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A Victory for Reliable Scientific Opinion in the Third Circuit

A recent Third Circuit decision reinforces that courts must rigorously review - and opposing parties should challenge - the reliability of experts' methodologies. In In re Zoloft (Sertraline Hydrochloride) Products Liability...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Challenging Weight of the Evidence Methodology

Use of a WOE methodology may be appropriate for government regulation, but it should not establish legal liability. Originally published in In-House Defense Quarterly, a publication of DRI - Winter 2017....more

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

PA Court Permits Attorney General to Retain Contingency Counsel to Enforce Consumer Protection Laws Against Long-Term Care...

State and local governments will increasingly use consumer protection law to regulate long-term care facilities, with private plaintiffs’ counsel advocating for a role in government actions. Under GGNSC Clarion LP v....more

Defeating Economic Loss Claims In Pharma Class Actions

Where product liability actions or government investigators have targeted a prescription drug, class actions follow alleging that patients are entitled to a refund of what they paid for the medicine. The theory of these...more

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