Merck Clinical Trial Compliance Settlement Relies On Board Oversight
For a three-year period Merck will inform a committee of its board if trial results are not reported within 12 months; the agreement resolves a shareholder derivative suit claiming Schering directors caused results of the Vytorin ENHANCE trial to be suppressed.
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Investors alleged they lost money from the nearly two-year delay in release of results of the Enhance trial; Merck and Schering previously paid $5.4 million to states to resolve Enhance investigation.
Merck has settled Vioxx shareholder derivative litigation by agreeing to implement a host of corporate governance changes. Among the new requirements, Merck must run ads in medical journals publicizing its clinical trial registry, post reviews of its compliance procedures, and create two safety committees
This marks the second time in recent weeks that the drug makers have settled large-scale litigation related to the medicines.