Failure To Warn

News & Analysis as of

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

The Failure to Warn of Cannabinoid Hyperemesis Syndrome

As more states legalize marijuana for recreational use, the long-term effects of marijuana use —the good and the bad — will continue to have a significant effect on the law, and in particular, products liability law. Products...more

Hip Case Breaks the Right Way in New York

A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one: A medical device is defective if it fails. Myth number two: A plaintiff can prove causation on a...more

Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

This is a guest post from Michael Salimbene, an associate at Reed Smith. It’s about learned intermediary causation, and the need for prescriber testimony. Not infrequently, in mass torts with lots of solicited plaintiffs,...more

Heeding Presumption Only Goes So Far In Post-Sale Warning Case

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the...more

11th Circuit Upholds Stent Defense Verdict

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term...more

Can a Football Helmet Manufacturer Be Responsible for High School Football Player’s Tragic Death?

A Chicago mother who tragically lost her son following a football-related injury recently filed suit against the city school board and the helmet manufacturer, alleging both parties failed to take reasonable steps to ensure...more

Asbestos Alert: Government Contractor Defense Available to Broker Which Arranged for Asbestos-Containing Insulation to Be Provided...

California Court of Appeal, First Appellate District (November 22, 2016) - The Government Contractor defense is available in asbestos lawsuits brought against manufacturers and suppliers of military hardware and...more

Plaintiffs Withdraw Motion to Centralize Essure Birth Control Litigation

Essure birth control is a medical device designed to provide permanent sterilization. Since 2002, about 750,000 women worldwide have undergone Essure sterilization procedures. Although the device has been marketed as a...more

The Cannabis Industry: Burning Batteries, Tasty Treats and Budding Product Liability Litigation

Pot smokers are not the only ones lining up outside the local dispensaries; plaintiff personal injury attorneys are as well. Watching, lurking, waiting with dollar signs in their eyes for the chance to seek punitive damages,...more

Smoking Out the Scope of Preemption

Last month, while grappling with an aphrodisiac false-advertising case, we joked that we felt like having a cigarette after reading the court’s opinion. Today we get our cigarette. Or, rather, our e-cigarette. Today’s post...more

Probably the Best Wisconsin Law Decision We’ve Ever Seen

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law...more

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

October 2016: Entertainment Litigation Update

Pokémon GO: What Legal Pitfalls Await Augmented Reality Games? On July 6, 2016, Pokémon GO launched in the United States to immediate popularity—more than 45 million people downloaded and played the game on their smartphones...more

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

The Learned Intermediary Rule in Consumer Protection Claims

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes. See Andren...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

Regulatory and Product Liability Overview for Distributors of Food Products in California

Welcome to California! California is a great place to live and work, and we are fortunate to call it home. But there is no sugarcoating the fact that California presents unique and daunting challenges to product...more

Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand...more

Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims...more

11th Circuit Upholds Award of Summary Judgment in Mirena Lawsuit

In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more

Another Make Work Project In New Jersey – Duty To Update Claims

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the...more

Litigation Alert: The Ninth Circuit Limits Immunity From Negligent Failure To Warn Cases Under The Communications Decency Act

Last week, the Ninth Circuit limited the ability of websites and online services to use Section 230 of the Communications Decency Act (CDA) to shield themselves from failure to warn lawsuits arising out of the offline conduct...more

Product Liability Update: April 2016

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

A Banner Week For Buckman Preemption

There used to be a TV show called “That Was the Week That Was.” It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career. Without an ounce of...more

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