Practice Tip: Internet Market Promotion of FDA-Regulated Products and Product Liability

Yes, I am what some refer to as a “crackberry addict.” However, as my wife constantly reminds me, particularly during dinner, weekends, and “vacation” visits to her family in Maryland, there must be limits. This rang true for me recently.

We live in the digital age. We want instant interaction and immediate response. A client asked me a few weeks ago to co-present at a conference about liability and regulatory concerns associated with the use of digital media. The audience is expected to be representatives from pharmaceutical and medical device companies and for-profit digital media providers that approach these FDA-regulated industries to sponsor, or help the companies sponsor, programs, Webcasts, or Web sites that focus or discuss disease states, therapeutic treatments, or even specific company products. While I had heard of Web 2.0 in the past, no one who knows me would confuse me with an IT specialist. However, now I was asked to speak on the legal ramification of using the World Wide Web as a marketing tool to promote medical products.

Everyday, our law firm advises companies concerning the FDA and fraud- and abuse-related legal and regulatory issues. For example, we counsel on the use of the regulatory implications of Internet promotion, such as providing truthful and complete labeling information to comply with FDA requirements. However, there are liability considerations when companies use the Internet to facilitate communications about their products through chat rooms or blogs. This article focuses on product liability issues, although companies must also consider FDA and state regulatory laws, False Claims Act, competitor complaints and individual liability issues, before initiating Internet promotional programs.

Web Very Carefully

When a company promotes or educates on its Web site or engages a third party to promote or educate about a specific product, the ultimate user, whether a doctor or patient, relies on the accuracy of the information presented. Therefore, if the material provided is about an unapproved use or is false or misleading, and an injury results due to this presentation of data, a company exposes itself to a product liability risk. Based on case law, the risk may increase when the communication is directed to consumers, because the learned intermediary doctrine provides little protection. (The so-called “learned intermediary” doctrine for prescription drugs and restricted devices, whereby only the physician need be warned about risks associated with use of the prescription drug or device, may be in the process of change.)

One area that continues to surface is the use of chat rooms, blogs, and other venues by which users of the Web site, whether the company's or a third-party site supported by the FDA-regulated company, can exchange experiences about medical treatments, comment on the company or competitor's products, or otherwise share information. Some companies may provide such forums on their own Web sites to amass the information for market research or generate goodwill. Other companies may engage a third-party site to control the dissemination of information and even disclaim responsibility for the content by giving an unrestricted grant and allowing the third party to run and control the information posted on the Web site.

Regardless of the arrangement, if a company either directly or indirectly controls the dissemination of information, or creates a forum, such as a blog, extranet, social networking site, or chat room where product information is communicated, and the information is false, misleading, or unapproved, it opens the door for a party to sue for injury. An injured party, represented by a plaintiff's lawyer, will likely allege that, but for the company-sponsored or provided forum and the erroneous information presented, the patient would not have suffered harm. (On a related note, if a drug company, for example, provides on its Web site an open forum discussion, and it learns of an adverse event by a participant through the Web site, it might have a regulatory obligation to investigate and, perhaps, report the incident to FDA. While such a notification to FDA is not an admission of guilt, the report is made publicly available and could be used by a plaintiff's attorney to demonstrate causality and injury. See, e.g., 21 C.F.R. ” 314.80-.81.)

What Is a Company to Do?

With every marketing or educational effort, the facts of the program will dictate whether these are regulatory or liability risks.

One: 'Hands Off'

In a case where the company is actively providing and supporting the dissemination of information, the company is responsible for the content of the information. Therefore, the more company involvement, the more exposure. Conversely, the less the company involvement or direction, the less exposure. The author appreciates the company's commercial interests in controlling this “open” forum, but this article focuses on potential risks.

Two: No Online Discussion

Many companies decide not to allow online discussion on their Web sites where non−company-reviewed materials are presented. The liability, regulatory, and other concerns previously identified dissuade such proactive dissemination. Some companies might give an unrestricted grant to a third- party company, such as unaffiliated patient advocacy group sites, to create a Web site that provides information on disease states, potential treatment options, and medical education. The drug or device company may have its name associated with the Web site to create goodwill, but it leaves all content decisions to the third party and typically the Web site contains a disclaimer statement that the drug/device company is not responsible for the content or monitoring the site. In many respects, this approach follows the FDA's Continuing Medical Education Guidelines, and as a result, the FDA is less likely to regulate a non-promotional, independent educational event. (See Guidance for Industry: Industry-Supported Scientific and Educational Activities (1997).

Three: Extranets

There are some companies that have created extranets or portals by which doctors may be given access, through passwords or specified codes, to certain information on the company Web site. In some cases, those with access may engage in disease discussion or product-specific communications. Such an approach has potential risks, for example allowing doctors to access potentially volatile information, not properly controlling access so that patients, competitors, or government officials may participate, and possibly requiring the company to constantly monitor the blogs or chat rooms.

Which Is Best?

In the author's opinion, from a regulatory and liability perspective, Option Two, i.e., the hands-off-approach, is preferable. While there is always the risk that an injured party might try to sue for some injury, a company that can demonstrate it had no ' or minimal ' role in the information dissemination likely minimizes exposure. The causation event needed to demonstrate culpability seems absent. In contrast, a company will have a difficult argument that it should not be accountable for an injury caused by false or misleading information if its “fingerprints” (e.g., control or content, hosting discussion forum on company Web site, restricted grants to third-party sites where the company is the only therapeutic treatment discussed) are present.

Conclusion

Companies continue to evaluate programs by which they can educate and promote their products, amass market research, and learn more about their target audience. However, with any potential benefits that might arise, companies must also consider and balance the risks, including those in the product liability area.

Alan Minsk, a member of this newsletter's Board of Editors, is a Partner at Arnall Golden Gregory LLP, Atlanta.

Yes, I am what some refer to as a “crackberry addict.” However, as my wife constantly reminds me, particularly during dinner, weekends, and “vacation” visits to her family in Maryland, there must be limits. This rang true for me recently.

We live in the digital age. We want instant interaction and immediate response. A client asked me a few weeks ago to co-present at a conference about liability and regulatory concerns associated with the use of digital media. The audience is expected to be representatives from pharmaceutical and medical device companies and for-profit digital media providers that approach these FDA-regulated industries to sponsor, or help the companies sponsor, programs, Webcasts, or Web sites that focus or discuss disease states, therapeutic treatments, or even specific company products. While I had heard of Web 2.0 in the past, no one who knows me would confuse me with an IT specialist. However, now I was asked to speak on the legal ramification of using the World Wide Web as a marketing tool to promote medical products.

Everyday, our law firm advises companies concerning the FDA and fraud- and abuse-related legal and regulatory issues. For example, we counsel on the use of the regulatory implications of Internet promotion, such as providing truthful and complete labeling information to comply with FDA requirements. However, there are liability considerations when companies use the Internet to facilitate communications about their products through chat rooms or blogs. This article focuses on product liability issues, although companies must also consider FDA and state regulatory laws, False Claims Act, competitor complaints and individual liability issues, before initiating Internet promotional programs.

Web Very Carefully

When a company promotes or educates on its Web site or engages a third party to promote or educate about a specific product, the ultimate user, whether a doctor or patient, relies on the accuracy of the information presented. Therefore, if the material provided is about an unapproved use or is false or misleading, and an injury results due to this presentation of data, a company exposes itself to a product liability risk. Based on case law, the risk may increase when the communication is directed to consumers, because the learned intermediary doctrine provides little protection. (The so-called “learned intermediary” doctrine for prescription drugs and restricted devices, whereby only the physician need be warned about risks associated with use of the prescription drug or device, may be in the process of change.)

One area that continues to surface is the use of chat rooms, blogs, and other venues by which users of the Web site, whether the company's or a third-party site supported by the FDA-regulated company, can exchange experiences about medical treatments, comment on the company or competitor's products, or otherwise share information. Some companies may provide such forums on their own Web sites to amass the information for market research or generate goodwill. Other companies may engage a third-party site to control the dissemination of information and even disclaim responsibility for the content by giving an unrestricted grant and allowing the third party to run and control the information posted on the Web site.

Regardless of the arrangement, if a company either directly or indirectly controls the dissemination of information, or creates a forum, such as a blog, extranet, social networking site, or chat room where product information is communicated, and the information is false, misleading, or unapproved, it opens the door for a party to sue for injury. An injured party, represented by a plaintiff's lawyer, will likely allege that, but for the company-sponsored or provided forum and the erroneous information presented, the patient would not have suffered harm. (On a related note, if a drug company, for example, provides on its Web site an open forum discussion, and it learns of an adverse event by a participant through the Web site, it might have a regulatory obligation to investigate and, perhaps, report the incident to FDA. While such a notification to FDA is not an admission of guilt, the report is made publicly available and could be used by a plaintiff's attorney to demonstrate causality and injury. See, e.g., 21 C.F.R. ” 314.80-.81.)

What Is a Company to Do?

With every marketing or educational effort, the facts of the program will dictate whether these are regulatory or liability risks.

One: 'Hands Off'

In a case where the company is actively providing and supporting the dissemination of information, the company is responsible for the content of the information. Therefore, the more company involvement, the more exposure. Conversely, the less the company involvement or direction, the less exposure. The author appreciates the company's commercial interests in controlling this “open” forum, but this article focuses on potential risks.

Two: No Online Discussion

Many companies decide not to allow online discussion on their Web sites where non−company-reviewed materials are presented. The liability, regulatory, and other concerns previously identified dissuade such proactive dissemination. Some companies might give an unrestricted grant to a third- party company, such as unaffiliated patient advocacy group sites, to create a Web site that provides information on disease states, potential treatment options, and medical education. The drug or device company may have its name associated with the Web site to create goodwill, but it leaves all content decisions to the third party and typically the Web site contains a disclaimer statement that the drug/device company is not responsible for the content or monitoring the site. In many respects, this approach follows the FDA's Continuing Medical Education Guidelines, and as a result, the FDA is less likely to regulate a non-promotional, independent educational event. (See Guidance for Industry: Industry-Supported Scientific and Educational Activities (1997).

Three: Extranets

There are some companies that have created extranets or portals by which doctors may be given access, through passwords or specified codes, to certain information on the company Web site. In some cases, those with access may engage in disease discussion or product-specific communications. Such an approach has potential risks, for example allowing doctors to access potentially volatile information, not properly controlling access so that patients, competitors, or government officials may participate, and possibly requiring the company to constantly monitor the blogs or chat rooms.

Which Is Best?

In the author's opinion, from a regulatory and liability perspective, Option Two, i.e., the hands-off-approach, is preferable. While there is always the risk that an injured party might try to sue for some injury, a company that can demonstrate it had no ' or minimal ' role in the information dissemination likely minimizes exposure. The causation event needed to demonstrate culpability seems absent. In contrast, a company will have a difficult argument that it should not be accountable for an injury caused by false or misleading information if its “fingerprints” (e.g., control or content, hosting discussion forum on company Web site, restricted grants to third-party sites where the company is the only therapeutic treatment discussed) are present.

Conclusion

Companies continue to evaluate programs by which they can educate and promote their products, amass market research, and learn more about their target audience. However, with any potential benefits that might arise, companies must also consider and balance the risks, including those in the product liability area.

Alan Minsk, a member of this newsletter's Board of Editors, is a Partner at Arnall Golden Gregory LLP, Atlanta.