Carl Alexander Cohen, v. Boston Scientific Corporation, et al.

2024 DNH 028
CourtDistrict Court, D. New Hampshire
DecidedMarch 26, 2024
Docket20-cv-00943-PB
StatusPublished
Cited by1 cases

This text of 2024 DNH 028 (Carl Alexander Cohen, v. Boston Scientific Corporation, et al.) is published on Counsel Stack Legal Research, covering District Court, D. New Hampshire primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Carl Alexander Cohen, v. Boston Scientific Corporation, et al., 2024 DNH 028 (D.N.H. 2024).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE

Carl Alexander Cohen,

v. Case No. 1:20-cv-00943-PB Opinion No. 2024 DNH 028 Boston Scientific Corporation, et al.

MEMORANDUM AND ORDER

The plaintiff, Alex Cohen, underwent laser surgery for an enlarged

prostate that resulted in diffuse thermal burns to his bladder. He has

brought a products liability action against Boston Scientific Corporation, the

manufacturer of the laser, and Republic Surgical Incorporated, the company

who provided a central component of the laser for use in the surgery and a

medical technician who operated the component during the surgery. Both

defendants have filed motions for summary judgment (Doc. 71 and Doc. 72).

I. BACKGROUND

A. The GreenLight XPS Laser System

Boston Scientific manufactures the GreenLight XPS Laser System, a

medical device used in various surgeries to vaporize and coagulate tissues.

Doc. 69-2 at 16. The device consists of two components: a console, which

generates a green laser light, and a fiber, which transmits the laser light

from the console to the targeted tissue in a patient’s body. Id. The laser light is absorbed by the red blood cells in the targeted tissue, which generates heat

and causes the cells to burst, thereby vaporizing the tissue. Id. at 17.

One type of surgery the GreenLight device can be used for is

photoselective vaporization of the prostate (PVP). Id. at 17, 24. This

procedure is used to treat benign prostatic hyperplasia (BPH), id., a condition

in which a patient’s prostate gland becomes enlarged and squeezes the

urethra, Doc. 82-11 at 4. During a PVP procedure, a laser technician operates

the console, turning it on and placing it on standby mode while the surgeon

prepares for surgery. Doc. 71-3 at 28-29. The surgeon has a bag of saline

solution connected to the laser fiber and adjusts the flow until she and the

laser technician are “happy with the drip rate.” Id. at 27. This saline, which

Boston Scientific notes should be at room temperature, Doc. 82-3 at 30, “runs

through the fiber” throughout the surgery and “aids with cooling” the fiber,

Doc. 71-3 at 26. The fiber is then inserted into the surgeon’s resectoscope, a

surgical instrument that also includes a camera device as well as a tube for a

second, separate supply of saline solution. Id. at 24, 27; Doc. 71 at 4. The

surgeon inserts the resectoscope into the patient’s bladder via the urethra.

Doc. 75 at 1. When she is ready to begin the procedure, she instructs the laser

technician to switch the device off standby mode. Doc. 71-3 at 28. At this

point, the surgeon controls the laser by using a foot switch, which includes

2 pedals to initiate coagulation, vaporization, or standby modes. Id.; Doc. 69-2

at 45.

Throughout the procedure, the surgeon uses the irrigation tube

attached to her resectoscope to “constantly” deliver saline fluid to the surgical

area, controlling the flow using a valve on the resectoscope. Doc. 71-3 at 23,

25. This irrigation helps the surgeon visualize the surgical field by moving

tissues out of the way and flushing away blood and other debris. Id. at 23.

The GreenLight device does not specify the temperature to which this

irrigation fluid should be heated, and surgeons have varying preferences,

electing to use saline heated to either room temperature (approximately 68°F

or 20°C) or just above physiological temperature (around 104°F or 40°C). See

id. at 19; Doc. 71-8 at 17. As the saline circulates through the patient’s

urinary system and is replaced by new irrigant, it is then drained out via a

catheter. Doc. 71-3 at 23; Doc. 75 at 2.

B. Cohen’s Surgery and the Aftermath

In 2016, Cohen saw Dr. Shilpa Lamba, M.D., a board-certified urologist

at Manchester Urology Associates in Dover, New Hampshire, complaining of

“lower urinary tract symptoms.” Doc. 71-3 at 5-7. She diagnosed him with

BPH and, after a year of trying various medications to no avail,

recommended surgical intervention. Id. at 7-8. She presented Cohen with two

3 options: PVP or transurethral resection of the prostate (TURP). 1 Id. at 8-9.

Cohen elected PVP, and Dr. Lamba performed the procedure in July 2017, at

Wentworth-Douglass Hospital (WDH) in Dover, New Hampshire using the

GreenLight device. Doc. 11 at 10; Doc. 75 at 2.

WDH purchased the GreenLight fiber directly from Boston Scientific.

Doc. 72-3 at 2. Republic Surgical provided the console, which it had previously

purchased from Boston Scientific. Doc. 72-7 at 2. Republic Surgical charged

WDH a “[r]ental” fee to use the device, Doc. 81-2; however, Republic Surgical

owned the device at all relevant times, see Doc. 72-7 at 2-3. Republic Surgical

also arranged for a laser technician to operate the console throughout Cohen’s

procedure. Id. at 2-3.

Dr. Lamba used the GreenLight device and irrigation saline solution

heated to approximately 103 or 104°F, Doc. 71-3 at 19; Doc. 71-5 at 6, to

vaporize several sections of enlarged prostate tissue, Doc. 75 at 3. The

surgery proceeded as normal until Dr. Lamba encountered an eight-to-ten-

millimeter nodule at the apex of the prostate that would not vaporize. Doc. 75

at 3. In her attempt to remove this nodule, she “passed the laser fiber

between the nodule and the capsular wall and initiated laser vaporization,”

1 In contrast to PVP, which uses the GreenLight device to vaporize tissue, TURP uses a surgical instrument containing electrodes—either a monopolar loop or a bipolar loop—to resect unwanted tissue. Doc. 69 at 3; Doc. 82-2 at 88.

4 but the metal cap at the end of the fiber broke off. Id. At this point, one of the

device’s “automatic safety mechanism[s]” activated, and the device switched

back to standby mode. 2 Doc. 71-3 at 29. Dr. Lamba was able to safely retrieve

the fiber’s cap from Cohen’s body but decided to abandon the PVP procedure,

switching to the TURP technique and successfully excising the nodule using a

bipolar loop. Doc. 75 at 3.

Towards the end of the surgery, Dr. Lamba inspected the surgical area

for bleeding and evidence of laser vaporization, which has an immediate,

visible effect on the tissue. Id.; Doc. 71 at 5. She documented in her surgical

notes that the ureteral orifices were “away from any vaporization or

resection.” Doc. 75 at 3. She then removed her resectoscope and irrigated the

bladder. Id. All in all, she recorded that Cohen “tolerated the procedure well

with no complications.” Id.

But a few days after his surgery, Cohen began reporting adverse

symptoms, including general feelings of malaise and incontinence, which

persisted over the next several months. Doc. 11 at 10; Doc. 71-3 at 11-12. In

2 This mechanism, known as FiberLife, “continuously monitors the temperature of the tip of the fiber and momentarily stops the laser emission when the fiber gets too hot.” Doc. 69-2 at 16. It is activated if “tissue or vapor bubbles accumulate on the tip [of the fiber], or if for other reasons there is damage due to excessive heating of the fiber.” Id. In “most cases,” the laser will “turn back on immediately and the procedure continues without interruption”; but if FiberLife is “activated continuously,” the console “will automatically detect this condition, [and] put the laser in Standby mode.” Id.

5 October 2017, Dr. Lamba’s colleague, Dr.

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