LexisNexis® Legal Newsroom
Lawsuits Follow Diabetes Drug Actos' Link To Cancer Risk

TRENTON, N.J. - (AP) The maker of the world's best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer. In June, Takeda Pharmaceuticals Co. Ltd. halted sales of Actos. . . ...

N.J. Appeals Court: Hormone Replacement Therapy Plaintiffs Didn't Rebut Label Adequacy

TRENTON, N.J. - (Mealey's) A New Jersey appeals court panel on Sept. 29 affirmed summary judgment in two hormone replacement therapy (HRT) cases in which the state's mass tort court found that the plaintiffs failed to present sufficient evidence to rebut the state's presumption that warnings...

Avastin Breast Cancer Approval Revoked By FDA After Little Benefit Shown

ROCKVILLE, Md. -- The Food and Drug Administration on Nov. 18 revoked approval for Avastin to treat breast cancer after concluding that the drug did not slow progression of tumors and that any benefits did not outweigh the drug's risks. ( Decision. Document #28-111201-001X .) In 2008, the...

Stryker Biotech Pleads Guilty, Will Pay $15 Million For Promoting Bone Repair Products

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 care professionals ( United States of America...

Understanding Recalls

By Richard P. Console When a consumer product is manufactured there are specific, federal regulations in place to make sure they are safe for the public. This is true of all products from cars and tires to food to lamps-everything needs to be free of hazards before hitting the market. However, everyone...

N.J. High Court Says State Discovery Rule Not Foreclosed By Product Liability Law

TRENTON, N.J. - (Mealey's) New Jersey's discovery rule is not foreclosed by a presumption in the state's product liability law that Food and Drug Administration-approved warnings are adequate, the state Supreme Court ruled 5-1 on Feb. 27 in an Accutane case now headed for retrial ( Kamie...

Graphic Images On Cigarette Packs Are Unconstitutional Compelled Speech, Judge Says

WASHINGTON, D.C. - (Mealey's) The Food and Drug Administration's proposed graphic warnings for cigarette packs violate the First Amendment bar against compelled speech, a District of Columbia federal judge ruled Feb. 29 in granting summary judgment in favor of five tobacco companies ( R.J. Reynolds...

9th Circuit: Federal Law Doesn't Preempt Parallel State Law Device Claim

SAN FRANCISCO- (Mealey's) The Ninth Circuit U.S. Court of Appeals, sitting en banc , ruled Jan. 10 that federal law does not preempt, expressly or by implication, a state law failure-to-warn claim alleging that Medtronic Inc. violated its federal duty to report problems with a drug pump ( Richard...

2nd Circuit Upholds Fosamax Bellwether Defense Verdict

NEW YORK - (Mealey's) A defense verdict for Merck, Sharp & Dohme in the fourth federal Fosamax jaw injury trial was upheld Jan. 30 by the Second Circuit U.S. Court of Appeals, which found that the trial court didn't err in excluding a plaintiff expert or in its trial rulings ( In Re: Fosamax...

Failure To Update Generic Metoclopramide Label Not Preempted, 6th Circuit Says

CINCINNATI - (Mealey's) A plaintiff's claim that PLIVA Inc. failed to add a 2004 warning from the Reglan label to its label for generic metoclopramide is not preempted, a panel of the Sixth Circuit U.S. Court of Appeals said March 13 in what it described as question of first impression in the...

2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal

NEW YORK - (Mealey's) The Second Circuit U.S. Court of Appeals on June 5 said the federal government failed to meet the standard to obtain a stay of a lower court order that the Food and Drug Administration immediately make the older, two-pill Plan B emergency contraceptive available without prescription...

FDA Lifts All Restrictions On Plan B One-Step Contraceptive, Will Drop Appeal

BROOKLYN, N.Y. - (Mealey's) The federal government on June 10 told a federal judge that it will make the one-pill Plan B One-Step emergency contraceptive available without age or point-of-sale restrictions and intends to voluntarily withdraw its appeal of the judge's order requiring the lifting...

U.S. High Court Won’t Hear Arguments That Punitives Are Preempted In Drug Cases

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on Oct. 7 refused to hear arguments by Novartis Pharmaceuticals Corp. that federal drug regulations and high court precedent preempt the awarding of state law punitive damages in an Aredia/Zometa jaw injury case ( Novartis Pharmaceuticals...

U.S. High Court Changes Mind, Won’t Review Oklahoma Ruling Stopping Abortion Drug Ban

WASHINGTON, D.C. — (Mealey's) The U.S. Supreme Court on Nov. 4 decided not to review an Oklahoma Supreme Court ruling that found that the state’s ban on off-label use of abortion drugs is unconstitutional ( Terry Cline, et al. v. Oklahoma Coalition for Reproductive Justice, et al. , No...

Duane Morris LLP: Compounding Pharmacies Now Subject To Federal Oversight

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act . Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee drug compounding in human health. The CQA does not apply...

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...

Pa. Supreme Court Says Drug Companies Can Be Sued For Marketing Dangerous Drugs

PHILADELPHIA — (Mealey’s) Pennsylvania law allows drug companies to be sued if they fail to stop marketing drugs known to be unreasonably harmful, and the manufacturers are not immune from being sued for damages for lack of due care, the Pennsylvania Supreme Court ruled Jan. 22 in an eight...

La. Supreme Court Reverses $330M Verdict For Risperdal Medicaid Law Violations

NEW ORLEANS — (Mealey’s) In a 4-3 vote, the Louisiana Supreme Court on Jan. 28 reversed a verdict of more than $330.6 million against Janssen Pharmaceutical Inc. and parent company Johnson & Johnson, finding that the state attorney general failed to prove that misrepresenting the safety...

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...

U.S. Supreme Court Won’t Hear Drug Pump Adverse Event Preemption Case

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on June 23 let stand a federal appeals court ruling that there is no preemption of a claim that medical device manufacturer Medtronic Inc. violated its duty under federal law to report adverse events to the Food and Drug Administration...

Failure-To-Update Claims For Generic Drugs Not Preempted In New Jersey, Court Says

TRENTON, N.J. — (Mealey’s) A New Jersey state appeals court panel on Nov. 12 affirmed a lower court ruling that generic drug manufacturers can be sued for failure to update their labels with warnings added to the labels of the predecessor drug ( In Re: Reglan Litigation , No. A-2014-13T4...

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...

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...

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...