The Legal Intelligencer

Authors: George E. McDavid Jennifer A. Eppensteiner Shana E. Russo

Type: Articles Published

Google your favorite drug or medical device company and the words "social media" and you will likely find—to no surprise—that industry is embracing this multifaceted communications method. Blogs, Facebook, YouTube, Pinterest, Instagram, LinkedIn and of course Twitter are all devices used by industry to communicate with investors, consumers, journalists and the community at large. Industry use of this media is widespread and likely to increase.

According to a study published by the IMS Institute for Healthcare Informatics, in 2013 half of the top 50 pharmaceutical companies engaged with consumers on health care-related topics through social media, and 10 had a presence across all three main social media sites: Twitter, YouTube and Facebook. The highest number of pharmaceutical companies can be found on Twitter, followed by YouTube and Facebook, respectively, according to the study. IMS Health found that pharmaceutical companies are using social media in three main ways: social media analytics; broadcasting messages and content to consumers; and engaging people and organizations in public conversations on health care topics.

The pharmaceutical industry's increased visibility on social media has not gone unnoticed by the U.S. Food and Drug Administration, and in June 2014 the FDA issued two draft guidances regarding industry use of Internet and social media platforms. One guidance addressed presenting risk and benefit information for prescription drugs and medical devices on those platforms with character space limitations (Twitter, for example, limits users to 140 characters per post), and the other focused on correcting independent third-party misinformation about prescription drugs and medical devices. While both guidances are currently draft-only, and therefore contain nonbinding recommendations, they demonstrate recognition by the FDA that we can expect to see increased levels of communication between manufacturers, consumers and health care professionals on social media. In fact, Thomas Abrams, the director of the FDA's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research, stated on the FDA's blog in a June 17, 2014, post that the "FDA sees social media as an important resource for industry," and that it "is committed to developing additional guidance for drug and device manufacturers that outline the agency's current thinking," keeping "the best interest of patients in mind."
What the FDA's guidances cannot tell us, however, is the effect the pharmaceutical industry's embrace of social media will have on future prescription drug and device litigations. For example, certain exceptions to the "learned intermediary" doctrine at least raise the question as to whether we might expect to see a consumer's reliance on information gleaned from social media play a larger role at trial. In assessing the possible effect of the industry's use of social media on the learned intermediary doctrine, it is important to consider the rationale for the doctrine, namely that the physician is the gatekeeper to prescription medication, as well as other reasoning supporting the learned intermediary doctrine.

According to the learned intermediary doctrine, which has been either expressly or impliedly adopted in 47 states, a drug or medical device manufacturer's duty to provide adequate warnings is owed to prescribing physicians, and not to patients directly. The phrase "learned intermediary" was first used in Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966), when the court said: "We are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser's doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided."

The learned intermediary doctrine rests on several bases. First and most importantly, warnings go to physicians because they are the only people in a position to know both a particular patient's medical history, and the risk/benefit profile of the drug being prescribed and to evaluate how those two factors interact in the therapeutic decision to use or refrain from using the product, as in Taurino v. Ellen, 397 Pa. Super. 50, 54 (Pa. Super. Ct. 1990).

Additionally, limiting warning duties to physicians makes the common law consistent with warning duties imposed by the FDA, and routing prescription drug and device information through the doctor preserves the physician-patient relationship from outside interference, as in Coyle v. Richardson-Merrell, 526 Pa. 208, 214-15 (Pa. 1991). In some cases, the complicated medical terminology necessary to explain the risk/benefit profile of prescription drugs and devices is difficult for ordinary patients to understand.

Finally, practical difficulties often preclude drug and device companies from direct communication with patients.

The Pennsylvania Superior Court has on many occasions explained the rationale behind the learned intermediary doctrine. "It is for the prescribing physician to use his own independent medical judgment, taking into account the data supplied to him from the drug manufacturer, other medical literature, and any other source available to him, and weighing that knowledge against the personal medical history of his patient, whether to prescribe a given drug," the court held in Leibowitz v. Ortho Pharmaceutical, 307 A.2d 449, 457 (Pa. Super. Ct. 1973).

Although the majority of states have adopted the learned intermediary doctrine, specific states are not without exception to the rule. In Perez v. Wyeth Laboratories, 161 N.J. 1, 24 (1999), the New Jersey Supreme Court created an exception to the learned intermediary doctrine where a manufacturer engages in direct-to-consumer, or DTC, advertising, and that advertising influenced the consumer's decision to take the medication. The court was persuaded that the law needed to respond to marketplace changes in which mass advertising in "radio, television, the Internet, billboards on public transportation and in magazines" pushed consumers to particular products before they had discussions with their physicians.

In the Perez decision, the court required that in proving proximate causation in a DTC case, a plaintiff must establish that an advertisement violated FDA requirements, and that such advertisement was a substantial factor in bringing about the harm suffered. A constant review and analysis of the reported decisions in the context of claims stemming from the failure to warn where the plaintiff has requested an exception to the learned intermediary doctrine shows that the majority of states are not inclined to adopt an exception like provided for in Perez.

Examples include: Calisi v. Abbott Laboratories, CA No. 11-10671-DJC (D. Mass. Feb. 25, 2013), in which the court declined to adopt DTC exception to the learned intermediary doctrine, noting that such an exception had not been recognized by the Supreme Judicial Court of Massachusetts; DiBartolo v. Abbott Laboratories, 914 F. Supp. 2d 601, 614-16 (S.D.N.Y. 2012), in which the court declined to adopt a DTC exception to the informed intermediary doctrine, finding that "even in a world with widespread DTC advertising, however, physicians continue to fulfill the core functions that underlie [the informed intermediary doctrine]: they evaluate a patient's needs, assess the risks and benefits of available drugs and then prescribe a drug, advising the patient of its risks and possible side effects"; and Centocor v. Hamilton, 372 S.W.3d 140, 162 (Tex. 2012), which held that a DTC advertising exception did not apply.

Ultimately, the effect of the pharmaceutical industry's presence on social media on the learned intermediary doctrine remains to be seen. We were unable to locate any cases in which the interplay of social media and the learned intermediary was discussed. However, allegations that manufacturers downplay risk information on social media are becoming more prevalent, so we can expect to see developments in the area soon. The decision in Baker v. Bayer Healthcare Pharmaceuticals, No. C13-0490 TEH (N.D. Cal. Dec. 19, 2013), noted that "plaintiff alleges that defendant did not effectively test or analyze results of premarket tests before putting Mirena on the market, but nonetheless promoted Mirena through social media and online marketing campaigns while understating the associated risks"; however, because the defendant did not raise a learned intermediary defense, the relationship of the two was not explored.

Social media communications are different from communication in the mass media outlets Perez discussed in 1999. They can be read by larger numbers and are more targeted, reaching vast numbers of potential consumers with a particular interest in the product. Plaintiffs counsel in products liability matters may argue that through social media the industry has intensified the erosion of the physician's role as gatekeeper, first recognized in Perez, and has created a cadre of consumers in whom the decision to use the product was arrived at without physician input. We may expect to hear that such circumvention of physician input requires circumvention of the learned intermediary doctrine.

Using the pervasiveness of mass marketing—whether on billboards, desktops or smartphones—as the rationale for avoiding the learned intermediary doctrine is misplaced and can only be adopted by ignoring the central thesis of the doctrine. Irrespective of how or why the patient came to the decision that she needed or desired a particular product, under our system it is still the role of the physician to make an independent determination that the benefits of the product outweigh the risks before deciding to offer the product to the patient. The form or amount of advertising on a product does not change the essential fact: The physician—not the consumer—has to decide whether to prescribe the product. As long as the physician is the decision-maker, the law appropriately requires industry to warn him or her and the learned intermediary doctrine remains the appropriate policy choice.

Reprinted with permission from the February 10, 2015 edition of The Legal Intelligencer © 2015 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited. For information, contact 877-257-3382, reprints@alm.com or visit www.almreprints.com.