If preemption had a family tree, the drug and device branch would be heavy. And, as our scorecards and cheat sheets demonstrate, there are obvious sub-branches that sprouted out of major Supreme Court decisions. We have the Wyeth v. Levine, 555 U.S. 555 (2009) pharmaceutical branch; the Medtronic, Inc. v. Lohr, 518 U.S.
This post is from the non-Reed Smith side of the blog.
What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable…
This post is from the non-Reed Smith side of the blog.
It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law. This time in Minnesota state court which fortunately took a lot of its cues from strong federal law. In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.
Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later. Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries. Id. at *1. Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act. Id. Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption. Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel and Buckman – emphasis on the “narrow” part. To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted). Id. at *4.
Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations. Id. at *1. But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.” Id. at *6. “Must have” is about on par with “would of, should of, could of.” Not nearly enough.
This post comes from the non-Reed Smith side of the blog.
Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases. Think of it like taking a shot on goal. The shot deflects off the goalie’s stick and goes wide – that’s express preemption. The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements. You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion. Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot. Wrong. No free shot. No empty net. All the obstacles remain in place. Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series. Go Capitals!).
Even a casual reader of the blog would know that we like it when drug or device manufacturers defeat dubious claims. It is also no secret that we are enamored of the learned intermediary doctrine and challenging the link of proximate cause for failure to warn. We also value decisions that use common sense, at least what our biased perspective allows us to see as common and sensical. When these things come together, we are as pleased as a robin finding juicy, wriggling worms after the spring thaw.
The decisions in Averhart v. Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. Dist. LEXIS 38446 (N.D. Ohio Mar. 24, 2014), and Casso v. Ortho-McNeil Pharm., Inc., No. 1:11 oe 40006, 2014 U.S. Dist. LEXIS 38443 (N.D. Ohio Mar. 24, 2014), largely satisfy our annelid cravings. First, the defense won summary judgment on the warnings claims they moved on in each case. (The defense moved for judgment on the pleadings on some other claims and apparently raised some new arguments for summary judgment in reply briefs. Defendants were rebuffed in almost all of those attempts. We cannot tell from the decisions why summary judgment was not sought across the board or if the plaintiffs had any evidence for their non-warnings claims, so we will focus of the warnings part of the decisions.) Second, the warnings claims fell because the prescribers testified to their understanding of the risk at issue and the plaintiffs had nothing else suggesting that the warnings were inadequate in any material way. Third, the warnings analysis, despite some quirks of the phrasing of the applicable Mississippi and Minnesota law, was pretty straightforward, focusing on the actual testimony of the prescribers and some of the basics of how drugs are prescribed to patients.
The drug at issue in these cases was Ortho-Evra, a combination hormonal contraceptive patch; “combination” means that there is estrogen with the progestin. It has long been common knowledge in the medical community, and, we think, the population of patients who use hormonal contraceptives, that this class of products has a risk of blood clots. Patient package inserts started forty years ago because of this risk with these products. Advertisements for these products on television and in popular magazines have identified this risk since the 1990s. There has been litigation for decades over various hormonal contraceptives and their risk of blood clots (among other things). Because of this, to say nothing of medical journals, medical schools, and medical education, it is hard to imagine healthcare providers making decisions on prescribing hormonal contraceptives without being aware of the risk of blood clots and at least thinking about what to tell the patient about the risk with the product or products that might be prescribed. Because of the nature of hormonal contraception, it is particularly important that the prescriber and patient work together to identify the particular medication that the patient will actually use as directed. The risk of blood clots present in all marketed prescription combination hormonal contraceptives goes up with pregnancy–that is, when contraception fails—so the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations. Thus, for warnings claims on blood clots, there are some obvious challenges for plaintiffs: (1) that the claims are for inadequate warnings rather than failure to warn completely, (2) that prescribers will typically be well-versed in the risks regardless of the label, and (3) decisions to prescribe one combination hormonal contraceptive instead of another will usually not be based on a comparison of their blood clot risk. This means the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.
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 discussed at 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.
out of California. It was a food case, but we wondered whether primary
jurisdiction could be a more active, robust line of defense in drug and device
cases now that Wyeth v. Levine has curtailed the preemption defense. Just last week we showered praise
Joke Machine. Not surprisingly, a lot of the jokes involve doctors. For
news for you. The good news is that these test results say you have 24 hours to
live. The bad news ….
Today’s post is by a guest blogger, Reed Smith’s own Jobina Jones-McDonnell.
She gets all the credit, and you can just blame Bexis.
This post discusses a recent Minnesota Supreme Court opinion rejecting a “duty to train” claim in a non-drug/device case. The Court held that a manufacturer doesn’t have a duty to train persons how to use its products, even where the manufacturer undertook to provide training as part of the purchase price of the product at issue.
The case, Glorvigen v. Cirrus Design Corp., ___ N.W.2d ___, 2012 WL 2913203 (Minn. 2012), decided on July 18, 2012, involved an airplane crash where the pilot/owner and his passenger died. The estates of the pilot and passenger filed suit against (guess who?) the manufacturer and seller of the plane. The Minnesota Supreme Court was reviewing the appellate court’s reversal of the jury’s special verdict in plaintiffs’ favor. That procedural posture meant that, if the defendant was going to win on appeal, it essentially had to do it as a matter of law, and that’s just what happened.
The pilot purchased the plane about a month prior to the crash. As part of the purchase price, the manufacturer defendant provided a 2-day on the ground and in-flight transition training course. Transition training is standard in the aviation industry. It builds on the pilot’s previous experience and gives the pilot individualized training in the new plane. We’ve seen similar programmes offered by makers of complex medical devices.
We really don’t like it when state aspiring governors (that’s what “AG” stands for, isn’t it?) come after our clients − especially when our clients were merely exercising their First Amendment rights to make truthful statements about this or that off-label use. But then, the state AGs never cared what we thought before, so why…