O'Neil v. Somatics, LLC

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Diane O'Neil v. Somatics, LLC

No. 20-cv-175-PB

Opinion No. 2022 DNH 121

United States District Court, D. New Hampshire

September 30, 2022

MEMORANDUM AND ORDER

Paul J. Barbadoro United States District Judge

Diane O'Neil is seeking damages from Somatics, LLC, for injuries she alleges were suffered while undergoing electroconvulsive therapy (ECT) at Elliot Hospital. The ECT device that O'Neil's doctors used to treat her was produced and sold to Elliot by Somatics. Somatics has challenged O'Neil's claims in a motion for summary judgment.

I. BACKGROUND

A O'Neil's ECT Treatment

O'Neil was suffering from severe treatment-resistant depression when her treating psychiatrist, Dr. David Ledner, referred her to Elliot Hospital for observation and an ECT consult. O'Neil was admitted on August 17, 2016. Her admitting psychiatrist, Dr. A. J. Ramirez, performed a psychiatric consult and physical examination. O'Neil's medical records state that she was feeling “pretty depressed” then and believed that ECT would be a reasonable alternative to continuing with medications that were not alleviating her symptoms. O'Neil Dep., Doc. No. 52-4, 70.

A few days later, O'Neil had her initial ECT consultation with Dr. Reinhard Viehoff. See Viehoff Session Notes, Doc. No. 52-5; ECT Authorization, Doc. No. 52-6. During the consultation, O'Neil confirmed that she had watched an informational film provided by Elliot about ECT. Dr. Viehoff also noted that O'Neil appeared to be “knowledgeable” about ECT and the risks and benefits associated with it. See id. at 68. O'Neil recalls only reading positive things about ECT before her treatments. See O'Neil Dep., Doc. No. 52-4, 29.

Dr. Viehoff wrote in his notes that he discussed “the risk and benefits of [ECT]” with O'Neil, including a “1/10,000 death rate, seizure cardiac issues, dental complications, [and] cognitive side effects.” See Viehoff Dep., Doc. No. 52-3, 23. They also discussed how Dr. Viehoff might approach her treatments. One option they discussed was bitemporal electrode placement, which “works more rapidly” but “may have more cognitive side effects” than right unilateral electrode placement, which “may not be as effective . . . [and] would require more treatments, and is associated with less cognitive side effects.” See id.

Dr. Viehoff also outlined various cognitive risk factors associated with ECT. He noted that patients could experience “a spotty memory” or “difficulty recalling the events around the time of the hospitalization, the inpatient treatments, [and] the initial index course” and “may have to relearn information that they previously knew.” See id. at 24. For example, ECT might force a patient to “relearn a specific piece of information,” such as “where something is at a grocery store or a phone number.” See Viehoff Dep., Doc. No. 61-1, 25-26. Still, the patient would “absolutely” be able to “retain that information going forward” after relearning it. See id. Dr. Viehoff also typically warned that cognitive side effects might extend for “weeks to months” but would “generally” go away. See Viehoff Dep., Doc. No. 52-3, 13, 24; Doc. No. 61-1, 27. To color what he meant by “permeant memory loss,” Dr. Viehoff ordinarily gave “the example of [a] patient [he] knew who had [a] trip to Hawaii” that he “didn't recall.” See id. at 35-36. Such “memory deficits” are “not usual,” Dr. Viehoff would be sure to emphasize. See id. It is unclear how else, if at all, Dr. Viehoff warned O'Neil about the risk of permanent memory loss. See id. at 34, 94.

O'Neil ultimately agreed to proceed with bitemporal ECT with “the requisite monitoring of the cognitive [screening] evaluation pretreatment on an inpatient basis.” See id.; 8.22 Consultation Notes, Doc. No. 52-5, 4. O'Neil signed an ECT Authorization form that same day. See ECT Authorization, Doc. No. 52-6.

The Authorization form cautioned that “[a]s with all forms of medical treatment, there is a possibility of some side effects of treatment.” Id. That is, some patients, after undergoing ECT, “report difficulty remembering some things such as the names of friends, dates, or other facts.” Id. Those cognitive effects “normally” clear up “within four weeks after the last treatment.” Id. It states that a patient might also expect “a headache, muscle soreness, or nausea.” Id. Other side effects could include “[m]inor irregularities in heart rate and rhythm”; “[v]ery rarely, myocardial infarction (heart attack) or stroke”; “extremely rarely,” “[d]islocations or bone fractures”; and “a slight risk of damage to fragile teeth.” Id. “To reduce the risk of medical complications,” the form explained that O'Neil would “receive a careful medical evaluation prior to starting ECT.” Id.

Between August 2016 and February 2017, O'Neil underwent 22 bitemporal ECT sessions. As her treatments got underway, O'Neil's memory issues started to present themselves. During an October 2016 meeting with Dr. Ledner after her sixth treatment, O'Neil reported mild short-term memory impairment but also that her depression symptoms were improving. See Ledner Dep., Doc. No. 52-8, 33. Dr. Ledner expected that her memory impairment “would resolve over time after the cessation of the ECT treatments.” See Ledner Dep., Doc. No. 61-3, 23. But about a month after her last session, O'Neil informed Dr. Ledner that she was “off all of her medications” and had “decided to stop ECT because she could not tolerate the memory impairment that went with it.” See id. at 38.

B. Somatics's ECT Devices

The ECT device that Dr. Viehoff used to treat O'Neil is known as the Thymatron IV. Somatics manufactured the device and sold it to Elliot in December 2005.

Before acquiring the Thymatron IV, Elliot used an older Somatics ECT device, the DGx, which it bought in 1999. See Swartz Dec., Doc No. 51-3, ¶ 6. Somatics provided two copies of its 1996 ECT Instruction Manual along with the DGx. See id. The 1996 Manual included a warning about potential side effects of ECT, such as “cognitive and memory dysfunction.” See 1996 Manual, Doc. No. 51-4, 5-6. It noted that memory loss could consist of both “a retrograde amnesia that is more pronounced for most recent events, and an anterograde amnesia for events that occur during or shortly after the course of ECT.” See id. The 1996 Manual also explained that while “many patients receiving ECT experience improved memory . . ., a few have complained of persistent memory or cognitive impairment months or years later.” Id. And for those “few” patients, “memory loss might result from concurrent antidepressant medication, residual depression, progression of pre-existing brain disease, or effects of ECT itself.” See id. The 1996 Manual also noted that although two studies had reported “[p]ersistent memory deficits for autobiographical (personal) events lasting at least six months,” “no such deficits have been reported after brief pulse unilateral ECT.” See id.

When Somatics sold Elliot the Thymatron IV, it supplied the hospital with copies of the eleventh edition of its Thymatron Instruction Manual, published in 2005. See Swartz Dec., Doc. No. 51-3, ¶ 7. Unlike the 1996 Manual, the 2005 Manual did not include a substantive “side effects” section. Instead, it merely recommended “that doctors planning to use the [Thymatron] read and follow the recommendations of the Task Force Report of the American Psychiatric Association as set forth in ‘The Practice of Electroconvulsive Therapy (American Psychiatric Association, 2001) [(“APA Task Force Report”)].” See 2005 Manual, Doc. No. 51-5, 2-3.

The APA Task Force Report is over three hundred pages long, and, among other things, it does describe potential negative ECT side effects. It explains how:

A small minority of patients treated with ECT later report devastating cognitive consequences. Patients may indicate that they have dense amnesia extending far back into the past for events of personal significance or that broad aspects of cognitive function are so impaired that the patients are no longer able to engage in former occupations. Because these subjective reports of profound cognitive deficits are rare, determination of their absolute base rates is difficult. Multiple factors likely contribute to these perceptions by former patients.

[S]ome patients' self-reports of profound ECT-induced deficits may reflect objective loss of function. As noted, as with the adverse effects of any medical intervention, individual differences occur in the magnitude and persistence of ECT's cognitive effects. In rare cases, ECT may result in a dense and persistent retrograde amnesia extending to years before the treatment[.]

Id. at 14-15. The APA Task Force Report also identifies how for some patients, “the recovery from retrograde amnesia will be incomplete, and evidence has shown that ECT can result in persistent or permanent memory loss.” Id. at 13. While O'Neil's doctors were somewhat familiar with the APA Task Force Report, they were generally unfamiliar with the 2005 Manual, but they were confident that they would have reviewed it. See Viehoff Dep., Doc. No. 52-3, 63; Schwartz Dep., Doc. No.52-7, 8-9. And while Somatics updated its instruction manual many times between 2005 and 2016, Elliot did not keep detailed records of which manuals it possessed. See Elliot Responses, Doc. No. 51-23, 1-2.

In 2018, after O'Neil's ECT treatments, Somatics updated its Thymatron manual to include updated warnings about ECT's side effects. The new manual warned that “ECT may result in anterograde or retrograde amnesia. Such post-treatment amnesia typically dissipates over time however, incomplete recovery is possible. In rare cases, patients may experience permanent memory loss or permanent brain damage.” See 2018 Regulatory Update, Doc. No....