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No Old Kentucky Home for Parallel FDCA-Based Tort Claims

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

In a Word - Incredible

Summary judgment isn’t normally available for credibility issues. During the “summary judgment trilogy” of 1986, the Supreme Court stated, “[c]redibility determinations, the weighing of the evidence, and the drawing of...more

Where To Find Our Research 3.0

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour...more

Inauspicious Debut for Depakote Plaintiffs’ First Amendment Argument

We’ve been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time. It first cropped up in a 2015 360 article by a P-side thought leader (no, not necessarily...more

Addendum to the Worst Prescription Drug/Medical Device Decisions of 2017

Sometimes it happens.  For eleven years, we have published our annual “worst of” the year post on the Thursday before Christmas and our annual “best of” the year post on the Thursday before New Year’s....more

The Lows - Mourning the Worst Prescription Drug/Medical Device Decisions of 2017

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.” ...more

Quasi Guest Post – 50 State Survey On General Jurisdiction Through Consent By Registration To Do Business: Putting Bauman And...

What follows is a collaborative effort between Bexis and Reed Smith‘s Kevin Hara, who helped research and write this post. It’s not really a guest post, but Kevin had such a large hand in it that his contribution deserves to...more

Innovator Liability – A Word to the Wise

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

Latest Batch of 2017 Updates to Ediscovery for Defendants Cheat Sheet

We update our cheat sheet devoted to ediscovery for defendants differently than the others. Because of the broad nature of the topic – these cases arise in a wide variety of non-drug/device contexts – other personal injury,...more

12/4/2017  /  Discovery , Email , Social Media , Text Messages

Unavoidably Unsafe PMA Medical Devices

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related...more

PMA Preemption & Fraud by Omission/Concealment

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, “different from or in addition to,” precludes plaintiffs from...more

The Opioid Epidemic – What Kind of a Problem Is It?

We know that our blogposts are carried by legal aggregating services, such as Lexology and JDSupra. Some of you may even be reading this post via one of these services. In addition to writing for them, we actually read...more

BMS and Nationwide Class Actions

We have not been shy in predicting that Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017) (“BMS”), and Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (“Bauman”), should restrain certain abusive class action...more

Items of Interest on the Federal Civil Rules Committee Agenda

The federal Advisory Committee on Rules of Civil Procedure released its latest Civil Rules Agenda Book on November 7, 2017. A couple of items on the agenda should be of interest to blog readers. The first topic has to do...more

West Virginia Plaintiffs Haunted by Past Excesses

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl...more

Standing Out

Last month we brought you word of an excellent result (preemption) in a ridiculous case - a class action claiming that the drops in eye-drops are too big. That decision was in accord with an earlier decision likewise...more

11/6/2017  /  Damages , FDA , Injury-in-Fact , Preemption , Standing

Medtronic v. Lohr Has Two Shadows

For over fifty years, the BBC has been chronicling the exploits of that ultimate learned intermediary, Dr. Who. Over the decades, successive Doctors have crossed swords (or sonic screwdrivers) with a wide variety of enemies,...more

10/30/2017  /  FDA , FDCA , Medtronic , SCOTUS

Preemption as a Mass Tort Talisman?

A talisman is something thought to protect whoever has it from evil or harm. In the old days a talisman might be something like garlic to ward off vampires or the Seal of Solomon to keep away various evil spirits. Nowadays,...more

Reaping the Jurisdictional Whirlwind

Literally for decades plaintiffs in mass torts have employed the business model of flooding jurisdictions seen as friendly to them with more solicited plaintiffs than any court system can possibly handle. They have employed...more

MDL Direct Filing & Personal Jurisdiction

Bexis gave a talk the other day at the Washington Legal Foundation on personal jurisdiction after last term’s United States Supreme Court decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017)...more

Double Preemption Win in Amiodarone Litigation

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...more

Empty Gestures – Pennsylvania’s Right To Try Legislation

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets...more

Lucky Seven – Multi-Plaintiff Misjoinder Fails in Illinois Post-BMS

Once the Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), definitively determined that non-resident plaintiffs can’t go suing non-resident defendants anywhere they want,...more

Fraud on the FDA? If Not Preempted, It Is Trumpery

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent...more

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