Failure To Warn Design Defects

News & Analysis as of

Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud

In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

New Jersey Mesh Summary Judgment Hat Trick

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick...more

Preemption And Causation Do Away With Contraception Lawsuit

With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal....more

Power Morcellator Cases Transferred to Kansas

Power morcellators are electric surgical devices used to cut tissue has been used in recent years as an alternative to traditional, abdominal surgical hysterectomies, laparotomies and myomectomies. In April 2014, the...more

Mentor Case Time Barred

In 2004, North Carolina resident Melanie Cole was implanted with Mentor’s OB Tape, which is a sling device that is used to treat urinary incontinence. Three weeks after the surgery, Ms. Cole visited her surgeon and...more

Boston Scientific Prevails in North Carolina Mesh Case

The Uphold Vaginal Support System is a transvaginal mesh product used to treat pelvic organ prolapse (“POP”). Marta Carlson sued Boston Scientific Corporation (“Boston Scientific”), the maker of the Uphold Vaginal Support...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

“May the Odds Be Ever in Your Favor” – The Ten Best Prescription Drug/Medical Device Decisions of 2015

The iconic Hunger Games line, “may the odds be ever in your favor” pretty much sums up how we feel about our top ten best decisions of 2015. These are results that put the “happy” in Happy New Year – which we wish all our...more

N.D. Mississippi Invokes Buckman in Rejecting Plaintiff Efforts to Screw Up Product Liability Law

We are determined not to end 2015 on a bad note. Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning. ...more

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104...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

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

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

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

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

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

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

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

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

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

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