Failure To Warn

News & Analysis as of

Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted...more

SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

California Dreaming: The Bite of Bauman, the Perfume of Preemption, the Stink of Stengel

This week the Drug and Device Law Son turns 20. It is apparently an age of discontent, of gripes and snipes. When we asked the DDLS what he wanted for his birthday, he said he wanted to move "back" to California. Something...more

Claims of Negligent Design and Breach of Implied Warranty to Proceed Against Boston Scientific Mesh

On February 9, 2009, a North Carolina resident was implanted with the Obtryx Transobturator Mid- Urethral Sling System (Boston Scientific Mesh). She sued Boston Scientific Corp., the maker of the sling, asserting claims of...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...more

More Lawsuits Filed Against the Makers of Zofran

Zofran (ondansetron) is an anti-nausea medication made by GlaxoSmithKline (“GSK”). In 1991, the Food and Drug Administration (“FDA”) approved it for chemotherapy patients with severe nausea and vomiting. However, it has been...more

Product Liability Update - July 2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Little Reprieve for Prisoner Zyprexa Suit

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

GlaxoSmithKline Files Motion To Consolidate Zofran Litigation In Philadelphia

Zofran was developed to prevent nausea and vomiting caused by cancer chemotherapy. However, doctors prescribed it for the treatment of morning sickness in pregnant women. GlaxoSmithKline is the world’s seventh largest...more

New IUDs and the Failure to Warn

Are intrauterine devices (IUDs) safe for use? For a number of years, patients have filed lawsuits against Bayer, the maker of Mirena. Mirena is one of three IUDs that is currently on the U.S. market, accompanied by ParaGard...more

The Elephant in the Room in Alabama

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and...more

Lawsuits Allege LinkBetween Zoloft and Birth Defects

Report Suggests Anti-Depressant May Cause Birth Defects - Last year, a Pfizer report included information from a scientist that suggested a “potential link” between birth defects and the manufacturer’s anti-depressant...more

The Bard Mesh Litigation

All filed federal product liability lawsuits claiming injuries with transvaginal mesh or bladder slings used for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) are centralized. In February...more

More Drake Dreck – Vermont Federal Court Refuses to Overturn Botched Botox Verdict

“We’ve seen this movie before.” That is something people say when they encounter something that seems simultaneously dreadful and predictable. That is how we felt upon reading the latest dismal opinion out of the Drake...more

The Boston Mesh Litigation

Mesh products have been regularly used to repair abdominal hernias since the 1950s. In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs....more

Newton’s Third Law: The Alabama Legislature Supersedes Weeks v. Wyeth and Disallows Innovator Liability in Product Liability Cases

Sir Isaac Newton’s Third Law of Motion states, loosely, that for every action there is an equal and opposite reaction. A force exerted by one body upon another causes an equal reaction by the second body. Want an...more

Negligence –Duty Owed by a Religious Organization to One of its Members Who Has Been Harmed By Another Member

Candace Conti v. Watchtower Bible & Tract Society of New York, Inc., et al. - Court of Appeal, First Appellate District (April 13, 2015) - Historically, churches have not been found vicariously liable for the...more

Freehand Line-Drawing in Affirmance of Huge Verdict in Children’s Motrin/TEN Case

A couple of days ago, we watched the lovely “St. Vincent.” The film stars a spot-on Bill Murray as Vincent, an unemployed curmudgeon living alone in an otherwise tidy residential neighborhood. Disrepair has turned Vincent’s...more

Health Alert (Australia) - April 28, 2015

In This Issue: Judgments; Reports; and Legislation. Excerpt from Judgments: Australia. Federal Court - 15 April 2015 - Australian Competition and Consumer Commission v ACN 117 372 915 Pty Limited (in...more

Actos Drug Settlement Pros and Cons

Takeda Offers Settlement for Dangerous Drug Lawsuits - Thousands of lawsuits have been filed across the country alleging that Takeda Pharmaceuticals, the largest drug manufacturer in Asia, “hid the cancer risks...more

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

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

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