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Bertolini-Mier v. Upper Valley Neurology Neurosurgery, P.C.

United States District Court, D. Vermont

November 4, 2019

KIM BERTOLINI-MIER and ROGER MIER, Plaintiffs,
v.
UPPER VALLEY NEUROLOGY NEUROSURGERY, P.C., and DONALD W. AYRES, M.D., Defendants.

          DECISION ON MOTION FOR PROTECTIVE ORDER (DOC. 96)

          GEOFFREY W. CRAWFORD, CHIEF JUDGE UNITED STATES DISTRICT COURT

         In this diversity action, Plaintiffs Kim Bertolini-Mier and her husband Roger Mier have sued Upper Valley Neurology Neurosurgery, P.C. ("UVNN"), UVNN physician Dr. Donald W. Ayres, and Alice Peck Day Memorial Hospital ("APD") for medical malpractice and loss of consortium. They allege that, between 2007 and 2011, APD improperly administered and interpreted radiologic studies as indicating that Ms. Bertolini-Mier suffered from multiple sclerosis ("MS"). (See Doc. 8 ¶ 12.) According to the Amended Complaint, Dr. Ayres determined that Ms. Bertolini-Mier "might not reach research criteria for diagnosis" based on the tests that were done, but nevertheless made the diagnosis of "highly probable" MS. (Id. ¶ 13.)

         Plaintiffs allege that, from 2007 until May 2014, Dr. Ayres treated Ms. Bertolini-Mier with a series of MS drugs, including the powerful drug Tysabri (natalizumab) beginning in April 2011. (Id. ¶¶ 14-15.) Plaintiffs further allege that Dr. Ayres stood by his diagnosis and treatment plan despite being aware that other medical providers questioned the MS diagnosis and the administration of Tysabri. (Id. ¶¶ 16-17.) Also according to the Amended Complaint, between 2007 and May 2014, Dr. Ayres was conducting "trials" of Tysabri for which he was compensated by pharmaceutical manufacturer Biogen, and Ms. Bertolini-Mier was a subject of that trial without her knowledge. (Id., ¶¶ 18-19.) Plaintiffs allege that Ms. Bertolini-Mier suffered a neurological event in May 2014 that required extended hospitalization and that she has required ongoing treatment since her discharge. (Id. ¶ 20.)

         The court dismissed the claims against APD for lack of personal jurisdiction on September 13, 2017. (Doc. 51.) The remaining parties have since engaged in extensive discovery, as evidenced by numerous discovery certificates filed in 2017-2019. Currently pending is UVNN's September 23, 2019 Motion for a Protective Order under Fed.R.Civ.P. 26(c). (Doc. 96.) Plaintiffs oppose the motion. (Doc. 99.) UVNN filed a reply on October 11, 2019. (Doc. 101.)

         Background

         Plaintiffs served UVNN with a notice of deposition under Fed.R.Civ.P. 30(b)(5) and (6) on June 18, 2019. (Doc. 96-5.) The notice seeks testimony regarding "[t]he number of patients to whom Tysabri was administered by any provider associated with UVNN between 2007 and 2014." (Id. at 4.) It also seeks testimony regarding the following subjects:

a. the relationship between Ayres & Associates Clinical Trials and UVNN;
b. the clinical trials and studies performed by Ayres & Associates Clinical Trials or by UVNN between 2007 and 2014;
c. the UVNN agents or employees who performed work of any sort under the name, or auspices of Ayres & Associates Clinical Trials between 2007 and 2014;
d. the persons who maintained records, including records of clinical trials, persons involved, companies involved, and financial records for Ayres & Associates Clinical Trials between 2007 and 2014;
e. the Consideration (as defined in Plaintiffs' Second Set of Interrogatories and Requests to Produce) provided to UVNN, Ayres & Associates Clinical Trials, or any of its agents or representatives for work done under the name, or auspices of Ayres & Associates Clinical Trials between 2007 and 2014;
f. the entities which provided Consideration to UVNN or Ayres & Associates Clinical Trials, or any of its agents or representatives for work done under the name, or auspices of Ayres & Associates Clinical Trials between 2007 and 2014;
g. [t]he records of time, expense, and Consideration provided to UVNN or Ayres & Associates Clinical Trials, or any of its agents or representatives for work done under the name, or auspices of Ayres & Associates Clinical Trials between 2007 and 2014 ....

(Id. at 3-4.)

         UVNN asserts that the evidence produced in discovery proves that Dr. Ayres and UVNN never conducted or participated in a "clinical trial" of Tysabri. Instead, UVNN states that Ms. Bertolini-Meir consented to participate in a voluntary observational study of individuals receiving or considering Tysabri treatment for relapsing MS. (See Doc. 96-4 (consent forms signed by Ms. Bertolini-Mier on January 24, 2011 and April 24, 2012).) The "observational, longitudinal cohort study"-dubbed "Stratify-2"-was sponsored by Biogen, but the study itself involved no treatment or intervention; it consisted instead only of blood testing of participants with relapsing MS who received commercial natalizumab. (See Id. at 3 ("Only the cost of the antibody test will be paid for by Biogen Idec. Expenses related to your therapies, such as doctor charges, other office visits, or other tests are not covered under this study.").) See also JC Virus ...


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