Science, Computers & Technology Products Liability

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Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week,...more

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

Handy-Dandy Checklist for Admissibility of Electronic Evidence

For years we’ve advocated about ediscovery for defendants – consisting mostly of material gathered from a plaintiff’s social media postings. OK, so let’s assume some degree of success. Defense-side ediscovery has generated...more

Tougher Oversight Needed on Harms of Medical Devices

Problems with medical devices contribute to 3,000 Americans’ deaths annually, research shows, and fixing any one of the problem devices can cost hundreds of millions. So why aren’t government officials doing more and better...more

Discovery - Oppenheimer’s Half Life Has Long Been Exceeded

As we’ve discussed previously, and as the legal profession is by now well aware, the discovery provisions of the Federal Rules of Civil Procedure were significantly amended effective December 1, 2015. One of the foundational...more

Lawsuits Involving Fluoroquinolones Piling Up Against Manufacturers

Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

Gutsy Gatekeeping: Plaintiffs’ Experts Excluded in Lipitor MDL

This week, as Drug and Device Law Jews, we are preparing for Passover, which, like most Jewish holidays, begins with a multi-generational dinner at the home of the Drug and Device Law Bubbie (our mother). Although we of the...more

New Regulations on the Horizon for Commercial Drones

Currently, the use of drones or unmanned aircraft systems (UAS) for commercial purposes in general is not permitted in the United States, although there is one exception. The Federal Aviation Administration (FAA) allows...more

Breaking News – No General Jurisdiction by Consent in Delaware

From our prior personal jurisdiction posts concerning Daimler AG v. Bauman, 134 S. Ct. 746 (2014), and the plaintiff-side dodge of “general jurisdiction by consent,” regular blog readers were aware that one of the few...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

Learning Something New – Limits To Human Tissue Liability

Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op....more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

So Long Zoloft MDL

The Zoloft MDL has finally collapsed. We started to see the writing on the wall in June 2014, when the MDL judge ruled that none of the plaintiffs’ experts could testify that taking Zoloft while pregnant could cause birth...more

FDA Recalls Custom Ultrasonic

AERs (automatic endoscope reprocessor) are free-standing units used in health facilities to disinfect flexible endoscopes and scope accessories between uses. Custom Ultrasonic AERs should wash and high- level disinfect...more

Talkin Bout Your (?) Generation

For once, our happy birthday wish really has something to do with births, specifically the significance of birth cohorts for litigation strategies and tactics. The actor Paul Rudd is celebrating his birthday today, April 6. ...more

Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers

We recently read an interesting new empirical study that confirms what we’ve long suspected - that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some...more

FDA Asks for Comments on Refurbishing and Servicing of Medical Devices

The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket,...more

Silly chocolate milk ‘study’ leaves Terps looking like health information twerps

The University of Maryland has taken a hit to its credibility as a major research institution-and for one of the silliest reasons possible: The Terps, officials have conceded, showed almost no internal rigor nor basic...more

Bauman Personal Jurisdiction In-House Counsel Checklist

The revolution in personal jurisdiction touched off by Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (“Bauman”), is in full swing. The favorable results obtained by numerous corporate defendants that have managed to “get out...more

Sales Representatives Face Increased Risk of Being Named in Medical Device Product Liability Litigation

Why is there a rise in sales representatives being sued in medical device product liability cases? Robyn Maguire: Five to ten years ago, the primary reason sales representatives were sued in product liability cases was...more

Liability and Autonomous Vehicles

As a trial lawyer who handles a lot of automotive disputes and product liability claims, I get asked more and more, “when an autonomous vehicle has an accident, who will be liable?” People – clients, contacts, business...more

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