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Perhaps one of the most challenging issues to pharmaceutical manufacturers and the lawyers who sue and defend them involves the role of direct-to-consumer advertising (DTCA) in the complicated evidentiary equation of a drug products liability case. This article will briefly explore the impact of DTCA on the learned intermediary defense in pharmaceutical litigation and on the medical profession. Learned Intermediary Defense Unique to pharmaceutical and prescription medical device cases, plaintiffs counsel in Pennsylvania and elsewhere encounter a formidable obstacle in the quest for a legal remedy: the learned intermediary defense. The Pennsylvania Supreme Court’s seminal decision in 1971′s Incollingo v. Ewing articulated and adopted this defense in the commonwealth and also held that the liability of prescription drug manufacturers in a failure-to-warn case must be evaluated using a reasonableness standard under Section 388 of the Restatement (Second) of Torts and not the strict liability provision of Section 402A, since pharmaceuticals cannot be made completely safe for every potential user. In cases subsequent to Incollingo, our appellate courts have reinforced the principles of the learned intermediary defense and its prerequisite that drug manufacturers adequately warn physicians, rather than their patients, of foreseeable health risks flowing from the administration or ingestion of prescription medications. In stressing that the information supplied by the drug manufacturer is only one source of data that prescribing doctors must consult in determining whether a drug is appropriate for a specific patient, authorities after Incollingo have described other factors brought to bear upon the prescribing doctor’s decision. The physician, for example, must know the characteristics of the drug, the amount that can be safely administered, the medical history of the patient including medications he or she is taking, and relevant information available to the physician from medical literature. The Restatement (Third) of Torts: Products Liability incorporates the learned intermediary rule but also requires drug manufacturers to furnish warnings directly to consumers if the drug is dispensed without the personal intervention or evaluation of a physician. This provision, however, has not yet been adopted by Pennsylvania’s appellate courts. Thus, under current law, providing an adequate warning of the proper administration of a drug and its known health risks to the prescribing physician generally protects the manufacturer from liability for adverse consequences to the patient, both known and unknown. ‘Overpromotion’ of Drugs Incollingo and its progeny have made the learned intermediary rule an integral feature of prescription pharmaceutical products liability litigation in Pennsylvania. However, as ingrained as this defense has become, early on courts allowed for an exception arising out of the “overpromotion” of prescription drugs by a manufacturer. Incollingo found that a jury properly considered whether a drug company’s marketing methods may have “cancelled out” the “printed words of warning” contained on a pharmaceutical’s carton, label and literature. See also the Superior Court’s recent decision in Pierce v. Northwestern Human Services. A similar issue was raised in Baldino v. Castagna, another drug products liability case. In deciding Baldino in 1984, 13 years before the Food and Drug Administration (FDA) issued its draft DTCA regulations, the Supreme Court could not have anticipated the abundance of pharmaceutical advertising as exists today, involving patients in a conversation that previously had taken place exclusively between drug manufacturers and prescribing physicians. DTCA ADVERTISING RULES FDA regulations require DTCA to be fairly balanced to communicate both the benefits and the risks associated with a drug. DTC broadcast advertisements do not have to present all of the risks, but may instead furnish major risk factors and advise consumers where to find additional information about the drug. FDA rules, proposed in 1997 and finalized in 1999, require drug companies to submit all DTC advertisements to the FDA when they are aired or disseminated to the public. The FDA division in charge encourages but does not require companies to submit ads for comment prior to their use. In 2004, the FDA reviewed approximately 52,800 promotional materials and print ads and 586 broadcast ads. The FDA sends warning letters to drug companies whose DTCA is found in violation of the regulations, generally for overstating product efficacy or the patient population approved for the drug’s use, or for minimizing potential health risks. Since 1997, the FDA has issued approximately 150 such letters. PhARMA Guidelines In response to recent pressures from Congress and the states, an industry trade association, Pharmaceutical Research and Manufacturers of America (PhARMA), recently promulgated specific rules on DTC advertising, which, while voluntary, arguably supplement existing standards for American prescription drug manufacturers. Announced in August and effective next January, the so-called “Guiding Principles” are intended through DTCA to increase awareness about diseases, especially those that are underdiagnosed and undertreated, educate patients about treatment options, motivate patients to engage their doctors “in a dialog about health concerns,” and encourage patients to comply with drug dosing regimens. The PhARMA guidelines largely mirror the FDA’s existing regulations, but they extend beyond them by recommending a moratorium on drug ads for new medicines or new therapeutic uses of existing pharmaceuticals until doctors are sufficiently educated and prepared to evaluate their appropriateness for specific patients. Perez In 1999, New Jersey became (and has remained) the only jurisdiction to adopt a direct-to-consumer advertising exception to the learned intermediary rule. In Perez v. Wyeth Laboratories, the plaintiffs filed suit against a pharmaceutical manufacturer for injuries sustained as a result of using the implanted Norplant contraceptive device. In reversing the grant of summary judgment to the manufacturer, the New Jersey Supreme Court held that the learned intermediary defense may not apply when a pharmaceutical company engages in direct-to-consumer advertising. The court reasoned that the bases for the learned intermediary doctrine are absent in the DTC advertising of prescription drugs. Specifically, the court found that DTCA allows patients to actively participate in their health care decisions, including the choice of medication. The court also discounted the argument that requiring drug companies to directly warn consumers would undermine the doctor-patient relationship, observing that DTC advertising already “encroaches” on this relationship by encouraging patients to ask for advertised medications. Finally, the court held that the very existence of DTCA belies any notion that communication of the potential adverse effects of prescription drugs are too complex for lay consumers to understand. Thus, the court concluded that “a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product.” As noted above, a provision of the Restatement (Third) of Torts, not yet adopted in Pennsylvania, mandates direct warnings to consumers for limited classes of pharmaceuticals distributed without the active involvement of a physician (mass inoculations, certain contraceptives). Impact of DTCA More than $4 billion was spent on prescription drug ads last year. Research shows most adults have seen these ads, and many, prodded by ads, have spoken to their doctors about specific drugs. Patients have also researched the side effects and benefits of advertised drugs. Most doctors, too, say DTCA assists in their discussions with patients. In a study published earlier this year in the Journal of the American Medical Association, researchers sought to determine whether DTC advertising of prescription drugs may lead to over-prescribing. Using actors feigning symptoms of depression, the researchers found a higher prescription rate for patients making brand-specific or general requests for medication. But they also found that those patients received a higher quality of medical care than patients making no such requests. While some argue that DTCA encourages doctors to inappropriately prescribe prescription drugs, the courts have been reluctant to interfere in the patient-physician relationship. Ceding to the prescribing physician the individualized medical judgment to prescribe a drug or not ( e.g., Leibowitz v. Ortho Pharmaceutical) Pennsylvania courts have thus far rejected claims that DTCA has watered down the learned intermediary defense. For example, in Lennon v. Wyeth-Ayerst, a vaccine products liability case, the Superior Court in 2001 concluded that “[m]edia dissemination of information concerning the existence of these drugs does not enhance the public’s ability to acquire them, as the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate to the condition of the patient . . . the learned intermediary still stands between the advertisement and public consumption of the product.” Preserving the Defense Contrary to the core of the New Jersey Supreme Court’s holding in Perez, the premises of the learned intermediary rule are not rendered obsolete by DTC advertising. Patients can be active participants in their health care decisions without materially eroding a doctor’s ability to decide whether a drug is appropriate for them. Product warnings are only one aspect of many factors that a doctor, and only a doctor, may consider before prescribing medicine. Just because a patient discusses a specific advertised product with their physician does not mean that the physician will prescribe the product if it is unsuitable for the patient. By encouraging a dialogue between patient and physician in DTC ads, and by disclosing in a clear way the risks and benefits of advertised products, drug companies increase the odds that an undiagnosed medical condition will be treated, perhaps earlier than it might otherwise have been, and that patients in consultation with their physicians will be better equipped to make informed choices among treatment alternatives. Pharmaceutical companies, by educating physicians, especially on new drugs and therapies can remain effective partners in this process. To preserve the availability of the learned intermediary defense, a drug manufacturer in its DTC advertising must inform physicians and consumers of safety risks and potential side effects. It cannot minimize serious health risks or downplay possible side effects through its marketing and promotional activities. Doing so may risk nullifying otherwise adequate warnings contained, for example, in package inserts or the Physicians’ Desk Reference. By complying with FDA labeling, advertising and warning requirements, and ensuring that DTC marketing campaigns do not mislead or deceive physicians or consumers, pharmaceutical companies will go far in ensuring the continued vitality of the learned intermediary defense in product liability litigation in Pennsylvania. These efforts will also assist them in similar claims brought under state consumer fraud and federal false claim statutes. Dana L. Scott assisted in the preparation of this article. ALAN KLEIN, a partner with Duane Morris, focuses his practice on product liability and toxic torts litigation. CARRIE E. NELSON is an associate with Duane Morris who practices in the area of commercial litigation, product liability and toxic torts.

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