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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

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

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

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

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

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

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

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

Breaking News - Arizona Supreme Court to Review Watts Learned Intermediary decision

We've posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015). Well, that's not the last word anymore. Today...more

SDNY Sacks Treanda Failure to Warn Claim

Failure to warn cases remind us of sports talk radio and paleontology. Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination. The Iggles are terrible, their deficiencies...more

Another Major Earthquake: California Creates Big Fissures in Proposition 65 Regulations – Proposals Could Shatter Defenses

In the midst of making Proposition 65’s longstanding warning regulations far more onerous, and vexatious litigation far more likely, California’s Office of Environmental Health Hazard Assessment (OEHHA) has unveiled still...more

SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...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

More CAFA “Mass Action” Gamesmanship In The Ninth Circuit

Permitted gamesmanship versus prohibited conduct. That is the dichotomy that one district judge adopted to describe the transparent forum manipulation that some plaintiffs undertake under CAFA. To be honest, neither...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...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

Cymbalta Class Certification Denied Again

Is there a tougher federal district judge than Stephen Wilson in Los Angeles? By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

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