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Manufacturers Pharmaceutical Industry Failure To Warn

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

Fourth Circuit Punts West Virginia Innovator Liability Issue

by Reed Smith on

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Heeding Presumption Only Goes So Far In Post-Sale Warning Case

by Reed Smith on

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the...more

New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

by Reed Smith on

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted,...more

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

by Reed Smith on

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

by Reed Smith on

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

Another Prescription Drug Warnings Preemption Decision

by Reed Smith on

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

by Latham & Watkins LLP on

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

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

by Reed Smith on

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

Another Outlier From California On Innovator Liability

by Reed Smith on

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in...more

The Renaissance of the Learned Intermediary Rule

by Reed Smith on

Our recent “breaking news” post on West Virginia’s statutory restoration of the learned intermediary rule started us thinking about how every state now has pro-learned intermediary precedent. That’s a big change even from...more

Breaking News - West Virginia Statute Adopts Learned Intermediary Rule

by Reed Smith on

The West Virginia legislature has passed, and the governor signed, S.B. 15, adopting the learned intermediary rule on February 26, 2016. ...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

by Reed Smith on

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

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

by Reed Smith on

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

FDA Proposed Rule in Flux?

by Morrison & Foerster LLP on

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Morrison & Foerster LLP on

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

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