Michigan Social Security Disability Law Blog

Last week, the pharmaceutical company, Actavis Totowa, announced that it would close its Falls River, New Jersey manufacturing facility, as well as another in Riverview and a packaging plant in Taft, as part of a Consent Decree it reached with federal regulators. The Falls River plant made several generic drugs, including Digitek, which was subject to recalls in 2008.

Activis has a long history of safety violations.

In August 2006, the FDA issued a warning letter to Actavis for failing to provide periodic safety reports at one of its oral dose manufacturing plants in New Jersey. Another FDA inspection, in early 2006, revealed that the pharmaceutical company also failed to report six potentially serious and unexpected adverse drug events, dating back to 1999, for generic Digitek and other products.

In April of last year, Actavis recalled Digitek tablets, some of which were made in Falls River. At the time, the company admitted that some Digitek tablets might be oversized and could expose patients to a dangerously high level of digitalis, the drug’s active ingredient. The FDA deemed this a Class I recall, because the defective Digitek tablets might result in serious health problems or death. Patients suffering from renal failure were among those at gravest risk, because a double strength Digitek tablet could cause digitalis toxicity.

Last August, Actavis finally issued another recall of all generic drugs made at the Falls River facility. That recall was prompted by an inspection that showed facility operations did not meet FDA standards for good manufacturing practices. After the August recall, Actavis finally closed the New Jersey plants and announced plans to improve operations. In November 2008, when the company sought to reopen the facilities, the U.S. Justice Department filed a lawsuit to keep the plants closed.

Recently, the Center for Public Integrity published a report that found that the number of fatalities associated with Digitek spiked around the time of the recall. According to the report, there were 667 deaths involving Digitek, which were reported to the FDA between April 1 and June 30. The group also found that FDA received just one reported death attributed to Digitek in the previous three-month reporting period.

At the Bernstein Law Firm, we are dedicated to protecting the legal rights of victims of pharmaceutical company negligence. If you or a loved was injured due to a defective prescription medication, contact one of our experience personal injury attorneys immediately.