By Ginger Pigott and Natassia Kwan, Greenberg Traurig
As plaintiffs pursuing medical device and pharmaceutical product liability actions run into various dispositive legal defences to traditional tort claims, such as express and implied preemption, defence attorneys are seeing an increasing trend toward creative pleading in plaintiffs’ efforts to raise potential issues regarding the conduct of health care industry representatives who are either present in surgery or otherwise providing technical support to medical providers.
Historical defences to the conduct of these industry representatives have led to a series of decisions interpreting the older theories of who is responsible for patient decisions and outcomes. More strategy is being played out on the battleground of the trial court. This brief article outlines some of the legal developments and provides tips on key facts to develop in defending against claims pleading negligence on the part of a representative.
As medical device and pharmaceutical products evolve, representatives from companies provide important technical support for such products in doctors’ practices and in the operating room. In fact, the American College of Surgeons has stated a formal policy about such representatives: “Health care industry representatives (HCIR), by virtue of their training, knowledge, and expertise, can provide technical assistance to the surgical team, which expedites the procedure and facilitates the safe and effective application of surgical products and technologies.” Similarly, the American Medical Association (AMA) issued an Opinion stating, “Manufacturers of medical devices may facilitate their use through industry representatives who can play an important role in patient safety and quality of care by providing information about the proper use of the device or equipment as well as technical assistance to physicians.” The Association of Perioperative Registered Nurses (AORN) has stated, “AORN acknowledges and values the role of the health care industry representative in perioperative settings.” The health care industry recognises the value of these industry representatives. A Heart Rhythm Society (HRS) Policy Statement Update noted that industry-employed allied professionals “often have expertise about specific features of pacemakers or ICDs that is unique to the manufacturer’s product. This expertise may be extremely valuable to physicians and the clinical allied professionals … they employ.” What they don’t do is engage in the practice of medicine. But what they do, and how they do it, can open a window to a creative litigator. However, while their presence provides a potential target in litigation, the doctor still plays a crucial role in the hierarchy, and the legal duties applicable can provide a defensive posture to any claims regarding the conduct of the representative.
The “captain of the ship” doctrine traces its roots to the Pennsylvania Supreme Court case McConnell v Williams, 361 Pa. 355 (1949). There, the Court explained until the surgeon leaves the room at the conclusion of the operation, “he [the surgeon] is in the same complete charge of those who are present and assisting him as is the captain of a ship over all on board”. Some states have criticised the “captain of the ship” doctrine and declined to apply it to hold physicians liable, such as Iowa, New Jersey, Ohio, West Virginia and Maryland. However, other jurisdictions such as California, Colorado, Pennsylvania and Nebraska have applied it to varying degrees.
In 2010, a Colorado appellate court applied the “captain of the ship” doctrine to shield a medical device manufacturer and its representative from a negligence claim brought by a patient (O’Connell v Biomet, 250 P.3d 1278 (2010)). In O’Connell, a patient alleged that Biomet Inc’s representative was liable for negligence as an agent of the operating surgeon. The trial court found that any alleged advice that the Biomet representative gave to the surgeon “was done as a crew member, so to speak, of the surgical ship.” The court upheld the trial court’s findings, concluding that the “captain of the ship” doctrine not only includes hospital personnel, but also includes non-medical persons present in the operating room upon the request and authorisation of the physician, where the physician has the right to control and supervise the activities of the non-medical persons.
Other examples include Wolicki-Gables v Arrow Int’l, Inc, 641 F.Supp.2d 1270, 1279 (MD Fla. 2009) (court was unwilling to find that a sales representative’s presence in the operation room during implantation of a pain pump created a duty for the medical device manufacturer in breach of alleged duty to instruct/educate the physician) and Labzda v Purdue Pharma LP, 292 F.Supp.2d 1346, 1354 (SD Fla. 2003) (sales representative and pharmaceutical manufacturer have no duty to control doctor’s prescribing practices). But, beware of other not-so-favourable decisions and consider when to raise the issue so as to present the most developed argument. See, eg, Adkins v Cytyc Corp, No. 4:07CV00053, 2008 WL 2680474 (W.D. Va. 3 July 2008) (allowing plaintiff leave to amend to attempt to bring claims against the representative notwithstanding the preemption defence applicable to the manufacturer’s product).
Prescription drugs and medical devices also find a legal shield in the context of alleged warning claims and often that defence can include the words of a representative as well as the labelling. A majority of states have adopted the learned intermediary doctrine and thus warning duties run to the prescriber, not the patient. One such state is California, where the manufacturer of a prescription medical device has no duty to warn patients of the risks associated with its product. See Carlin v Superior Court, 13 Cal. 4th 1104, 1126 (1996). Rather, the manufacturer’s duty to warn is owed to the prescribing physician, because the physician stands between the manufacturer and the patient as a “learned intermediary”, who has the knowledge and expertise to decide which medical devices are appropriate for a patient. See Valentine v Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1483 (1999): “In the case of prescription drugs and implants, the physician stands in the shoes of the ‘ordinary user’ because it is through the physician that a patient learns of the properties and proper use of the drug or implant. Thus, the duty to warn in these cases runs to the physician, not the patient.” The learned intermediary doctrine has been adopted in California for cases involving claims of failure to warn about the risks of a prescription medical device. See Carlin, 13 Cal. 4th at 1126; Tapia v Davol, Inc, 116 F. Supp. 3d 1149, 1158 (S.D. Cal. 2015): “A manufacturer fulfills its duty to warn if it provides adequate warnings to the physician.”
Thus, much like the “captain of the ship” doctrine, the doctor’s position as a medical expert diminishes the duty owed by manufacturers. And rightly so, as the doctor exercises a medical judgment bottomed on his or her knowledge of each unique patient’s condition and how best to treat that individual. Pharmaceutical and medical device manufacturers, even the best in their field, are not treating physicians attuned to each individual patient’s needs. But a doctor’s education and experience allows him or her to “take into account the propensities of the drug as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, and an individualized medical judgment.” (Mohr v Targeted Genetics, Inc, 690 F. Supp. 2d 711, 719 (CD Ill. 2010) (citing Kirk v Michael Reese Hospital and Medical Center, 117 Ill.2d 507, 518 (1987).) As another court put it, under the learned intermediary doctrine, “[t]he doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer’s control, on the part of the doctor.” (Hill v Novartis Pharmaceuticals Corp, 944 F.Supp.2d 943, 953 (ED Cal. 10 May 2013).) Though some states vary, this provides another tool to explore when plaintiffs become creative in an effort to bring claims about the conduct of representatives who are often providing information to the companies’ sophisticated customers.
While prescription drug and medical device manufacturers have a duty to warn physicians (Martin v Ortho Pharmaceutical Corp, 169 Ill.2d 234, 238 (1996)), there is no duty to warn physicians of a drug or device’s dangers “which the medical community generally appreciates” (Hansen v Baxter Healthcare Corp, 309 Ill.App. 3d 869, 881 (1999); see also Carlin, 13 Cal. 4th at 1116 (“A pharmaceutical manufacturer may not be required to provide warning of a risk known to the medical community”); and Plenger v Alza Corp, 11 Cal. App. 4th 349, 362 (1992) (applying same principles to medical device case: “If the risk of death from untreated infection is universally known in the medical profession, the failure to warn the physician of that risk cannot be the legal cause of the decedent’s death”). Here again, in the context of a sales representative, a doctor should not be relying on such a person to provide warnings of known risks and, as outlined below, should not defer to non-medical personnel to make medical decisions.
When defending against duty to warn claims – whether warnings issued directly or through the representative – manufacturers should be cognisant of both the subjective and objective defences to a duty to warn claim, among other defences. The subjective defence is whether the doctors who prescribed the medical device or pharmaceutical product were actually sufficiently warned of the harmful risks associated with that medical device or pharmaceutical product. The objective defence is whether the risks associated with the product are commonly known among the medical community, such that the exception to the learned intermediary rule applies, since there is no duty to warn of a risk that is already known by those to be warned.
Lastly, as we review the interplay between physicians and medical product manufacturers in the products liability context, what happens when the tables are turned and the doctor claims he or she relied on a medical device sales representative’s advice? That scenario occurred in Hall v Horn Medical, LLC, 2012 WL 1752546 (ED La. 2012). There, the doctor testified that he relied upon a medical device sales representative’s advice that a bone graft was not needed for the medical device to work, and attempted to dodge blame. The court found the doctor’s position unreasonable as a matter of law. It explained that the doctor was a seasoned neurosurgeon, and it was patently unreasonable for him to rely on a sales representative’s opinion about the type of procedure that should be employed in operating on a patient’s spine. Moreover, the warnings on the medical device’s packaging were clear. Accordingly, the doctor could not dodge the claims asserted against him because of his reliance on a sales representative’s advice.
Similarly, in Arthur v Medtronic, Inc, a patient claimed that a medical device manufacturer’s sales representative committed fraud by telling a surgeon that it was “appropriate” to use the medical device during plaintiff’s surgery (2015 WL 5012312, at *3 (ED Mo., 24 August 2015). The court found the surgeon could not have reasonably relied on statements made by sales representatives regarding whether it was “appropriate” to use the medical device in the procedure, and cited Hall for the proposition that, as a matter of law, “it is patently unreasonable for [a surgeon] to rely on a sales representative’s opinion” about a medical procedure. Courts have also refused to accept plaintiffs’ theories that medical device manufacturers should be sanctioned for failing to train, supervise, or otherwise instruct doctors. In Sons v Medtronic, 915 F.Supp.2d 776, 783 (WD La. 2013), the Court rejected plaintiff’s claims that the medical device manufacturer failed to train, supervise and educate the doctors and surgical technicians because “it is well established that a medical device manufacturer is not responsible for the practice of medicine.” The proposition in Sons v Medtronic that “medical device manufacturers are not responsible for the practice of medicine” was also recently affirmed by the California Court of Appeals in Glennen v Allergan, 247 Cal. App.4th 1 (2016).
In an age where medical device and pharmaceutical manufacturers are taking a bigger role in the marketing and sale of products, and instructing about product use, it is useful for manufacturers to compare the respective legal duties of surgeons, physicians, and medical device or pharmaceutical company representatives. Lawsuits based on failure to warn are often brought against physicians and medical device or pharmaceutical companies concurrently, and it is helpful to assess the roles of each defendant pursuant to the learned intermediary doctrine. When claims are brought against manufacturers based on a representative’s participation in an operation room, be mindful of the “captain of the ship” doctrine. Understanding those doctrines and principles will provide the underpinnings for a vigorous and effective defence against product liability claims against medical device and pharmaceutical manufacturers.