Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.

According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.

Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.

Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.

According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.

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U.S. District Judge Joseph Goodwin, who is striving to resolve the national litigation over Digitek, wants separate complaints from separate plaintiffs. On December 2, he signed an order stating that all Digitek attorneys who have numerous plaintiffs in single suits must separate the claims.

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John Anthony Conte of Madison County, Kentucky, filed a Digitek lawsuit against a West Virginia pharmaceutical company, Mylan Pharmaceuticals, for his wife’s estate. His wife is believed to have died after taking Digitek. This suit was filed on October 9, 2008.

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U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations.

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On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.

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Many previous Digitek consumers have steered away from Digitek after the recall. However, as Digitek has lost consumers, Lannett Company has only reaped the benefits.

Sales for Lannett’s digoxin, a generic form of Digitek, still have been strong since the recall of Digitek in April of this year.

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According to Huntington News, the United States Judicial Panel on Multidistrict Litigation (MDL) has ordered that all federal lawsuits about the double strength, defected Digitek be transferred to the U.S. District Court for the Southern District of West Virginia. This development in the lawsuit is taken as a result of the April 2008 recall on Digitek. Some tablets were twice as thick as usual, made with the double amount of medication.

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Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

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.