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Pfizer To Pay $325M To Settle Neurontin 3rd-Party Payer, Antitrust Class Action

BOSTON — (Mealey’s) Pfizer Inc. has agreed to a $325 million class settlement of claims by third-party payers that allege that the off-label promotion of the epilepsy drug Neurontin violated the Racketeer Influenced and Corrupt Organizations Act and that the drug maker’s efforts to...

Pa. Supreme Court Vacates $27.7M Drug Pricing Judgment Against Bristol-Myers

HARRISBURG, Pa. — (Mealey’s) The Pennsylvania Supreme Court on June 16 vacated a $27.7 million drug pricing judgment against drug maker Bristol-Myers Squibb Co. (BMS) because a trial court failed to account for billions of dollars in drug rebates paid to the state government ( Commonwealth...

6th Circuit Panel Affirms Most Darvon/Darvocet/Propoxyphene Claims Are Preempted

CINCINNATI — (Mealey’s) The Sixth Circuit U.S. Court of Appeals on June 27 affirmed dismissal of 67 of 68 Darvon/Darvocet/ propoxyphene multidistrict litigation cases, finding that the plaintiffs either failed to properly plead their claims or that the claims are preempted by federal law...

Pennsylvania Appeals Court Affirms $10M Children’s Motrin TEN Injury Verdict

PHILADELPHIA — (Mealey’s) A Pennsylvania appeals court panel on July 22 affirmed a $10 million Children’s Motrin verdict for a girl who suffered toxic epidermal necrolysis (TEN) after being given the over-the-counter pain/fever reducer at age 3 ( Alicia E. Maya, et al. v. Johnson and...

$2M N.J. Accutane Verdict Reversed, 2 Defense Verdicts Affirmed On Appeal

TRENTON, N.J. — (Mealey’s) A New Jersey appeals panel on Aug. 4 vacated a $2,125,617 Accutane bowel injury verdict and affirmed defense verdicts in two other cases tried at the same time ( Gillian Gaghan v. Hoffman-La Roche Inc., et al. , Nos. A-2717-11T2, A-3211-11T2 and A-3217-11T2, N.J...

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...

Alabama High Court Again Says Brand-Name Drug Makers Liable In Generic Injury Case

MONTGOMERY, Ala. —(Mealey’s) A brand-name drug manufacturer may be liable under Alabama law for fraud or misrepresentation in a drug label used by generic drug makers, the Alabama Supreme Court held Aug. 15 after reconsidering its 2013 decision in a Reglan/metoclopramide case ( Wyeth, Inc...

Pennsylvania State Court Jury Awards Plaintiff $2 Million In Actos Bladder Cancer Case

PHILADELPHIA — (Mealey’s) A Pennsylvania state court jury on Oct. 3 awarded an Actos bladder cancer patient $2.05 million in economic and noneconomic damages but declined to award punitive damages ( Frances Wisniewski v. Takeda Pharmaceuticals America Inc., et al. , No. 120702272, Pa. Comm...

Generic Drug Failure-To-Update Preemption Ruling Won’t Be Reviewed By High Court

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on Jan. 20 denied review of a California appeals court ruling that a drug company may be liable for failure to update a generic drug’s warning label ( Teva Pharmaceuticals USA Inc., et al. v. Superior Court of California, et al. ...

Pennsylvania State Court Jury Awards $2.5 Million In Risperdal Gynecomastia Trial

PHILADELPHIA — (Mealey’s) A Pennsylvania state court jury on Feb. 24 awarded $2.5 million to the family of a man who claimed that the atypical antipsychotic drug Risperdal caused gynecomastia, or enlarged male breasts ( P.P., et al. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., et al. ,...

S.C. Supreme Court Oks Risperdal Unfair Trade Verdict, Lowers Penalty To $136 Million

COLUMBIA, S.C. — (Mealey’s) In a 4-1 ruling, the South Carolina Supreme Court on Feb. 25 affirmed that Janssen Global Services LLC engaged in unfair trade practices through its marketing of the atypical antipsychotic drug Risperdal but shortened the violation time period and lowered the civil...

McNeil Pleads Guilty, Pays $25M For Making Adulterated Children’s Medicines

PHILADELPHIA — (Mealey’s) The McNeil-PPC Inc. subsidiary of Johnson & Johnson on March 10 pleaded guilty to a federal misdemeanor criminal charge of making adulterated children’s over-the-counter medicines and agreed to pay a criminal fine and forfeiture totaling $25 million ( United...

N.J. Accutane Judge: Post-2002 Warnings Of Bowel Injury Are Adequate Under Law

ATLANTIC CITY, N.J. — (Mealey’s) A judge overseeing New Jersey’s Accutane litigation on April 2 granted summary judgment to Accutane manufacturer Hoffman-La Roche after finding that as a matter of law, the drug’s post-April 2002 warnings about inflammatory bowel disease (IBD)...

Massachusetts High Court Affirms $63 Million Children’s Motrin Verdict For Child, Parents

BOSTON — (Mealey’s) The Massachusetts Supreme Judicial Court on April 17 affirmed a $63 million Children’s Motrin verdict, finding that the plaintiffs’ warning claim is not preempted, that its key expert was qualified to testify about causation and that the awards for the victim...

Defense Verdict Returned In Purported 1st Zoloft Birth Defect Trial

ST. LOUIS — (Mealey’s) A Missouri state court jury on April 17 returned a defense verdict in a Zoloft birth defect trial said by the parties to be the first trial of its kind in the nation ( Kristyn Pesante, et al. v. Pfizer, Inc. , No. 122-CCO-2441-01, Mo. Cir., St. Louis City.). Kristyn...

Takeda To Pay Up To $2.4 Billion To Settle About 9,000 Actos Bladder Cancer Claims

LAFAYETTE, La. — (Mealey’s) Takeda Pharmaceutical Co. Ltd. will pay up to $2.4 billion to settle the “vast majority” of Actos bladder cancer lawsuits in the United States, the company, plaintiff attorneys and the multidistrict litigation court said April 28 ( In Re: Actos [Pioglitazone...

Another Specialty Pharmacy Settles Exjade False Claims Allegations For $45 Million

NEW YORK —(Mealey’s) Specialty pharmacy Accredo Health Group Inc. on April 30 agreed to pay $45 million to settle a whistle-blower’s allegations that its efforts to push prescriptions for the iron chelation drug Exjade resulted in false claims being submitted to federal health care...

U.S. High Court Denies Review Of Last Pending Appeal Of Generic Label-Update Claim

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on May 18 denied review in the last pending “failure-to-update-warnings” preemption appeal by generic drug manufacturers ( Teva Pharmaceuticals USA, Inc., et al. v. Paul E. Hassett , No. 14-705, U.S. Sup. [lexis.com subscribers...

California Appeals Court Reinstates $6.5 Million Actos Verdict; Expert Back In

LOS ANGELES — (Mealey’s) A California appeals court panel on July 16 reinstated a $6.5 million Actos bladder cancer verdict, finding that the trial court erred in excluding the plaintiffs’ causation expert in a post-verdict ruling ( Nancy Cooper, et al. v. Takeda Pharmaceuticals America...

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...

Warner Chilcott Pleads Guilty, Pays $125M In Criminal, Civil Fines For Fraud

BOSTON — (Mealey’s) Pharmaceutical company Warner Chilcott on Oct. 23 pleaded guilty to health care fraud, and its former president was arrested for conspiracy to pay kickbacks to physicians, the U.S. Attorney for the District of Massachusetts announced Oct. 29 ( United States of America...

Preemption Summary Judgment Granted In Incretin-Mimetic Multidistrict Litigation

SAN DIEGO — (Mealey’s) The California federal judge overseeing the incretin mimetic multidistrict litigation on Nov. 9 granted summary judgment to five makers or promoters of the diabetes drugs, finding clear evidence that the Food and Drug Administration would have rejected a new warning...

U.S. High Court Won’t Decide ‘Clear Evidence’ In $63 Million Children’s Motrin Verdict

WASHINGTON, D.C. — (Mealey's) The U.S. Supreme Court on Jan. 19 denied a petition by Johnson & Johnson and a subsidiary to decide if denial of a citizen petition constitutes “clear evidence” that the Food and Drug Administration rejected a stronger warning about the risk of...

Arizona High Court Adopts Learned Intermediary Doctrine; No Conflict With Tort Law

PHOENIX — (Mealey’s) The Arizona Supreme Court on Jan. 21 adopted the learned intermediary doctrine and said it can be used by drug manufacturer Medicis Pharmaceutical Corp. to defend against a drug liability claim ( Amanda Watts v. Medicis Pharmaceutical Corporation , No. CV-15-0065-PR,...