Court Opinion

ID: 9726076
Source: CourtListenerOpinion
Date Created: 2023-08-26 12:30:06.223888+00
Date Added: 2024-06-11T13:12:47.688860
License: Public Domain

FINE, J.
¶ 22. (dissenting). The Majority asks and answers the wrong question. Assuming that state tort law can be pre-empted by 21 U.S.C. § 360k, see Majority, ¶¶ 8-19, cf. Estate of Kriefall ex rel. Kriefall v. Sizzler USA Franchise, Inc., 2003 WI App 119, ¶¶ 3-4, 265 Wis. 2d 476, 484-487, 665 N.W.2d 417, 421-423 (Federal Meat Inspection Act, 21 U.S.C. §§ 601-695), the nub here is: Whether Medtronic is protected by the pre*373emption doctrine when it had the option under federal law of selling two approved devices (for shorthand purposes, the good one and the not-so-good-one) but sold the not-so-good-one — knowing that it had a better device that was also approved — in order to clear its inventory of the obsolete, less-safe devices. In my view, it is not.
¶ 23. In its essence, the pre-emption doctrine is a rule against retrospective second-guessing. See Gomez v. St. Jude Med. Daig Div., Inc., 442 F.3d 919, 930 (5th Cir. 2006).1 But there is no danger of second-guessing *374here; when Medtronic sold the out-of-date defibrillator to Joseph Blunt, Sr., it knew that it was more dangerous (both because of its own tests and also reports it was getting from patients implanted with that model) than its new, improved model, which, when it sold the old one to Blunt, had also been approved by the Food and Drug Administration. Majority, ¶¶ 2-4. Yet, even though at oral argument, Medtronic's lawyer admitted that the Food and Drug Administration "did not force us to clear the inventory out," the Majority gives it pre-emption immunity for a purely economic decision that put patients like Blunt at risk.
¶ 24. In response to a hypothetical asked during oral argument, Medtronic's lawyer said that preemption would shield it from liability even if the mortality rate were 80% (80 of 100 patients dying)! And, I see nothing in the Record or in the Majority opinion that leads me to believe that the answer of Medtronic's lawyer would be any different if 85 persons out of one-hundred were to die, or 90, or 95, or if the total lethality was 100% (everyone dying).
¶ 25. To say, as the Majority says in ¶ 20, that pre-emption gives Medtronic immunity for selling a less-safe product to clear its inventory merely because *375the Food and Drug Administration did not act immediately even though Medtronic both (1) had an approved device that was more safe, and (2) was under no pre-emption-compulsion to sell the less-safe device, transforms the valuable pre-emption shield into a dagger poised above the hearts of patients, contrary to the intent of Congress. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 491 (1996) ("[T]he primary issue motivating the [Medical Device Amendments]'s enactment [was] the safety of those who use medical devices."). Accordingly, I respectfully dissent.2

 The Majority quotes from the approval in Horn v. Thoratec Corp., 376 F.3d 163, 178 (3d Cir. 2004), of a statement of policy submitted to Horn by the Food and Drug Administration in an amicus brief that permitting state-tort-law actions could have all sorts of dire consequences: "This situation can harm the public health by retarding research and development and by encouraging 'defensive labeling' by manufacturers to avoid state liability, resulting in scientifically unsubstantiated warnings and un-derutilization of beneficial treatments." Majority, ¶ 18. The plurality in Medtronic, Inc. v. Lohr, 518 U.S. 470, 490-491 (1996), however, determined that those concerns were not as significant as Medtronic there argued:
While the Act certainly reflects some of these concerns, the legislative history indicates that any fears regarding regulatory burdens were related more to the risk of additional federal and state regulation rather than the danger of pre-existing duties under common law. See, e.g., 122 Cong. Rec. 5850 (1976) (statement of Rep. Collins) (opposing further "redundant and burdensome Federal requirements"); id., at 5855 (discussing efforts taken in [the Medical Device Amendments) to protect small businesses from the additional requirements of the Act). Indeed, nowhere in the materials relating to the Act's history have we discovered a reference to a fear that product liability actions would hamper the development of medical devices. To the extent that Congress was concerned about protecting the industry, that intent was manifested primarily through fewer substantive requirements under the Act, not the pre-emption provision; furthermore, any such *374concern was far outweighed by concerns about the primary issue motivating the [Medical Device Amendmentsl's enactment: the safety of those who use medical devices.
(Footnote omitted; emphasis by Medtronic.) Further, as we noted in Estate of Kriefall ex rel. Kriefall v. Sizzler USA Franchise, Inc., 2003 WI App 119, ¶ 45, 265 Wis. 2d 476, 517, 665 N.W.2d 417, 437, "the United States Supreme Court has assumed that the agency's view is entitled to no deference. Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735, 744 (1996) (assuming, but not deciding, that 'whether a statute is pre-emptive ... must always be decided de novo by the courts')." (Emphasis by Kriefall.)

 I recognize that an intermediate appellate court in California held that a manufacturer that sold a soft-lens cleaning solution in a package that could be mistaken for a soft-lens rinse was protected by federal pre-emption when the cleaning solution would hurt the eyes unless rinsed off before the lenses were used, even though the Food and Drug Administration had also approved less-confusing packaging when the old packages were apparently sold to the plaintiff. See Scott v. CIBA Vision Corp., 38 Cal. App. 4th 307, 320-321 (Cal. Ct. App. 1995). We are, of course, not bound by Scott, and, in my view, it is wrong.