a moral and legal responsibility to warn the FDA, the public, and health care providers of any health risks associated with the drugs that they produce. If a drug maker fails to perform this basic duty, it can be held legally responsible for the harm it caused and required to pay all of the costs and damages of its victims. Patients and families who have been harmed by defective prescription drugs should not hesitate to consult a drug defect lawyer to learn more about recovering medical costs, lost income, and compensation for pain and suffering. If you are in a situation like this, please call Carey, Danis & Lowe for a free consultation at 1-877-678-3400, or use our online form.