LexisNexis® Legal Newsroom
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...

Department of Justice Files Amicus Curiae Brief In First Circuit Seeking Reversal of Decision That Could Significantly Impair False Claims Act Enforcement

On August 1, 2013, the Department of Justice (the “DOJ”) submitted an amicus curiae brief asking the First Circuit to reverse a significant False Claims Act (“FCA”) decision issued in United States ex rel. Helen Ge, M.D. v. Takeda Pharmaceutical Company Limited, et al. (“Takeda...

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...

State Net Capitol Journal Spotlight: Hot Issues Won’t Vary Much in 2014

By Rich Ehisen | For most states, 2013 was a welcome respite from the usual election year political gridlock. That all changes next year, with 38 governorships, 46 legislative chambers, 33 United States Senate seats and all 435 House of Representatives seats up for grabs. But amidst all that politicking...

Supreme Court Justice Halts Birth Control Mandate For Catholic Group

WASHINGTON, D.C. — (Mealey’s) U.S. Supreme Court Justice Sonia Sotomayor on Dec. 31 temporarily blocked the federal government from enforcing the birth control mandate contained in the Patient Protection and Affordable Care Act (PPACA) against an order of Catholic nuns at the request of the...

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...

Lidoderm Settlement Costs Endo Pharmaceuticals $192.7 Million

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug...

DLA Piper Alert: Federal Agencies Propose Health IT Regulatory Framework, Seek Stakeholder Input and Participation In New Initiatives

By Mary B. Langowski and Kristen E. Ratcliff A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the National Coordinator for Health IT have...

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...

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...