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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. ...

Arkansas: Worker Fails to Rebut Presumption That Accident Was “Substantially Occasioned” by Drugs

An Arkansas appellate court has affirmed a decision denying workers’ compensation benefits to a worker who fell as he descended a ladder on the basis that following the accident he tested positive for methamphetamine and that he failed to rebut the statutory presumption in Ark. Code Ann. §...

Jay Shapiro on Rodriguez v. United States: The Supreme Court Hears Oral Argument on the Reasonableness of a Traffic Stop Extended for a Canine Sniff

Rodriguez v. United States presents an important issue concerning permissible police conduct during a traffic stop, particularly: after a law enforcement officer has completed a traffic infraction stop, does the continued detention of the driver to conduct a dog sniff, without probable cause or reasonable...

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...

FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate

In response to the U.S. Supreme Court's holding in Pliva v. Mensing , 131 S. Ct. 2567 (2011), [ enhanced version available to lexis.com subscribers ], that federal laws and regulations preempted state failure-to-warn claims, the U.S. Food and Drug Administration (FDA) in 2013 proposed to allow generic...

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...

Biosimilars In The US: Still At The Starting Line?

By Erica J. Pascal Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act, which regulates market entry of generic small molecule...

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...

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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...