Science, Computers & Technology Products Liability

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Knee Implant MDL Judge Enters Aggressive Lone Pine Order

We love Lone Pine orders. First of all, we love the name. Makes us think of a cowboy eating beans under a scraggly tree. On the prairie. Listening to Dolly Parton. We also love Dolly Parton, whom we saw in concert last week...more

Autonomous Vehicle Manufacturers Do Not Need to be Shielded from Lawsuits

Full disclosure # 1: I, the author of this blog post, am a trial lawyer. Full disclosure # 2: The law firm that allows the publication of this blog post has many, many, many more trial lawyers. Without disputes that could go...more

Latest on Personal Jurisdiction – Using Bauman To Quash Third-Party Subpoenas

In updating our post-Bauman personal jurisdiction cheat sheet, we recently came across an interesting application of Daimler AG v. Bauman, 134 S.Ct. 746 (2014) – lack of general personal jurisdiction requiring that a...more

Can Plaintiffs Sue a “Celebrity Spokesperson”?

We’ve thought a lot about the various secondary entities that plaintiffs sometimes sue in prescription medical product liability litigation – such as sales reps, physicians, hospitals, pharmacies, distributors, and a number...more

W.D. Penn. Dismisses Most Claims in Hernia Mesh Case

You’ve probably heard James Carville’s description of Pennsylvania as Pittsburgh on one end, Philadelphia on the other, and Alabama in-between. Let’s put aside that last bit, which manages simultaneously to insult both...more

French Supreme Court Ruling Clarifies Liability For Defective Products

A February 25, 2016, decision by the French Supreme Court clarifies some conditions for the imposition of liability with respect to defective products in ways that may be surprising to those more accustomed to U.S. product...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

Calif. Asks Innovator Drug Brands to Do the Impossible

Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

U.S. DOT Moving Closer to Certification of Driverless Cars

Motor vehicle design continues to make significant technological leaps incorporating a number of automated features, with many manufacturers pioneering the concept of driverless cars. What was once the stuff of science...more

It’s Not The Same Old JPML

Back when we were first getting into the drug and device practice, a senior partner we know and trust told us that the JPML was “in the MDL business.” What did he mean by that? Well, that unique panel of federal judges never...more

Food Product Recalls – Are You Covered?

Food and beverage recalls, regardless of the reason, continue to proliferate in the news cycle. At the end of May General Mills issued a recall of 10 million pounds of flour due to a potential link to an outbreak of E. coli...more

Defective products liability: new clarifications on the regime’s implementation

In a ruling handed down on 25 February 2016, the Court of Cassation clarified the conditions for implementation of the defective products liability regime. In this case, a patient was prescribed Mediator treatment...more

Dismissing Drug Design Defect Based on Preemption

In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee....more

Breaking News – California Supreme Court To Consider Innovator Liability

We’ve always hated Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), and the whole concept of innovator liability (imposing liability on the original innovator drug manufacturer for injuries allegedly caused by a generic...more

Developments in Compassionate Use and Right To Try Laws

We blogged a couple of years ago about the beginnings of what has become a wave of state “Right to Try laws” – laws that purport to give terminal patients with no other medical options the right to seek investigational drugs...more

D. Mass. (!) Refuses to Certify Celexa/Lexapro RICO Class Action

Is there a more misused statute than RICO? Or one that more convincingly shows the weakness of the textualist position, which wads up any evidence of legislative intent and tosses it into the trash bin? RICO was clearly...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

EPA Chemical Data Reporting Rule Brings Challenges and Opportunities

Every four years, companies that manufacture or import chemical substances in the U.S. in quantities greater than 25,000 lbs./year by site must submit detailed manufacturing, processing and use information on each of these...more

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

Spokeo – Half a Loaf, Maybe More, from the Supreme Court

We can’t stand no-injury class actions – those that allege only “I got exactly what the product I paid for, and wasn’t hurt, but for X reason I paid ‘too much’ for it.” Such litigation is a waste of time and money, and is...more

San Francisco vs. The Monster (aka Federal Regulation)

There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli...more

Cook Medical Issues Voluntary Global Recall of Beacon Tip

FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. ...more

New Duty To Supply Decision

Ever since we first waded into the issue of “duty to supply” back in 2007 in connection with the litigation that produced Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir....more

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