Our two favorite television shows occasionally force us to follow subtitles while a character is speaking a harsh (to our ears, anyway) foreign language. In The Americans, the spies in the Russian embassy treat us to long exchanges in their mother tongue, reminding us of the bad old days of Kruschev, Brezhnev, and Tretiak,
What’s left of the OxyContin litigation produced a recent decision that addresses a myriad of procedural and substance issues, some of which we often see and others not so much. If you don’t recall, in 2007, Purdue Frederick Corp. and some of its executives pled guilty to criminal charges related to the marketing of OxyContin and paid approximately $600 million in fines. That was almost 7 years ago. The plaintiff in Luberda v. Purdue Frederick Corp., 2014 U.S. Dist. LEXIS 41951 (D.S. Car. Mar. 28, 2014), on the other hand, filed his complaint in 2013 in South Carolina – six years after those guilty pleas and ten years after he became addicted to OxyContin. Although the court’s opinion doesn’t provide much detail on the background of the case, it appears that the plaintiff was asserting negligent and fraudulent failure to warn claims and attempting to assert a private right of action under South Carolina’s criminal statute on misbranding. He sued nine companies within the Purdue Frederick family of companies and almost two-dozen executives.
This history created a background ripe for motion practice.
Personal Jurisdiction
Many of the individual defendants moved to be dismiss for insufficient service of process and/or lack of personal jurisdiction. Two of them won their insufficient service of process motions. They never signed for the certified mail that carried their summons and complaint. Id. at *12-13. Those two defendants and approximately 20 others also won dismissal because they did not have sufficient minimum contacts with South Carolina to be sued there. The court laid out a useful primer on the procedure for analyzing personal jurisdiction:
The party seeking to invoke personal jurisdiction over a nonresident defendant bears the burden of proving the existence of personal jurisdiction. ESAB Group, Inc. v. Centricut, LLC, 34 F.Supp.2d 323, 328 (D.S.C.1999). At the pretrial stage, the burden of proving personal jurisdiction over a nonresident is met by a prima facie showing of jurisdiction either in the complaint or in affidavits. In determining whether a prima facie showing has been made, the Court may consider the uncontroverted allegations in Plaintiff’s pleading. However, whenever the allegations in Plaintiff’s pleading are contested by sworn affidavit, Plaintiff can no longer rest on those allegations. Instead, it then becomes Plaintiff’s burden to present an affidavit or other evidence proving that jurisdiction exists over the nonresident defendant. See Wolf v. Richmond Cnty. Hosp. Auth., 745 F.2d 904, 908 (4th Cir. 1984); Clark v. Remark, 993 F.2d 228 (table), 1993 WL 134616, at *2 (4th Cir. 1993).
The Court summarily dismissed a multitude of defendants because plaintiff simply didn’t make a prima facie showing of personal jurisdiction. Id. at *11-12. For four of the defendants, however, the court determined that their affidavits and the complaint didn’t clarify whether they were involved in company’s decision-making regarding the marketing of OxyContin. Id. at *15. So the court denied the motions of these defendants, but without prejudice to their raising the arguments again at the summary judgment stage after the plaintiff had a chance for “jurisdictional discovery.” Id. at *16.
Learned Intermediary Doctrine
The court also applied the learned intermediary doctrine to the plaintiff’s negligent failure to warn claim. Plaintiff’s allegations were, in essence, this: “Defendants owed Plaintiff a duty to properly warn of the potential for and/or risk of addiction associate (sic) with their product.” Id. at *17. That’s wrong. South Carolina recognizes the learned intermediary doctrine, and as we all know under that doctrine the manufacturer’s duty to warn runs to the prescribing doctor, not the patient. Id. at *17-18. The plaintiff has the burden to show – and allege – that the “undisclosed risk was sufficiently high that it would have changed the doctor’s [prescribing] decision.” Id. at *18. The court dismissed the claim but gave the plaintiff a chance to amend his pleading to add factual allegations suggesting that his doctor would have changed his prescribing decision had there been a different warning. Id.Continue Reading An OxyContin Decision That Addresses Everything from Negligence Per Se Claims to Personal Jurisdiction
This post is from the non-Reed Smith side of the blog.
We’ve been updating you regularly on the equally regular dismissal of the majority of claims in the Infuse litigation on the grounds of preemption and TwIqbal. Well, here’s a quick reminder that preemption isn’t the only arrow in device manufacturers’ quivers. All those
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.Continue Reading Common Sense Contraceptive Warnings Cases
Not too long ago (March 28, and April 2) we read with interest a couple of articles on 360 that brought back unpleasant memories. The articles discussed congressional inquiries to the FDA (including “pointed questioning” of FDA Commissioner Margaret Hamburg) about undisclosed (to the public, anyway) meetings between “FDA officials” and the plaintiff’s bar concerning
This post discusses litigation holds. Litigation holds aren’t sexy. They aren’t going to take counsel to the Supreme Court. They aren’t going to make the nightly news – at least we hope. But you know and we know that in a mass tort between 90 and 99% of the cases generated by plaintiffs’ solicitation machines
Happy Birthday LEXIS/NEXIS, whose legal research service went up on this date back in 1973. There’s no doubt that LEXIS/NEXIS has made our professional lives considerably easier. We’ve long since given up our campaign to persuade young lawyers to venture beyond computerized research. What’s the point of suggesting that lawyers occasionally cuddle up with digests
This post is from the non-Reed Smith side of the blog only.
Since September we’ve been bringing you news from the Infuse litigation on about a monthly basis. The overwhelming majority of that news has been positive. And, when you’ve got a good thing going, you want to keep it going. You also don’t want