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Minnesota Court Excludes Plaintiff Expert Opinions For Lack of General Acceptance

All of us – defense lawyers, plaintiff lawyers, and judges – tend to assume that the federal Daubert standard for admissibility of expert testimony is more rigorous than competing standards, particularly the Frye standard,...more

N.D. Illinois Dismisses Accutane Case for Lack of Personal Jurisdiction

With a little luck on our part, by the time you read this we will be vacationing in a sunnier clime. Our beachfront cottage is an Oddjob’s hat-toss away from where Ian Fleming wrote the James Bond novels. Mind you, we are...more

M.D. Florida Shoots Down All Breast Implant Claims Except for Negligent Manufacturing Defect

Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts. Yikes. And it is not as if the bad appellate decisions were spread around. Two came from our home circuit,...more

Certification to Utah Supremes on Whether Comment K Applies to Medical Devices – Part 2

Last weekend we returned to Utah, one of the most beautiful states in the USA. Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the...more

EDNY Lays Out Disclosure/Report Requirements for Nonretained Treating Doctor Experts

When a drug or device case goes to trial, who is the most important witness? Let’s straightaway eliminate the plaintiff as a possible answer to that question. Based on what we’ve heard from jurors (both real and mock), when...more

E.D. Wash. Rejects Successor Liability in Hip Implant Case

Our first stint in a law firm was on the transactional side. Yes, it sounds crazy even to us, but we spent our first 18 months in the profession pulling all-nighters on triple-tier financings of leveraged buyouts, doing...more

Federal Court Certifies Question to Utah Supreme Court of Whether Comment K Applies to Medical Devices

Strict liability is not the same as absolute liability. We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way. The key separator between strict liability and...more

Guidance on Guidances: DOJ Says its Litigators May Not Use Noncompliance with FDA Guidances as Basis for Civil Enforcement Actions

Having worked in the federal government, we are familiar with how important Department of Justice Guidance Policy memoranda can be. They set priorities, outline criteria for acceptable guilty pleas and sentencing factors,...more

The F-word and Preemption

There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug...more

1/25/2018  /  FDA , Food Labeling , Organic , Preemption

FDA Proposes to Delay Off-Label “Intended Use” Rule

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

Third Circuit Requires But-for Causation for False Claims Act/Off Label Retaliatory Claim  

Today we are talking about a case that is not exactly in the heartland of what we generally examine. It is not a product liability or mass tort case. But it is reasonably close. It is kind of an off label promotion/False...more

Avandia Case Flunks Warning Causation

We’re now into the New Year but aren’t completely done with the old one. The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways....more

The Case of the Double-Dipping, Creative-Editing Plaintiff

This week saw the birthdays of two folks who were sort of prominent in our youth. First, Uri Geller, the Israeli ‘psychic’, turned 71. He showed up on our tv constantly in the 1970s and 80s, bending spoons with his mind. ...more

EDNY Rejects Successor Liability in Hip Implant Case

Happy birthday, Christopher Plummer. The great Canadian actor turns 88 today, and seems as vibrant as ever. What a marvelous career Plummer has had. He is a preeminent Shakespearean actor. We saw him play Iago to James...more

Utah Federal Court Dismisses Birth Defect Failure to Warn Claim

On December 5, 2017, Time Magazine announces its Person of the Year. The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an...more

Eleventh Circuit Affirms Preemption of HRT Complaint

Today, December 1, 2017, is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our...more

For N.D. Cal., Primary Jurisdiction is the “Natural” Outcome

We’ve got food on our mind. Last Sunday, the CBS Sunday Morning show ran its food episode, with segments about, inter alia, a little restaurant in the north of England being rated the best in the world, the Martha Stewart...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

A Second Look at Eye-Drop Litigation

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017). In a 2-1 decision, the Cottrell court permitted the...more

M.D. PA Declines to Dismiss Monitoring/Declaratory Judgment Action vs.  Blood Temperature Regulation Device

We thought we were on a winning streak on medical monitoring. In August, we blogged about plaintiff lawyers stumbling in their efforts to walk the not-quite-yet-injury line. In September, we blogged about a denial of a...more

Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964. That law is charmingly known as RICO, in an allusion to the big bad in the...more

The Bank Rejects Fosamax Folly

Look what just fell into our lap. Our blogging about the favorable California Risperdal preemption decision last week shook loose from that same case a subsequent denial of reconsideration of a summary judgment motion in...more

10/11/2017  /  Evidence , Preemption , SCOTUS , Summary Judgment

The Third Circuit Fosamax Preemption Error Has Got To Go, Part 2

We’ve come to expect top-flight work product from the Product Liability Advisory Council (PLAC), even when it isn’t Bexis pushing the pen or pecking at the keyboard (as he has done so many times on so many important issues)....more

N.Y. Court Holds that Manufacturer Cannot be Responsible for Medical Malpractice

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes). We’ve said before that both Levine and Riegel...more

Bah to Legal Lambs

Like many of you, on Friday mornings we turn to the “Legal Lions and Lambs” section of Law360. It is not only voyeurism. We are constantly working on things in media res (the middle of things), building slowly and gradually...more

9/21/2017  /  Courthouses , Judges , Jury Trial
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