Law

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. 

Plaintiff’s decedent (“Taylor”) was a prostate cancer patient.  He was morbidly obese and had undergone three previous abdominal surgeries. Id. at *7.  His surgeon, though highly experienced in traditional “open” prostatectomy, had never performed an unproctored procedure using the da Vinci System.  Id. at *6-7.  Despite Taylor’s obesity, the surgeon attempted to remove his prostate using the da Vinci system.  Because of his obesity, Taylor could not be placed in the steep incline ISI recommended, and the lesser incline “made it difficult [for the surgeon] to see what he was doing due to the intestinal contents continually getting into the visual field.”  Id. at *8.  Ultimately, after several hours of trying, the surgeon “gave up on the da Vinci System” and switched to traditional open prostatectomy.  During this procedure, the surgeon “tore Taylor’s rectal wall with his finger.  Fecal matter escaped Taylor’s rectum and caused a blood infection.”  Id.

After surgery, Taylor “experienced a massive breakdown of muscle and kidney failure . . . . [and] experienced brain swelling because his head was tilted down for an extended time during his surgery.”  He had nerve and muscle damage, and he suffered a stroke. Id.   For the next four years, Taylor progressively declined.  He “suffered weakness in his shoulders, back, hip, and left arm; an atrophied right thigh; incontinence; and cognitive defects, including poor memory, depression and anxiety.”  He died four years after his surgery of “preexisting hypertensive cardiovascular disease.”  The parties “disagreed about whether the prostatectomy surgery hastened Taylor’s death.”  Id. at *8-9.

Plaintiff sued the surgeon, his medical practice, the hospital, and ISI.   She settled with the doctors and dropped the hospital as a defendant, leaving only ISI.  ISI won summary judgment on all of plaintiff’s claims except her claims that ISI:  1) breached duties to warn and train the doctor; and 2) breached a duty to provide separate warnings to the hospital.  At trial, the judge instructed the jury that ISI’s duty to warn ran only to the doctor.  The jury returned a defense verdict, and ISI appealed to a three-judge panel of the Washington Court of Appeals.

The Court of Appeals explained that, under Washington law, “the manufacturer’s duty to warn of dangers [associated with prescription medical products] runs only to the physician; it is the physician’s duty to warn the ultimate consumer.” Id. at *14 (emphasis in original).  The Court explained,

The reason for this doctrine is that when a medical product is available only by prescription . . . , the physician acts as a gatekeeper who stands in the place of the manufacturer in relation to the patient.  That is, the physician acts as a “learned intermediary” who undertakes the duty to inform himself of the qualities and characteristics of those products which he prescribes for . . . his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product.

Id. at *14-15 (internal punctuation and citation omitted).  Thus, “the physician is in a superior position to warn the patient and the courts should not interfere with the physician-patient relationship.”  Id. at *15.

 In contrast, the hospital is “a third party that facilitates distribution of a medical product, yet does not exercise its own individual medical judgment, [and] is not a learned intermediary.” Id. at *18.   The Court drew an analogy to cases declining to impose a duty on pharmacies to warn patients filling prescriptions, holding that “neither manufacturer nor pharmacist has the medical education or knowledge of the medical history which would justify a judicial imposition of a duty to intrude into the physician-patient relationship.”  Id. at *19 (citation omitted).  Similarly, the hospital

did not take Taylor’s individualized circumstances or medical history into account.  Nothing in the record indicates that [the hospital] played any role in deciding whether Taylor should receive a da Vinci System surgery.  [The hospital] did not and could not exercise independent medical judgment in Taylor’s specific case.  It merely made the da Vinci System available for physicians, . . . and credentialed them.  But . . . a party that simply enables a medical product to get to a patient does not share the special type of relationship with the patient as does the prescribing physician.

Id. at *19-20 (emphasis in original).  The Court concluded, “We reject Taylor’s invitation to extend the learned intermediary rule to a hospital that does not exercise patient-specific judgment.”  Id. at *20.

The decision was not unanimous.  The dissenting judge commented,

 

Because physicians are gatekeepers between manufactures and unwarned patients, the physician protects the unwarned patients.  Thus, the learned intermediary doctrine serves to remove a manufacturer’s duty to warn the patient.  But the physician does not stand between manufacturers and unwarned hospitals, the physician does not protect the unwarned hospital.   Thus the learned intermediary doctrine does not remove a manufacturer’s duty to warn hospitals about medical equipment purchased by that hospital.  Because sufficient evidence supports Taylor’s theory that ISI’s negligent failure to warn [the hospital] caused Taylor’s harm, I would hold that the trial court erred in failing to give an instruction [on ISI’s failure to warn the hospital].

Id. at *28.

Dogmatic as we usually are, we were surprised, as we read the dissent and considered the plaintiff’s position, that we could not dismiss them out of hand.  One could argue – though he or she would be wrong – that this case is something of an outlier, riper than most for the imposition of a duty to warn hospitals.  For example, hospitals are required to create their own credentialing protocols, presumably against a backdrop of understanding the risks and rigors of using the product.  But there is peril in the slippery slope this would create.  We can imagine all sorts of horrors if plaintiffs were invited to argue that prescription drug and device manufacturers’ duties to warn ran beyond physicians.  Moreover, the implication of a duty to warn the hospital is that the hospital, in turn, would have a duty to do something with the information.  This is a duty that would expand liability on two levels. In addition, the dissent ignores the reality that prescription medical devices may be purchased by hospitals, but they aren’t used for patients unless a doctor prescribes them.  That is why the doctor is the learned intermediary, and the duty to warn runs only to him or her.  The bottom line is that the policies underlying the learned intermediary doctrine are sound and are exactly as the majority articulated, and we applaud the majority for holding the line.