Tuesday, January 06, 2009

Sprint Fidelis Preemption Decision - Yessssss

The first really, really major post-Riegel preemption battle in the PMA device product litigation has been the Sprint Fidelis implantable cardiac defibrillator lead MDL, in which Medtronic moved to dismiss (that means on the pleadings - without discovery) against all claims on the strength of the express preemption clause as interpreted by Riegel.

In what will certainly be an early entry for one of the top ten decisions of 2009, Medtronic just won. The short of it:

Medtronic, the Defendant in this multidistrict litigation, asserts the same doctrine here, arguing that Plaintiffs’ claims – sounding in negligence and strict products liability – are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. Having carefully considered the parties’ voluminous submissions, the Court agrees.

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, slip op. at 2. A tip of the cyberhat to Dave Gossett at Mayer Brown for passing along the good news.

On one ground or another, the court dismissed all 21 claims in the master complaint: (1) strict liability – failure to warn; (2) strict liability – manufacturing defect; (3) negligence; (4) negligence per se; (5) breach of implied warranty; (6) breach of express warranty; (7) negligent misrepresentation; (8) intentional misrepresentation; (9) fraud; (10) constructive fraud; (11) violation of the Minnesota False Statements in Advertising Act; (12) violation of the Minnesota Deceptive Trade Practice Act; (13) violation of the Minnesota Prevention of Consumer Fraud Act; (14) violation of the Minnesota Senior Citizen and Handicapped Person Consumer Fraud Act; (15) negligent infliction of emotional distress; (16) loss of consortium; (17) wrongful death; (18) survival action; (19) medical monitoring; (20) unjust enrichment; and (21) Medicare Secondary Payer Act.

That means that the entire master complaint - the entire MDL - is dismissed with prejudice. Slip op. at 34-37. It's an appealable order and will make for a donnybrook of an appeal. Once again Medtronic leads the charge.

The court made the following significant rulings:

(1) The Class I FDA recall that the Medtronic leads underwent did not deprive the defendant of its preemption defense. Slip op. at 14-17. A recall does not invalidate an in-force PMA, and in any event the recall could not affect the status of devices implanted before the recall occurred.

(2) Claims asserting manufacturing defects are preempted. Slip op. at 18-22. These claims do not "parallel" FDA manufacturing requirements because manufacturers have to develop their own quality control systems under what are "flexible" regulations. The "level of fine detail" necessary to establish an actual violation does not exist. Plaintiffs' claims are would impose a level of detail "different from or in addition to" the FDA's regulations. "Violation" is not a "magic word" that defeats preemption. Twombly requires the factual basis of a violation claim to be pleaded.

(3) Warning claims, including post-sale duty to warn allegations, are preempted. Slip op. at 22-27. Preemption under the MDC is much broader than the Cigarette Act. Regulations that "permit" manufacturers to modify their warnings (the CBE regulations in the device context) do not save claims that would "require" such modifiications without being "different from or in addition to" those regulations. The conditions of the PMA itself did not impose any greater warning or reporting requirements than the FDA regulations themselves. Plaintiffs reporting-based allegations amount to a prohibited attempt at enforcing the FDCA - which is a form of implied preemption based upon 21 U.S.C. §337(a), providing for exclusive federal enforcement of the Act. Remember the §337(a) point. That may turn out to be the most important single ruling in the opinion.

(4) Design defect claims are preempted. Slip op. at 27-29. The introduction of a new "safer" model does not create a duty requiring immediate withdrawal of prior versions, unless the FDA so requires. It did not, so there is no "parallel" federal requirement for the plaintiffs to hang their state-law claims on. "Adulteration" claims are either a restatement of preempted manufacturing defect claims or amount to prohibited private enforcement.

(5) Negligence per se claims are preempted for the same reasons that the manufacturing, warning and design claims are. Slip op. at 30-31. Negligence per se does not "magically" permit private rights of action where such rights do not exist, and in any event the underlying claims for which negligence per se would set a standard of care, are already preempted.

(6) Breach of warranty claims (express and implied) are preempted. Slip op. at 31-33. Implied warranty merely tracks preempted manufacturing/warning/design claims. The 21 C.F.R. §808.1(d)(1) argument was rejected in Riegel. An express warranty of "safety" would require a jury to find the devices unsafe, which is what Riegel prohibits.

(7) Miscellaneous claims are preempted. Slip op. at 33-34. Derivative claims (consortium, unjust enrichment, consumer fraud) fail for the same reason as the claims from which they derive. Medicare Secondary Payor Act cases fail for essentially the same reason. If the individual insureds have no claims, their insurers have no claims on their behalf.

As we've said before, preemption can be a very powerful defense.


Ron Miller said...

"Once again Medtronic leads the charge"

Maybe this will show up on the companies brochure selling products. If you have a claim against us, we will defeat you even if all of your allegations are true.

Regardless of where you stand on the merits of preemption, I don't think continuing to lead the charge in defeating lawsuits against you regardless of negligence is a badge of honor anyone really wants to wear. I'm just guessing on this. But you are right, Medtronic is wearing that badge.

Brian Wilson said...

Great point! Somehow I don't think that the comment "in order to spur product development we're not liable to you even if we screw up and kill a family member and have to recall the product" will find it's way into Medtronics marketing materials...

I'm guessing either the author or the attorneys for Medtronic would perhaps not be so giddy if one of their family members were harmed by this product. Just another form of tort reform and lack of accountability that doesn't apply to anyone else if they screw up. Actually it's worse--it's collectivism that sacrifices individual rights for abstract notions of "product development" and "the good of the whole" (Marx would be quite proud of this doctrinal decision)

At the end of the day, all this tort reform, masquarading as statutory interpretation, is like people wanting to "get tough on crime." Sounds good until you find out the prison is being built next door...and then it doesn't sound too palatable. Reminds me of a quote from Lincoln: "Whenever I hear any one arguing for slavery I feel a strong impulse to see it tried on him personally." Not comparing this decison/issue to slavery, but By analogy it serves the point.

Some "victory." What's next, "freedom of contract" and privity and other legal anachronisms retreived from the dust bin of legal jurisprudence?
While we're at it, let's just give immunity to everybody for a few years and see what happens...we're truly becoming a first rate, second rate legal system.

Not really something to pop the champagne corks over...

TN DeNike said...

Mr. Hermann truly gives the "Short of It" leaving off the lines in the decision preceding the quote in his blog, which reads, in part " .. it is important to point out that the absence of a particular remedy.. does not imply.. the lack of a legal wrong. "

Medtronic could sit back and enjoy their victory but I imagine their next focus will be on doing everything they can to try to defeat passage of The Medical Device Safety Act of 2008. Wonder how they will fare against a bill co-sponsored by Mr. Obama ?

T DeNike


I am one of the "victims" if you will. I suffered 54 shocks inside of 2 hours, the first 30 were in the first 15 minutes.

All that I would like to see happen is for all of those who voted for this law in congress, all the Supremes, all of the Officers of Sprint, and all the high ranking officials at the FDA to get lined up, hooked up, and have 800 volts of electricity shot through their hearts. I would be willing to bet that after the first 5 80% of those who voted for it would change their votes, and I think I can guarantee that within 30 they would all change their votes.

If they can all do it without changing their votes I'd be willing to go peacefully into the night.

donf said...

I am also a victim of Sprint Fidelis, having been shocked more than 20 times.
I have some specific comments:
1. My ICD detected the impending failure more than 2 weeks prior to the final failure. Had Medtronic offered just bi-weekly monitoring, the failure would have been detected prior to the shocks. I would still have required surgery, but would not have been shocked.
2. The courts' preemption decisions preempt me from learning whether my failure was the result of a failure in Medtronic's manufacturing (ie the device did not meet the FDA approved standards) or was a failure due to a design flaw.
3. There remain well over 150,000 people out there with these leads installed. The FDA claims there's no need to withdraw the PMA because the device is no longer on the market. How can they reconcile their mission to protect the public with their failure to protect those 150,000 who just might have devices that WILL someday fail?