PITTSBURGH – A federal judge has granted a final opportunity to amend a class action complaint for plaintiffs who claimed significant harm was sustained on behalf of themselves and/or their loved ones based on a shortage of the pharmaceutical drug Fabrazyme that began in 2009 and lasted until 2012.
D.J., Toni Cordova, John Cortina, George Demko, Donovan Helton, Mary Helton, Sydney Johnson, Damon LaForce, Michael Masula, James Matthews, Thomas Olszewski, Thomas Stanziano, James Wallace, Jeanne Wallace, Samuel Wallace and Eddie Viers first filed suit in the U.S. District Court for the Western District of Pennsylvania on May 21, 2022 versus Ademola Abiose, Ann & Robert H. Lurie Children’s Hospital of Chicago, Maryam Banikazemi, Baylor College of Medicine, Cedars-Sinai Medical Center, Joel Charrow, Children’s Memorial Hospital, Cincinnati Children’s Hospital, Columbia University Medical Center, Dominique Germain, Duke University Health Center, Christine Eng, Massachusetts General Hospital, Michael Mauer, Manesh Patel, Ronald Scott, Katherine Sims, University of Alabama at Birmingham Medicine, University of Iowa Hospitals and Clinics, University of Minnesota, University of Versailles, University of Washington Medicine, David Warnock and William Wilcox.
“Plaintiffs and/or their decedents suffered from Fabry disease, a rare, but lethal, heritable, genetic illness, in which a gene for an enzyme required to metabolize a certain fat is mutated or missing, resulting in the build-up of that fat in cells, blood vessels and organs, resulting in inflammation and, ultimately, death. Fabrazyme is a synthetic version of the enzyme that is infused every two weeks to treat Fabry disease and mitigate its effects. Fabrazyme manufacturer, Sanofi Genzyme Corporation, is the sole FDA-approved supplier of enzyme replacement therapy for Fabry disease in the United States market,” U.S. District Court for the Western District of Pennsylvania Judge Cathy Bissoon said, in a Sept. 30 memorandum opinion.
“The moving defendants include eleven medical centers and their respective physicians. Four of the medical center defendants – University of Iowa Hospitals and Clinics, University of Minnesota, University of Washington and University of Alabama at Birmingham – are public entities. The physician defendants did not treat any of the named plaintiffs or their decedents; rather, they represented their respective medical institutions as members of the Fabry Stakeholder’s Working Group (FSWG), a group of experts convened by Sanofi Genzyme to prepare guidance to the Fabry community on the management of Fabrazyme supply during the drug shortage. The amended complaint alleges that the guidance was disseminated to all Fabry patients and their physicians, nationwide. The lawsuit essentially contends that defendants, through their participation in the FSWG, intentionally initiated a harmful experimental medical protocol on plaintiffs and collected research data on low-dose Fabrazyme efficacy without plaintiffs’ informed consent.”
Bissoon added that on Dec. 5, 2022, the defendants filed a motion to dismiss the plaintiffs’ amended complaint against all moving defendants under Federal Rule of Civil Procedure 12(b)(2), based upon lack of personal jurisdiction. The motion to dismiss additionally seeks dismissal of the claims against the public entity defendants and their respective physicians, pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(2), based on lack of standing and Eleventh Amendment immunity.
“After careful consideration of the submissions of the parties, the Court agrees with defendants that personal jurisdiction is lacking in this case. As an initial matter, plaintiffs concede the absence of general jurisdiction over defendants, and the amended complaint itself confirms that none of the individual defendants reside in Pennsylvania, and none of the medical center defendants are incorporated, or have a principal place of business, in Pennsylvania. It likewise is undisputed that no federal statute authorizes nationwide service of process for any of plaintiffs’ claims. Thus, plaintiffs must establish specific jurisdiction under the minimum contacts analysis or the Calder effects test. This, plaintiffs have failed to do,” Bissoon stated.
“In short, plaintiffs have not provided any evidence that any of the moving defendants purposefully directed any activities at Pennsylvania, let alone activities from which any of plaintiffs’ claims arose or to which they relate. Among other things, there is no evidence (or allegation) that the moving defendants: reside in Pennsylvania; have or had offices in Pennsylvania; have a bank account in Pennsylvania; are licensed to practice medicine in Pennsylvania; have ever treated patients in Pennsylvania; have directed advertising or marketing at Pennsylvania; have an authorized agent to receive service of process in Pennsylvania; own land in Pennsylvania; or have a mailing address, telephone number or fax number in Pennsylvania. In addition, only two of the named plaintiffs purport to be Pennsylvania residents, neither of whom were patients of the moving defendants.”
Bissoon further explained that “the only Pennsylvania contact that plaintiffs even remotely assert is the dissemination via FedEx of the two FSWG guidance letters to all Fabry patients nationwide, including any patients who happened to live in Pennsylvania” – but specified that “neither these contentions nor plaintiffs’ conclusory allegations that the FSWG interfered with their patient-doctor relationships and ‘forced its will on Pennsylvanians’ establishes the requisite minimum contacts with the forum.”
“The effects test likewise fails to establish personal jurisdiction over plaintiffs’ intentional tort claims. Again, as defendants state, even assuming the effects of the alleged intentional torts were felt by Pennsylvania patients, the effects test is not satisfied when, as here, a defendant’s ‘allegedly tortious conduct impacted a wider population beyond Pennsylvania’s borders.’ Conclusory allegations aside, plaintiffs have not made any showing that Pennsylvania had a unique relationship with Fabry disease or Fabry patients, or that the guidance otherwise was aimed at Pennsylvania such that Pennsylvania could be said to be the focal point of the tortious activity. In sum, there has been no showing that exercising personal jurisdiction over the moving defendants comports with Pennsylvania’s long-arm statute or that haling the moving defendants into court in Pennsylvania would be fair, reasonable or consistent with federal due process standards for specific jurisdiction. Accordingly the motion to dismiss for lack of personal jurisdiction will be granted as to all moving defendants,” Bissoon concluded.
“For these reasons, the motion to dismiss for lack of personal jurisdiction is granted without prejudice. Should plaintiffs choose to amend their complaint, they may do so by Oct. 17, 2023. Given that plaintiffs already have amended their complaint once, they must make last, best efforts in these regards, because further opportunity for amendment will not be afforded. If plaintiffs do not timely file an amended complaint, identifying a valid jurisdictional basis for proceeding, all claims against the moving defendants will be dismissed without prejudice, to plaintiffs’ ability to re-file this lawsuit in an appropriate forum.”
For counts of tort and constitutional rights violation claims and violation of the Interstate Compact Clause, the plaintiffs are seeking compensatory damages, punitive damages, equitable and/or restitution damages, medical monitoring, costs of suit and any other and further legal and/or equitable relief to which plaintiffs might be entitled at law, or which this Court deems proper.
The plaintiffs are represented by Allen Black Jr. and Charles Allen Black of the Law Office of C. Allen Black, in Pittsburgh.
The defendants are represented by Thomas F. Cocchi Jr. of Husch Blackwell, in Washington, D.C., Abigail A. Golden, Mark E. Anderson, Samuel Lewis Tarry Jr. and Natalie L. Zagari of McGuire Woods, in Charlotte, N.C., Raleigh, N.C., Tysons, Va. and Pittsburgh, Peter Joseph Fazio of Aaronson Rappaport Feinstein & Deutsch, in New York, N.Y., Joseph Comer and Andrea Kott of Barker Castro & Steinback, in Chicago, Ill., Jacob C. Lehman of German Gallagher & Murtagh, in Philadelphia, Beth A. Bryan and William E. Braff of Taft Stettinius & Hollister, in Cincinnati, Ohio, Bruce Megard Jr. and David M. Norman of Bennett Bigelow & Leedom, in Seattle, Wash., Tory A. Weigand of Morrison Mahoney, in Boston, Mass., Cole Robinson Gresham and Jay Michael Ezelle of Starnes Davis Florie in Birmingham, Ala., Sandra L. Alven of Riley Hewitt Witte & Romano, in Pittsburgh, plus Michael Grimaldi, Jon Peter Kardassakis and Ashley N. Rodgers of Lewis Brisbois Bisgaard & Smith, in Los Angeles, Calif. and Pittsburgh.
U.S. District Court for the Western District of Pennsylvania case 2:22-cv-00752
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com