Answer: To be a viable going concern today, it is almost mandatory that companies have websites. Most life sciences companies do have websites, often featuring their product offerings and even instructions for product use. This is important because research demonstrates that a majority of people turn to the web first when looking for health information. While being potentially valuable sources of health information, company websites and the content therein can also have serious regulatory and liability implications.
Though drug and device manufacturers are keenly aware that their labels and warnings must be submitted to the FDA and are subject to the Agency’s oversight, companies may not be aware that FDA’s purview extends to companies’ online presence and website marketing materials as well. Despite not requiring submission or approval of website content prior to its publication, the FDA still scrutinizes and content and it can certainly be the basis for agency disciplinary action or worse.
Too often, the product listing or product information on life-sciences companies’ websites do not comport with the approved product list or information they have filed with the FDA. The most common, and substantial, mistake medtech companies make is treating their websites like marketing venues rather than regulated sources of product information. This often occurs because a company’s marketing personnel, who may have the website in their charge, are not in communication with the company’s quality assurance/regulatory affairs personnel (QA/RA) or legal counsel.
Websites cannot feature products without providing full risk disclosures required by the FDA to accompany other product literature. The FDA requires that medtech companies provide labeling for drugs and medical devices including their contraindications, appropriate warnings and precautions, and information about adverse reactions from use of the drug or device. In the absence of specific FDA guidance, medtech companies should ensure that they are also providing all of this information on their websites. In other words, life sciences companies should interpret the same guidances and regulations that the FDA has published in regard to advertising and marketing materials as also applying to their own websites and online product catalogues.
Misleading Photographs or Portrayals
Another common mistake is to feature photographs or pictograms implying the use of the drug or device in circumstances or by users for which the drug or device is not FDA approved. For instance, a company website might feature a photograph depicting an attractive teenage girl using a company’s product. This can be problematic if the drug or device has only been approved for adults.
Banner or Billboard Ads
It is also increasingly common for medtech companies to advertise online, often in the form of banner or “billboard” ads that appear at the top or side of other website. An inherent problem of such advertisements is their small size, which may not permit the display of all user warnings and contraindications. Rather than omitting this data, companies would be wise to opt out of this kind of advertising, or else to advertise their brand—which does not require risk disclosures—rather than their specific products, which do.
Social Media Implications
Company websites and online advertising are not the sole sources of potential liability on the internet—companies’ social media presence is also becoming increasingly scrutinized by the FDA. This has been particularly true of company Facebook pages. Company pages on Facebook feature virtual “walls” on which the company and individual Facebook users can post information, reviews, messages, news, etc. Information posted by companies on their Facebook pages can have the very same ramifications as information posted on their official websites. That is, information the company posts on its Facebook page that differs from the FDA-approved content of its warnings, labels, and product uses can certainly be the subject of FDA enforcement action and may be deemed to be adulteration or off-label promotion.
While this Facebook page-company website parallel may be somewhat obvious, what is especially unique to company Facebook pages is that individuals can post on them. In past years, this was not a problem because Facebook allowed companies the ability to delete individual posts for any reason. Unfortunately, many felt this led to a misrepresentative picture of product effectiveness as companies would often delete only negative reviews of their products. For this and other reasons, Facebook changed its rule last year and mandated “open walls” on company pages, meaning that anyone could post and companies could not delete user posts. This has presented companies with another problem. Users are free to post about the successes of on and off label uses of the company products, and companies no longer have the ability to delete specific posts.
This problem became a basis for a Warning Letter for one company recently. The Warning Letter, issued in January, cited a laundry list of instances that FDA concluded were off-label promotion, including the posting of testimonials on the company’s website that touted product success for an off-label use. The company’s conduct on Facebook further bolstered the FDA’s account of off-label promotion. According to the Warning Letter, the company had “liked” (a Facebook feature in which one user can give a virtual “thumbs up” to another user’s content) a user’s post that claimed that one of the company’s nutritional supplements as having kept his cancer at bay. This Letter would indicate that the Agency viewed the company's action of “liking” as affirmatively endorsing the post’s content and thus engaging in off-label promotion.
In addition to off-label promotion, a company website or social media page can be a new portal of access to the company. As such, such sites may be the unintentional recipient of users’ adverse event reports. If a user reports an adverse event on a company’s Facebook page, the company will likely be deemed to have notice of that event and thus require an appropriate CAPA in response. If this event becomes a bigger problem down the road and it was not followed up on appropriately, the company may face with both regulatory and liability consequences.
Products Liability Repercussions
The FDA’s scrutiny and regulatory action are not the only potential consequences of improperly maintained medtech company websites. Companies’ websites can also be a significant source of products liability, often laying the groundwork for failure-to-warn claims.
Erosion of Learned Intermediary Doctrine
First, advertising online and communicating directly to consumers through a website or social media presence can erode the protections of something called the Learned Intermediary Doctrine, which can be a substantial protection for the makers of prescription drugs or devices against failure-to-warn claims. This is because the Doctrine holds that for prescription drugs and devices, patients’ physicians should be their principle source of product usage advice and warnings, and not the products' manufacturers. Thus, under the Doctrine, patients cannot maintain failure-to-warn claims against manufacturers. However, the Doctrine assumes that the physician is the patient’s primary source of product information, and when a manufacturer takes steps to fill that role, and provide product information directly to the consumer—for instance through their websites or social media— several courts have ruled that manufacturers thereby erode the viability of the Doctrine.
Failure to Warn Claims
The other way medtech companies’ online presence can translate to products liability is in providing insufficient or false product information. Patients and consumers are not the only ones that may view and access information on company websites; physicians may also reasonably expect to obtain product information there. The Learned Intermediary Doctrine can only be asserted where the company has satisfied its warning duty to the physician, and provided those who can prescribe the drug or device with all the necessary information (approved by the FDA) to use their medical expertise in deciding whether to prescribe the drug or device. Where this information is inadequate or incomplete, the company may be liable.
After the Fact
Even if the company website was not the first or only source of product information for the doctor or consumer (the plaintiff), it may still be used as evidence in a products liability trial as an indication of general company practices, including regulatory compliance (or lack thereof) and levels of transparency. If a company has not been very careful about its website content and social media interactions, plaintiffs can use small portions of a company’s website, or a comment made on a social media site, to paint a derogatory picture of the defendant company.
Risk Management Tips
- Make sure there is quality assurance/regulatory affairs (QA/RA) and/or legal oversight of website content, and that the marketing department is either versed in the Quality System Regulations (QSR) and other applicable components of the Food, Drug and Cosmetic Act (FDCA), or is in frequent communications with someone who is. Website content should be approved by QA/RA prior to publication for regulatory compliance and products liability implications.
- Do not feature any product without its accompanying full risk disclosures.
- If presenting the product in an advertisement with a person, only use a person whose age, gender, and general health is reflective of the population for which the drug or device is approved and intended to be used.
- Implement a social media policy for all employees. In the policy, address whether and what kind of social media presence the company will have, designate particular individuals in the company who will be the only ones transmitting information on social media sites, and outline procedures for addressing negative reviews, reports of adverse events, and false or misleading information.
Kathleen D. Wilkinson is a partner in the Philadelphia office of Wilson Elser, LLP.
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