LexisNexis® Legal Newsroom
DePuy To Pay $2.5 Billion To Settle National ASR Hip Litigation, Parties Announce

WARSAW, Ind. — (Mealey’s) The DePuy Orthopaedics Inc. subsidiary of Johnson & Johnson will pay $2.5 billion to settle about 8,000 claims involving its recalled ASR hip prosthesis, according to a joint announcement Nov. 19 by the company and plaintiff attorneys representing litigants....

Norton Rose Fulbright: Rise Of Predictive Coding For Pharmaceutical Companies

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 some point during strategy sessions over how to...

Medical Device Manufacturer To Pay $30M For Role In Securities Fraud Scheme

WASHINGTON, D.C. — (Mealey’s) Medical device manufacturer ArthroCare Corp. will pay a $30 million monetary penalty to settle claims that certain of its senior executives engaged in a securities fraud scheme that bilked the company’s shareholders out of more than $400 million, according...

Split 6th Circuit: Michigan Drug Shield Law Does Not Apply To Fentanyl Patch

CINCINNATI — (Mealey’s) A split Sixth Circuit U.S. Court of Appeals on Jan. 21 reversed dismissal of a fentanyl patch overdose lawsuit, saying the trial court needs to determine whether the patch is a combination product that is not preempted by Michigan’s drug preemption law ( Beth...

D.C. Circuit Says FDA Can Regulate Stem Cell Drugs; Company Properly Enjoined

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 enjoining the company from violating federal drug...

Merck Settles All NuvaRing Birth Control Injury Cases For $100 Million

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 filed Feb. 7 in a New Jersey and a federal court...

Judgment As Matter Of Law Granted In 1st Ethicon Pelvic Mesh Bellwether Trial

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 System Products Liability Litigation, MDL Docket No...

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices

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 a final guidance on the development, review and approval...

Jurors Return Defense Verdict In Massachusetts’ 2nd Pelvic Mesh Bellwether Trial (Watch The Video Of Closing Arguments)

LOWELL, Mass. — (Mealey’s) A Massachusetts state court jury on Aug. 29 returned a defense verdict for Boston Scientific Corp. after 2-1/2 days of deliberations in the state’s second bellwether pelvic mesh trial ( Maria Cardenas v. Boston Scientific Corp. , No. MICV2012-02912, Mass....

MDL Jury Awards $3.27 Million In 2nd Ethicon Pelvic Mesh Trial

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. 2:12-5201, S.D. W.Va.). After deliberating for less...

Defense Verdict Returned In 1st DePuy Pinnacle Hip Bellwether Case

DALLAS — (Mealey’s) Jurors in the U.S. District Court for the Northern District of Texas on Oct. 23 returned a defense verdict for DePuy Orthopaedics Inc. and parent company Johnson & Johnson in the first Pinnacle hip multidistrict litigation bellwether case ( In Re: DePuy Orthopaedics...

Stryker Rejuvenate/ABG II Hip Implant Litigation Settles For At Least $1.42 Billion

(Mealey's) Howmedica Osteonics Corp. has set aside at least $1.42 billion to pay patients who had to undergo revision surgery as a result of corrosion or fretting of Stryker metal-on-metal Rejuvenate Modular-Neck and ABG II Modular-Neck hip implants, according to settlement documents released Nov...

Jury Awards $26.7 Million To 4 Women In Boston Scientific Pelvic Mesh MDL Trial

MIAMI — (Mealey’s) A federal jury in Florida on Nov. 13 awarded four women a total of $26.7 million in a multidistrict litigation trial involving Boston Scientific Corp.’s Pinnacle Pelvic Floor Repair Kit pelvic mesh repair device ( Amal Eghnayem, et al. v. Boston Scientific Corporation...

Stryker Subsidiary, Ex-CEO Plead Guilty, Pay $79 Million For Illegal Device Marketing

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 denied clearance for the device ( United...

Boston Scientific Pays $600 Million To Settle Guidant Contract Suit By Johnson & Johnson

MARLBOROUGH, Mass. — (Mealey’s) Boston Scientific Corp. on Feb. 17 announced that it has agreed to pay Johnson & Johnson (J&J) $600 million to settle a nine-year-old lawsuit alleging that Guidant Corp., which is now a Boston Scientific subsidiary, in 2006 interfered with J&J’s...

4th Circuit Affirms Directed Verdict In 1st Ethicon Pelvic Mesh MDL Trial

RICHMOND, Va. — (Mealey’s) The Fourth Circuit U.S. Court of Appeals on March 2 affirmed a directed defense verdict last year in the first Ethicon pelvic mesh multidistrict litigation trial ( Carolyn Lewis, et al. v. Johnson & Johnson, et al. , No. 14-1244, 4th Cir.). ( Opinion available...

Jury Hears Opening Statements In Suit Over Infant’s Brain Injury

WEST PALM BEACH, Fla. — (Mealey’s) Trial got under way March 4 with opening statements in the Florida 15th District Circuit Court for Palm Beach County in a suit alleging that injuries suffered by a now-17-year-old boy resulted from the unnecessary use of vacuum extraction during his March...

California Jury Awards $5.7 Million In Ethicon Pelvic Mesh Trial

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 Co.). The jury in the Kern County Superior Court...

10th Circuit Majority Says Infuse Off-Label Claims Are Preempted By Congress

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 by federal law and congressional intent ( Patricia...

Delaware Jury Awards $100 Million In Boston Scientific Pelvic Mesh Injury Case

WILMINGTON, Del. — (Mealey’s) A Delaware state court jury on May 28 awarded $100 million to a woman who says she was injured by pelvic mesh devices made by Boston Scientific Corp. ( Deborah A. Barba v. John C. Carlson, D.O., et al. , No. N11C-08-050, Del. Super., New Castle Co.). According...

Poor ‘Fit And Fill’ Caused Hip Stem To Break, Defense Tells California Jury (Watch The Opening Argument Video)

LOS ANGELES — (Mealey’s) The stem of a Wright Medical Technology Inc. Profemur R hip prostheses broke because of bad “fit and fill” inside the femur and because of the patient’s poor bone quality, a defense attorney told a California state court jury May 29 during opening...

California Jury Awards $2.5 Million In Wright Medical Technology Profemur R Hip Case

LOS ANGELES — (Mealey’s) A California state court jury on June 12 found that the femoral stem of a Wright Medical Technology Inc. Profemur R hip prosthesis was defectively manufactured and ordered the manufacturer to pay $2.5 million to a patient and his wife for pain, suffering and loss...

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory

. . . 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 traditional compliance analysis regarding the legality...

Cadwalader: Pharmaceutical Manufacturer's Preemptive Suit Secures Preliminary 1st Amendment Protection for Script to Promote Off-Label Use

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 its drug, Vascepa, for off-label use through...

4th Circuit Affirms $2 Million Award In 1st Pelvic Mesh Trial, Says 510(k) Not Probative

RICHMOND, Va. — (Mealey’s) In an expedited appeal, the Fourth Circuit U.S. Court of Appeals on Jan.14 affirmed a $2 million verdict in the first pelvic mesh multidistrict litigation case to go to trial and affirmed the trial court’s exclusion of the device’s 510(k) clearance as...