Photo of Bexis

This post is not from the Butler Snow part of the Blog.

The plaintiff in Sheinfeld v. B. Braun Medical, Inc., 2024 WL 635483 (Mag. S.D.N.Y. Feb. 1, 2024), adopted 2024 WL 1075329 (S.D.N.Y. March 12, 2024), was representing himself (“pro se” in legal Latin).  Why was that?

Well, let’s start with PMA preemption.  The medical device at issue, an “artificial disc replacement,” was pre-market approved by the FDA, which means that under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), most product liability claims are preempted.  Sheinfeld, 2024 WL 635483, at *2-3.  That is, except for the “parallel” claim exception courts have invented from some unfortunate dictum in Riegel.  However even that “exception applies only in a narrow set of circumstances: where the defendant allegedly violated FDA regulations, but the violation is not itself the basis of the claim.”  Sheinfeld, 2024 WL 635483, at *2 (citation and quotation marks omitted).

The plaintiff in Sheinfeld couldn’t take advantage of the parallel claim exception, not even for manufacturing defect claims, let alone design defect.  Plaintiff pleaded only that the device performed “below any reasonable expectation” because “[i]f an FDA approved device is used as instructed and as intended, one has the right to assume that the device will perform as designed and not lead to potentially catastrophic injury.”  Id. at *3.

Yeah, right.  Perfection has never been the standard – either under the common law or the FDCA.

The court didn’t fall for that kind of “circular” reasoning, either.  Id.  A parallel claim cannot be established by what amounts to res ipsa loquitur:

Plaintiff’s theory amounts to a res ipsa loquitor argument that, because the . . . Device migrated after surgery, there must have been negligence in its manufacture or design.  But Plaintiff does not plead that the . . . Device, which was approved by the FDA through the PMA process, violates any specific federal requirement that could be the basis for a parallel state claim.

Id.  That was the end of the manufacturing claim in Sheinfeld.  The design claim was also preempted.  “[A]ny design defect claim would seek to impose a state requirement that is ‘different from, or in addition to’ the FDA’s federal requirements.”  Id. at *6 n.5.

Plaintiff’s warning claims attacked the device’s FDA-approved warnings as “overly broad and nonspecific.”  Id. at *4.  The warning about the risk of “movement of the implant out of place,” Plaintiff argued, was a “generic catchall” that does not provide enough information.  Id.  But plaintiff failed to establish that any difference “between >3 mm and <3 mm of movement constitutes a violation of [FDA] regulations.’  Id. at  *5.  No violation = preemption.

And no causation either.  All the Sheinfeld plaintiff pleaded was that a better warning “might” have made a difference.  Id.  “Might” is not enough.  “[A] failure to warn claim must plead enough facts for the Court to draw an inference that the inadequate warning was the proximate cause of Plaintiff’s injuries.”  Id.

Even if Plaintiff could point to a federal regulation requiring warnings about migration to be more specific . . ., he cannot show that the lack of a more specific warning caused his injury.  Plaintiff’s assertions that his surgeon “might” not have [treated him as he did] had the labeling contained more information is pure conjecture.


Plaintiff objected to the magistrate’s opinion, claiming that, without discovery, he could not plead causation more specifically.  He got nowhere, since causation involved the actions of his own surgeon, not anything under the defendant’s sole control.  “A plaintiff who has failed adequately to state a claim is not entitled to discovery, cabined or otherwise.”  Sheinfeld II, 2024 WL 1075329, at *2 (citation and quotation marks omitted).  As for the warning claim, none of plaintiff’s supposed “new evidence” required the defendant to tell surgeons what to do.  That “evidence does not support the inference that surgery is necessarily inappropriate . . . or that Defendants were required to warn against surgical intervention.”  Id. at *2.

Good lawyers on the other side (at least when not playing the MDL game) know a lousy case when they see one.  The Sheinfeld decisions fully demonstrate why the plaintiff in that case could not find a lawyer.