Federal Court Boots Medtronic Insulin Pump Recall Litigation to State Court

by | Aug 11, 2020 | Defective Medical Devices, Product Liability Law

Kevin Haverty, Defective Medical Device Lawyer

Concluding that the court lacked jurisdiction, United States District Court judge Dolly M. Gee remanded a case involving the recent Medtronic insulin pump recall of its 600 series insulin infusion pumps to the California state court where it originated. The case, Plum, et al. v. Medtronic, was originally filed in California Superior Court in Los Angeles on behalf of 7 plaintiffs – all Type I diabetics – who allegedly suffered injuries relating to defective retainer rings on the insulin reservoir chamber which caused either over- or under-infusion of insulin. In February 2020 the FDA ordered a recall of more than 300,000 Medtronic 630G and 670G model pumps due to “broken or missing” retainer rings. It was reported that Medtronic had received over 26,000 complaints which included 2,175 reports of injuries and 1 death.

Medtronic had removed the case to federal court claiming both diversity and federal question jurisdiction and then moved to sever the plaintiffs claiming that one – a resident of California – was fraudulently misjoined to destroy diversity jurisdiction. The company also argued that the court had jurisdiction because plaintiffs’ claims are preempted under federal law thereby implicating federal question jurisdiction. The court rejected both contentions.

While noting that the issue of misjoinder in a state case is more properly addressed to the state court, the court nevertheless addressed Medtronic’s argument that the joinder of the plaintiffs in Plum was so “egregious” as to amount to fraud saying:

Plaintiffs bought nearly identical types of insulin pumps from the same manufacturer and suffered the same type of injury as a result of the same alleged defect. These commonalities support the conclusion that Plaintiffs’ claims “arose out of the same series of transactions or occurrences” – namely a manufacturing defect – thus satisfying the first prong of joinder analysis under Federal Rule of Civil Procedure 20. In addition, because there need only be “some questions of fact and law common to all of the plaintiffs” to satisfy the second prong of the joinder analysis, this prong is also satisfied by Plaintiffs’ allegations. Thus, Plaintiffs’ claims cannot be severed on this basis even if the Ninth Circuit adopted the theory of fraudulent misjoinder. The California citizenship of both Weisshar and Minimed precludes this Court from exercising jurisdiction based on party diversity.

The claim of federal question jurisdiction based upon the affirmative defense of preemption was easily dispatched by the court who observed that “in the Ninth Circuit, it is “settled law” that Plaintiffs’ anticipation of a preemption defense does not create federal question jurisdiction.”

In the absence of subject matter jurisdiction, the court remanded the case to the Superior Court.

WILLIAMS CEDAR Partner KEVIN HAVERTY, along with JULIA REED ZAIC and LAURA SMITH HATCH of HEAVISIDE REED ZAIC in Newport Beach, CA represent the plaintiffs.

Julia Reed Zaic, Lawyer
Laura Smith Hatch, Lawyer

U.S. Supreme Court Rejects Appeal of 9th Circuit Decision Allowing Expert Testimony in Products Case Involving Rare Cancer

by | Mar 21, 2018 | Defective Medical Devices, Product Liability Law

In a decision with important implications for the admission of expert testimony in cases involving rare diseases, the Supreme Court of the United States declined to review a decision of the 9th Circuit which reversed a trial court’s decision barring plaintiff’s experts from testifying about the cause of plaintiff’s cancer.  Wendell v. GlaxoSmithKline, 838 F. 3d 1227 (9th Cir. 2017), cert. den. ___ S.Ct. ___ (2018).

In 2007, at the age of 21 and after years of taking a combination of drugs to treat his ulcerative colitis, Maxx Wendell developed a rare and deadly form of lymphoma called hepatosplenic T-cell lymphoma. In the years leading up to his diagnosis these drugs had increasingly been associated with this form of lymphoma particularly in young males with ulcerative colitis, although it’s exceeding rarity made it nearly impossible to specifically quantify the risk through epidemiologic studies.  While the background risk for this cancer (which had only first been identified in 1994 with only 200 or so cases reported in the medical literature worldwide from the 1990’s until the mid-2000’s) was understood to be approximately 1 in six million, the risk in young males with ulcerative colitis taking this combination of drugs increased to 1 in 35,000; a 300-fold increase in risk among this particular group.

Maxx’s parents, Lisa and Stephen Wendell brought an action against the manufacturers of the drugs used to treat his ulcerative colitis and produced two experts who were among the world’s leading experts on T-cell lymphomas.  Both of the experts testified that the absolute rarity of the disease generally, combined with the highly specific incidence in young male patients with ulcerative colitis taking a particular combination of drugs, made it more likely than not that Maxx’s HSTCL was caused by the use of these medications; particularly in the absence of any other risk  factors.  Both experts testified that they relied upon differential diagnosis in reaching this conclusion even in the face of no epidemiologic studies which they explained would be impossible to conduct given the rarity of the disease.

The district court excluded the opinions of these experts under Daubert v. Merrill Dow, finding their opinions unreliable because not based on epidemiologic studies and because their opinions were formed for litigation purposes and not for publication in the medical literature.  On appeal, the 9th Circuit reversed holding that the district court “looked too narrowly at each individual consideration, without taking into account the broader picture of the experts’ overall methodology . . . [and] improperly ignored the experts’ experience, reliance on a variety of literature and studies, and review of Maxx’s medical records and history, as well as the fundamental importance of differential diagnosis by experienced doctors treating troubled patients.”   The appeals court took particular aim at the over-reliance on the existence or absence of epidemiological studies as a criteria for evaluating the reliability of an expert’s methodology for Daubert purposes noting its fundamental unavailability in the cases of rare dieases:

Perhaps in some cases there will be a plethora of peer reviewed evidence that specifically shows causation. However, such literature is not required in each and every case. “The first several victims of a new toxic tort should not be barred from having their day in court simply because the medical literature, which will eventually show the connection between the victims’ condition and the toxic substance, has not yet been completed.

Thus, court concluded “[i]n the case of a rare disease like HSTCL, the Supreme Court’s mandate that in determining the admissibility of expert testimony, the focus ‘must be solely on principles and methodology, not on the conclusions that they generate’ is especially important.”  And, “[w]here, as here, the experts’ opinions are not the ‘junk science’ Rule 702 was meant to exclude, the interests of justice favor leaving difficult issues in the hands of the jury and relying on the safeguards of the adversary system—’vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof’—to ‘attack shaky but admissible evidence.’”

The case has significant implications for the admission of expert testimony in cases involving rare diseases for which no epidemiologic evidence either doesn’t exist or may never exist because of the disease’s rarity.  The broader import of the decision is a rejection of what has become an almost mechanical binary gatekeeping application of Daubert heavily reliant on the presence or absence of epidemiology.  The decision recognizes that reliable opinions can be based upon multiple factors and district courts must (at least in the 9th Circuit) be sensitive to the context in which the expert opinions are formulated.

Williams Cedar partner Kevin Haverty was trial and appellate counsel for the Wendells, and, together with Michael Quirk of the Berezofsky Law Group, represented the family on appeal.

For more information, call our legal team at 215-557-0099 or contact us online.