Jessica Rickabaugh

Jessica Rickabaugh

Pepper Hamilton LLP

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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

1/31/2017 - Comment Period Draft Guidance FDA First Amendment HCEI Health Care Providers Healthcare Labeling Manufacturers Medical Devices Off-Label Use Payor Contracts Pharmaceutical Industry Prescription Drugs Product Labels Public Health Required Communications

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

1/18/2017 - Evidence Expert Testimony Litigation Strategies Risk Assessment

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

10/31/2016 - Enforcement Actions FDA FOIA Healthcare Medical Devices Pharmaceutical Industry Professional Misconduct Regulatory Standards Websites

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

1/26/2016 - Health Care Providers Long Term Care Facilities Nursing Homes

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

10/29/2013 - Class Action Economic Loss Doctrine Pharmaceutical Industry

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