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PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

SDNY Brushes Away Presumption Against Preemption and Stays Class Action Via Primary Jurisdiction

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients. By and large, those associates do an excellent job. On those rare occasions when we find...more

New Mexico Wrongful Conduct Rule Shuts Down Opioid Case Against Pharmacist

New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up. You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots...more

Law Review Article on Off-label is On Target

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

Ninth Circuit Reverses Daubert Exclusion

Let’s start with a shameless plug: the author of this post, along with Sean Wajert (Shook Hardy & Bacon), will present a Strafford webinar on June 21 entitled, “Daubert/Frye Motions in Product Liability Litigation: Bringing...more

Georgia, Tennessee, and Texas Statutes of Repose Limit IVC Filter Cases in Different Ways

In the annals of history, June 6 gets prime billing. That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization. (Or maybe that heroic endeavor simply...more

Kentucky Trial Court follows U.S., not Kentucky, Supreme Court Precedent to Hold that Claims Against Investigational Device Were...

It is quite unusual for a state trial court to depart from that state’s highest court precedent. But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.” If the United...more

N.D. Florida Permits (Some) Discovery of Expert Who Changed from Consulting to Testifying Expert

Discovery regarding expert witnesses can be tricky. In our neck of the woods, the great Commonwealth of Pennsylvania, state courts almost never permit depositions of experts. If you want to ask the expert questions – and...more

N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability. Rear-end a car and you’re liable,...more

SDNY Rejects Innovator Liability

May 10 is an important day in the history of the law. On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit. The case was called Nix v. Hedden, 149 U.S. 304 (1893). The issue...more

Comparative Fault of Government Regulators Might be a Defense

‘Pointing to the empty chair’ is a well-known defense trial tactic. It allows the defendant to go on offense. Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party. ...more

Ninth Circuit Stumbles on CAFA

Plaintiff lawyers must be mighty allergic to federal court. They perform all sorts of maneuvers to avoid CAFA removal of mass actions. For example, they will artificially subdivide their cases into groups of under 100. ...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

Does Buckman Preemption Apply to Antitrust and RICO Claims?

We talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened...more

4/5/2017  /  FDA , Fraud , Preemption

Court Rules that Prisoner is Entitled to Off Label Drug Treatment

Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe. In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs. When he proposed a song for The Life of Brian, he ran into...more

Warning: Lawyers May Be Hazardous To Your Health

Most of the cases we defend involve claims of inadequate warnings. What makes a warning inadequate? Falsehood is the first thing that comes to mind. But the Pontius Pilate question of “What is truth?” continues to vex. We...more

There’ll Always Be Posner: Reversal of Class Certification in the Blink of an Eye

We’ve seen it before. The Southern District of Illinois will certify class actions with no real cause of action and no real damages. While not as bad as the drive-through-class-certification state courts in southern...more

JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

A multidistrict litigation (MDL) can be a sound way of managing a mass tort. Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale. Then again,...more

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

Fourth Circuit Vigorously Applies Daubert

Last week three of our posts dealt with Daubert issues. That was not intentional. Chalk it up to coincidence. Or was it? We are not especially superstitious, but maybe the passing last week of the great “Professor” Irwin...more

Reclast Plaintiff Experts Hobbled by Daubert

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than merely count whether there are enough other experts out there who seem to be...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

Medical Causation Experts Pass Daubert Test, But Cannot Opine on Plaintiff’s Lack of Capacity to Sign Release

We typically write about product liability cases, not medical malpractice actions. But the two are not mutually exclusive, and similar issues arise in those cases. Medical causation is an issue we often see in both. Capacity...more

SDNY Applies Preemption in Favor of Branded Drug

On January 3, 2017, we commenced the dreary process of taking down the Christmas decorations. The German nutcrackers slid back into their cartons. Stockings marched from the mantle into plastic storage containers. We picked...more

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