Merck Settles Charges Over Vioxx Marketing For $950M, Guilty Plea

BOSTON - Merck, Sharp & Dohme Inc. has agreed to plead guilty to a criminal misdemeanor and to pay $950 million to resolve criminal charges and civil claims stemming from its marketing of the painkiller Vioxx a decade ago, the U.S. Department of Justice announced yesterday ( United States v....

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...

Another Generic YAZ Birth Control Pill Is Approved, Just One Week Before FDA Drug Safety Meeting

Coincidence, But Ironic, Given Several Recent Medical Studies Which Suggest Drospirenone (DRSP) Causes Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com ) On November 29, 2011 Watson Pharmaceuticals issued this press release, "Watson's Generic Yaz(R) Receives FDA Approval" ,...

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...

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...

Ballard Spahr LLP: New Jersey Supreme Court Clarifies Impact Of FDA Approval On Discovery Rule

Adopting a middle-of-the-road approach that may raise more questions than it answers, the New Jersey Supreme Court has ruled that FDA approval of drug and medical device warnings creates a presumption against application of the discovery rule to a defendant's otherwise-valid statute of limitations...

Split 6th Circuit Says Graphic Cigarette Pack Warnings Are Constitutional

LOUISVILLE, Ky. - (Mealey's) Given that tobacco companies have learned to circumvent bans on marketing to minors, a divided Sixth Circuit U.S. Court of Appeals said March 19, the U.S. Food and Drug Administration's proposal for large, graphic warnings on packs pursuant to the 2009 Family Smoking...

Drug Pump Claims Preempted Expressly, Implicitly, 9th Circuit Panel Majority Says

SAN FRANCISCO - (Mealey's) In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme...

Troutman Sanders LLP: Big Tobacco Loses Appeal in Racketeering Case

A federal appellate court recently rejected the tobacco industry's argument that restrictions imposed as part of a 2006 judgment should be set aside because Congress, in 2009, passed a law that imposed other restrictions on the industry and gave the Food & Drug Administration ("FDA"...

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...

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 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...

William A. Ruskin: Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders

By William A. Ruskin In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers . The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this scale have often been the impetus for major changes...

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...

FDA Announces Ban On Chinese Company’s ‘Bidi’ Type Cigarettes

ROCKVILLE, Md. — (Mealey’s) For what it says is the first time since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the U.S. Food and Drug Administration on Feb. 21 ordered an end to the sale in the United States of a Chinese company’s “bidi” tobacco...

William A. Ruskin: Pharmaceutical Failure to Warn.... On Facebook?

By William A. Ruskin The Facebook page of Switzerland-based drug maker, IBSA Institut Biochimique S.A . (“IBSA”), appeared innocent enough: If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about...

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance seeks to clarify and expand upon FDA's 2009 draft...

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...

Norton Rose Fulbright: Breadth Of Primary Jurisdiction Expanded In Class Actions

By Matthew Gurvitz The doctrine of primary jurisdiction gained ground in false advertising litigation, as Judge Sammartino of the Southern District of California dismissed a putative class action against Kashi Company because FDA signaled that it was reevaluating draft guidance that served as a partial...