Similarly, preemption is at the epicenter of medicaldevice product liability litigation involving PMA devices.
Since plaintiffs are able to avoid federal courtthrough the simple stratagem of suing defendants (all defendants, not justmedical device manufacturers) in their “home” courts, we have been wonderinghow PMA preemption would fare in Minnesota state court. Minnesota already has a relatively expansiveconsumer protection statute and (until recently) an extremely long (six-year)statute of limitations for personal injury cases. If there were also an indication that Minnesotacourts would view PMA preemption in a pro-plaintiff fashion, we could seePhiladelphia-style influx of litigation tourism.
Fortunately that doesn’t appear to be in theoffing. A couple of years ago, Medtronicscored big with In re Medtronic Sprint Fidelis Leads State Court Litigation,2009 WL 3417867 (Minn. Dist. Hennepin Co. Oct. 20, 2009), which as we discussedat the time, adopted just about all the pro-preemption holdings in In re MedtronicSprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D.Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. Oct 15, 2010). There were a lot of good holdings, which wegloated over here.
Still, Sprint Fidelis was just acounty-level trial court. The SprintFidelis plaintiffs chose not to take their chances on appeal. One bad decision from the Court of Appeals ofMinnesota could wipe everything out.
Or, conversely, one good appellate decision couldcement everything in place and send the litigation tourists scurrying elsewhere.
Fortunately, the latter happened the otherday. See Lamere v. St. JudeMedical, Inc., ___ N.W.2d ___, 2013 WL 599178, slip op. (Minn. App. Feb 19, 2013). Lamereinvolved a Class III PMA approved mechanical heart valve, and the courtaffirmed summary judgment on the basis of preemption. Not even the Public Citizen Litigation Group(probably the other side’s biggest guns on preemption) could sway the result inLamere.
The valve in Lamere was implanted in1988. Nearly 20 years later therecipient died, allegedly as a result of a valve failure. The plaintiff – like the decedent aCalifornia resident – chose to bring suit in Minnesota state court. Thus Lamere was a blatant example oflitigation tourism.
The defendant manufacturer received summary judgment,on both preemption and (ironically) statute of limitations grounds, and theplaintiff appealed. The Court of Appealsaffirmed. We won’t spend much time onthe statute of limitations, which the court applied (to a wrongful death claim)in a manner similar to a statute of repose. Based on what appears to us to be strong Minnesota precedent, the courtconcluded that the six-year statute runs from the time of the defendant’s “actor omission,” which in this instance was “either . . . the date themedical device was manufactured or the date it was implanted.” 2013 WL 599178, at *4. Since the implant had lasted for over 19years, the plaintiff was out of luck. Id. The court refused to expand a “latentdisease” (read, asbestos) exception to include other products that simplylasted a long time before allegedly malfunctioning, id. at *4-5, andrefused to apply the discovery rule to wrongful death cases. Id. at *5.
Now on to why we’re posting about Lamere. The court held, as an alternative, ground,that summary judgment could be affirmed on the basis of PMA preemption. Who knows? If it weren’t for all of Public Citizen’s caterwauling about preemption,the court may have left sleeping dogs lie with the statute of limitations.
As usual in PMA preemption cases, the argument camedown to the court’s view of the vexing and ill-defined concept of “parallel”violation claims under (1) the throw-away dictumin Riegel concerning a waived claim and (2) vague claims that the Court tookless-than-seriously in Lohr. SeeLamere, 2013 WL 599178, at *6 (dealing with these cases’ “parallel”violation language in a paragraph).
The plaintiff in Lamere took themanufacturing defect/good manufacturing practice (“GMP”) approach to preemption, id.,arguing that, even though the valve operated properly for almost twenty years,it was nonetheless manufactured in violation of … something…. Plaintiff never was very clear; even thePublic Citizen folks weren’t able to come up with a viable theory.
So they argued that they didn’t have to − any oldGMP was enough. The two GMPs that theplaintiff settled on were:
Each manufacturer shall develop, conduct, control, andmonitor production processes toensure that a device conforms to its specifications. Where deviations from device specificationscould occur as a result of the manufacturing process, the manufacturer shall establish and maintain processcontrol procedures that describe any process controls necessary toensure conformance to specifications.
21 C.F.R. § 820.70(a) (emphasis added).
Each manufacturer shallestablish and maintain procedures to control product that does not conform tospecified requirements. Theprocedures shall address theidentification, documentation, evaluation, segregation, and disposition ofnonconforming product. The evaluation ofnonconformance shall include adetermination of the need for an investigation and notification of thepersons or organizations responsible for the nonconformance.
21 C.F.R. § 820.90(a) (emphasis added) (both quoted at 2013WL 599178, at *7).
As the emphasized language makes quite clear, theseGMPs are of the “umbrella” variety. Theytell a manufacturer what topics to pay attention to, but provide absolutely nospecifics about what the manufacturer is supposed to do in order tocomply. They are, in short, the classicvague regulations that leave it to the manufacturer to decide how to comply. That's exactly the opposite of how state law ordinarily works, with violation claims replacing the "reasonable man" default standard only if the violated enactment provides a specific substitute (like "speed limit 55" instead of a "reasonably safe speed under the circumstances"). The Court of Appeals went through the “split” amongthe federal circuits about whether GMPs had to be “specific” in order tosupport a viable “parallel” claim. Lamere,2013 WL 599178, at *6. Ultimately, thecourt came down on the side of specificity – at least that a GMP had to do morethan tell a manufacturer that it needed to do something about this or that:
Without concluding that a GMP may never form the basisof a valid parallel claim, we hold that in this case [plaintiff] failed tosufficiently plead a parallel claim based on the specific GMPs she cites. We observe that those circuit court casesapproving of the use of GMPs as a basis for a parallel claim require that the plaintiff plead withgreater specificity.
2013 WL 599178, at *7 (emphasis added). For this proposition the court cited Bassv. Stryker Corp., 669 F.3d 501, 511-12 (5th Cir. 2012). Bass isn’t exactly the greatestdecision we’ve ever seen on specificity (the complaint survived), although Bassdid involve a relatively detailed complaint, as we discussed here. So Lamere had to be prettypoorly pleaded to fail that test.
Not only that, but these plaintiffs weren’t allthat sympathetic, even with Public Citizen on the case. Lamere was decided on summary judgment(remember, if you want to win a preemption motion, your odds are considerably betteron summary judgment – it’s just a lot more expensive). Thus, Lamere wasn’t a case where theplaintiffs were being shown the door without benefit of discovery. Rather, they “had ample opportunity to discoverwhether any GMPs had been violated” and hadn’t been able to come up withanything (not surprising, given that the valve lasted for almost twentyyears). Plaintiffs have to do better thanthat:
[T]o survive a motion for summary judgment followingdiscovery, [plaintiff] is required to do more than merely cite two GMPs withoutexplaining how the violation of these GMPs occurred or how such a violation wascausally related to the failure of the mechanical heart valve.
2013 WL 599178, at *7.
But Public Citizen was persistent, if notpersuasive. Plaintiff kicked “parallel”violations to the curb and attempted to make a virtue of their inability tofind anything. In a frontal assault on Riegelplaintiff argued that precisely because there wasn’t any federal regulation“specifically” on point, their claims couldn’t be preempted. Id. at *7. Talk about chutzpah – that’s precisely what Riegelwas all about.
The Court of Appeals quite rightly rejected thisclaim as incompatible with Reigel’s holding that the PMA process, in andof itself, provides whatever “specificity” is necessary under the statute’s expresspreemption clause:
[Plaintiff] argues that a general state-law duty not todistribute products with manufacturing flaws does not impose any requirementson [defendant] that are different from or in addition to federal requirementsthat are specifically applicable. Butthis argument ignores Riegel,which concluded that “[g]eneral tort duties of care ... ‘directly regulate’ thedevice itself, including its design.” Weconclude that imposing the state’s strict-liability rules on a PMA device wouldimpose a general duty that would directly regulate the device itself, whichwould be a regulation that is different from the federal regulations applicableto the PMA device.
2013 WL 599178, at *8 (Riegel citationomitted) (emphasis added). In other words, PMA preemptionactually means something. Getting hurtisn’t carte blanche to sue. “PMA process does not guarantee that everydevice is safe.” Id.
So much for medical device litigation tourism inMinnesota.
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