Design Defects Medical Devices

News & Analysis as of

Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case

We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post. It is a beautiful fall day where we have a relative lull in our slate of...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

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

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

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

Another Decision Applying Bartlett Preemption to All Drugs

Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post...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

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

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

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

How Does a Bad Idea Get Implanted?

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway. The plaintiff bar is nothing if not persistent. ...more

Medical Device Decision Plays PA’s Greatest Hits

When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio...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

MDL Court Agrees – Tincher Doesn’t Change Pennsylvania Drug/Device Law

Several months ago we responded with some disdain to recent plaintiff-side arguments we had seen claiming that the strict liability decision in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow altered...more

Are hospitals or medical scope companies to blame for Superbug breakouts?

The price of liability can be extremely high. A medical malpractice lawyer in Lake County understands that when doctors, staff or manufacturers make medical mistakes, they are not likely to readily admit their errors. ...more

Punitive Damages Awarded in J&J Transvaginal Mesh Lawsuit

Reuters recently reported that a California state court jury (in the case of Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123) awarded $5.7 Million to plaintiff Coleen...more

Some Ideas About 3D Printing

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

Dallas Woman Awarded $1.2 Million, Mesh Called Defectively Designed

For the first time, a Texas jury has decided the pelvic mesh made by healthcare giant Johnson & Johnson was defectively designed. The jury awarded the 64-year-old Dallas woman $1.2 million following a two-and-a half week...more

Product Liability Update -- October 1, 2013

In This Issue: ..Massachusetts Supreme Judicial Court (Finally) Enforces Agreement for Individualized Arbitration of Unfair and Deceptive Practices Claims Following United States Supreme Court Decision Reversing...more

Ontario Court Certifies Class Action Relating to Allegedly Faulty Hip Implants

In a decision released on August 27, 2013, Justice Belobaba of the Ontario Superior Court of Justice certified a class action against DePuy Orthopaedics Inc. on behalf of persons who were surgically implanted with any one of...more

The Exclusion of Other Incident Evidence in Product Liability Litigation

A crucial issue in the successful defense of a product liability case is the exclusion of other incidents and accidents involving products of the manufacturer. In old school parlance, prior incidents were often referred to...more

Product Liability Law Medical Device Law Update: December 2012 - “A State of Profound Uncertainty”: The Crisis in Pennsylvania

Since the mid-1960s, Pennsylvania has adhered to the strict liability tenets of section 402A of the Restatement (Second) of Torts. Its version of strict liability had a number of unique features, including the determination...more

Strict Products Liability Claims Based On Design Defect Are Inapplicable To Implanted Medical Devices That Are Available Only...

A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design...more

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