Friday, February 22, 2013

Preemption in the Land of 10,000 Medical Devices

For some reason, just as pharmaceutical manufacturing is concentrated in New Jersey and Southeastern Pennsylvania, and just as there are an abnormal number of Class II implant manufacturers in Indiana, the epicenter of American pre-market approved medical device manufacturing seems to be in Minnesota.

Similarly, preemption is at the epicenter of medical device product liability litigation involving PMA devices.

Since plaintiffs are able to avoid federal court through the simple stratagem of suing defendants (all defendants, not just medical device manufacturers) in their “home” courts, we have been wondering how PMA preemption would fare in Minnesota state court.  Minnesota already has a relatively expansive consumer protection statute and (until recently) an extremely long (six-year) statute of limitations for personal injury cases.  If there were also an indication that Minnesota courts would view PMA preemption in a pro-plaintiff fashion, we could see Philadelphia-style influx of litigation tourism.

Fortunately that doesn’t appear to be in the offing.  A couple of years ago, Medtronic scored 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 Medtronic Sprint 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 we gloated over here.

Still, Sprint Fidelis was just a county-level trial court.  The Sprint Fidelis plaintiffs chose not to take their chances on appeal.  One bad decision from the Court of Appeals of Minnesota could wipe everything out.

Or, conversely, one good appellate decision could cement everything in place and send the litigation tourists scurrying elsewhere.

Fortunately, the latter happened the other day.  See Lamere v. St. Jude Medical, Inc., ___ N.W.2d ___, 2013 WL 599178, slip op. (Minn. App. Feb 19, 2013).  Lamere involved a Class III PMA approved mechanical heart valve, and the court affirmed 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 in Lamere.

The valve in Lamere was implanted in 1988.  Nearly 20 years later the recipient died, allegedly as a result of a valve failure.  The plaintiff – like the decedent a California resident – chose to bring suit in Minnesota state court.  Thus Lamere was a blatant example of litigation tourism.

The defendant manufacturer received summary judgment, on both preemption and (ironically) statute of limitations grounds, and the plaintiff appealed.  The Court of Appeals affirmed.  We won’t spend much time on the 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 court concluded that the six-year statute runs from the time of the defendant’s “act or omission,” which in this instance was “either . . . the date the medical device was manufactured or the date it was implanted.”  2013 WL 599178, at *4.  Since the implant had lasted for over 19 years, the plaintiff was out of luck.  Id.  The court refused to expand a “latent disease” (read, asbestos) exception to include other products that simply lasted a long time before allegedly malfunctioning, id. at *4-5, and refused 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 came down to the court’s view of the vexing and ill-defined concept of “parallel” violation claims under (1) the throw-away dictum in Riegel concerning a waived claim and (2) vague claims that the Court took less-than-seriously in Lohr.  See Lamere, 2013 WL 599178, at *6 (dealing with these cases’ “parallel” violation language in a paragraph).

The plaintiff in Lamere took the manufacturing 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 the Public Citizen folks weren’t able to come up with a viable theory.

So they argued that they didn’t have to − any old GMP was enough.  The two GMPs that the plaintiff settled on were:

Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.  Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

21 C.F.R. § 820.70(a) (emphasis added).

Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.  The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.  The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.

21 C.F.R. § 820.90(a) (emphasis added) (both quoted at 2013 WL 599178, at *7).

As the emphasized language makes quite clear, these GMPs are of the “umbrella” variety.  They tell a manufacturer what topics to pay attention to, but provide absolutely no specifics about what the manufacturer is supposed to do in order to comply.  They are, in short, the classic vague 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” among the federal circuits about whether GMPs had to be “specific” in order to support a viable “parallel” claim.  Lamere, 2013 WL 599178, at *6.  Ultimately, the court came down on the side of specificity – at least that a GMP had to do more than tell a manufacturer that it needed to do something about this or that:

Without concluding that a GMP may never form the basis of a valid parallel claim, we hold that in this case [plaintiff] failed to sufficiently plead a parallel claim based on the specific GMPs she cites.  We observe that those circuit court cases approving of the use of GMPs as a basis for a parallel claim require that the plaintiff plead with greater specificity.

2013 WL 599178, at *7 (emphasis added).  For this proposition the court cited Bass v. Stryker Corp., 669 F.3d 501, 511-12 (5th Cir. 2012).  Bass isn’t exactly the greatest decision we’ve ever seen on specificity (the complaint survived), although Bass did involve a relatively detailed complaint, as we discussed here.  So Lamere had to be pretty poorly pleaded to fail that test.

Not only that, but these plaintiffs weren’t all that 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 better on summary judgment – it’s just a lot more expensive).  Thus, Lamere wasn’t a case where the plaintiffs were being shown the door without benefit of discovery.  Rather, they “had ample opportunity to discover whether any GMPs had been violated” and hadn’t been able to come up with anything (not surprising, given that the valve lasted for almost twenty years).  Plaintiffs have to do better than that:

[T]o survive a motion for summary judgment following discovery, [plaintiff] is required to do more than merely cite two GMPs without explaining how the violation of these GMPs occurred or how such a violation was causally related to the failure of the mechanical heart valve.

2013 WL 599178, at *7.

But Public Citizen was persistent, if not persuasive.  Plaintiff kicked “parallel” violations to the curb and attempted to make a virtue of their inability to find anything.  In a frontal assault on Riegel plaintiff 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 Riegel was all about.

The Court of Appeals quite rightly rejected this claim as incompatible with Reigel’s holding that the PMA process, in and of itself, provides whatever “specificity” is necessary under the statute’s express preemption clause:

[Plaintiff] argues that a general state-law duty not to distribute products with manufacturing flaws does not impose any requirements on [defendant] that are different from or in addition to federal requirements that are specifically applicable.  But this argument ignores Riegel, which concluded that “[g]eneral tort duties of care ... ‘directly regulate’ the device itself, including its design.”  We conclude that imposing the state’s strict-liability rules on a PMA device would impose a general duty that would directly regulate the device itself, which would be a regulation that is different from the federal regulations applicable to the PMA device.

2013 WL 599178, at *8 (Riegel citation omitted) (emphasis added).  In other words, PMA preemption actually means something.  Getting hurt isn’t carte blanche to sue.  “PMA process does not guarantee that every device is safe.”  Id.

So much for medical device litigation tourism in Minnesota.

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