Actavis, Mylan continue defense in Digitek API suits

The family of a heart patient who died while taking atrial-fibrillation drug Digitek is appealing a West Virginia judge's ruling exonerating manufacturer Actavis and distributor Mylan ($MYL). Quality control checks and the many hands involved in drug manufacturing, packaging and distribution make it unlikely that the man died from taking a pill containing excess API, as the family claims.

The verdict came Nov. 3. The family filed its appeal last week, according to a report in West Virginia's The State Journal.

The wife and sons of Daniel McCornack initially brought suit against manufacturer Actavis and Mylan in June 2009, according to the report.

Digitek has an excess-API history. Actavis initiated a Class 1 recall of the drug in the spring of 2008 for pills that potentially contained twice the approved level of API digoxin, the story said. The FDA cited the drugmaker in a 2006 warning letter over violations in adverse-event report filing for digoxin and other drugs, stretching back to 1999.

In all, Actavis and Mylan have faced more than 1,000 excess-API civil lawsuits, according to the report, with only the McCornack and one other suit remaining. The rest have been settled or dropped.

- read the story
- here's the 2006 Warning Letter 06-NWJ-15

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