Litigation

Recent Posts

Stryker Biotech Pleads Guilty, Will Pay $15 Million For Promoting Bone Repair Products
Posted on 18 Jan 2012 by Tom Moylan

BOSTON - (Mealey's) Stryker Biotech LLC on Jan. 17 pleaded guilty to one federal misdemeanor count of misbranding a medical device and agreed to a $15 million fine for promoting the mixing of its OP-1 and Calstrux orthopedic repair products to health... Read More

Tags: conspiracy , Stryker Biotech , false statements , Food and Drug Administration , bone morhpogenic protein , OP-1 , misbranding , medical devices , Calstrux , a bone void filler , orthopedic repair products , Mark Philip , William Heppner , Litigation , wire fraud , United States of America v. Stryker Biotech , Jeffrey Whitaker , David Ard

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns
Posted on 28 Mar 2014 by William A. Ruskin

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance... Read More

Tags: unapproved new uses , off-label promotion , draft guidance , product liability , Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Reco , misbranding , FDA , William A. Ruskin , unapproved uses , FDCA , product label , u.s. v. caronia , Litigation , First Amendment , torts , Pharmaceutical & Medical Device

D.C. Circuit Says Former Purdue Pharma Execs Excludable But Questions Term
Posted on 27 Jul 2012 by Tom Moylan

WASHINGTON, D.C. - (Mealey's) The Department of Health and Human Services is authorized to exclude three former Purdue Pharma executives from participating in federal health care programs, but it must explain why it thinks they should be excluded... Read More

Tags: District of Columbia Circuit , OxyContin , health care , Michael Friedman , misbranding , Michael Friedman v. Kathleen Sebelius , Litigation , narcotic , Purdue Frederick Co. , Paul Goldenheim , Purdue Pharma , pain drug , Howard Udell , Department of Health and Human Services

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution
Posted on 14 Dec 2012 by William A. Ruskin

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending... Read More

Tags: False Claims Act , Second Circuit , off-label promotion , Drug & Medical Device , misbranding , Stuart Gerson , William A. Ruskin , FDCA , Litigation , Food Drug and Cosmetics Act , United States v Caronia , qui tam , First Amendment