Originally appeared in the Winter 2016 edition of IDQ on January 14, 2016.
—By Sheila Boston and Candice Andalia
For many industries, the Internet and social media are no longer trends, but essential tools for marketing their products. However, the pharmaceutical and medical device industry has been slow to embrace these new media markets, in large part because of the uncertainty about the appropriate parameters for marketing and promoting pharmaceutical products, biologics, and medical devices in these markets. The Food and Drug Administration (the “FDA”), the agency that regulates this industry, has slowly and only incrementally issued guidance for the industry’s use of the Internet and social media for marketing and promotions. To date, the FDA’s regulation has primarily taken the form of warning letters and draft guidance documents, neither of which establishes formal policy. Without detailed regulations or finalized guidance, the scope of the FDA’s nascent Internet and social media policies is unclear and leaves open many questions for the pharmaceutical and medical device industry.
Notably, more than 72 percent of American Internet users have searched for health-related information online, searching health information portals like WebMD, social networking sites like Facebook, Twitter, and Reddit, and blogs that are home to support groups for caregivers of patients with rare and sometimes terminal illnesses. See Women More Likely to Seek Healthcare Advice Online, eMarketer.com, Feb. 21, 2013; Erin Meyer, Social media a godsend for those with rare diseases, Chicago Tribune, June 12, 2012. The numbers of the potential audience for healthcare-related information are staggering, with 900 million unique users visiting Facebook, 310 million unique visitors using Twitter, and 100 million unique visitors on Instagram each month. http://www.ebizmba. com/articles/social-networking-websites.
Given these statistics, it is almost inconceivable that the pharmaceutical and medical device industry has not taken full advantage of all of the new social media outlets available for the promotion of its products. However, the industry has failed to do so and is proceeding at a glacial pace because of the unclear regulatory dictates in the social media arena. While the patient-driven exchange of information via social media and the Internet can be educational and sometimes useful in addressing certain healthcare problems, it can also unfortunately be the source of inaccurate or inadequate information about diseases and treatment options. These inaccuracies or omissions of pharmaceutical, biologic, and medical device product risks and indications can, in turn, easily give rise to regulatory violations. Thus, the use of social media by this industry is rife with potential regulatory land mines, and the companies in the industry are justified in proceeding with great caution.
This article describes the ever-evolving regulatory landscape for pharmaceutical and medical device companies that desire to utilize the Internet and social media outlets to market their healthcare products. Although the regulation of the future use of Internet and social media in the pharmaceutical and medical device world remains uncertain, a few trends have begun to emerge that clarify some of the boundaries of the FDA’s future regulations and enforcement actions. Based on those trends, this article identifies the potential regulatory issues that may arise and provides best practices for engaging in online and social media promotional activity.
In 2009, the FDA’s Division of Drug Marketing, Advertising, and Communications (now called the Office of Prescription Drug Promotion (“OPDP”)) announced that it would regulate the promotion of medical products on social media and the Internet. See FDA, Public Hearing on the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (Nov. 12-13, 2009). Since then, the FDA has addressed a variety of specific topics including regulatory requirements for post-marketing submissions, promoting regulated prescription drugs and medical devices on platforms with character space limitations (such as Twitter), using links on the Internet, and correcting misinformation disseminated by third parties. The FDA has addressed these topics in the form of a series of draft guidance documents. See FDA, Draft Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (January 2014); FDA, Draft Guidance for Industry: Internet/Social Media Platforms with Character Space Limita-tions—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014); FDA, Draft Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014). FDA guidance documents describe the agency’s current thinking on a particular topic and are only considered to be recommendations; these documents generally do not establish legally enforceable responsibilities unless specific regulatory or statutory requirements are actually cited. Thus, it is important to review the draft guidance documents thoroughly in order to get a sense of the parameters for marketing and promoting pharmaceutical products, biologics, and medical devices.
However, because the process of drafting guidance can take years, an accurate view of the FDA’s inclinations in a particular area must take into account the regulatory letters the agency issues to companies in the industry. In this regard, the FDA has issued both warning letters and notice of violation letters (sometimes referred to as untitled letters) to pharmaceutical and medical device companies concerning activity on social media and the Internet. Warning letters are official but informal correspondence from the agency advising that it has found that a manufacturer has violated some rule in regulated activity; these letters are only issued for violations of regulatory significance, meaning that there may be an enforcement action if the documented violations are not promptly and adequately corrected. Notice of violation letters, by contrast, are initial correspondence from the agency to the regulated industry that cite violations that do not meet the threshold for a Warning letter; in other words, these letters are for instances when the FDA needs to communicate with the industry but may not wish to take enforcement action.
Together, the regulatory letters and the guidance documents provide great insight into how the pharmaceutical and medical device industry should proceed in the marketing of products on the Internet and social media platforms. A close analysis of these documents demonstrates that the FDA’s new Internet and social media policy adheres to the same standards applicable to traditional promotional media in that companies are required to provide balanced risk and benefit information in advertisements and promotional materials, and must guard against minimizing or omitting risks, overstating efficacy, making unsubstantiated claims, and suggesting off-label indications.
Letters Regarding Unsubstantiated Claims and Risk Minimization and/or Omission
Long before the FDA’s draft guidance documents were issued in 2014, the FDA issued several letters indicating that it expects Internet-based marketing to adhere to the same strictures as traditional marketing. For example, since at least 2007, the FDA has focused on ensuring that all advertising claims are supported by substantial evidence and that all safety data is properly presented. See Arnold I. Friede, Recent Warning Letters for Ads Reflect FDA’s Fixation on “Substantial Evidence,” Washington Legal Foundation, Aug. 10, 2007. This enforcement trend made the transition to social media and Internet promotions in September of 2008, when the FDA issued a warning letter to Shire Development, Inc. The FDA’s letter concerned a YouTube video featuring Ty Pennington’s endorsement of Adderall, an attention deficit hyperactivity disorder (“ADHD”) drug. Ty Pennington is a television personality and host of “Extreme Makeover: Home Edition.” In the video, Pennington stated:
Now once I got on medication it’s just amazing the transformation I made. I— it literally changed my life, and gave me the confidence to achieve my goals, like being an artist. As a kid, I never could have imagined I could do it. But with the medicines like Adderall XR, it’s truly a transformation. I mean talk about an extreme makeover, I’m like living it. Now growing up with ADHD can be a little difficult. It’s not easy to communicate with people, including your own family. So you become kind of alienated. You feel like you’re different, and you don’t really fit in. And that, well, can kind of cause you to feel different, and nobody likes to feel different. So as someone who has had ADHD, and is overcoming it, proper treatment has truly changed my life and made an amazing difference.
The FDA asserted that, by stating that the drug could “transform” lives, the video overstated the efficacy of and broadened the indication for the drug by suggesting uses that were not FDA-approved. FDA, Warning Letter to Shire Development Inc., Sept. 25, 2008. The FDA’s conclusion that Shire had overstated the efficacy and broadened the indication of its drug was based in part on materials available on Shire’s website, which discussed the consequences of not treating ADHD in teenagers and adults, including academic problems, difficulty maintaining friendships, impulsive behavior, and sexual promiscuity. The FDA concluded that the references to which Shire cited did not provide “substantial evidence” in support of these assertions. For example, Shire cited a study examining the “academic and social outcomes in young adults diagnosed with ADHD,” but failed to “study the effects of drug treatment on those outcomes.” Id. The FDA found that Shire’s claims were misleading because they implied that the drug prevented these ADHD “side effects” when there is no scientific proof of such claims. Id.
More recently, the FDA has been closely policing companies’ unauthorized health claims on social media. For example, in 2011, the FDA sent a warning letter to Nenningers Naturals, LLC for posting unauthorized health claims on the company’s Twitter account regarding a product that had not been submitted for FDA approval as a flu-prevention and relief drug. FDA, Warning Letter to Nenningers Naturals, LLC (Dec. 14, 2011).
Similarly, the following year, the FDA issued a warning letter to Quincy Bioscience regarding its promotion of a dietary supplement, Prevagen, on social media. FDA, Warning Letter to Quincy Bioscience Manufacturing Inc. (Oct. 12, 2012). The letter stated that Quincy was selling “unapproved new drugs,” rather than a dietary supplement, because it was making unverified health claims on its Facebook page (and website), including “miraculous” cures of memory loss, Alzheimer’s, and dementia. Id. The FDA also asserted that Quincy’s promotional materials failed to reflect the more than 1,000 “adverse events” amongst Prevagen users, including some that required hospitalization. Id. Then, in 2013, the FDA issued a warning letter to Oasis Consumer Healthcare, LLC
for allegedly misbranding its Halo “germ defense” product as providing protection against cold viruses and the flu in posts the company made to Twitter and Facebook. FDA, Warning Letter to Oasis Consumer Healthcare, LLC (Feb. 11, 2013). Of particular note is the fact that the FDA cited Oasis’ tweet using the website’s mobile device URL, indicating that inspectors may be ensuring compliance from their own mobile devices.
The FDA has also required companies using electronic media to follow the same rules as traditional marketing with regard to the obligation to provide accurate risk information. On April 2, 2009, the FDA issued warning letters to fourteen pharmaceutical manufacturers for their use of “sponsored links,” a type of short advertisement with a web link that appears on search engine result pages. The sponsored links ran afoul of the FDA’s regulations because the ads did not contain any risk information whatsoever. Although the risk information was available at the manufacturers’ websites, to which users could navigate by clicking the provided web link, the FDA’s warning letters dictated that this design was insufficient to comply with FDA regulations requiring promotional materials to include risk information as necessary to qualify any claims made about the drug or product being promoted.
Draft Guidance and Enforcement Regarding Company Promotional Activity on Its Own and Third-Party Social Media Accounts and Websites
In January of 2014, the FDA issued draft guidance addressing the degree to which companies are responsible for content generated and posted on company social media platforms, as well as that generated and posted outside of the companies’ own websites, social media pages, or feeds. The draft guidance, entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, outlines three categories of interactive promotional media in which companies are considered responsible for content and, accordingly, must file submissions with the OPDP of the FDA for review and approval.
First, a company is responsible for interactive promotional media it submits beyond its own website or sponsored blog. Therefore, a company bears responsibility for “product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of” the company, such as the company’s Facebook page, Twitter feed, Pinterest board, Snapchat advertisements, or other social media accounts. Second, a company may be responsible for the content on third-party sites if the company has control or influence over the site or content, including editorial, preview, or review privileges, even if the influence is limited in scope. Although limited influence is enough to trigger the company’s obligation to file submissions with the FDA, the company must provide more than mere financial support to the site. Third, a company is responsible for content created by an employee or agent acting on its behalf to promote its drug, device, or product, including postings on Facebook, Twitter, a blog, or even responses to consumer questions on a discussion board, even if these forums are not controlled by the company. Notably, the FDA will not hold companies accountable for third-party user-generated content posted to a site solely controlled by the third-party.
Finally, the FDA’s draft guidance counsels that a company should submit an updated listing of all sites for which the company is responsible or in which it actively participates, with interactive or real-time communications that do not restrict visitor or user access. However, because the FDA does not require manufacturers to report all real-time communications in separate submissions to the agency, it is likely that the FDA will independently monitor manufacturers’ real-time promotional communications by reviewing the listed sites. This also suggests that the FDA will increase enforcement of this type of media going forward.
Just one month after the release of the draft guidance, the FDA sent a warning letter to Institut Biochimique SA & Akri-max Pharmaceuticals, LLC (“IBSA”) alleging that the company’s Facebook page for the prescription drug, Tirosint, violated the FDA’s promotional labeling requirement because IBSA had failed to disclose any risks associated with Tirosint. FDA, Warning Letter to Institut Biochimique SA & Akrimax Pharmaceuticals, LLC (Feb. 24, 2014). Tirosint is a medication for hypothyroidism, and its product label contains a black box warning, the highest form of warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of a serious hazard related to the use of the drug. As IBA’s Facebook page contained no references to risks, including the relevant black box risk for the medication, the OPDP considered the company’s Facebook post to be misleading because it “suggest[ed] that Tirosint is safer than has been demonstrated.” Id.
Acknowledging that pharmaceutical and medical device companies face additional and unique challenges on social media platforms that have limited character spacing (such as Twitter, Instagram, and Snapchat), the FDA also released draft guidance in June 2014 titled, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The agency reiterated that social media promotions must adhere to the “fair balance” requirement applicable to traditional media:
[r]egardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
Id. The draft guidance also indicates: risk information should be presented together with benefit information within each individual character-space-limited communication.... the content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product (i.e., all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling).
Id. The post must also include the brand and generic name of a medicine.
In an effort to provide additional guidance, the FDA offered an example of a compliant tweet for promoting a pharmaceutical product. That sample tweet included information about a medication that treats memory loss; the medication’s brand name is NoFocus and its generic name is rememberine HCL. The compliant tweet stated: “NoFocus (rememberine HCL) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk.” The example uses 134 characters of Twitter’s 140-character limit. The tweet includes both the generic name and the brand name of the medication. Moreover, it conveys not only the benefit of the medication (e.g., to treat mild to moderate memory loss), but also provides risk information (e.g., seizures as well as other risks that are available for review at the provided website link). Notably, the FDA draft guidance acknowledges that requiring risk information this complete could eliminate character-restricted platforms as a promotional tool for many drugs and products, explaining that if an “accurate and balanced” presentation of both the risks and benefits is not possible within the constraints of a specific platform, the company should not use that platform. Id.
In August of this year, the FDA took enforcement action based on this draft guidance when the OPDP issued a warning letter to Duschesnay based on reality television star Kim Kardashian’s social media posts in Facebook, Twitter, and Instagram regarding her celebrity endorsement of Diclegis. FDA, Warning Letter to Duchesnay (Aug. 7, 2015). Kardashian tweeted that she was was “partnering with Duchesnay USA to raise awareness about treating morning sickness.” Id. The tweet linked to an Instagram post, which read:
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad, so I talked to my doctor. He prescribed me #Diclegis, I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with the results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafety.info.com.
The OPDP flagged the posts as false and misleading because they presented efficacy claims for Diclegis without communicating any risk information associated with its use, material information regarding the drug’s full approved indication, or important limitations of use. According to the OPDP, the social media posts not only misbranded Diclegis, but also raised serious concerns from “a public health perspective because they suggest that Diclegis is safer than has been demonstrated.” Id. The agency noted that the posts were particularly misleading because they failed to convey that Diclegis had not been studied in women with an extreme, persistent, and potentially life-threatening type of morning sickness called “hyperemesis gravidarium.” Id.
Consistent with the draft guidance, the FDA held Duchesnay responsible for Kardashian’s social media posts because the agency concluded that she was acting as an agent and/or on behalf of Duchesnay in publishing the posts about Diclegis. See FDA Postmarketing Interactive Promotional Media Guidance at 4. Furthermore, although her posts included a link to the drug’s safety information on the manufacturer’s site, OPDP warned that the links did “not mitigate the misleading omission of risk information” because potential risks were not covered in the content she published. Id.
Significantly, Kardashian’s Facebook post did not have space or character limitations and her submission to Instagram only used 424 of her 2200 character limit on that platform. Thus, her posts on those two platforms could have included the necessary risk information required by the FDA. OPDP directed Duchesnay to cease this promotional activity immediately; list all promotional materials for Diclegis that contain presentations such as those that prompted the warning letter; and explain its plan for discontinuing use of these materials or, in the alternative, for ceasing distribution of Diclegis. And because the FDA had previously warned Duchesnay in 2013 (for announcing the FDA’s approval of the drug without including any risk information), the FDA required Duchesnay to “include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.” Id. This enforcement action indicates that a company facing similar FDA action may be required to issue corrective social media posts in order to cure the violation.
Draft Guidance Regarding Misinformation Disseminated by Independent Third-Parties on Electronic Media
The Internet has sometimes been called “the great equalizer” in that it is virtually accessible to anyone and everyone. However, due to the widespread and rampant accessibility of the Internet and other social media outlets, there are plenty of opportunities for the dissemination of inaccurate data regarding drugs, biologics, and medical devices. Because there is so much information that circulates by electronic media, healthcare product manufacturers often cannot and do not control all of the information about their products that is disseminated by third parties. Although the FDA does not typically require a company to correct misinformation about its products that was spread by an independent third-party, there are some exceptions. Those exceptions are outlined in the FDA’s draft guidance, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” (the “Correcting Misinformation Draft Guidance”). FDA, Draft Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014).
One exception is that if a company has a certain measure of control over the information generated and disseminated by a third-party, then the company has an obligation to correct the misinformation. More specifically, the draft guidance states that a company has such an obligation if it is responsible for “communications that are owned controlled, created, influenced, or affirmatively adopted or endorsed by, or on behalf of, the firm.” Id. Furthermore, if a company owns or operates the platform or created or initiated the forum on which the independent third-party generated content appears, the company should include a clear statement that the firm did not create or control the user-generated content. (Interestingly, by contrast, monitoring a forum for profanity and obscenity does not trigger a company’s responsibility for third-party content.)
Another exception is that when a company chooses to correct information over which it does not have any control, then the company must comply with the steps outlined in the draft guidance to correct the information. More specifically, a company choosing to correct independent third-party information about its products must post corrective information in conjunction with the misinformation in the same area or forum as the misinformation. A company that does not have permission to post on the forum can issue a correction and identify the source and location of the misinformation. To that end, the company must clearly identify the misinformation it is correcting, define the scope of the forum to which the correction applies, and correct all of the misinformation appearing in the identified forum.
Moreover, the guidance document appears to intimate that it is important for a company to guard against the inclusion of advertising in its correction of independent third-party information. This content falls outside the scope of the draft guidance and must comply with applicable regulatory requirements for labeling and advertising.
Alternatively, to correct misinformation a company may also request that the author or site administrator remove the misinformation or allow comments to be posted. In these circumstances, the FDA will not hold a company responsible for the independent third-party’s subsequent actions or lack of action. Finally, the draft guidance recommends that companies keep records of their efforts to correct misinformation, including records of the content in the misinformation, the date the misinformation was posted or noticed, the forum to which the misinformation was posted, and the corrective information provided by the company.
Hence, companies choosing to address independent third-party misinformation must remain cognizant of the nuances required by the FDA when issuing such corrective information.
Although the draft guidance documents and corresponding enforcement actions have clarified many of the parameters for social media promotion, there are still areas of uncertainty. For example, the FDA has not clarified whether “liking,” “retweeting,” or “sharing” a third party’s post gives a company “control or influence” over a third-party’s website. However, a recent warning letter indicates that the FDA does consider “likes” to be a promotional activity. For example, the FDA issued a warning letter to AMARC Enterprises, a dietary supplement company, for “liking” a consumer’s testimonial on the Facebook page for Poly MVA. FDA, Warning Letter to AMARC Enterprises, Inc. (Dec. 11, 2012). The testimonial read, in part, “Poly MVA... enabled me to keep cancer at bay without the use of chemo and radiation.” According to the FDA, AMARC’s “like” of the unapproved claim was a violation of FDA guidelines. Id.
Second, the FDA’s guidance leaves open the issue of liability faced by drug and device companies for “failure to warn” claims. As the draft guidance currently stands, it may be possible for a company complying with the FDA’s draft guidance on advertising on social media to face liability over its labeling if, for example, its tweet covers only its product’s most significant risk, rather than a complete list of risks. In addition to product liability litigation, social media advertising raises the issue of competitors being able to bring suit under the Lanham Act (15 U.S.C. §1525). This law provides a private right of action for a company to sue a competitor for any false or misleading description or representation of fact that, “in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services or commercial activities.” Companies face potential Lanham Act liability for claims such as risk minimization, the broadening of indications, overstating efficacy, and making comparative claims in the absence of supporting evidence.
Finally, because the draft guidance compels drug and medical device companies to include detailed risk and benefit information in their commercial speech, there is also a possibility that companies’ social media speech is so constrained that it may be chilled—giving rise to potential First Amendment claims.
Companies should design flexible social media policies that can change in response to additional guidance and/or regulations. In developing its policy, a company should choose its Internet and social media platforms carefully. Companies should work with outside counsel to design internal policies for employees posting about products in order to ensure that they comply with the FDA’s restrictions and recommended submission methods. Central to the process will be procedures for internal review, auditing, and monitoring of employee messages, statements, “likes,” “retweets,” and “shares” regarding drugs and other medical products.
It is also important to integrate the social media policies into contracts with agents and celebrity spokespeople in order to ensure that their messages, statements, “likes,” “retweets,” and “shares” regarding company products comply with the FDA’s restrictions and recommended submission methods. The social media posts of celebrity spokespeople should be internally developed and vetted, and then monitored after publication. A company’s agreement with a celebrity spokesperson should also incorporate provisions for releases of liability, indemnification, and compensatory and punitive damages. These terms may better insulate the company from the repercussion of a potential enforcement action in the event a spokesperson goes off script and runs afoul of the FDA’s regulations.
A company should also put in place mechanisms for tracking the websites and platforms on which employees, agents, and spokespeople post messages or statements about drugs, biologics, and medical devices. This will help the company ensure that posts comply with the FDA’s restrictions and will enable the company to submit all representative interactive promotional materials to the FDA. Monitoring third-party content on company sites and pages is also advisable.
In order to minimize potential product liability, the Lanham Act, and off-label marketing claims, companies should limit social media to the dissemination of non-promotional information and/or neutral scientific medical information only. With particular regard to requests for off-label information, companies should exercise caution in responding and should make certain that records of all requests and responses are maintained. Because discussion groups are difficult to control within the strict parameters of the FDA’s draft guidance, companies should prohibit discussion groups on their own websites and forums.
In addition, companies should limit social media advertising to those drugs, biologics, and medical devices that have few risks and clearly defined patient populations. Also, it is of particular importance that companies ensure that direct-to-consumer content is only available for consumers in the United States, since this kind of advertising is generally not legal in other jurisdictions or countries. And finally, the most cautious course of action would be for a company’s electronic and social media communications manager to work with in-house and outside counsel to craft individual Internet content and social media posts.
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