We made our annual pilgrimage to the Arizona Cactus League last week. As we’ve done for the past 20-plus years, we rendered homage to our favorite sport, baseball, and, more importantly, to our sisters, one of whom lives quite close to the San Diego Padres Spring Training field in Peoria, AZ, and the other of whom hails from San Diego. It was a splendid couple of days. The food was good, the conviviality was marvelous, we got to see Tatis, Soto, and Machado play, and we never had to don a sweater.
The more we go to Arizona, the more we like it. To start with the obvious, 73 degrees in mid-March suits us right down to the ground (rocks and sand in Phoenix; frozen tundra in Philly). While our friends back in the Delaware Valley suffered through chilly, gray dampness, we knocked back tall cans of Alesmith 394 (honoring the highest batting average posted by the great Tony Gwynn) under benevolent sunshine. To our mind, Arizona boasts America’s greatest natural and man-made features (the Grand Canyon and Hoover Dam). There are eleven Frank Lloyd Wright buildings in the Phoenix area. And while the rest of the country was emerging from fuzzy-headedness due to the time change, Arizona is one of the very few places in this benighted country intelligent enough to remain on standard time all year long. (One of our fellow bloggers would prefer all-year daylight savings time. He is obviously scared of the dark or is definitely not a morning person.)
Arizona has not always been considered a place where common sense reigns. The 1917 Bisbee deportation was a national disgrace. The opening scenes in Hitchcock’s Psycho were set in Phoenix. Bob Crane, star of Hogan’s Heroes, met a grisly end in Scottsdale in 1978. It was arguably an Arizona senator who ushered in right-wing extremism. (And yet Goldwater today would probably be considered a paragon of moderation and compromise compared to today’s chuckleheads). But Arizona is now a purple state. Niceness prevails. It isn’t that hard to find interesting, thoughtful public officials.
There are also plenty of interesting, thoughtful judges in Arizona. We know of at least one Arizona judge, for example, who shares our exasperation at the ridiculous pelvic mesh rulings preventing juries from hearing that the products were cleared by the FDA. This blog has often taken note of sound Arizona case law. (There is also an old, bad preemption decision out of Arizona, but we won’t help the plaintiffs’ bar by reminding them of it.)
Harris v. Medtronic Inc., 2023 WL 2478913 (D. Arizona March 13, 2023), is another sound Arizona decision. It is a decision that both limits the overused parallel claim exception to preemption and puts Stengel into the dustbin of history where it belongs. The Harris decision is another example of the fact that, while the Arizona Cardinals might disappoint, the Phoenix Suns might puzzle, and the Arizona Diamondbacks might bore, the Arizona Judges usually rise to the occasion.
The plaintiff in Harris claimed injuries (severe electrical shocks) from a heart pacemaker, a Class III device, subject to pre-market approval by the Food and Drug Administration (“FDA”) under the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act. Pre-market approval imposes requirements on how a medical device is manufactured. The plaintiff in Harris argued that he sustained the injuries because the defendant manufactured the pacemaker using defective welding, metals, and insulation and failed to warn the FDA about these defects.
The defendant moved to dismiss both claims. As our overly long prefatory remarks signaled, the Arizona judge granted the defendant’s motion.
Plaintiffs sometimes think they can dodge preemption by styling their claims as attacking manufacturing defect rather than design defect. That maneuver did not work here. There remains the issue of whether the plaintiff’s claim was attempting “to impose requirements relating to safety and effectiveness that are different from, or in addition to the federal requirements.” To satisfy the dreaded parallel claim exception to preemption, the plaintiff must point to valid state law claims that parallel a violation of an FDA requirement. The Harris court held that the plaintiff’s manufacturing defect claim was insufficiently pleaded as a parallel claim under Ninth Circuit law. Bare allegations that a product was “adulterated” or “misbranded” without identifying the FDA specifications allegedly violated will not suffice to state a parallel manufacturing-based claim. “Absent allegations specific to the relevant protocols or specifications, Plaintiff has not pled a parallel claim for manufacturing defect, and his claims are thus preempted.”
Failure to Warn
The plaintiff alleged that the defendant “failed to warn the FDA of alleged deviations and defects.” In holding the warning claim preempted, the Harris court rejected the plaintiff’s reliance on the execrable Stengel case. In Stengel, the Ninth Circuit “concluded that Arizona law recognizes a duty to warn third parties, such as the FDA.” Having clerked on the Ninth Circuit, it pains us to report that the Ninth Circuit was flat-out wrong. But the Harris court seemed to be feeling no pain when it concluded that the Arizona Supreme Court does not recognize any duty to warn the FDA: “But the later Arizona Supreme Court Conklin opinion concluded Stengel had ‘incorrectly recited and applied Arizona law’ and declined to follow it.” Because the Arizona Supreme Court, not the Ninth Circuit, decides what Arizona law is, the Harris court followed the state-court decision (another excellent Arizona judicial opinion!) and held that the failure-to-report warning claim failed to state a cause of action, notwithstanding Stengel.
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Thanks, Arizona. You gave the world Linda Ronstadt and Stevie Nicks. You gave us the Gadsden Purchase and the Gunfight at the O.K. Corral. You gave us some of the coolest stretches of Route 66. You gave us the Miranda decision. And you have given us some pretty good drug and device decisions.