November 8, 2017
Non-Missouri residents’ contention that they can sue Essure maker Bayer Corp. in Missouri based on the drugmaker’s in-state clinical studies and other activities met some skepticism at a Nov. 7 oral argument before the Missouri Supreme Court.
Plaintiffs’ attorney G. Sean Jez faced a barrage of questions asking him to explain how the out-of-state plaintiffs’ claims connect with Bayer’s activities in Missouri, a requirement under the U.S. Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court .
Since the BMS ruling, Bayer and other companies have challenged state courts’ jurisdiction to hear non-residents’ suits, and have focused particular attention on the state court in St. Louis, which is perceived as plaintiff-friendly.
Juries there have handed down high-profile awards, including massive talc verdicts against Johnson & Johnson.
Here, 92 plaintiffs allege they were harmed by the permanent contraceptive device Essure; 85 of them are not Missouri residents ( State ex. rel. Bayer Corp. v. Moriarty, Mo., No. SC96189, argued 11/7/17 ).
Bayer is challenging a trial court’s decision that denied its motion to dismiss the case, arguing the ruling is contrary to well-established law and the Supreme Court’s recent jurisdictional decision in BMS.
But Jez told the Missouri top court that Bayer reached out to Missouri physicians to conduct Essure studies, and that these contacts were sufficient to establish jurisdiction in the state.
These doctors were principal investigators for the device, which wouldn’t have reached the market and the plaintiffs without those clinical studies, Jez, of Fleming Nolan Jez LLP in Houston, said.Jez later told Bloomberg Law that the U.S. Supreme Court declined in October to review M.M. v. GlaxoSmithKline LLC, an Illinois appeals court decision that allowed non-residents to sue a drug company based on clinical trials done in Illinois. That’s a clear indication clinical studies are enough for personal jurisdiction, Jez told Bloomberg Law. “I think that’s what we have here.”
More than 2,000 women have sued Bayer in St. Louis, and 90 percent of those plaintiffs have no connection to St. Louis, Bayer’s attorney Jonathan F. Cohn told the court. Plaintiffs are trying to make St. Louis a hub for this litigation, Cohn, of Sidley Austin LLP in Washington, said.
Essure consists of two coils that get implanted in the fallopian tubes and cause tissue inflammation that becomes a barrier to fertilization.
Plaintiffs allege the device was defectively manufactured, that Bayer failed to adequately train doctors how to place Essure, that it failed to report adverse events to the Food and Drug Administration, and that it misrepresented the device’s safety and effectiveness.
Women allege they suffered allergic reactions to nickel in the coils, pain, and perforation of other organs when the device migrated.
Some allege they had to undergo hysterectomies to achieve complete removal of the coils; others allege they faced unwanted pregnancies.
These claims “arose from or related to” Bayer’s Missouri contacts, satisfying the BMS test, they argue.
But none of these claims can be linked to Bayer’s conduct in Missouri, meaning the Missouri court lacks jurisdiction over non-residents, Cohn told the court.
The plaintiffs’ theories also rely on a speculative chain of events, assuming that additional information would have somehow have kept them from getting the device, Cohn said.
And multiple clinical trials were conducted in multiple states, he said.
Allowing claims to proceed in Missouri based on clinical trials conducted there, or based on an alleged failure by the company to report adverse events to the FDA, would create nationwide “general jurisdiction,” not based on conduct at issue in a specific lawsuit, he said.
That would undercut decisions by the Missouri Supreme Court and the U.S. Supreme Court saying corporations can be sued only in states where they are incorporated or headquartered, he said.
The plaintiffs here are looking to the experiences of other women who were in studies 10 years ago. That’s not linked to their claims, Cohn said.
Jez told the top court the drugmaker’s outreach to Missouri doctors, who were chief investigators for the device’s clinical studies, sufficiently established jurisdiction in Missouri.
But no device gets approved without clinical trials, one judge said, so that can’t be enough.
“I am drawing a conclusion that there is no connection, so if there is one, please tell me what it is,” another judge said.
The initial training site for doctors was in Missouri, Jez continued, drawing a question about whether the plaintiffs’ doctors had been trained in Missouri.
Jez said he didn’t have specific information as to where physicians later received training, but the training program began along with a significant clinical study in Missouri, he said.
Additionally Bayer directed a marketing campaign that had its “ground zero” in Missouri, Jez said. Bayer hired three Missouri companies to develop the campaign, and said it increased web traffic and brand awareness, he said.
Asked how that links to the plaintiffs’ claims, he said the campaign began in Missouri, and misrepresentations were projected all through the United States.
And Essure was first made commercially available in St. Louis, he said.
Bayer has also appealed a similar trial court ruling in another case, Dorman v. Bayer Corp.
In that case, Judge Michael K. Mullen of the St. Louis Circuit Court said the plaintiffs’ claims stemming from alleged negligent testing, marketing, and labeling of Essure “directly connect these activities to St. Louis.”
Plaintiffs contend that clinical studies conducted at Missouri hospitals using Missouri physicians as investigators were key to the regulatory approval of the device, Mullen said.
The Essure facts are different from the facts of BMS, where the Supreme Court held that the defendant drug company didn’t develop the drug in California, and didn’t manufacture, label, package, or work on regulatory approval in California, the Missouri court said.
Bayer filed a challenge to Dorman Nov. 6 with the Missouri Supreme Court, Cohn said at argument.
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