Health Products Liability

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

What Is “Product Liability”?

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court. In addition to that, this blogger’s mother grew up on a farm in...more

Unreliable Expert Causation Evidence Ends Birth Defect Case

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy. Perhaps because of the inherent sympathy for the plaintiff...more

Product Liability Update: January 2017

Massachusetts Appeals Court Holds Birth Control Patch Manufacturer Had Duty to Warn Patient Directly But Packet Insert Adequately Warned of Greater Risk of Blood Clots As Compared to Birth Control Pill; Design Defect Claim...more

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety. The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to...more

Gorsuch Looks Pretty Good On Preemption

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important...more

Your Cyber Minute: Top threats for 2017 [Video]

Hogan Lovells Partner Harriet Pearson and Managing Principal of our Cyber Risk Services Jeff Lolley look ahead to 2017's major cyber vulnerabilities and where clients need to safeguard. ...more

Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care

Like most Americans, we like our doctor. We like doctors in general. We are not looking to start another song battle with our friends over at the Abnormal Use blog, like when we competed to name as many law songs as...more

Big Tobacco Still Manipulating into the 21st Century

A doctor at his desk takes a drag off a Camel, deliberately deceiving the public about the dangers of the drug. Fred Flintstone fires up a Winston in front of Wilma and rattles off the company’s slogan, “Winston tastes...more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Update: US Supreme Court Grants Certiorari on California Personal Jurisdiction Case

Nation’s highest court agrees to hear appeal of a California Supreme Court case with far-reaching implications for personal jurisdiction. In the recently published opinion in Bristol-Myers Squibb Co. v. Superior Court...more

EPA, CDC and CPSC Investigating Potential Health Effects of Recycled Tire Crumb Used on Playing Fields and Playgrounds

Public concern is increasing over the safety of recycled rubber tire crumb used as infill for synthetic turf fields and playgrounds. There are currently between 12,000 and 13,000 synthetic turf fields in the United States,...more

New Jersey Supreme Court Turns Back The Clock on Statute of Limitations

We thought we understood statutes of limitations and choice-of-law rules in New Jersey. Until yesterday. That was when we read the New Jersey Supreme Court’s opinion in McCarrell v. Hoffmann-La Roche, Inc., No. 076524, 2017...more

Going After A Hospital For Off-Label Use Of A Device

It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist...more

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

Guest Post – MDL Court: Preemption Leaves No “Glimmer of Hope” for Labeling Claims Against a Pharmacy

What follows is a post authored by Jaclyn Setili, a Reed Smith associate. She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously...more

“Regulatory Causation” Roundup

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called...more

Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the...more

Lessons Emerging from Pinnacle Hip Bellwether Trials

In a staggering verdict, a Texas jury recently awarded over $1 billion against Johnson & Johnson (“J&J”) and its subsidiary DePuy Orthopaedics Inc. (“DePuy”) (collectively referred to as “Defendants”) to six California...more

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