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
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
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
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
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
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
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
. . . 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 This ruling, while not precedential, alters the...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
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
WASHINGTON, D.C. - (Mealey's) Electronic cigarettes, which deliver a dose of nicotine vapor without flame or smoke, are for regulatory purposes tobacco products, not medical devices, the District of Columbia Circuit U.S. Court of Appeals ruled Dec... Read More
On August 7, 2015, the U.S. District Court for the Southern District of New York invoked the First Amendment, granting Amarin Pharma, Inc. ( Amarin ) preliminary protection against federal criminal prosecution for misbranding and allowing Amarin to promote... Read More
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
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
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
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