Medical Device Link.

PRODUCT LIABILITY

Sidebar: Speaker

Today’s sophisticated healthcare consumers are playing an increasingly active role in seeking and directing their own medical care and treatment. In this context, direct-to-consumer (DTC) advertisements for prescription drugs and medical devices are also taking on more and more importance. Such advertisements can help grow public awareness of treatable diseases and health conditions, encourage greater interaction between patients and their doctors, and improve patient compliance with prescribed treatment regimens.

Panel Discussion Information

Thursday, October 4 2:00–2:45 P.M.

Kevin J. Dunne Chairman Sedgwick Detert Moran and Arnold LLP Special contribution with Genese K. Dopson and Sunny S. Shapiro

For the sponsors, however, such advertising can represent a two-edged sword. Addressing a broad consumer audience can help a medtech manufacturer to establish a foothold for a new product or grow market share in a competitive market. But having such a high profile may also make the manufacturer a more likely target in product liability litigation resulting from adverse events. This article describes some of the ways that DTC advertising can increase the potential for product liability suits against medtech manufacturers, and what company executives can do to protect themselves from this risk.

Risks of DTC Advertising

The higher profiles resulting from a DTC marketing approach can put manufacturers at greater risk of lawsuits. But the approach itself can also have detrimental effects on the defenses available to the manufacturer. Following are some of the ways that a manufacturer’s legal defenses may become impaired as a result of DTC marketing.

Erosion of the Learned Intermediary Doctrine. First presented in 1948, and more fully articulated in 1966, the learned intermediary doctrine holds that pharmaceutical manufacturers are obligated to warn only the physicians who prescribe their medicines.^1,2 The rationale for this doctrine rests on the notion that doctors have the knowledge, training, and experience necessary to understand the warnings, and stand in a better position to communicate risks and complications to patients with varying degrees of education, interest, and sophistication.³

In other words, the courts considered the consumer of a prescription drug or device to be the physician—not the patient—and the manufacturer’s duty to adequately warn therefore extended only to the doctor. Once upon a time, manufacturers could rely on this doctrine as a defense against any suit brought for injuries caused from use of a prescription drug or device—assuming they had adequately warned the physician.

Over time, however, exceptions have somewhat eroded the learned intermediary defense, most notably in the areas of mass vaccinations and oral contraceptives. The courts reasoned that an exception is appropriate where the traditional relationship between physician and patient is marked by heightened patient participation and limited monitoring by the doctor.

In the 1999 case Perez v. Wyeth Laboratories, the New Jersey Supreme Court denied the learned intermediary doctrine entirely.⁴ In the Perez case, the court ruled that the learned intermediary defense was not available to a manufacturer in circumstances where DTC advertisements did not list any side effects or warnings. On the positive side for drug companies, the Perez court added that compliance with FDA standards for direct-to-consumer advertising would be a presumptive defense for manufacturers in pharmaceutical cases.

Recently, in State of West Virginia ex rel. Johnson & Johnson Corp. v. Karl, the West Virginia State Supreme Court rejected Johnson & Johnson’s assertion of the learned intermediary defense after a decedent’s death from Propulsid samples provided by her doctor.⁵ The court pointedly observed that DTC advertising has so dramatically supplanted the ‘doctor knows best’ dynamic that the storied premises upon which the learned intermediary doctrine rests have been neutralized.

So far, the Perez and Johnson decisions have not met with widespread approval in other jurisdictions. However, there is increasing concern among marketers that the growing use of DTC ads may lead more courts to restrict application of the learned intermediary doctrine.⁶

Users Deny Warnings. Since last year, 135% more Web sites advertise prescription drugs such as Xanax, Vicodin, and Ritalin, and 7% more sites offer to sell the drugs—sometimes without a prescription.^7,8 By way of the Internet, consumers can also easily purchase medical devices such as contact lenses, hearing aids, and various types of diagnostic test kits. Such easy availability, coupled with insufficient consumer understanding, is a setup for a failure-to-warn claim.

Plaintiffs attorneys are aware that if they penetrate the learned intermediary defense, they can then argue that a manufacturer failed to warn the ultimate consumer. Unlike doctors, who take pride in their knowledge and sophistication, consumers freely claim they did not see or did not understand the manufacturer’s warnings.

Fashioning user-friendly product descriptions in full compliance with FDA guidelines is vital to establishing that warnings were easily understood by the average consumer.

Nevertheless, plaintiffs will argue that it is harder to communicate risks than to communicate benefits, and that 30- to 60-second television advertisements are not conducive to a fair and balanced presentation. Others will argue that it is impossible to fully explain a medication’s risks in the package insert page of a print advertisement, or during a fast-paced barrage of side effects during the last five seconds of a commercial.

Losing the Doctor as Advocate. The American Medical Association (AMA) has historically opposed DTC advertising, arguably on the grounds that it undermines the doctor-patient relationship and fails to provide vital safety information. As a result of these concerns, in 1998 the AMA council on ethical and judicial affairs drafted a new policy as part of the AMA Code of Medical Ethics (E-5.015), which addresses issues related to DTC ads for prescription drugs. This section urges physicians to deny requests for inappropriate prescriptions and to educate patients about the reasons that some advertised prescription products may not be suitable treatment options.⁹ The section also encourages doctors to report to FDA any DTC ads that do not conform to FDA requirements, and it invites doctors to participate in studies regarding the effects of DTC advertising.

In 2005, AMA called for a moratorium on DTC advertising out of concern that patients perceive physicians as barriers to their access to the advertised product and that the brief warnings provided in DTC ads do not convey the severity of side effects that may be relevant to an individual patient.

The AMA House of Delegates has also adopted a policy on DTC advertising of prescription and implantable devices (H-105.998). The policy lists advertisements deemed acceptable by AMA and those that are not. Most notably, AMA has taken the position that companies engaging in DTC advertising assume an increased duty to warn consumers, as well as an increased responsibility for the informational content of their ad.¹⁰ AMA has further asserted that companies engaging in DTC advertising may lose an element of protection normally accorded under the learned intermediary doctrine.

Reducing the Risks of DTC Advertising

Although DTC advertising may increase the risk of litigation, medtech companies can take steps to counter these risks. By doing so, they can make DTC advertising a useful tool for communicating with broad audiences of prospective patients.

Educating the Learned Intermediary. In 2006, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary guidelines on DTC ads, wherein manufacturers were advised to spend an appropriate amount of time educating healthcare professionals prior to the commencement of a DTC ad campaign.¹¹

Because most DTC ads urge consumers to “ask your doctor if product X is right for you” or state that “product X is one of many treatments for you and your doctor to consider,” PhRMA recommends that manufacturers take the initiative to educate prescribing doctors so that they are prepared to address patient inquiries.

A comprehensive and effective DTC ad campaign will raise awareness in consumers and educate physicians about the product. Working closely with physicians to provide product education should be key to reducing the risk of future liability and can be an invaluable defense in any lawsuit.

Warning the Unsophisticated. Even in cases where the learned intermediary defense is unavailable, the manufacturer can still prevail if it adequately warned the ultimate consumer—the patient.

Generally, the ultimate consumer is less sophisticated than the treating physician. Thus, the manufacturer should explore methods of clearly communicating with the ultimate consumer. Precisely following FDA guidelines is the best method.

A manufacturer can also supplement its ad campaign with informative materials sometimes referred to as patient decision aids. According to Marshall Chin, MD, patient decision aids using comprehensible information can “explore relevant factors in much more detail than is possible” in brief commercials, supplement the doctor-patient dialogue, serve as a reference tool, aid patients to have more realistic expectations, and educate about the risks associated with a particular treatment.¹²

Such patient decision aids should have a flexible model to allow for changes and advances, balance quantitative and qualitative data, and be cognizant of the intended audience. In addition to patient aids, other effective tools include promotional speakers, patient ambassadors, and testimonials.

Consumer-Friendly Information and Warnings. The manufacturer’s overarching goal must be to develop an ad campaign that strikes the proper balance between conveying the risks and benefits of the product. One element of all such ads in the campaign is the section commonly referred to as the brief statement—the portion of an advertisement that presents the public with a true statement of information relating to a product’s side effects, contraindications, and effectiveness.

The key to writing an appropriate brief statement is making sure there is a fair balance, giving equal time to describing the product’s effectiveness, while also raising awareness of the pertinent risks and warnings. If in doubt, manufacturers should err on the side of ensuring that “the presentation of true information relating to side effects and contraindications is comparable in depth and detail with the claims for effectiveness or safety.”¹³

Manufacturers should exercise caution when using certain terms, whether in their product’s advertising or elsewhere. Recognizing the gravitas and appeal of a drug that is described as ‘new,’ for example, FDA has prohibited the use of that term after six months from first marketing. Another pitfall proscribed by FDA is use of phrases such as drug of choice, or other similar superiority claims.

FDA requires that any ad that makes claims of statistical significance must support those claims with clinical evidence from studies amenable to formal statistical evaluation. For example, it would be misleading to use only favorable results derived by pooling data from various insignificant or dissimilar studies while suggesting that the studies supporting the favorable conclusions were large and significant.

Color, font, and formatting also play roles in developing an advertisement that complies with current FDA requirements and guidelines. One requirement is that the established prescription drug name appear at least half the size of the proprietary name.¹⁴ FDA suggests that side effects and contraindications be presented with “reasonably comparable” prominence and readability as the effectiveness of the product, with adequate emphasis on color, scheme, borders, and headlines.¹³ Adequate warnings are crucial to avoiding liability.

Use Caution with Reminder Ads. FDA defines reminder advertisements as those that call attention to the name of the product but do not include information regarding indications, dosage recommendations, representations, or suggestions for use. The use of such reminder ads is a rocky road. In its 2006 guidelines, PhRMA recommended the elimination of TV reminder ads, urging that commercials should not only identify a product by its name, but also state the health conditions for which the product is approved and the major risks associated with the product.¹²

Prepublication Submission to DDMAC. Enforcement of FDA’s DTC advertising guidelines for drugs is assigned to the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC). This division is responsible for ensuring that such advertisements and labeling are not false or misleading.

There is currently no requirement that sponsors submit their advertising to DDMAC for approval prior to publication. Nevertheless, advertisers are well advised to submit their material for approval in order to avoid unnecessary postpublication enforcement actions, such as retraction or corrective advertising.¹³

Importantly, prepublication submission bolsters a manufacturer’s potential to succeed on a federal preemption argument.¹⁵ In FDA’s preamble to its new rules for drug labeling, the agency indicates its belief that federal preemption precludes plaintiffs from using state law to support lawsuits pertaining to drugs that have obtained FDA approval.

Nevertheless, recent preemption cases dealing with failure to warn are currently on appeal with the Third and Fifth Circuit courts, with preemption arguments having been simultaneously upheld and struck down in lower trial courts.^16–21 Given the split of authority among district courts, the future of the federal preemption doctrine for drug advertising is unclear.

In June 2007, however, the U.S. Supreme Court agreed to review the case of Reigel v. Medtronic, which will specifically address the issue of whether FDA’s express preemption provision preempts state-law tort claims relating to the safety or efficacy of medical devices that have received premarket approval from the agency.²² It is expected that the court’s ruling will provide a definitive interpretation of this doctrine that will influence the marketing and liability positions for a wide range of medical products.

Benefits of DTC Advertising

Statistics confirm that consumers see DTC ads and respond by discussing their conditions and treatment options with their doctors. A good example is the success of Viagra advertisements, which tackled an embarrassing but pervasive problem, heightening awareness and reducing the stigma of erectile dysfunction. Surgeon General Richard H. Carmona, MD, promoting FDA’s 2004 guidance toward health literacy, said, “By closing the gap between what doctors know and what patients understand we can begin to help Americans take better care of themselves and improve their health.”²³

Informative advertisements play a pivotal role in prompting patients to begin a dialogue with their treating physician on new medical drugs and technology.²⁴ Doctor visits occasioned by DTC advertisements have the potential to help identify undiagnosed, undertreated, and life-threatening conditions.

Manufacturers can heighten awareness among physicians and patients not only through advertisements, but also through guidance materials supporting disease- or issue-awareness. While doing so, however, companies should ensure that they also take the necessary steps to avoid the risks of consumer lawsuits.

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