Cavanaugh v. Stryker Corp.
| Decision Date | 07 October 2020 |
| Docket Number | No. 4D19-523,4D19-523 |
| Citation | 308 So.3d 149 |
| Parties | Lisa CAVANAUGH, as the Personal Representative of the Estate of William Cavanaugh, deceased, Appellant, v. STRYKER CORPORATION, a foreign corporation, et al., Appellees. |
| Court | Florida District Court of Appeals |
Paul M. Silva and Peter J. Somera, Jr. of Somera & Silva, LLP, Boca Raton, Jack Scarola and Michael H. Kugler of Searcy Denney Scarola Barnhart & Shipley, P.A., West Palm Beach, and Andrew A. Harris and Adam Richardson of Burlington & Rockenbach, P.A., West Palm Beach, for appellant.
Hildy M. Saste, William P. Geraghty, Daniel B. Rogers and Jennifer M. McLoone of Shook, Hardy & Bacon, L.L.P., Miami, for appellee.
The Plaintiff, Lisa Cavanaugh, as personal representative of the Estate of William Cavanaugh, appeals a final judgment entered upon a defense verdict in her wrongful death action against Stryker Corporation, a medical device manufacturer ("the manufacturer"). We affirm on all issues raised, addressing only a jury instruction dispute and a juror selection issue. On all other issues we affirm without discussion.
In November 2012, Mr. Cavanaugh died while undergoing lung-removal surgery at Lawnwood Regional Medical Center ("the hospital"). The surgical team included a surgeon with the assistance of a registered nurse ("the nurse").
The manufacturer's medical device, called the Neptune 2, was used throughout the procedure in order to remove blood and clear the surgical field. The Neptune 2 is a high-flow suction device "intended to collect and dispose of surgical fluid waste." The device is not intended to be connected or used during passive chest drainage.
During Mr. Cavanaugh's surgery, the Neptune 2 was connected to suction tubing
, which had what is called a Yankauer suction tip attached to it. When the operation was almost finished, the surgeon inserted a chest tube into Mr. Cavanaugh's chest. The chest tube should have been connected to an Atrium or Pleur-evac, which are devices for passive chest drainage. Instead, the nurse either touched or connected the Yankauer suction tip
(and therefore the Neptune 2) to the chest tube, causing Mr. Cavanaugh's heart to be "sucked ... over to the other side" of his chest. Mr. Cavanaugh unfortunately died from the immediate and severe blood loss.
Both the surgeon and the nurse testified that they thought standard wall suction was being used for the chest drainage. They both added that they were not aware that the Neptune 2 device was being used. The Plaintiff brought this wrongful death action against various defendants, including the manufacturer. The Plaintiff's original complaint asserted medical malpractice claims against the hospital and the nurse, but those claims were settled. The claims in the complaint against the manufacturer were for strict liability based on design defects (Count I), strict liability based on failure to warn (Count II), and negligence (Count III).
The manufacturer answered and asserted various defenses, including (1) the learned-intermediary defense, (2) the intervening or superseding cause defense, and (3) a Fabre1 defense.
At trial, the following evidence was presented about the Neptune 2 device. The Neptune 2 came on the market in 2007. The Neptune 2 had higher suction capabilities than its predecessor, the Neptune 1. Nevertheless, the manufacturer asserted that the Neptune 2 was covered by the clearance that it had obtained from the U.S. Food and Drug Administration ("FDA") to market the Neptune 1 device.
In June 2012, the manufacturer sent an urgent medical device notification to its customers regarding the instructions for use on the Neptune 2. The Notification stated that "Stryker received one report of a [2010] fatality from a customer in which the Neptune [2] was connected to a passive chest drainage tube post-operatively," that the current instructions for use did "not specifically warn against connecting the Neptune [2], which is a high vacuum/high flow device, to a passive drainage tube," and that the instructions for use were being updated with a new warning.
In August 2012, the FDA notified the manufacturer that the Neptune 2 needed its own FDA clearance, as the FDA considered the Neptune 2 to be a potentially adulterated device. The FDA advised the manufacturer that the Neptune 2 "may not be used at this particular time," but created an exception whereby the device would be allowed to stay in medical use under a certificate of medical necessity.
The next month, Stryker issued a recall notice advising customers that they should no longer use the Neptune 2 unless they had no alternative device to use. The notice stated that, "if you do not have an alternative device to use, you should weigh the risk and benefits of using these devices and if you choose to continue using the either the Neptune Silver or the Neptune 2, you must complete the attached Certificate of Medical Necessity ...." An executive of the hospital's parent company signed a Certificate of Medical Necessity. This certificate was in effect at the time of Mr. Cavanaugh's surgery.
The warning label affixed to the Neptune 2 at the time of Mr. Cavanaugh's surgery stated: "DO NOT apply high flow suction in applications that may result in severe injury or death; for example, passive chest drainage," while still characterizing the device's suction capabilities as "LOW," "MEDIUM," and "HIGH."
The instructions for use provided a similar warning not to apply high flow suction during procedures such as passive chest drainage, adding that failure to comply may result in serious injury or death. Although the nurse testified that he never read the warnings or instructions for use concerning the Neptune 2, he generally knew that it was not appropriate to apply high suction to a closed drainage system.
The surgeon testified he did not know that the Neptune 2 was only a high-suction device. The surgeon explained that a device without low suction would be inappropriate to use during a lung-removal surgery. Had the surgeon known that the Neptune 2 device was not FDA-approved, or that a previous patient had been severely injured by the device, he would not have allowed the Neptune 2 to be used during the surgery.
The Plaintiff presented expert testimony from a materials scientist, who opined that the Neptune 2 was defectively designed, unreasonably dangerous, and lacked proper warnings. The materials scientist testified that the user interface was confusing, which could result in the user applying "unsafe vacuum or inappropriate vacuum in the wrong application." The materials scientist also testified that the warning was confusing and failed to inform the user that, even at its lowest setting, the device should not be connected to a chest tube or closed-wound drain.
The Plaintiff also presented the testimony of a medical device engineer and a former medical officer in the FDA's Office of Compliance. Taken together, their testimony was that (1) the manufacturer should have sought clearance from the FDA before releasing the Neptune 2; (2) the manufacturer did not undertake a proper risk analysis when it determined that it was not required to obtain separate FDA clearance for it; and (3) the FDA communicated to the manufacturer that the Neptune 2 was an adulterated device which was marketed without FDA clearance.
The manufacturer's principal defense was that Mr. Cavanaugh's death was attributable to misuse of the Neptune 2 by medical staff, not design defect or insufficient warnings. It argued that the Neptune 2 is not intended to be used for passive chest tube drainage, as it is widely known in the medical profession that high suction should not be connected to chest tubes. The manufacturer also maintained that there were sufficient warnings to this effect accompanying the Neptune 2 at the time of Mr. Cavanaugh's surgery, and that three weeks before the surgery a representative of the manufacturer had provided in-service training for the hospital's operating room staff, wherein they were advised that the Neptune 2 should not be used for passive chest drainage because it could cause death. Nonetheless, the manufacturer asserts in its answer brief that the nurse "mistakenly connected the chest tube to the Yankauer suction tip
[which had been connected to the Neptune 2]," which resulted in the death of Mr. Cavanaugh.
When the trial lasted longer than expected, the parties learned that scheduled jury deliberations might interfere with a juror's prepaid weekend vacation from Friday, June 1 to Sunday, June 3.
On Wednesday, May 30, the Plaintiff finished her rebuttal case. The next day, the trial court and defense counsel questioned the juror, who answered that staying to complete the deliberations "would be a little bit of a hardship," but that he "could do half a day" on Friday "if that would finish things up."
The Plaintiff moved to excuse the juror and "to seat the first alternate juror in [the juror's] place." The manufacturer objected, arguing that "there's no reason why if he needed to leave [on Friday] we couldn't bring the jury back on Monday to finish deliberations if that was necessary."
The trial court stated that it would "excuse [the juror] on its own for cause." The trial court inquired about who would replace the juror, and Plaintiff counsel responded: "Yes, we seat ... the first alternate juror."
However, the trial court, sua sponte, made the following offer to the parties:
Defense counsel then exercised a peremptory strike on the first alternate juror. Plaintiff counsel immediately objected:
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