Failure To Warn

News & Analysis as of

Judge Denies C.R. Bard’s Request to Seal Documents in IVC Settlement

In August 2005, a patient was implanted with a Bard Recovery Filter System in order to catch blood clots or “thrombi” traveling from the lower portions of his body toward his heart and lungs. Unfortunately, the device failed...more

Court Allows Pennsylvania Punitive Damages Claims in Petroleum Exposure Case

The judge in a petroleum exposure case will allow a jury to decide whether a gas station operator and its environmental consultant recklessly failed to inform a plumber of the risks of working in an excavated pit with a...more

Judge Presiding over Risperdal Litigation Issues Decision on Choice of Law

Last week, the coordinating judge for the Risperdal mass tort litigation released an opinion explaining why punitive damages claims are barred in the nearly 1,500 cases consolidated in the Philadelphia Court of Common Pleas. ...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Product Liability Update - October 2015

Massachusetts Federal Court Holds Proof of Testing of Proposed Alternative Design Not Required in Design Defect Claim, Evidence Plaintiff Ignored Defendant’s Warnings Did Not Establish He Was Sole Proximate Cause of Injury on...more

Philly Court Applies Michigan Law to Dismiss Risperdal Cases

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida. True, Justified was set in Kentucky. But...more

Plaintiffs Allege GSK Hid Risk of Birth Defects

The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting...more

C.R. Bard Awarded Summary Judgement on Warning Claim in IVC Case

An inferior vena cava (IVC) filter is used to prevent life threatening pulmonary emboli. Once installed, the filter’s arms and legs open and anchors it to the walls of the IVC. The filter then catches blood clots that would...more

Lack of Warning Causation Dooms Aredia-Zometa Case

Warning: You have heard all this before. Still reading? Okay. But please don't tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more...more

Ohio Couple Says Zofran Caused Infant’s Death

In 1991, the Food and Drug Administration (FDA) approved Zofran, which is manufactured by GlaxoSmithKline LLC (GSK) for use in cancer patients who require chemotherapy or radiation therapy. An Ohio couple has sued GSK, the...more

Limiting Tort Liability for Cannabis: Failure to Warn Part I – the LivWell Lawsuit

On Oct. 5, 2015, two plaintiffs filed a class action lawsuit in Denver against the owner of a large cannabis grow facility, LivWell. They assert that LivWell used a purportedly dangerous fungicide on its cannabis plants...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Heedless Heeding Presumptions – How New York Law Became a Morass

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.” This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning...more

Judge Consolidates Design Defect Claims for Trial in Ethicon Mesh

Judge Goodwin, who oversees the Ethicon mesh pelvic repair system multidistrict litigation in West Virginia, has consolidated 26 actions for trial on the issues of design defect, negligent design, and strict liability. The...more

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist....more

M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

Today’s case gives us a lesson and a laugh. The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes. The...more

Breaking News - Arizona Supreme Court to Review Watts Learned Intermediary decision

We've posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015). Well, that's not the last word anymore. Today...more

SDNY Sacks Treanda Failure to Warn Claim

Failure to warn cases remind us of sports talk radio and paleontology. Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination. The Iggles are terrible, their deficiencies...more

Defective Design and Transvaginal Mesh Lawsuits

With hundreds of thousands of women alleging injuries from transvaginal mesh, the potential risks of this dangerous product are becoming better known. In numerous cases, affected victims have alleged that the makers of...more

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

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