Failure To Warn

News & Analysis as of

Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law

In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

A Victory Well Won

Today’s case, blogger fanatics, is a good illustration of grinding out a victory. It’s the story of a defendant calmly and effectively pressing its legal and factual arguments, winning a partial victory before trial,...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Ninth Circuit: CDA Does Not Bar Claims for Failure to Warn

Reversing the dismissal of a negligent failure to warn action, the Ninth Circuit Court of Appeals carved out a key exception to the immunity afforded to website operators under the Communications Decency Act (CDA)....more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

Toxic Tort & Product Liability Quarterly Volume 7, Number 2

MASS TOXIC TORTS - West Virginia Chemical Spill Prompts Wave of Lawsuits - The January 9th, 2014 chemical release at a Freedom Industries, Inc. facility in West Virginia has shown, yet again, that major...more

A Brief Overview of the Case Law Regarding "Failure to Train" Claims - And Its Implications for Medical Device Manufacturers

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

Pennsylvania Supreme Court Rules on Whether Drug Company Has Expanded Duties

On January 21, 2014, the Pennsylvania Supreme Court held in a 4–2 vote in Lance v. Wyeth, 2014 PA. 17 EAP 2011 (PA Supreme Court 2014), that a pharmaceutical company for the first time under Pennsylvania law may face...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Florida High Court Reinstates $1.2 million Judgment Against Law Firm of Prospective Client

On October 24, 2013, the Florida Supreme Court reinstated a $1.2 million final judgment awarded to a prospective client of a personal injury law firm who sat in a chair that collapsed during a consultation at the firm. See...more

California Court of Appeal Holds Intermediary’s Sophistication Not Sufficient, as a Matter of Law, to Avoid Supplier’s Liability...

On October 29, 2013, the California Court of Appeal affirmed as proper a trial court’s refusal to give defendant John Crane, Inc.’s (Crane’s) requested jury instruction on the “sophisticated user” defense. In Anne Pfeifer, et...more

Product Liability Update -- October 1, 2013

In This Issue: ..Massachusetts Supreme Judicial Court (Finally) Enforces Agreement for Individualized Arbitration of Unfair and Deceptive Practices Claims Following United States Supreme Court Decision Reversing...more

Ontario Court Certifies Class Action Relating to Allegedly Faulty Hip Implants

In a decision released on August 27, 2013, Justice Belobaba of the Ontario Superior Court of Justice certified a class action against DePuy Orthopaedics Inc. on behalf of persons who were surgically implanted with any one of...more

Does Mutual Pharmaceutical Co., Inc. v. Bartlett Herald the Demise of the "Failure-To-Withdraw" Theory?

In most states that use a “risk utility” test to determine whether a product is “not reasonably safe” (i.e. defective) as designed, an alternative design for the product is generally considered to be a critical element of the...more

Is There Any Legal Liability Following Airbag Malfunctions?

As reported by the New York Times and Forbes, airbag supplier Takata Corp. announced to the National Highway Traffic Safety Administration (NHSTA) that some of its products had the possibility of malfunctioning. ...more

When In Doubt, Write Your Doctor A Letter

"Dear Doctor" letters were front and center in the recently tried case of Tietz v. Abbott Laboratories Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

Second Circuit Labels Expert’s Testimony a Sham in Pharmaceutical Products Liability Litigation

As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more

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