The Minnesota State Fair, the biggest in the country, is going on now. If you are lucky enough to attend, you can check out the butter sculptures, eat cheese curds, gaze at seed portraits of Prince, wave hello to our law school classmate Senator Amy Klobuchar, eat cheese curds, ride the big slide (though you
We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734 (Minn. 4th Dist. May 24, 2022), is unusual. It is not a product liability case. Rather, a pharmaceutical company sued a compounder for fraudulently
There are some basic rules for medical product liability litigation, at least as we—and the vast majority of courts—see it. One is that the manufacturer of the medical product that the plaintiff used and allegedly injured her is typically the right defendant. Part of what a potential plaintiff is supposed to do during the statute
It’s crunch time people. No more browsing. No more pondering. No more scrolling. Pick something and buy it. More importantly, you need to ship it. You may not be able to see all of your family this year, but you still want to make sure your gift makes it under their tree. If so, today
We are writing about a case that does not involve drugs or devices because it runs through some of the very same personal jurisdiction issues we have warned about post-Bauman. Adams v. NHL, MDL No, 14-2551, Case No. 15-cv-00472 (SRN/JSM), 2019 WL 5079980 (D. Minn. Oct. 10, 2019), is a case from the
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.
Continue Reading In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific
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.