The U.S. Food & Drug Administration (FDA) has virtually shut down St. Louis, Missouri drug manufacturer KV Pharmaceuticals until the company complies with the FDA’s Good Manufacturing Practices and new drug approval requirements for five years.

Permanent injunction filed

On March 2, 2009, the FDA filed a permanent injunction against KV Pharmaceuticals and its subsidiaries, Ethex Corporation and Ther-Rx Corporation from making and distributing adulterated and unapproved drugs. The injunction was filed after FDA officials inspected KV’s processing centers between December 2008 and February 2009 and found many regulatory violations. Those inspections prompted the company to recall many products and to destroy much of the remaining inventory in their warehouses.

The companies will no longer be allowed to manufacture or distribute adulterated and unapproved drugs until they comply with the FDA’s Good Manufacturing Practices and new drug approval requirements for five years. Failure to comply with the FDA’s consent decree could subject the company of fines up to $15,000 per day – and up to $5,000,000 per year.

Ongoing investigation

KV Pharmaceuticals has been the focus of FDA staff for several years. In 2007, the FDA and the company signed and agreement which prohibited the company from manufacturing certain drugs. However, in 2008, the FDA found that the company had blatantly violated that agreement and seized over $24 million in unapproved drugs from the company’s warehouses. Then, in late 2008, the company announced that it was recalling a pain management product because it was manufactured larger than it should have been and could have caused serious injury.

The FDA then did a complete investigation of KV’s facilities from December 2008 through February 2009. Following that investigation, KV has now agreed not market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA’s current good manufacturing practices (CGMP) regulations. KV has also agreed that it will not distribute certain products, including its prenatal vitamins and hematinic products, until those products are approved by the FDA’s processes.

To learn more about the products KV Pharmaceuticals and its subsidiaries manufacture, go to its website.

New ruling may allow state lawsuits

A recent ruling by the U.S. Supreme Court allows patients who have been injured by dangerous drugs to sue manufacturers in state court in some situations. In the past, drug companies insisted that federal law preempted state lawsuits. However, the new ruling, Wyeth v. Levine, says that state lawsuits may be allowed.

If you’ve been injured due to a dangerous drug, contact an experienced drug litigation attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.