Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.” Id. at 323. Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope
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Fifth Circuit Holds That Cardiac Defibrillator Complaint Does Not State A “Parallel Claim” And Is Therefore Preempted
By Stephen McConnell on
There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease…
Door Still Shut to Parallel Violation Claims in Florida
By Michelle Yeary on
This post is from the non-Reed Smith side of the blog.
Today’s case – Bernasek v. Gatz, 2021 WL 2152968 (Fla. Cir. May 20, 2021) – doesn’t exactly break new ground. But it does support that all of the federal courts to rule on parallel violation claims under Florida law are getting it right. …
TwIqbal in Third Circuit “Parallel Claim” Preemption Cases
By Bexis on
Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”)…
Ninth Circuit Says “No” to Res Ipsa-Based Parallel Claims
By Bexis on
In a significant PMA preemption win, the Ninth Circuit rejected a plaintiff’s attempt, in a breast implant case, to base a “parallel” violation claim on nothing more than a res ipsa loquitur inference. Weber v. Allergan, Inc., ___ F.3d ___, 2019 WL 5090757 (9th Cir. Oct. 11, 2019). Weber involved a Class III breast…
No Duty to Report to FDA in North Carolina, No “Parallel” Claim
By Steven Boranian on
We take every chance we can get to drive nails into the coffin of the Ninth Circuit’s spectacularly wrong opinion in Stengel v. Medtronic. That’s the case where the court held that federal law did not preempt negligence claims alleging that the defendant medical device manufacturer failed adequately to report adverse events to the…
Still No Causation, Still No “Parallel Claim”
By Steven Boranian on
We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA. As we have said here…
When Parallel Claims Are Neither Claims Nor Parallel
By Eric Alexander on
This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the…
Another Parallel Violation Claim about Riata Leads Fails
By John Sullivan on
(Note that this post comes from the Cozen O’Connor side of the blog.)
Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most…
No Old Kentucky Home for Parallel FDCA-Based Tort Claims
By Bexis on
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 FDCA) are prohibited. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky.
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