News & Analysis as of

Design Defects The United States Food and Drug Administration

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts

by Reed Smith on

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug...more

Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

by Sands Anderson PC on

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim....more

SDNY Rejects Innovator Liability

by Reed Smith on

May 10 is an important day in the history of the law. On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit. The case was called Nix v. Hedden, 149 U.S. 304 (1893). The issue...more

Vast – Or at Least Half-Vast – Conspiracy Claim Dismissed

by Reed Smith on

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and...more

On Alternative Design, Take Two - Negligence

by Reed Smith on

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

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

by Reed Smith on

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

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

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

by Reed Smith on

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

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

by Butler Snow LLP on

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...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

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

by Reed Smith on

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

In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

by Reed Smith on

We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S....more

Preemption (and Other Things) Defanging Depakote Claims

by Reed Smith on

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

Product Liability Update - July 2015

by Foley Hoag LLP on

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

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

by Wilson Elser on

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

Some Ideas About 3D Printing

by Reed Smith on

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

Liability for Pharmaceutical Manufacturers Expands for the First Time to Include Design Defect Claims

by Nelson Brown & Co. on

Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

by Cozen O'Connor on

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

DePuy Wants to Slip Away From Metal Hip Jury Verdict

Johnson & Johnson (J&J) has requested that an $8.3 million judgment against the company over its DePuy metal-on-metal (MoM) hip implant be put on hold....more

Breaking Down The Bartlett Oral Argument

by Morrison & Foerster LLP on

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Design Defect Claims Against Vaccine Manufacturers Are Preempted by Federal Law

On February 22, 2011, in Bruesewitz v. Wyeth, Inc., the U.S. Supreme Court held in a 7–2 decision that the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) preempts all design defect claims brought against...more

Another Liability Shield for Vaccine Manufacturers: U.S. Supreme Court Rules that Design Defect Claims Against Vaccine...

by Morrison & Foerster LLP on

On February 22, the Supreme Court issued its decision in Bruesewitz v. Wyeth, 562 U.S. __ (2011). The Court’s 6-2 opinion, written by Justice Scalia (Justice Kagan took no part in the decision), held that design defect claims...more

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