The recent decision in Mize v. Mentor Worldwide LLC, ___ Cal. Rptr.3d ___, 2020 WL 3602482 (Cal. App. July 2, 2020), demonstrates why California courts – particularly state courts – have such a poor reputation when it comes to product-related litigation. In Mize, a combination of questionable reasoning, together with the state’s absurdly lax pleading standard, resulted in claims surviving that have been almost universally preempted elsewhere.
Mize involved what we think were “investigational device” breast implants. We’re not sure because Mize never made the timing clear. The most basic information – when plaintiff was implanted with the product at issue – is nowhere stated. Mize simply recounts that “[t]wo years after” some “consent decree” (which may or may not have been in force at the time), the plaintiff “receiv[ed]” the implants. 2020 WL 3602482, at *2. If the date of the consent decree had been provided, we could have figured that out, but that’s not stated either. All we know is that it happened sometime after 1998. Id.
The date matters. As to this line of implants, “an IDE [investigational device exemption] study [was] approved [by the FDA] in August 2000.” Id. We infer that plaintiff was a subject of that study, but we’re not entirely sure. We’re also not entirely sure what the status of consent decree. Mize recites that it was “dissolved” in August 2003.” A PMA application for the implant line at issue was submitted that October, and after three-plus years of FDA review, PMA was granted in November 2006. Id. at 83. So while it appears from Mize that plaintiff’s implant surgery occurred while the device was in its IDE stage, one can’t be sure from the court’s opinion.
That’s just plain sloppy. To be sure, we consulted the trial court opinion and – sure enough − plaintiff’s surgery occurred “in September 2000,” shortly after the FDA allowed the IDE to proceed. Mize v. Mentor Worldwide LLC, 2018 WL 5085716, at *1 (Cal. Super. Oct. 1, 2018).
OK – it’s an IDE device. What should that mean? Well until Mize, every other case in the country, since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), was decided, has applied the same standards to IDE devices as are applicable to the PMA device at issue in Riegel itself. That even includes another California case. See Robinson v. Endovascular Technologies, Inc., 119 Cal. Rptr.3d 158, 164 (Cal. App. 2010) (“In granting IDE approval, the FDA imposes detailed requirements on the design, manufacture, and warnings for class III devices as well as the conduct of the clinical investigation.”). Did Mize discuss Robinson? No, it didn’t even cite it.
For the record, the other post-Riegel IDE preemption cases are: Bush v. Goren, 2014 WL 4160245, at *7 (Mich. App. Aug. 21, 2014); Parks v. Howmedica Osteonics Corp., 2016 WL 7220707, at *6-8 (M.D. Fla. March 11, 2016); Grant v. Corin Group PLC, 2016 WL 4447523, at *3-5 (S.D. Cal. Jan. 15, 2016); Day v. Howmedica Osteonics Corp., 2015 WL 13469348, at *4-5 (Mag. D. Colo. Dec. 24, 2015); Burgos v. Satiety, Inc., 2013 WL 801729, at *7-8 (E.D.N.Y. March 5, 2013); Killen v. Stryker Spine, 2012 WL 4498865, at *1 (W.D. Pa. Sept. 28, 2012); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *2-3 (D. Ariz. Oct. 14, 2009); Dorsey v. Allergan, Inc., 2009 WL 703290, at *7 (M.D. Tenn. March 11, 2009). Russell v. Johnson & Johnson, Inc., 2018 WL 5851101, at *9 (Ky. Ct. App. Nov. 9, 2018), review granted (Ky. Sept. 18, 2019).
Did Mize cite and either distinguish or dispute any of these cases? Nope. No mention.
Numerous cases had also imposed broad IDE preemption before Riegel. Here are just the appellate decisions: In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791-92 (3d Cir. 1999); Chambers v. Osteonics Corp., 109 F.3d 1243, 1247-48 (7th Cir. 1997); Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1097 (6th Cir. 1997); Gile v. Optical Radiation Corp., 22 F.3d 540, 542-45 (3d Cir. 1994); Becker v. Optical Radiation Corp., 66 F.3d 18, 20 (2d Cir. 1995); Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th Cir. 1992), Evraets v. Intermedics Intraocular, Inc., 787, 34 Cal. Rptr.2d 852, 856-58 (Cal. App. 1994).
Did Mize cite and either distinguish or dispute any of these cases?
Only Evraets, not the half-dozen federal appellate decisions. 2020 WL 3602482. At *6. First, it distinguished Evraets as not involving manufacturing defect. Id. (“That case involved [various] claims . . . not manufacturing defects.”). Fair enough, but then comes this jaw dropping statement:
More significantly, Evraets predated the U.S. Supreme Court’s decision in Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 497-502, 116 S.Ct. 2240, 135 L.Ed.2d 700 (Lohr), which held that the MDA does not preempt state-law claims based on manufacturing defects. Thus, to the extent Evraets suggested otherwise, it is no longer good law.
Mize, 2020 WL 3602482, at *6. That’s simply wrong. It ignores Riegel altogether. The only authority Mize cites for this proposition, Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 773 n.13 (Cal. App. 1996), predates Riegel. Robinson, which specifically pointed out (see above) that Riegel preempts manufacturing claims, is nowhere mentioned.
In fact, Riegel affirmed preemption of a manufacturing defect claim. The Second Circuit in Riegel, “held that the MDA pre-empted a negligent manufacturing claim.” 552 U.S. at 321. The Supreme Court held:
Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.
Id. at 319 (citation omitted) (emphasis added). The FDA also “supported the position taken by our opinion”:
The agency’s reading of its own rule is entitled to substantial deference, and the FDA’s view put forward in this case is that the regulation [relied on by plaintiff] does not refer to general tort duties of care, such as those underlying the claims in this case that a device was designed, labeled, or manufactured in an unsafe or ineffective manner.
Id. at 328 (citing FDA amicus brief) (emphasis added). Thus, after Riegel, manufacturing defect claims are plainly preempted, unless they amount to “parallel” FDA regulatory violation claims. The cases so holding are legion, see Bexis’ Book §5.01[c][ii] at n.158. A typical statement is, “an alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations” and “seeks to impose an additional requirement as precluded under Riegel.” Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012). Mize nowhere conducts a parallel claims analysis for manufacturing defect claims – making itself a post-Riegel minority of one.
And that’s not all. Mize allows a “failure to report”-type of warning claim under Stengel v. Medtronic, Inc., 704 F.3d 1224, 1233 (9th Cir. 2013), even though Stengel purported to apply Arizona law, and the Arizona Supreme Court has since disagreed. Mize, 2020 WL 3602482, at *7. However, during the interim between Stengel and Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018), while Stengel’s erroneous application of Arizona law was on the books, an earlier California appellate court did adopt Stengel as its own. See Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 311-12 (Cal. App. 2014).
While Mize was content to ignore the defense-friendly Robinson decision (that was in no way impaired), it was not willing to do the same for the seriously impaired plaintiff-friendly Coleman decision. That “The Arizona Supreme Court subsequently rejected Stengel . . . does not mean that Coleman is no longer good law in California.” 2020 WL 3602482, at *7. Maybe not, but it does indicate a very result-oriented choice of which precedent to follow and which not to.
But it gets worse. Plaintiff pleaded practically nothing to establish how a failure to report could have caused the claimed injury. But that didn’t matter in Mize either. First, the adverse events were actually reported, but in “spreadsheet” form. Id. at *8. So the dispute (unlike Coleman) was only about whether the defendant used the right reporting form. But was there even a violation? Mize thought so:
[T]his ignores that [defendant] was required to provide individual medical device reports − which could be included in the database − whenever one of its implants contributed to a person’s death.
2020 WL 3602482, at *8. As far as causation is concerned, that’s a non sequitur. Why? This plaintiff did not die. Failures to warn about risks that did not befall a plaintiff have never been considered causal. Once again the cases for this proposition are legion, so we’ll just cite to Bexis’ Book again. §2.05 at n.21.
Also as to causation, Mize takes refuge in California’s lax pleading requirements. FDA is not required to add any given adverse event reports to a public database, and nothing in the opinion indicates that – even now – the events at issue (which the FDA had in a different form) were ever actually added. Nor was were any facts apparent “that [plaintiff’s] doctors consulted the database when making decisions about her implants.” Id. No worries, held Mize:
But [plaintiff] alleges otherwise, and further claims that her doctors would have told her of the information in the database. It is reasonable to infer that they did review the database and would have provided that information to [plaintiff].
Id. (citation omitted). To that Mize adds the judicial equivalent of “nyah, nyah, nyah.” “One of the dangers of winning on demurrer is that you are stuck, on appeal, with your opponent’s version of the facts.” Id. at *9 (citation and quotation marks omitted). But not a single supporting fact is found anywhere in Mize that plaintiff supposedly “sufficiently pled” as supporting this causation rule. TwIqbal this is not.
The last holding in Mize is that the plaintiff’s negligence per se claim is not preempted. Id. in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 252-53 (2001), the Court recognized that private assertion of FDCA violations conflicts with 21 U.S.C. §337(a), and is impliedly preempted. Claims that include FDCA violations as “a critical element in their case,” are impliedly preempted, as are claims that “exist solely by virtue of the [FDCA’s] … requirements.” Buckman, 531 U.S. at 353. Since negligence per se, by definition, substitutes a statutory or regulatory enactment for the “duty” element of negligence, a large majority of cases holds such claims preempted under Buckman when the claimed violations are of the FDCA. E.g., Jones v. Medtronic, Inc., 745 F. Appx. 714, 718 (9th Cir. 2018) (“negligence per se claims regarding the Class II and Class III devices are preempted”). Those interested in the issue can find those cases in Bexis’ Book §5.02[d] at n.354. And these decisions keep coming. In the year or so since Bexis’ preemption chapter was last updated, we add: Hayes v. Endologix, Inc., ___ F. Supp.3d ___, 2020 WL 1624022, at *4 (E.D. Ky. Mar. 26, 2020); Green v. Medtronic, Inc., 2019 WL 7631397, at *5 (N.D. Ga. Dec. 31, 2019); Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264, at *5-7 (D. Kan. Sept. 23, 2019).
Here is the complete discussion in Mize concerning negligence per se and implied preemption under Buckman:
Nor are such claims impliedly preempted when the plaintiff attempts to enforce state requirements that parallel federal law.5 (Coleman, supra, 223 Cal. App.4th at pp. 432-433, 167 Cal .Rptr.3d 300.)
5We disagree with the pre-Lohr and other non-California cases cited by [defendant] that hold otherwise.
2020 WL 3602482, at *9 & n.5. This is a classic example of the usually apocryphal “No, they explained.”
Mize will almost certainly have a spot in our 2020 bottom ten cases. It’s easy to see why.