According to the West Virginia Record, Goodwin wrote, “Some complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they ingested the drug at issue.”

Goodwin gave all plaintiff lawyers a Dec. 31 deadline “to identify all multi-plaintiff actions subject to his order and propose a severance order.”

After the 30 days of separation, the plaintiff must file a revised complaint. Goodwin wrote, “The severed and amended complaint must contain the specific claims asserted by the plaintiffs named in it.”

In cases of husbands and wives as plaintiffs, Goodwin won’t sever the cases.

For deaths and illnesses associated with Digitek, plaintiffs seek compensation from the Digitek drug companies Mylan Pharmaceuticals of West Virginia and Actavis Group.

SOURCE: Digitek Recall › Goodwin to seperate federal digitek complaints

According to the Associated Press, the suit requests the court to not allow Actavis Inc. and Actavis Totowa to manufacture drugs until the company complies with FDA regulations for testing, quality control, and test response. The company must also stop selling unapproved and misbranded drugs.

Filed by U.S. Attorney Christopher Cristie and the Department of Justice’s Officer of Customer Ligation, the suit states Actavis’ facilities in Totowa and Little Falls, N.J., have not only continued to fail FDA examinations, but Actavis has not made the required changes.

Between January 2006 and May 2008, the FDA examined the two facilities in Totowa and the one in Little Falls five times overall.

In April of 2008, Actavis recalled its heart drug Digitek due to pills being twice as thick as the original form. Due to the doses being doubled, Digitek posed a threat to its consumers.

The FDA discovered in the inspections that Actavis did not have complete lab records of its testing information, and did not verify that its testing methods “matched up with actual conditions under which the products would be used.”

These are just a few of many violations that continued throughout FDA inspections of Actavis.

SOURCE: Digitek Recall › U.S. attorneys sue makers of Digitek, seek to close facilities

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Digitek Recall › doctors support drug safety litigation