We admit it. We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.” We tend to eschew any intellectually-challenging material that may be available on this medium. Instead, when we are not ourselves posting pictures of the Drug and Device Law Rescue Pets, we most enjoy reading accounts of others’ rescues of doggies and kitties. (Don’t start – we know.) These stories always begin with horrific, heart-wrenching facts but generally wend their way to satisfying endings.
Today’s case, Taylor v. Intuitive Surgical, Inc., 2015 Wash. App. LEXIS 1442 (Ct. App. Wash. July 7, 2015), follows a similar formula, although the ending is happy only for “learned intermediary” jurisprudence, not for plaintiff’s unfortunate decedent. Taylor involved the da Vinci System, manufactured by defendant Intuitive Surgical, Inc. (“ISI”). The highly complex da Vinci system allows surgeons to perform minimally-invasive prostatectomies, remotely operating small instruments inserted through very small incisions in the patient’s body. Taylor, 2015 Wash. App. LEXIS at *3.
Apparently, ISI tightly controls physician access to its system. We are not sure how, but the opinion describes a specific credentialing process under which every surgeon is required to be credentialed, before using the da Vinci system, by the hospital where the procedure will be performed. Each hospital sets its own credentialing protocol. Surgeons must initially perform proctored cases – two, or a number set by hospital protocol. Id. at *4-5. Next, ISI requires surgeons to “choose simple cases for their first four to six unproctored procedures and to slowly progress in case complexity.” Id. at *5 (internal punctuation and citation omitted). During their early surgeries, “surgeons are advised to choose patients with . . . BMI of less than 30 and no prior history of lower abdominal surgery.” Id.
Continue Reading No Duty for Device Manufacturer to Provide Separate Warnings to Hospital, According to Washington Court of Appeals