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Patteson v. Maloney

United States District Court, District of Columbia

September 16, 2013

JOHN R. MALONEY, M.D., Defendant

Page 170

For KAY PATTESON, GARY PATTESON, Plaintiffs: Kenneth M. Trombly, LEAD ATTORNEY, SCHULTZ & TROMBLY, PLLC, Washington, DC; Timothy J. Aiken, PRO HAC VICE, AIKEN & SCOPTUR, S.C., Milwaukee, WI.

For JOHN MALONEY, M.D., Defendant: Andrew E. Vernick, LEAD ATTORNEY, VERNICK & ASSOCIATES, LLC, Annapolis, MD.


Page 171

JAMES E. BOASBERG, United States District Judge.


In 2008, Plaintiff Kay Patteson's doctor diagnosed her with tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements and uncontrollable muscular tics. Patteson then brought this suit against her former psychiatrist, Defendant John Maloney, M.D., who had prescribed Seroquel - an antipsychotic drug - to treat Patteson's insomnia in 2006. She claims that the Seroquel caused her tardive dyskinesia. To establish that causal link, Patteson relies on expert testimony both from medical researchers and from her own treating physicians.

Maloney now moves to exclude all testimony linking Seroquel to tardive dyskinesia. He argues that Patteson's expert testimony is unreliable under Federal Rule of Evidence 702 and the testimony should thus be excluded. In essence, Maloney contends that his expert's study - which shows no link between Seroquel and tardive dyskinesia - is scientifically more rigorous than that of Patteson's experts. The Court, however, finds that the science linking Seroquel to tardive dyskinesia is sufficiently reliable under Rule 702 to be admitted - and that Maloney's argument goes to the weight of the testimony, not to its admissibility. The Court therefore denies the Motion.

I. Background

Patteson first sought treatment from Maloney on or about May 30, 2006. See Patteson v. AstraZeneca, LP (Patteson I), 876 F.Supp.2d 27, 30 (D.D.C. 2012). At the time, she complained of " depression, anxiousness, chronic insomnia, and serious alcohol abuse/dependence." Id. Maloney eventually prescribed Seroquel to address Patteson's insomnia. See id.

Seroquel is a second-generation antipsychotic. Antipsychotics are typically used to treat psychoses; for example, Seroquel itself is approved for the treatment of schizophrenia and bipolar mania, as well as bipolar depression, bipolar maintenance, and major depressive disorder. See id. 30-31. Seroquel, however, is not currently approved for the treatment of insomnia, although such off-label prescription does not necessarily constitute negligence. See id. at 31; see generally Ortho Pharm. Corp. v. Cosprophar, Inc., 32 F.3d 690, 692 (2d Cir. 1994) (" FDA permits doctors to prescribe drugs for 'off-label' uses." ); James M. Beck & Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 76-77 (1998) (" Courts have repeatedly recognized the propriety of off-label use, and several states statutorily recognize off-label use in various contexts." ) (footnote omitted).

" Second-generation" antipsychotics were engineered to treat psychoses with a lower risk of certain side effects, such as the risk of movement disorders like tardive dyskinesia. See Mot., Exh. 2 (Deposition of Dr. Thor W. Rak) at 15:23-16:10. Whether second-generation antipsychotics actually carry a lower (or no) risk of those side effects is a matter of research and debate among the medical community. Compare Opp., Exh. A (Affidavit of Dr. Robert Rosenheck) at 8 (side effects of second-generation antipsychotics are more or less the same as first-generation antipsychotics) with Rak Dep. at 123:23-124:15 (Seroquel cannot be shown to cause tardive dyskinesia). Nevertheless, Seroquel's FDA-approved label includes warnings for many of

Page 172

those side effects, including a warning concerning the risk of tardive dyskinesia, a " syndrome of potentially irreversible, involuntary dyskinetic movements." See Rak Dep. at 11:6-9.

In April 2007, around 10 months after she began taking Seroquel, Patteson began experiencing difficulty walking. See Patteson I, 876 F.Supp.2d at 31. In January and February of 2008, Patteson's doctors determined that tardive dyskinesia was most likely responsible for her symptoms and that Seroquel could be the cause. See id. at 31-32. Patteson subsequently sued Maloney in D.C. Superior Court in 2010. See id. at 32. She alleged that he had improperly managed her course of treatment and that her tardive dyskinesia was a side effect of the Seroquel. See Amended Compl., ¶ ¶ 46-48. The case was removed to federal court, and trial is currently scheduled for October 2013.

Patteson plans to call three experts to prove that Seroquel caused her tardive dyskinesia: Dr. Robert Rosenheck, a medical professor and researcher from Yale University School of Medicine, will testify generally that the link exists; and Drs. Steven Lo and Sudeshna Bose, who have been Patteson's treating physicians, will testify both that Seroquel can cause tardive dyskinesia generally and that the drug did, in fact, cause Patteson's condition. See Joint Pretrial Statement (JPS) at 12. Rosenheck will base his testimony on a study of second-generation antipsychotics that he co-authored and that was published in the New England Journal of Medicine, as well as on other published medical studies. See Rosenheck Aff. at 4. Lo and Bose will rely on their differential diagnoses of Patteson as well as medical literature to establish causation. See Opp., Exh. B (Affidavit of Dr. Steven Lo), ¶ ¶ 14, 15, 21; Exh. D (Deposition of Dr. Sudeshna Bose) at 14:7-15:16; JPS at 12. " Differential diagnosis" is the medical term for a diagnosis made by determining the potential causes of an ailment and then eliminating causes to reveal the most likely culprit. See Lo Aff., ¶ 15.

Maloney now moves in limine to exclude all testimony relating to causation. He contends that, under Federal Rule of Evidence 702, Patteson's expert testimony is unreliable and should not be admitted. Maloney argues, at bottom, that Patteson's expert studies are inadmissible because his own expert studies are better - that is, Maloney's studies are based on sounder scientific methodology. Defendant also maintains that, because Patteson's experts have not diagnosed other patients with Seroquel-induced tardive dyskinesia, such a diagnosis must not be accepted within the medical community and is inherently unreliable. At a minimum, Maloney asserts that the Court should hold a pretrial hearing to determine the admissibility of the causation testimony.

Because Patteson must prove causation to prevail on her medical-malpractice claim, excluding evidence of causation would, ...

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