Litigation

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Norton Rose Fulbright: Rise Of Predictive Coding For Pharmaceutical Companies
Posted on 2 Jan 2014 by Norton Rose Fulbright

By Jessica Sykora | Pharmaceutical and medical device companies in the midst of costly e-discovery battles and high-dollar litigation have more than likely heard the buzzwords "predictive coding" and "computer-assisted review" at... Read More

Study: Harmful Medical Devices Get Approval Too Easily
Posted on 17 Feb 2011 by LexisNexis Litigation Resource Community Staff

CHICAGO - (AP) Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don't require human testing, an analysis found. The report comes as the Food... Read More

Stryker Subsidiary, Ex-CEO Plead Guilty, Pay $79 Million For Illegal Device Marketing
Posted on 9 Dec 2014 by Tom Moylan

NEWARK, N.J. — (Mealey’s) Stryker Corp. subsidiary OtisMed Corp. and the former OtisMed chief executive officer on Dec. 8 pleaded guilty to marketing the unapproved OtisKnee Orthopedic Cutting Guide medical device after the Food and Drug Administration... Read More

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices
Posted on 7 Aug 2014 by Norton Rose Fulbright

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued... Read More

Merck Settles All NuvaRing Birth Control Injury Cases For $100 Million
Posted on 7 Feb 2014 by Tom Moylan

HACKENSACK, N.J. — (Mealey’s) Merck & Co. subsidiary Organon has agreed to a $100 million nationwide settlement of all claims alleging blood clot injuries from the NuvaRing contraceptive device, according to a master settlement agreement... Read More

D.C. Circuit Says FDA Can Regulate Stem Cell Drugs; Company Properly Enjoined
Posted on 4 Feb 2014 by Tom Moylan

WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on Feb. 4 said the federal government can regulate a company that cultures stem cells for injection in the donor patient and said a lower court did not err in permanently... Read More

Judgment As Matter Of Law Granted In 1st Ethicon Pelvic Mesh Bellwether Trial
Posted on 18 Feb 2014 by Tom Moylan

CHARLESTON, W.Va. — (Mealey’s) The first Ethicon pelvic mesh multidistrict litigation bellwether trial ended Feb. 18 when the judge granted the defendant’s motion for judgment as a matter of law ( In Re: Ethicon, Inc., Pelvic Repair... Read More

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory
Posted on 18 Aug 2015 by Ballard Spahr LLP

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the... Read More

3 Years' Probation Added To $296M In Fines, Forfeiture In Guidant Heart Device Plea
Posted on 18 Jan 2011 by Tom Moylan

MINNEAPOLIS - (Mealey's) Guidant LLC was sentenced Jan. 12 by a Minnesota federal judge to three years' probation and ordered to pay $296 million in fines and forfeiture for failing to tell the Food and Drug Administration about defects in three... Read More

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

10th Circuit Majority Says Infuse Off-Label Claims Are Preempted By Congress
Posted on 21 Apr 2015 by Tom Moylan

DENVER — (Mealey’s) In a 2-1 decision, a panel of the 10th Circuit U.S. Court of Appeals on April 21 affirmed that a plaintiff’s claim alleging off-label promotion and use of Medtronic Inc.’s Infuse bone graft system is preempted... Read More

California Jury Awards $5.7 Million In Ethicon Pelvic Mesh Trial
Posted on 7 Mar 2015 by Tom Moylan

BAKERSFIELD, Calif. — (Mealey’s) A California state court jury on March 5 awarded $5.7 million to a plaintiff in an Ethicon pelvic mesh injury trial ( Colleen Perry, et al. v. Ethicon Inc., et al. , No. S-1500-CV-279123, Calif. Super., Kern... Read More

MDL Jury Awards $3.27 Million In 2nd Ethicon Pelvic Mesh Trial
Posted on 8 Sep 2014 by Tom Moylan

CHARLESTON, W.Va. — (Mealey’s) A West Virginia federal jury on Sept. 5 returned a $3.27 million verdict in the second Ethicon Inc. multidistrict litigation pelvic mesh bellwether trial (Jo Huskey, et al. v. Ethicon, Inc., et al., No. 2:12... Read More