Judge Says Device Makers Must Warn Hospitals

Device makers know all too well about the need to notify providers of the hazards associated with their devices, but a new case in the Pacific Northwest would expand that liability to hospitals, seemingly destroying the learned intermediary doctrine in the process.

Intuitive Surgical, maker of the groundbreaking da Vinci surgical robot, was on the losing end of a lawsuit in the Washington State Supreme Court recently, which declared that the device maker is liable for notifying hospitals about the risks attached to the device’s use. The case, Taylor v. Intuitive Surgical, Inc., involved the da Vinci’s use in prostate surgery, and the decision from a state circuit court hearing said the surgeon acknowledged that the patient, the late Fred Taylor, was overweight and thus not a good candidate for the procedure using the da Vinci.

Trial, appeals courts exonerate Intuitive

The treating physician, Scott Bildsten, was performing his first non-proctored procedure with the da Vinci and informed Taylor that he (Bildsten) lacked the experience needed to conduct the procedure on obese patients. The patient was in the operating room for 15 hours while Bildsten switched from the da Vinci to open prostatectomy, following which the patient was in intensive care for 20 days. Taylor died four years later in 2012.

The jury trial determined there was no liability for Intuitive despite that the plaintiff’s attorney recommended that the jury be instructed that the device maker had a duty to warn Harrison Medical Center, a decision with which the appeals court agreed. The state high court decreed, however, that the physician “is often not the product purchaser,” and thus state law mandates that device makers inform hospitals “about their dangerous medical devices,” a passage penned by Justice Susan Owen.

Owen determined that the trial court had erred in its failure to instruct the jury that the device maker was legally required to inform the hospital of the hazards associated with the da Vinci, and remanded the case to the trial court. Owen acknowledged, however, that Harrison Medical Center was in the practice of providing credentials on the da Vinci after only two proctored procedures while other establishments in the state required three or more proctored procedures prior to credentialing.

 

Nonetheless, Owen said the learned intermediary doctrine was not applicable because the Washington Product Liability Act (WPLA) “imposes a separate and distinct duty” on the device maker to inform the hospital of any risks. She cited language from the dissenting opinion in the appeals court case, said to state that while a physician is the gatekeeper between the manufacturer and the unwarned patient, the physician is not the gatekeeper between the patient and “the unwarned hospital” (italics hers).

Owen asserted further that a hospital’s duty to ensure a device is safe is separate from that of a physician despite that a preceding case had determined that a pharmacist does not have a duty separate that from a prescribing physician, a reference to the 1989 decision in McKee v. American Home Products., another case specific to the Evergreen State.

Lone dissenter in en banc decision

Owen’s decision was backed by five other justices who took part in the en banc hearing, but Justice Barbara Madsen dissented, stating that Intuitive was indeed liable for informing a hospital as to the hazards entailed in the da Vinci’s use. Madsen asserted, however, that the wife of the deceased “cannot invoke a duty owed to Harrison to recover damages.” She noted that several steps stood between the widow and the device maker, starting with the sale of the da Vinci to the hospital, Harrison’s credentialing of Bildsten, and Bildsten’s use of the device on the patient. Madsen stated further that the widow of the deceased had already obtained a settlement from Harrison, which would eliminate any further claims arising from Harrison’s credentialing of Bildsten.

Among those providing briefs to the court was the D.C.-based Medical Device Manufacturers Association, which might mean nothing more than that the association sees this as a critical issue in the state of Washington. The reader may find it interesting that this same court recently found that the WPLA also truncated federal preemption of state law, although this was in the context of aviation law (see Estate of Becker v. Avco Corp.).

One cannot rule out the possibility that other states might amend their statutes to reflect the elements of the WPLA that proved pivotal in the case against Intuitive – and in any event, some would argue there is no shortage of jurisprudential adventurousness – but the message here is at least that the state of Washington presents much more legally hazardous terrain than is perhaps widely appreciated.

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