Wait a minute, you might be saying, breast implant litigation? Isn’t that passé? I n a sense, we’d agree with you. This isn’t your father’s breast implant litigation. Twenty or more years ago, one of the first wave of solicitation-driven medical device mass torts produced thousands of claims and multi-district litigation. In another precursor of things to come, causation of almost all of the claimed injuries was scientifically discredited. E.g., In re Silicone Gel Breast Implants Products Liability Litigation, 318 F. Supp.2d 879 (C.D. Cal. 2004); In re Breast Implant Litigation, 11 F. Supp.2d 1217 (D. Colo. 1998); In re Silicone Gel Breast Implant Products Liability Litigation, 1996 WL 34401766 (N.D. Ala. Oct. 31, 1996); Institute of Medicine, “Review of the Reports of the Independent Review Group and the National Science Panel on Safety of Silicone Breast Implants” (1999). The litigation was thus 99.9% junk science, but in another portent of things to come, it was nonetheless sufficiently expensive to bankrupt some defendants and to force others to settle.
One other effect of the original breast implant litigation was to spook the FDA. Motivated largely by fears of bad public relations – certainly not science – the FDA reclassified breast implants as Class III medical devices that required pre-market approval. However disruptive the FDA’s action may have been on the market, and however many women might have been deprived of this product’s benefits in the interim, the FDA’s action is also why this isn’t your father’s breast implant litigation.
Product liability actions against PMA medical devices are subject to broad preemption, and that’s a new way for breast implant defendants to win such litigation.
On Christmas Eve came Cashen v. Johnson & Johnson, 2018 WL 6809093 (New Jersey Super. Law Div. Dec. 24, 2018), which granted the defendants’ motion to dismiss with prejudice on preemption grounds. Cashen involved litigation tourists from Ohio who brought the usual strict liability, negligence, fraud, and consumer protection claims. Preemption wiped most of these out. Fraud claims “relating to the safety or effectiveness of the device” were preempted no matter how plaintiffs pitched them:
[C]laims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements. The former would make the claims expressly preempted while the latter would be impliedly preempted.
Id. at *7. Plaintiffs could not escape their complaint, which alleged fraud over the device’s “propensity to cause serious physical harm” and “misrepresentations and concealments regarding the safety” of the device. Id. at *8.
In addition, the Ohio legislature, had had enough of judicial expansion of common-law product liability and enacted a statute (“OPLA”) that abolished the common law altogether and replaced it with statutorily defined causes of action. The fraud claims also fell because they had been “abrogated.” Id. at 8-9.
Cashen dodged the question of whether Ohio’s consumer protection statute was preempted, because “it clearly falls within the umbrella of the OPLA . . . and is appropriately dismissed.” Id. at 9-10.
Finally, the statutory definitions of product liability claims was facially preempted, whether involving design, manufacturing, warnings, or warranty. Id. at *10-11.
Notably, Cashen appears to be the first claim of breast implant associated-anaplastic large cell lymphoma (“BIA-ALCL”) to be thrown out on a motion to dismiss. This “new disease” isn’t related to silicone and thus wasn’t addressed by the aforementioned Independent Review Group. It’s one way for plaintiffs to avoid the IRG’s devastating causation conclusions, thus it’s significant to see preemption stop a BIA-ALCL claim in its tracks.
Then came Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122 (C.D. Cal. Dec. 27, 2018). This is the third judicial decision in this case. We examined the other two, here and here. This time, the plaintiff’s now third amended complaint alleged “a single cause of action for strict product liability arising out of a manufacturing defect,” since everything else had already been held preempted. Id. at *1. The remaining claim fared no better.
The purported manufacturing defect simply wasn’t. Plaintiff in Ebrahimi had seized upon a descriptive sentence in the “product insert data sheet” (of which the court took judicial notice because “as it is available on the FDA’s website,” id. at 1 n.2.) and sought to convert it into a design specification. Ebrahimi called out the plaintiff’s ruse:
The Sheet simply indicates that [defendant] conducted a laboratory test on one of its Implants, and [description of test results]. The Sheet does not state that the FDA required Mentor to manufacture a shell that [always matches those results]. In fact, the Sheet does not purport to announce the FDA’s manufacturing specifications.
Id. at *2. That was pretty much all she wrote for plaintiff’s sole surviving claim. It’s not easy to gin up a manufacturing defect for violating a specification without having a specification in the first place. In judicial language, that’s “an unwarranted deduction of fact that is not entitled to the presumption of truth.” Id. (citation and quotation marks omitted).
Since the third amended complaint’s remaining allegations were a rehash of claims that had already been dismissed, id., that was the end of the line. Three strikes and yer out! “As [plaintiff] has once again failed to allege such a claim, the Court shall not grant her leave to file yet another amended complaint.” Id.
Happy New Year. And to the plaintiffs − so long, and thanks for all the fish.