Offhand, we cannot think of opinions we have blogged on that pleased us more than today’s cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC, et al., 2019 WL 3500331 (Aug. 1, 2019). The two decisions are virtually identical and come out the right way on issues important to drug and device defendants, such as snap removals, fraudulent joinder, and preemption. The decisions are well-reasoned, well-organized, and well-written All of that is encouraging and important. But the additional fact that delights us is that the author of the opinions is Judge Andre Birotte.

We have been an admirer of Andre Birotte for almost a quarter of a century. We were in the United States Attorney’s Office in Los Angeles back in 1995, when Birotte came on board. He had formerly served as a deputy public defender, so he brought a useful perspective to the task. Right from the start, Birotte was a superstar AUSA. He was brilliant, hard-working, and had a marvelous sense of humor. It was evident that he was destined for higher things. It did not take long. Birotte was appointed by President Obama as the United States Attorney. Later, he became a federal judge. His accomplishments are impressive. Birotte was born to Haitian immigrants in Newark , New Jersey, not far from where we grew up. The last time we saw Birotte was at a dinner in honor of an AUSA colleague who died of ALS. It was an evening filled with stories, tears, and laughter. Not to put too fine a point on it, we think the world of Birotte. So, in addition to our defense-hackiness, please take into account our veneration of the Judge as we take a look at the Jacob and Vieira opinions.

    Background

The Jacob and Vieira cases were both filed in California state court on behalf of multiple plaintiffs alleging injuries from ruptured silicone breast implants. The plaintiffs sued multiple defendants, including the manufacturer, the raw material supplier, and a holding company. The holding company, like some of the plaintiffs, was a citizen of California. The causes of action included negligence, failure to warn, and manufacturing defect. The defendants removed the case to federal court and then moved to dismiss the complaints for failure to state a claim. The plaintiffs moved to remand the cases to state court.

    Removal/Remand

The Jacob case involved a snap removal (that is, prior to service) by one of the defendants. As usual, the plaintiff resisted a literal interpretation of 28 U.S.C. section 1441(b)(2), which provides that a civil action “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” The Jacob case had been removed before any California defendant had been served, so the forum defendant rule of section 1441(b)(2) did not warrant remand. To be sure, there is some C.D. Cal. authority that waters down the availability of snap removals if there are “absurd or bizarre results.” For example, in one prior case the defendants filed a notice of removal on diversity grounds before the Superior Court made the summons available to the plaintiff. In that case, it was impossible for the plaintiff to serve the defendants before removal. But nothing like that unusual situation existed in Jacob. It had not been impossible for the plaintiff in Jacob to serve the defendants. Thus, the Jacob court followed C.D. Cal. precedent, followed the plain text of section 1441(b)(2), and refused to remand the case on the basis of the forum defendant rule. (You can find our magnum opus on pre-service removal here.)

That did not end the subject of subject matter jurisdiction. In both the Jacob and Vieira cases, the court could not retain federal jurisdiction without deciding whether the California holding company had been fraudulently joined. If the holding company was legitimately in the case, there was no diversity jurisdiction, at least not with the California plaintiffs. (The court decided that the various plaintiffs had been properly joined. That is the one part of these decisions we do not adore.) Most of you reading this blog know that it is not easy for defendants to show fraudulent joinder. Nevertheless, demonstrating fraudulent joinder did turn out to be pretty easy in Jacob and Vieira. In a product liability action, the plaintiff must establish that the defendant produced, manufactured, sold, or was in some way responsible for the allegedly defective product. (Is that “some way responsible for” the basis for innovator liability in The Golden State? Grrrr. Do not get us started.) The holding company did not produce, manufacturer, or sell. It merely … held. And it what it held was investments, not silicone breast implants. The holding company was not a proper defendant in these lawsuits. It was dismissed, and the cases stayed in front of an article III federal judge – and a very good one, at that.

    Preemption

The breast implants were class III medical devices that went through the rigorous pre-market approval (PMA) process. As such, they are covered by the express preemption provisions of the Medical Device Amendments (MDA). The plaintiffs, predictably, invoked the specious presumption against preemption. But Judge Birotte had read the SCOTUS Puerto Rico v. Franklin Cal. Tax-Free Trust case, and correctly ruled that there is no presumption against express preemption. The plain language of the MDA preempts state requirements that are “different from, or in addition to,” federal requirements. One does not need a presumption to interpret that statement of Congressional intent; one needs only literacy. The plaintiff desperately argued that it was “difficult to believe that Congress would remove all means of judicial recourse for consumers injured by FDA approved devices.” Judge Birotte’s riposte was definitive: “Contrary to Plaintiffs’ position, ‘this is exactly what a pre-emption cause for medical devices does by its terms.” (quoting Riegel). (We presumed to hold forth against the presumption against preemption here.)

Judge Birotte also ruled that the plaintiffs had not managed to thread the needle and state the dreaded parallel claim purportedly authorized by Riegel. As with many other circuits, the Ninth Circuit has recognized that there is a “narrow gap” through which a state-law claim must fit to escape preemption. The plaintiff must be suing for conduct that violates the federal Food, Drug, and Cosmetic Act (or else the claim would be preempted) but the plaintiff must not be suing because the conduct violates the FDCA (or else it would be preempted by Buckman). The plaintiffs in Jacob and Vieira claimed that the defendants violated federal and state law by failing to report adverse events to the FDA, but they cited no specific adverse events. The plaintiffs also claimed poor performance on post approval studies – but that results in a big so what. That is no violation of law. Finally, the plaintiffs claimed defective manufacturing that contravened federal regulations and state law, but the never identified the precise standards. In sum, the parallel violations were based on mere incantations, not allegations

    Failure to Report

Cases from and within the Ninth Circuit suggest that the failure to warn claim’s only hope for survival depended on a showing that if the defendants had properly reported adverse events to the FDA as required under federal law, that information would have reached the plaintiffs’ doctors and thereby prevented the plaintiffs’ injuries. Mind you, we think the theory is hogwash and should be preempted, but it doesn’t much matter in the Jacob and Vieira cases, because the plaintiffs’ allegations could not pass muster. The plaintiffs “have not explained how any purported failure to report the unspecified adverse events caused [their] injuries.” Moreover, the plaintiffs did not “allege facts showing that the FDA would have exercised its discretion to include additional adverse events in its publicly-accessible adverse- event database.” Nor did they allege that any of “their treating physicians even relied on information in the adverse event database making decisions.”

    Manufacturing Defect

Manufacturing defect claims are usually stinkers and that proved to be the case in Jacob and Vieira. The plaintiffs alleged that the implants “differed in some undefined way from the manufacturing and design specifications mandated by the FDA as part of the PMA.” The plaintiffs merely alleged that the defendants violated unspecified “laws and regulations” or produced a “nonconforming” device. Such bloviations do not adequately establish violation of a federal requirement. They also do not establish that the alleged violations actually caused the alleged injuries. As Judge Birotte concluded, “[m]ore is needed.”

Because the plaintiffs did not supply the more that was needed, and because it was clear that such “more” was not forthcoming, Judge Birotte dismissed the plaintiffs’ claims with prejudice, “[a]s amendment would be futile.”

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We knew when we were in the U.S. Attorney’s Office in the mid-90s that we were surrounded by a remarkable group of men and women. When we read opinions such as Judge Birotte’s, or learn of Dan Collins’s ascendancy to the Ninth Circuit, or see Representative Schiff on the cable news at night, or are treated to accounts in Law360 of former colleagues triumphing in front of juries and appellate panels, we count ourselves singularly blessed to have worked alongside such superb lawyers.