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Justia Weekly Opinion Summaries

Drugs & Biotech
June 5, 2020

Table of Contents

In re: MDL 2700 Genentech

Civil Procedure, Drugs & Biotech, Health Law, Products Liability

US Court of Appeals for the Tenth Circuit

Risperdal and Invega Cases

Drugs & Biotech

California Courts of Appeal

Rios v. Bayer Corp.

Civil Procedure, Constitutional Law, Drugs & Biotech, Products Liability

Supreme Court of Illinois

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Legal Analysis and Commentary

The Response to President Trump’s Shameless Religious Photo Op Gives Me Hope for the Future

MARCI A. HAMILTON

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University of Pennsylvania professor Marci A. Hamilton praises the response of liberal clergy in response to President Trump’s seemingly opportunistic photo op in front of St. John’s Episcopal Church in Washington, D.C. Hamilton calls upon these religious leaders to continue speaking out loudly in the name of inclusion, love, and truth.

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Drugs & Biotech Opinions

In re: MDL 2700 Genentech

Court: US Court of Appeals for the Tenth Circuit

Docket: 19-5035

Opinion Date: May 29, 2020

Judge: Mary Beck Briscoe

Areas of Law: Civil Procedure, Drugs & Biotech, Health Law, Products Liability

This appeal stemmed from a group of fourteen diversity cases that were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The plaintiffs in all fourteen cases were cancer treatment providers who purchased multi-dose vials of Herceptin, a breast cancer drug, from defendant Genentech, Inc. (Genentech). Plaintiffs alleged that Genentech violated state law by failing to ensure that each vial of Herceptin contained the labeled amount of the active ingredient, and by misstating the drug concentration and volume on the product labeling. After the cases were consolidated, Genentech moved for summary judgment, arguing that plaintiffs’ claims were pre-empted by federal law. The district court agreed with Genentech and granted its motion for summary judgment. Plaintiffs appealed. The Tenth Circuit disagreed with the district court's conclusion that plaintiffs' claims were preempted, and consequently, reversed summary judgment and remanded for further proceedings.

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Risperdal and Invega Cases

Court: California Courts of Appeal

Dockets: B284002(Second Appellate District) , B284315(Second Appellate District) , B284317(Second Appellate District)

Opinion Date: June 3, 2020

Judge: Dhanidina

Areas of Law: Drugs & Biotech

Plaintiffs, two adolescents who were prescribed the antipsychotic drug risperidone after it was approved by the FDA to treat behavioral symptoms in children with autism, filed suit against Janssen for failure to adequately warn of the risk of gynecomastia on the drug's label. In the published portion of the opinion, the Court of Appeal held that the trial court was correct to decide the issue of preemption without submitting any purported underlying factual questions to a jury. The court also held that Janssen did not meet its burden to establish its preemption defense and that plaintiffs' claims based on the information in table 21, studies 41 and 70, are not preempted. In this case, Janssen did not meet its burden to show by clear evidence that it fully informed the FDA and, in turn, the FDA rejected a proposed label change.

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Rios v. Bayer Corp.

Court: Supreme Court of Illinois

Citation: 2020 IL 125020

Opinion Date: June 4, 2020

Judge: Mary Jane Theis

Areas of Law: Civil Procedure, Constitutional Law, Drugs & Biotech, Products Liability

Essure--permanent birth control for women--originally was manufactured and developed by Conceptus, a California corporation. Bayer bought Conceptus. Bayer marketed Essure as safer and more effective than other birth control. Two residents of Madison County, Illinois, filed personal injury complaints, alleging that Essure caused debilitating pain, heavy bleeding that necessitated medication, and autoimmune disorders. including 179 plaintiffs from at least 25 states. Months later, the U.S. Supreme Court issued its “Bristol-Myers” decision. Bayer argued that, following Bristol-Myers, a court cannot exercise specific personal jurisdiction over an out-of-state defendant as to the claims of out-of-state plaintiffs when the conduct giving rise to the claims did not occur in the forum state. The plaintiffs argued Illinois courts had specific personal jurisdiction over Bayer because it “created the Essure Accreditation Program and the marketing strategy for Essure in Illinois,” conducted clinical trials in Illinois, and used Illinois as a testing ground for its physician training program. The appellate court affirmed the denials of motions to dismiss: Bayer “conducted a part of its general business in Illinois, and [p]laintiffs’ claims arose out of" trials conducted, in part, in Illinois. The Illinois Supreme Court reversed. The nonresident plaintiffs identified no jurisdictionally relevant links between their claims and Illinois. The nonresidents have not explained how Illinois could be a convenient location for this litigation; they were not implanted with their devices here and have identified no other activity that would connect their specific claims to Illinois. Many nonresident plaintiffs initiated duplicate actions in California, indicating that the interests of judicial economy are not furthered by permitting their claims to proceed in Illinois. A corporation’s continuous activity of some sort within a state is not enough to render the corporation subject to suits unrelated to that activity.

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