Failure To Warn

News & Analysis as of

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

Environmental Litigation and Toxic Torts Update – Mountain West Coast Case Law Highlights

COLORADO CITY FRACKING BANS PREEMPTED BY STATE LAW - City of Longmont v. Colo. Oil and Gas Ass’n, 369 P.3d 573 (Colo. 2016), 2016 Colo. LEXIS 442; City of Fort Collins v. Colo. Oil and Gas Ass’n, 369 P.3d 586 (Colo....more

How Far Is Too Far? New York Clarifies Potential Warnings Liability for Third-Party Products

It’s probably common knowledge to even a novice product liability practitioner that a manufacturer can be held liable for a defect in a component part supplied by another company that is integrated into the manufacturer’s end...more

New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted,...more

Mixed and Matched Hip Components Equal Express Preemption

If a surgeon combines a PMA device with a 510k device, what does that do to federal preemption? We ask this question because one of the more fascinating aspects of the medical device world is modularity. We have heard of...more

Federal Court Dismisses Essure Complaint

A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Xarelto Litigation – July Update

Searcy Denney has continued its commitment to seeking justice on behalf of victims of Xarelto (rivaroxaban) with the filing of a number of additional individual lawsuits on behalf of injured patients over the past few weeks....more

Another Prescription Drug Warnings Preemption Decision

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

Walt Disney World — Tragic Loss Should Have Been Avoided

Opened on October 1, 1971, Walt Disney World is the most visited vacation resort in the world. Reports estimate that over 52 million people visit Walt Disney World annually. For me, growing up in West Palm Beach,...more

Component Parts Doctrine not Applicable to Products Used in Manufacturing Process That are not Incorporated into a Different...

Flavio Ramos, et al. v. Brenntag Specialties, Inc., et al. - California Supreme Court (June 23, 2016) - In cases of claimed injury from asbestos exposure, the component parts doctrine was designed to provide...more

California Supreme Court Adopts the Sophisticated Intermediary Defense

In Webb v. Special Elec. Co., the California Supreme Court formally adopted the "sophisticated intermediary doctrine," which provides an additional defense that manufacturers and suppliers can assert against product liability...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

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