Products Liability Science, Computers & Technology

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The Internet of Things and the Inevitable Collision with Product Liability PART 5: Security and the Industrial Internet Consortium

The rapid emergence of the Internet of Things (IoT) led to the establishment of the Industrial Internet Consortium (IIC) in the spring of 2014 by five primary stakeholders: AT&T, Cisco, General Electric, IBM and Intel. IIC...more

Medical Device Manufacturers as "Health Care Providers"

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a...more

Essure Medical Device Faces Attacks on Multiple Fronts

The threat of a hunger strike against the Food and Drug Administration, a Facebook page titled “Essure Problems Lawsuit” and a congressional bill calling for a recall of the female contraceptive manufactured by Bayer have...more

New Preemption Decisions That We Can't Discuss Quite Yet

As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about...more

Punitive Damages – How Much Increased Risk Is Enough?

Back in 2009 – when the blog was still a Bexis/Herrmann operation – we wrote a catch-all punitive damages post entitled (oddly enough) “On Punitive Damages.” That post identified and briefly discussed a variety of punitive...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...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

What To Do About Junk Science That’s Published?

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...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

The Internet of Things and the Inevitable Collision with Product Liability PART 4: Government Oversight

The exponential growth of the Internet of Things (IoT) is far outpacing the ability of stakeholders to address safety standards and security concerns. This is not unusual as rapidly developing technology often challenges...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

Autonomous Vehicles – Where in the (Insurance) World Will They Go?

Self-driving cars are coming. In fact, Tesla Model S owners woke up on the morning of October 15, 2015 to discover that a software download to the cars has made them capable of steering and changing lanes at high speed,...more

Guest Post - First Contact - 3D Printing Meets the Learned Intermediary Rule

Here is a guest post on an interesting case. It's the first decision that we're aware of in which a 3D printed medical device (or any 3D printed product) has been the subject of litigation that involves product liability...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

Not Driving in America: Navigating New Territory in Product Liability

Driving in America: It’s a task almost universally reviled by those with hour-long commutes, practically a right-of-way to adulthood, a pastime romanticized in films, and – maybe – a soon extinct activity? Ever since Google...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

Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created "Quagmire"

Ninety-nine years ago today (October 7) Georgia Tech administered the most lop-sided beat-down in college football history, edging Cumberland University 222-0. (By the way, who was the head coach of Georgia Tech who presided...more

Consumer Products “Either/Or”: California Issues Guidance on Alternatives Analysis for Safer Products

California’s Green Chemistry Initiative has taken another step forward with the issuance of guidance on the heart of the law, the analysis of safer substitutes for chemicals in consumer products. On September 24, 2015, the...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

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

Your Data Breach Collided With My Personal Injury Coverage

Editors at Wired magazine recently engaged in a year-long project to develop a means to hack the onboard computer of a Jeep, and override the driver’s control of several critical vehicle functions. According to a disturbing...more

Illinois Federal Court “Sanctions” Fraudulent Joinder of Pharmacies

We learned a new word the other day while watching TV: Autoantonym. An autoantonym is a word that means one thing, but it also means the opposite. The word is its own antonym, and it is remarkably easy to think of examples...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

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