A recent court decision in a case involving Intuitive Surgical serves as a useful reminder for medical device manufacturers to review their approach to product warnings.
Terry M. Henry, Melanie S. Carter, Lauren E. O'Donnell, and Naomi Zwillenberg
Washington State's highest court set off a bit of a firestorm recently when it ruled that medical device manufacturers must warn those who buy their products about related risks. The court's decision in Taylor v. Intuitive Surgical, Inc., seemed to undermine the customary view that a device manufacturer need only provide its warnings to the prescribing physician; the learned intermediary. A broader review of the law shows that the court may not have strayed too far from basic product liability concepts and provides a good opportunity for medical device manufacturers to review their approach to product warnings.
Fred Taylor underwent surgery in September 2008 to treat prostate cancer. He suffered complications during the procedure and a medical expert testified that the complications from his surgery had hastened his death. Mr. Taylor's widow brought suit on a variety of claims against several parties, but the only claim to survive settlements and summary judgment was Mrs. Taylor's failure to warn claim against Intuitive Surgical, the manufacturer of the da Vinci robotic surgical assist device used by Mr. Taylor's surgeon, Dr. Scott Bildsten. Following trial, the jury delivered a defense verdict for Intuitive Surgical, finding that the company did not breach its duty to provide adequate warnings to Dr. Bildsten.
The trial court had refused to give an instruction to the jury that Intuitive Surgical had a duty to warn Harrison Medical Center of the risks involved in using its da Vinci system. Intuitive Surgical argued that it warned Dr. Bildsten, the surgeon that used the company's robotic da Vinci surgical system to perform surgery on Mr. Taylor, and had no duty to warn any other party.
On appeal, Washington's Court of Appeals agreed with Intuitive Surgical, but Washington's Supreme Court reversed. The Supreme Court found that Dr. Bildsten did not buy the da Vinci system and that the Washington Product Liability Act requires a manufacturer to warn purchasers. Because the trial court erred when it failed to instruct the jury on Intuitive Surgical's duty to warn Harrison Medical Center, the court vacated the jury verdict and remanded for retrial.
A Product Manufacturer's Duty to Warn
The first duty for any product manufacturer is to use reasonable care in designing and making a product so that it is not unreasonably dangerous. Because a product that is not unreasonably dangerous may still have some dangerous features or functions, a manufacturer must also provide with the product warnings that identify the dangerous aspects of the product. An adequate warning mitigates the risk of harm posed by a product because it allows consumers to make informed choices about whether and how to encounter certain risks.
The use of a medical device to treat a patient can result in harm to a patient by adverse consequences of the treatment or known side effects from use of the device. Because the benefits of using medical devices outweigh these risks, a determination usually made by FDA, public policy favors the manufacture and sale of medical devices. To mitigate these risks while using devices to treat patients, the warnings that accompany medical devices must disclose known risks to the patient, including potential adverse outcomes and side effects of using the medical device. Medical device warnings also serve to ensure that the medical provider (the learned intermediary, discussed below) knows the exact purpose and proper use for the device and can advise the patient concerning risks and potential adverse consequences.
Under the traditional strict liability standard, a warning may be defective even if the manufacturer did not know and could not have been expected to know about a dangerous aspect of the product.[i] The more contemporary formulation of strict liability injects "foreseeable risks of harm" into the analysis.[ii] In either case, medical devices are usually exempt from a strict liability analysis. Where a product has inherent dangers but still provides a public benefit, like prescription drugs or medical devices, the product may be termed "unavoidably unsafe." In many jurisdictions, a manufacturer may avoid strict liability for properly manufactured "unavoidably unsafe products" so long as the product is accompanied by "proper" warnings. The exemption from strict liability for unavoidably unsafe products is colloquially known as "comment k."[iii] The absence of strict liability for an unavoidably unsafe product often causes a court to place heightened scrutiny on the content and presentation of a medical device manufacturer's warning.
Several jurisdictions have legislatively imposed duties on product manufacturers in the form of Product Liability Acts. For example, New Jersey courts have consistently held that warnings and instructions provided in association with medical treatments are adequate as a matter of law where the manufacturer provided specific information on the risks associated with the treatment provided. New Jersey courts assess the seriousness of the involved risk; the accuracy, clarity, and relative consistency of the warning language; and the warning as a whole, to determine if it unmistakably conveys the consequences. Under the New Jersey Products Liability Act, a warning for a medical device that has been approved by FDA under the Federal Food, Drug, and Cosmetic Act is entitled to a rebuttable presumption of adequacy. Texas and Michigan have similar provisions.
A product manufacturer's duty is to direct its warning to the consumer or user of its product. However, a patient's access to a medical device is restricted by the patient's treating physician. A patient's treating physician is in the best position to evaluate the information provided by the manufacturer concerning the risks and benefits of its medical device, as well as available information from the scientific literature, and then weigh that information against the individual patient's condition and risk factors to determine whether treatment with a particular medical device is appropriate. The physician is also in the best position to communicate the risks and alternative treatments to the patient. For these reasons, nearly every jurisdiction in the United States recognizes that the patient's treating physician stands in as an intermediary between the medical device manufacturer and the patient; a "learned intermediary."[iv] Jurisdictions applying the learned intermediary doctrine require medical device manufacturers to warn prescribing physicians, not patients or consumers.
The Taylor Court's Consideration of a Medical Device Manufacturer's Duty
The Taylor court acknowledged Washington's adoption of the learned intermediary doctrine, explaining:
The patient is expected to, and is presumed to, rely on the independent judgment of the physician, with the physician deciding which facts should be told to the patient. Therefore, if a product is properly labeled with the necessary instructions and warnings, the manufacturer may reasonably assume that the physician will make an independent assessment based on the label and his independent learning, to act in the best interest of the patient. In this way, the physician acts as a 'learned intermediary' between the manufacturer and the patient.
Washington applies the learned intermediary doctrine to underscore the importance of patient safety and recognized that a hospital is not a "learned intermediary." Nevertheless, the court found statutory and public policy reasons to impose a duty to warn the hospital on Intuitive Surgical.
The starting point for the court's consideration of Intuitive Surgical's duty to warn was the Washington Products Liability Act (WPLA). The WPLA does not specify who should receive the warnings. It states only, somewhat confusingly, that "[a] product is not reasonably safe because adequate warnings or instructions were not provided with the product . . . ." The court reasoned that since the da Vinci system is owned and maintained by the purchasing hospital, the hospital is owed warnings with the product it purchases. The court concluded that, "the WPLA imposes a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product."
The court also acknowledged that hospitals have independent, non-delegable duties to patients that they cannot meet "without knowing the risks of the dangerous medical products they own." The critical duty the court identified in Taylor was that hospitals owe an independent, non-delegable duty to perform a due-diligence evaluation to determine whether each surgeon is competent to perform surgery using the da Vinci System without supervision. The court found it particularly important that because the da Vinci system is extremely complex and inherently dangerous, hospitals require warnings to be able to fulfill their non-delegable duties to keep patients safe.
The Duties a Hospital Owes to Its Patients
As in Taylor, the independent duties a hospital owes to its patients may have an impact on the scope of a medical device manufacturer's duty to warn. It is helpful, then, to consider the potential scope of the hospital's duties.
Many jurisdictions impose on hospitals duties of care owed directly to patients; duties derived from the corporate negligence doctrine. The duties we discuss here are those owed directly by the hospital to patients, not those attributed vicariously through the doctors, nurses, and other staff working in and around the hospital.
Although doctors may be in the best position to determine a patient's treatment and how to administer it, "[t]he hospital is not completely absent from the process." The corporate negligence doctrine recognizes "the onus on the hospital itself for the competency of the hospital's medical staff."
The corporate negligence doctrine imposes on a hospital "a nondelegable duty owed directly to the patient, regardless of the details of the doctor-hospital relationship." This doctrine requires that a hospital "furnish to the patient supplies and equipment free of defects, among others." As the Taylor court explained, the corporate negligence doctrine was adopted because hospitals are best positioned "'to monitor and control physician performance,'" and because the public perceives "'the modern hospital as a multifaceted health care facility responsible for the quality of medical care and treatment rendered.'" Moreover, patients receive care from multiple members from a hospital's staff, not merely one physician prescribing a singular means of treatment. The doctrine was adopted in Washington because doing so gives hospitals a "'financial incentive to insure the competency of their medical staffs.'"
The doctrine was first applied to hospitals in Darling v. Charleston Community Mem. Hosp. There, the Illinois Supreme Court held a hospital liable for failing to review a patient's treatment and for failing to require consultation to the patient. Prior to the corporate negligence doctrine's application, a plaintiff's typical form of recovery had been under a respondeat superior theory, but under the corporate negligence doctrine, a hospital is liable for its own negligent acts or omissions, as opposed to being liable by extension for a physician's negligence.
The doctrine may also extend beyond credentialing doctors to include a broader duty to "ensure the patient's safety and well-being while at the hospital." In Pennsylvania, a hospital will be charged with negligence if it is shown "that the hospital had actual or constructive knowledge of the defect or procedures which created the harm," and if the negligence of the hospital was "a substantial factor in bringing about the harm to the injured party."
In California, a hospital "has a duty of reasonable care to protect patients from harm . . . including the discovery and treatment of their medical conditions." California adopted the doctrine of corporate hospital liability, in part, because it aligned with statutory authority that recognizes that hospitals are accountable "for the quality of medical care provided and the competency of its medical staff." Like Pennsylvania, California also recognizes that the modern hospital is multi-faceted and is responsible for providing total care to a patient.
Although the boundaries of the hospital's duties are jurisdictionally dependent, the generally recognized duties of a hospital under a corporate negligence theory are:
- A duty to use reasonable care in the maintenance of safe and adequate facilities and equipment;
- A duty to select and retain only competent physicians;[v]
- A duty to oversee all persons who practice medicine within its walls as to patient care; and
- A duty to formulate, adopt and enforce adequate rules and policies to ensure quality care for the patients. [vi]
The test to determine whether a duty of care is owed and whether it has been breached "is what an ordinary hospital would have done under the same or similar circumstances," applying the medical standard of care as the threshold issue.
The Broad Nature of the Device Manufacturer's Duty to Warn
Unlike a prescription drug, there are many ways a medical device can adversely affect a patient even though the device reaches a patient only through a physician. Even before Taylor, a medical device manufacturer had a lot to consider when preparing the content of its package inserts or warnings.
As an example, plates, screws, rods, and other hardware for internal fixation of bone fractures are often sold to hospitals in sets for use as needed. Because an orthopedic surgeon may not know the specific device he or she will need prior to starting an open reduction internal fixation surgery, trays with a variety of sizes and types of fixation devices provide the orthopedic surgeon needed options. The hospital owns these trays and regularly replenishes the individual components. The literature that the medical device manufacturer provides with these devices for the surgeon must include foreseeable risks of harm, such as complications of surgery or potential device failure if the fracture does not heal. The device manufacturer may also provide a surgical guide that describes the manufacturer's recommended procedures for use of the devices. Where a hospital has duties it also owes to the patient, the device manufacturer may want to make available information regarding sterilization of the tray prior to use, handling of the devices to avoid scratches or damage prior to use, and even a copy of the surgical guide, to the extent the hospital needs that information for credentialing purposes.
A large joint replacement device, like a knee or hip, is typically delivered to the hospital on the day of the anticipated surgery (usually in the hands of the device manufacturer's representative) and the hospital's handling of the device is limited to a brief period of time in the operating room. Nevertheless, in light of Taylor, when an orthopedic surgeon agrees to begin using a certain device, the manufacturer may choose to send general warnings, instructions, and a surgical guide to the hospital to be sure the hospital is able to fulfill its duties to its patients. The device manufacturer may also want to ensure information is available for the operating room staff, such as instructions to be sure sterility expiration dates on the packages are verified, along with handling instructions to ensure the device components remain sterile and undamaged prior to use.
Complex, reusable devices like an anesthesia machine can raise multiple warning issues. As with the da Vinci device in Taylor, a hospital must have information on how the device operates to be sure that the anesthesiologists it credentials can operate and troubleshoot the device. The hospital also may have a non-delegable duty to use reasonable care in the maintenance of the anesthesia machines it makes available to the anesthesiologist it credentials. Because an anesthesia machine is designed to last several years, the device must undergo daily inspections, a pre-use checkout before each procedure, and regularly scheduled manufacturer's certifications. To satisfy its duty to its patients, the hospital must have the anesthesia machine's operating instructions to be sure its credentialing process is appropriate and the service manual for its medical technologists to properly service the device. Software updates or revisions to service manuals could be critical to the long-term functionality of such complex devices. Consequently, although there are jurisdictional variations on post-sale duties to warn and statutes of repose, the manufacturer should consider how service updates are provided to the entities that own or use its anesthesia machines. A hospital may engage a third-party service provider to maintain and regularly service devices like its anesthesia machines, but the hospital's duty is non-delegable, even though it may outsource the actual servicing.
There are also medical devices in which instructions to physicians are of little use. Consider a duodenoscope, a reusable device used to perform a procedure called an endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat problems in the bile or pancreatic duct. Perforation of the intestine, bleeding, and depressed breathing are among the potential side effects of ERCP, requiring the hospital to take seriously its duty to credential doctors to perform ERCP. Because the duodenoscope is reused, there is a potential risk of infection from improper cleaning between uses. The device used to clean a duodenoscope between procedures is an automated endoscope reprocessor (AER), another FDA-regulated medical device, but one a physician seldom, if ever, uses. The device is typically operated by a hospital's medical technologists. Unlike an anesthesia machine, there is no pre-use checkout a physician can perform to determine if all bacteria has been removed from the duodenoscope. For this reason, the warnings and instructions the duodenoscope and AER manufacturers provide to hospitals concerning how to properly reprocess duodenoscopes could play an important role in the hospital's ability to fulfill its duty to provide its patients with safe equipment.
The Interplay between a Hospital's Non-Delegable Duties and the Learned Intermediary
In most cases, the device manufacturer's duty to provide a device that is not unreasonably dangerous will be satisfied by providing adequate warnings to the prescribing physician. By providing adequate warnings to the physician, the device manufacturer's direct liability to the patient is cut off. In some cases, even if the manufacturer's warning was not adequate, there may be no liability if the physician was already aware of the potential side effects and decided to use the device anyway. But as Taylor and the above examples demonstrate, the medical device manufacturer's role may not be limited to the warnings it provides to the physician.
In the case of an anesthesia machine, a surgeon may recommend a particular procedure, but, even as captain of the ship, seldom selects the anesthesia machine used during the procedure, electing to use the machine in the operating room at the time of the surgery unless the patient or procedure presents risks requiring some other device. If the anesthesia machine fails during a procedure because the manufacturer did not alert the hospital about the servicing of some critical aspect of the device, the warnings the manufacturer provided to the anesthesiologist, the learned intermediary, may be of little use in its defense.
With respect to a device like a duodenoscope, a physician will likely warn his or her patient about the potential for infection from an ERCP procedure. But an infection that can be traced to the failure of the hospital to properly reprocess the duodenoscope presents different warnings issues. The AER is used by the hospital to fulfill its duty to provide its patients with safe equipment (a bacteria-free duodenoscope). So, although the AER does not come into direct physical contact with a patient, it is indirectly involved in patient care.
This separate avenue of potential liability, highlighted by devices like the da Vinici or AER, increases the importance of the warnings the device manufacturer provides to the hospital and may make the physician's warnings to the patient irrelevant to the device manufacturer's potential liability.
The various settings in which a medical device can be used to treat a patient present an assortment of challenges to a device manufacturer trying to satisfy its broad duty to warn. To evaluate the adequacy of existing warnings, or to develop warnings for a new device, a manufacturer should address these questions:
- In what way will this device impact patient treatment?
- Who will interact with this device before the device reaches the patient?
- What must be done to or with the device to prepare it for use in patient treatment?
- Who will use this device in treating the patient?
- What are the foreseeable risks associated with use of this device in patient treatment?
Answers to these questions should provide medical device manufacturers sufficient guidance as they develop warnings to accompany their devices and determine to whom those warnings should go.
Image courtesy of ACTIVEDIA/PIXABAY]
[i] (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS § 402A.
[ii] [A product] is defective because of inadequate instruction or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of a reasonable instructions or warnings by the seller and the omission of the instructions or warnings renders the product not reasonably safe. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2(c).
[iii] There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. RESTATEMENT (SECOND) OF TORTS § 402A, comment k (emphasis added).
[iv] 57 A.L.R. 1, at 26 (citing Flannagan, Products Liability: The Continued Viability of the Learned Intermediary Rule as it Applies to Product Warnings for Prescription Drugs, 20 U. RICH. L. REV. 405 (1986)).
[v] Johnson v. Misericordia Community Hosp., 301 N.W.2d 156 (Wis. 1981); Ferguson v. Gonyaw, 236 N.W.2d 543 (Mich. 1975); Corleto v. Shore Mem. Hosp., 350 A.2d 534 (N.J. 1975); Pedroza at 169 (citing Purcell v. Zimbelman, 500 P.2d 335 (Ariz. 1972)); Moore v. Board of Trustees, 495 P.2d 605 (Nev. 1972)).