News & Analysis as of

Failure To Warn Preemption

Still No “Newly Acquired Information,” Eliquis Claims Still Preempted

by Reed Smith on

The defendants in the Eliquis MDL have turned somewhat of a preemption hat trick. The latest order is In re Eliquis (Apixaban) Prods. Liab. Litig., No 17-md-2754 (S.D.N.Y. Nov. 29, 2017), where the district court dismissed...more

PMA Preemption & Fraud by Omission/Concealment

by Reed Smith on

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

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

No Causation, No “Parallel Claim”

by Reed Smith on

The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v....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

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....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

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

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

by Reed Smith on

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. Alabama Issues Mixed Bag of Branded Preemption Rulings

by Reed Smith on

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

Merck Fails to Obtain Summary Judgment on Preemption Defense – Third Circuit Rules “Impossibility Preemption” Presents a Question...

In re: Fosamax (Alendronate Sodium) Products Liability Litigation, Nos. 14-1900 et al. (3d Cir. March 22, 2017). In a precedential decision issued on March 22, 2017, the United States Court of Appeals for the Third...more

Aviation Happenings - Winter 2016-2017 Part 2

Part 2 of the winter edition of the Aviation Group’s newsletter examines some of the most recent and relevant cases and developments in aviation law, including: - Supreme Court Affirms Presumption Against Preemption...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

Smoking Out the Scope of Preemption

by Reed Smith on

Last month, while grappling with an aphrodisiac false-advertising case, we joked that we felt like having a cigarette after reading the court’s opinion. Today we get our cigarette. Or, rather, our e-cigarette. Today’s post...more

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

by Reed Smith on

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

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more

Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

by Reed Smith on

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims...more

Another Make Work Project In New Jersey – Duty To Update Claims

by Reed Smith on

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the...more

A Banner Week For Buckman Preemption

by Reed Smith on

There used to be a TV show called “That Was the Week That Was.” It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career. Without an ounce of...more

Environmental Litigation and Toxic Torts Update – Mountain West Coast Case Law Highlights

COLORADO CITY FRACKING BANS PREEMPTED BY STATE LAW - City of Longmont v. Colo. Oil and Gas Ass’n, 369 P.3d 573 (Colo. 2016), 2016 Colo. LEXIS 442; City of Fort Collins v. Colo. Oil and Gas Ass’n, 369 P.3d 586 (Colo....more

Mixed and Matched Hip Components Equal Express Preemption

by Reed Smith on

If a surgeon combines a PMA device with a 510k device, what does that do to federal preemption? We ask this question because one of the more fascinating aspects of the medical device world is modularity. We have heard of...more

Federal Court Dismisses Essure Complaint

by Reed Smith on

A couple of weeks ago we reported on our visit to the Women’s Health Litigation Conference. One of the conference panels discussed the most interesting ongoing litigations involving women’s health products. Essure, a...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

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