Mutual Pharmaceuticals v Bartlett

News & Analysis as of

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election. We believe that, for all practical purposes, this means that...more

Trimming Some Fat From Statin Litigation With Daubert and Preemption

In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

Comment K Case by Case – Falling Out of Favor?

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away...more

Guest Post - Design Defect Preemption - It’s as Simple as One, Two, Three

Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

Remembering Scalia, Remembering Riegel

For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

The Saga of Preempting Prescription Drug Design Defect Claims

Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined. Much like the origins of the Jedi or the major end-of-year...more

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104...more

Breaking News – Sixth Circuit Affirms Impossibility Preemption of Design Defect Claims Against Branded Manufacturers

We’ve been advocating preemption of all product liability design defect claims against prescription drug manufacturers – “whether generic or brand name” – since we read that phrase in Mutual Pharmaceutical Co. v. Bartlett,...more

Generic Preemption Prevails in Testosterone MDL

What? You were expecting another of our insensitive blogpost headlines? Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286...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

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

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

And That's The Ballgame: Summary Judgment for Forest Labs In Lexapro Suicide Case

Those of us who live in Philadelphia are endlessly fond of rocking on our porches and reminiscing about the halcyon baseball season of 2008, when our beloved Phillies won the World Series. These days, we are resigned to a...more

"Mass Tort and Consumer Class Action Outlook: A Mixed Landscape for Defendants in 2014"

Recent decisions by the U.S. Supreme Court have improved the landscape for defendants seeking to fend off mass tort and consumer class actions. In Comcast Corp. v. Behrend, 133 S. Ct. 1426 (2013), the Supreme Court tightened...more

August 2013: Appellate Update

U.S. Supreme Court Concludes October 2012 Term. The U.S. Supreme Court concluded its October 2012 Term in June with a number of highly publicized cases on issues like race and gay marriage, but equally notable are the Term’s...more

Product Liability Update - July 2013

Included in this Issue: ..United States Supreme Court Reverses First Circuit and Holds Federal Food Drug & Cosmetic Act Preempts Design Defect Claims against Generic Pharmaceutical Manufacturers ..United States...more

Does Mutual Pharmaceutical Co., Inc. v. Bartlett Herald the Demise of the "Failure-To-Withdraw" Theory?

In most states that use a “risk utility” test to determine whether a product is “not reasonably safe” (i.e. defective) as designed, an alternative design for the product is generally considered to be a critical element of the...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

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