We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant. He alleged that friction and wear caused the implant to release toxic metal ions and particles into his body. The plaintiff initially filed a class action. That case was sent to a Multidistrict Litigation, was later remanded back to the original court, and then was refiled as a Second Amended Complaint (SAC) that eliminated the class action allegations.
The defendants moved to dismiss the SAC in its entirety. When we say "entirety," we are talking about a ridiculously overpleaded complaint. There were claims for (1) negligence, (2) strict liability, manufacturing defect, (3) strict liability, design defect, (4) strict liability, failure to warn, (5) strict liability, failure to test, (6) strict liability, breach of express warranty, (7) strict liability, breach of implied liability, (8) fraud, (9) negligent misrepresentation, (10) false advertising, (11) violation of consumer legal remedies act, (12) violation of unfair competition law, and (13) civil RICO. It is a mess. It is a dog's breakfast. Or it is what our dogs deliver to our yard right after consuming their breakfast. And, for the most part, the plaintiff gets away with it.
Preemption
The defendant raises an interesting and not often litigated preemption argument that a subsequent FDA premarket approval (PMA) encompassing what defendant stated were the same components implanted in the plaintiff when they were only §510(k) cleared supports preemption. The court held that a fact issue as to whether plaintiff's surgery actually involved those same components precluded Rule 12 dismissal, but there is law to the effect that a subsequent PMA supports preemption in pre-approval uses of the same device. This significant issue has merely been postponed, because this factual predicate is something that a defendant should be able to determine and demonstrate conclusively.
Negligence
The court held that "the plaintiff's allegations that the product actually degraded inside his body are sufficient to please a breach of duty." And now we know that this opinion is likely to spoil our (non-dog) breakfast.
Manufacturing Defect
The plaintiff's manufacturing defect claim should have been dismissed because there was no allegation of deviation from manufacturer standards, but the court allowed it, citing to allegations that, as to deviation, were a non sequitur. The implant "broke apart and created metallic debris on his body, and/or the parts became loose or detached from each other." That was not supposed to happen. Ergo, manufacturing defect. That is, of course, a complete avoidance of the manufacturing defect issue. Groan.
Design Defect
Defense hacks are quick to grouse over California product liability law, but California law is actually pretty good and very clear that prescription drugs and medical devices cannot be the target of a design defect claim. (The court discussed the immunity of implanted medical devices, but as we have discussed before, the immunity should apply to any medical device that requires a doctor's prescription). Accordingly, the strict liability design claim was dismissed with prejudice. The plaintiff attempted to salvage the design defect claim by arguing that only PMA devices are exempt from design claim, but that theory was bereft of any legal support at all. At this point, bringing a design defect claim against prediction medical products in California borders on the frivolous.
Failure to Warn
The decision botches the warning claim, asserting that the learned intermediary rule is an affirmative defense. The brand-new Himes California Supreme Court decision definitively held that it is not. The opinion doesn't mention Himes, and cites only a non-learned intermediary decision for the contrary proposition. Anyway, because the defendant did not demonstrate that the warnings to the doctor were adequate (completely reversing the burden), the court denied the motion to dismiss the failure to warn claim.
Failure to Test
Failure to test does not state a claim in California. It is not an independent cause of action. Rather, failure to test "is subsumed under claims for negligence, design defect, or manufacturing defect." This claim was dismissed with prejudice. Yay.
Warranty Claims
Under California law, express warranty claims require privity, unless the plaintiff read and relied on a specific representation of the defendant. As the SAC did not allege either privity or the exception, that claim was dismissed, though with leave to amend. (In resisting the motion to dismiss, the plaintiff argued that he did, in fact, rely on claims made to him by the manufacturer. But that allegation resided nowhere in the SAC). Further, privity is absolutely required for implied warranty claims. If the plaintiff seeks to amend to allege privity, he must attach documentary proof.
Fraud Specificity
The misrepresentation and consumer statutory claims were all governed by the specificity requirement of Fed. R. Civ. P. 9(b). The plaintiff's SAC did not provide the what/where/when details of any misrepresentation, and therefore failed to satisfy Rule 9(b) specificity as to the negligent misrepresentation, fraud, and consumer protection claims. Significantly, the court held that an assertion that a product is "safe" or "effective" "generally constitutes unactionable puffery."
Consumer Legal Remedies Act
The court held that the plaintiff had not shown that he was a consumer for purposes of the CLRA. He needed to show that he had engaged in a "consumer transaction" relating to the goods at issue. But the plaintiff can save this claim if he produces "documentary proof of the purchase in the form of an invoice, receipt, and/or specific details of payment." Judge Wapner in the old version of The People's Court was always demanding that litigants produce receipts. He, too, was a California judge. Good times.
RICO
We wish courts would pronounce that RICO claims are simply unavailable in product liability cases. Sadly, that is not the law in California. Even so, the plaintiff's SAC failed to allege any RICO element, including enterprise, pattern of racketeering activity, predicate acts, and "California tort(s) that form(s) the basis of plaintiff's damaged property right with specificity and how the injuries relate to the torts." The plaintiff will doubtless try again.
Punitive Damages
Punitive damages is not a claim. It is a remedy. Because the failure to warn claim survived the motion to dismiss (it shouldn't have), it "could theoretically support an award of punitive damages." The court refused to dismiss or strike the plaintiff's election of punitive damages.
Judicial Notice
The court agreed with the defendants' request for judicial notice of FDA documents. Perhaps that judicial notice will support the inevitable part 2 preemption argument that is probably being written while you read this post.
This article is presented for informational purposes only and is not intended to constitute legal advice.