Some product liability cases are so bad they won’t fly even in California. Gall v. Smith & Nephew, Inc., ___ Cal. Rptr.3d ___, 2021 WL 5027197 (Cal. App. Oct. 29, 2021), is one of those. Plaintiff alleged that the defendant inadequately warned about the alleged risks of a hip implant, or alternatively that the device was defective in some other way, although “how” was never quite clear. The trial court held that plaintiff “did not show anything was wrong with his implant,” id. at *1, and on appeal the court of appeal affirmed.
One thing California law has always been pretty good on is the learned intermediary rule. As explained in Gall:
[F]or prescription drugs and implants, the doctor interrupts the ordinary commercial chain from the manufacturer to the final consumer. Patients want to be able to rely entirely on their doctors’ informed and independent judgments. The law and medical ethics both demand that doctors, for their patients’ benefit, evaluate scientific information about prescription drugs and implants. Manufacturers thus must warn doctors about product risks. This duty does not extend to patients.
Id. at *3 (emphasis original). Thus, the “decisive issue” was “what medical risks [the surgeon] knew” when he met with the plaintiff – “what [he] told [plaintiff] is a different matter.” Id. (emphasis original). When a prescribing physician is already “fully informed” about product risks, causation fails in a warning case because the physician “already had the needed warning.” Id.
This surgeon knew a lot.
[His] deposition was unambiguous. [The surgeon] knew about the metal ion issue because he read the underlying scientific studies as they appeared. [He] used primary materials to keep himself current in his specialty and did not need or use manufacturers’ republications and warnings.
Id. The surgeon “was clear and consistent throughout his deposition: he knew about this risk.” Id. Plaintiff’s attempt to seize on a single confused testimonial exchange punctuated by an objection from the surgeon’s counsel galled the court. Plaintiff’s “proposed interpretation is not reasonable. [The surgeon] testified he did know of the ion risk on [the relevant date]. [That] testimony was straightforward: steadfast, unequivocal, and with no backtracking.” Id.
The learned intermediary’s indisputable knowledge of the relevant risks “deflate[d]” the plaintiff’s other arguments. Purported “delay in getting data to the [FDA]” didn’t matter a hill of beans since the prescribing surgeon “knew of the . . . risk when counseling [plaintiff].” Id. at *4. These “secondhand reports were superfluous.” Id. For the same reason, neither did some foreign “agency alert” or “an allegedly deficient brochure.” Id. Those “merely repeated what [the surgeon] already knew.” Id. Addition of an FDA logo to previously known information changed nothing. Gall found no “authority for the notion that an agency imprimatur changes the quality or significance of the science the agency relayed.” Id. Summary judgment on warnings affirmed.
Plaintiff’s other theory was called “manufacturing defect.” Id. In California, that requires the product to “differ either from what the manufacturer intended or from the standard items in the manufacturer’s same product line.” Id. (citation omitted). What gall! Here the evidence was “contrary” to such a theory, showing instead two pre-implantation inspections of the product – one at the factory and one by the surgeon himself. “Both inspections showed [plaintiff’s] implant was free of defects.” Id.
Plaintiff relied on what sounds like an FDA inspection Form 483 that noted a “lack[ of] validation of supplier processes.” Id. Gall recognized that this was a load of gall – FDA process violations do not equate with defective products under California law:
[T]his report . . . show[ed] merely that [defendant’s] quality control process did not satisfy the regulatory authorities. No evidence shows any defective product entered the stream of commerce. [Plaintiff] cites no product defect precedent for substituting a process defect for a product defect.
2021 WL 5027197, at *4 (emphasis original). Gall rejected this “proposed doctrinal innovation.” Id. Summary judgment affirmed on manufacturing defect.
Going forward, this point is the most significant part of the Gall decision. Plaintiffs attempt this kind of claim all the time – asserting that claims that defendants failed to adhere to every jot and tittle of FDA-mandated GMP processes somehow equates to state-law product defects. Gall is binding authority that, in California anyway, such manufacturing process violations do not translate to state-law torts. Gall did not involve a Class III pre-market approved device, but its recognition of the inherent disconnect between FDA “processes” and California common-law “product defects” should result in preemption of similar Class III claims. To qualify as “parallel” claims, alleged FDCA violations must be genuinely equivalent to existing state-law product defects. Gall holds that FDA-related “process defects” simply aren’t.
Two more points. Gall also holds: (1) a plaintiff’s injury cannot be evidence of a defect where the same injury is also a “risk of nondefective” products; and (2) negligence claims fail along with their strict liability analogs because they “share the same causation element.” Id.
Finally, plaintiff had the gall to argue that summary judgment was erroneous because the affidavit attached to the winning motion was executed “outside California but did not include language stating [the affiant] made the declaration under penalty of perjury ‘under the laws of the State of California.’” Id. That mistake was corrected when first brought up. Id. To assert it on appeal was “meritless.” Id.