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Drug shortages could be costly for clinical trials

September 8, 2011 Leave a comment

A recent New York Times article highlighted the fact that there are “critical shortages of drugs to treat a number of life-threatening illnesses, including bacterial infection and several forms of cancer” and that “clinical trials for some experimental cures have been delayed”.

Unfortunately, this type of delay or interruption may not fall within the scope of a sponsor’s insurance coverage.  The reason is that traditional business interruption coverage is triggered only when the interruption is caused by direct physical loss or damage to a sponsor’s facility, i.e., their lab, office or manufacturing location.  Another coverage that may come into play is “contingent business interruption”.  Also triggered by direct physical loss or Read more…

Allergan pleads guilty and agrees to pay $600 million to settle charges that it marketed Botox for off-label uses

September 9, 2010 Leave a comment

According to the Department of Justice, Allergan made it a “top corporate priority” to maximize sales of Botox for off-label uses by employing illegal marketing tactics. Those tactics included 1) calling on providers who typically treated patients with Botox for off-label conditions, 2) conducting workshops on how to bill for off-label uses of Botox and 3) operating a hotline that provided free on-demand services to doctors for off-label uses. In addition, Allergan lobbied government health care programs to expand coverage for off-label uses, officials said.

Pharmaceutical companies should be aware of the fact that bodily injury claims resulting from off-label promotion may not be covered by their Product Liability insurance. Read more…

Securities litigation against life sciences companies

Various year-end securities litigation studies have shown exactly what one might expect, that cases involving financial services companies have dominated securities lawsuit filings for the last few years. What is surprising though is that plaintiffs’ attorneys have continued to pursue claims against companies in other industries, specifically the life sciences. Read more…

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