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Drug & Device News
Pelvic Mesh Defense Verdict Thrown Out
After determining that the exclusion of two U.S. Food and Drug Administration (FDA) letters and other evidence left jurors with an “incomplete picture” of the facts, a Massachusetts appeals court recently reversed a defense verdict for Boston Scientific Corp. The case was brought by plaintiff Diane Albright, who allegedly was injured by a surgical mesh device known as Pinnacle, with which she was implanted in 2010 as a treatment for pelvic organ prolapse. At trial, the plaintiff was barred from offering into evidence a 2004 warning sent by the manufacturer's polypropylene supplier, as well as two 2012 FDA letters telling Boston Scientific that further studies were required.
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The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
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How AI Has Affected PR
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New York's Latest Cybersecurity Commitment
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