HomeWebcastFDA’s Off-Label Information: A 2013 Update
 CLE

FDA’s Off-Label Information: A 2013 Update

Live Webcast Date: Tuesday, April 16, 2013 from 12:00 pm to 2:00 pm (ET)
Legal (CLE)Recording

Join us for this Knowledge Group Webinar. FDA’s Off-Label Information: A 2013 Update Webcast is a must attend event for healthcare and pharmaceutical companies seeking to understand compliance with FDA’s off-label regulations. Our panel of key thought leaders and practitioners will conduct a thorough discussion of the most critical issues, including:

  • Off-Label’s current regulatory environment: Where are we now and what to expect in the future?
  • Impact of FDA’s Off-Label Guidance to the industry
  • Pros and Cons of sharing Off-label information in social media
  • How to Respond to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
  • Lessons learned in recent cases
  • Up-to-the-minute regulatory update

Agenda

SEGMENT 1:
Nick Repucci, Manager, 
Dentons US LLP

  • The legal and regulatory issues that form the basis for the high-dollar settlements that we are seeing in the popular press have a long and deep-rooted history that dates back to the early years of the regulation of medicine in the United States.
    • The 2nd U.S. Circuit decision in United States v. Caronia may mark the tipping point of a judicial trend that could undermine the FDA’s ability to enforce the misbranding provisions of the FDCA. (This isn’t the first time we’ve seen the First Amendment used to thwart the Agency’s efforts to rein-in fraudulent promotional activities, and it certainly won’t be the last.) Still, companies should tread cautiously, as the law is not yet settled.
  • High-award, high-profile False Claims Act settlements, corporate integrity agreements, and threats of exclusion from participation in federal health care programs are ineffective strategies for deterring pharmaceutical companies from promoting their products off-label.
    • FCA prosecution (related to off-label promotion) has become an unfortunate but inevitable consequence of doing business.
    • United States v. Caronia provided the much needed incentive to the FDA to reconsider the goals of enforcement and to realize other means and incentives for achieving compliance.
  • For decades, the FDA has said that companies can respond to unsolicited requests for off-label information with “truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request,” without subjecting their products to the strict regulatory requirements for promotional labeling or advertising.
    • The FDA’s latest draft guidance, “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (December 2011), does not deviate from the Agency’s long held position. Merely, it explains in detail the FDA’s recommendations for responding to each type of request for off-label information –”non-public” and public, including through emerging social media.
      • In summary, regardless of where the unsolicited request for off-label information was made—in a non-public or public forum—the FDA recommends that a company only provide the requested off-label information about its product to the specific individual who requested the information in a private, one-on-one communication.

SEGMENT 2:
C. Scott Jones, Partner, 
Locke Lord LLP

  • Focusing on recent state court trials under individual States’ false claims act / Medicaid fraud prevention statutes, I will discuss the anatomy of a government lawsuit involving claims and allegations of off label promotion totaling in some instances more than $1 billion in damages and penalties.
  • “Call Notes and Business Plans – The Devil’s Tool.” The methods by which plaintiffs/relators and governments attempt to marshal evidence of off-label promotion so as to construct a large multiplier which can then be applied to a statutory penalty range so as to yield staggering awards, which may also then be used to bully a defendant into settling.
    • Plaintiffs’ use of “experts” to summarily present massive volumes of call notes in a compendium format so as to support huge penalty awards.
    • Ways to attempt to exclude call notes from evidence, or to otherwise undermine an expert’s “reliance” on them in rendering his or her opinions.
    • Plaintiffs’ mischaracterization and misuse at trial of business or marketing plans – many of which may have been generated before a product’s launch,or before an anticipated label change.
    • Evaluating whether to conduct a direct examination of one’s own witnesses during a deposition (e.g., sales representatives).
    • A sales representative’s focus on a product’s “favorable” side effects – Does such communications constitute off label promotion?
  • “Wolf in Sheep’s Clothing.” With the FDA’s Guidance, there remains ambiguity as to what constitutes an “unsolicited request” for off label information. Plaintiffs have attempted to exploit this uncertainty by arguing that ostensibly non-promotional events, such as advisory boards or continuing medical education symposia, are simply “dressed up” promotional events. In addition and in the alternative, plaintiffs have argued that the nature of these events (invitees are paid an honorarium to listen to presenters discuss off label information about a product, albeit in a “non-promotional” setting) serves to eviscerate the otherwise “unsolicited” nature of any follow-up requests for information.
    • Example – prescriber attends a company-sponsored advisory board put on by a third-party. Following the presentation, that prescriber calls the company’s medical affairs / scientific liaison “hotline” to request additional off label information. Some plaintiffs have argued that this sequence of events transforms an otherwise unsolicited request into one which the company has solicited.
  • “No Good Deed Goes Unpunished.” A company’s sponsorship of treatment guidelines or similar protocols, which culminates in a sponsor’s product being placed in a “preferred” position (or culminates in the product being listed on state’s preferred drug list because it is featured on the treatment protocol) has been exploited by plaintiffs. Specifically, plaintiffs have argued that such placement is the result of the company’s financial support and/or provision of company-sponsored, off-label studies, which, plaintiffs argue in turn conveys the “false or misleading” impression that the “preferred” product is superior to other, similar products.

SEGMENT 3:
Erik W. Snapp, Partner, 
Winston & Strawn LLP 
Off-Label’s current regulatory environment: Where are we now and what to expect in the future?

  • Lessons learned from recent settlements and FDA enforcement actions
    • While some hope the Caronia decision marks an end to off-label prosecutions, FDA, DOJ and HHS do not seem to think so. An FDA official speaking at a conference in late January indicated that the Caronia decision will not change the Agency’s enforcement activities. A DOJ official speaking at the same conference stated that misbranding prosecutions remain an enforcement priority. How important are these prosecutions to the federal government? DOJ and HHS reported in February that they recovered over $3.0 billion in health care fraud settlements in their last fiscal year, the vast majority of which was a settlement with GSK of off-label promotion and other allegations.
    • FDA’s Office of Prescription Drug Promotion (“OPDP”)(formerly the Division of Drug Marketing, Advertising and Communications or “DDMAC”) oversee thousands of ads every year, and must out of necessity prioritize certain categories of ads for further review. OPDP officials have stated that its priorities include ads involving drugs with significant risks, products subject to past violations, products subject to complaints, and newly approved products. Recent enforcement letters show the types of promotional activities drawing OPDP scrutiny.
    • Perhaps due to the sheer volume of ads it oversees, the FDA in 2010 implemented a “Bad Ad” Program in 2010. Through that program, FDA encourages health care providers to report false or misleading drug advertising and promotional materials. FDA has received hundreds of reports from HCPs and has issued enforcement letters stemming from some of those reports. With thousands of medical professionals helping FDA to police promotional activities, strong compliance programs are more important than ever.
    • The government relies on the responsible corporate officer doctrine, or “Park Doctrine,” as a way of deterring violations of and encouraging compliance with the FDCA. As applied by the FDA in its Procedures Manual, corporate officers can be charged with a first time misdemeanor “without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.” Participation in the violation – or even knowledge of it – can be relevant factors in the government’s decision to prosecute, but are not a prerequisite for prosecution. Recent cases show how the government has sought to apply the Park Doctrine.
    • Recent settlements involving off-label promotion allegations demonstrate the types of promotional activities attracting government scrutiny, and illustrate new approaches to corporate integrity agreements and probation provisions.

SEGMENT 4:
Jonathan Berman, Partner, 
Jones Day 
The Caronia Case, Mark Twain, and Off-Label Promotion

  • In Caronia, the Second Circuit “construe[d] the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” Even before the decision issued, the government had conceded that “promoting an approved drug for off-label uses is not itself a prohibited act under the FDCA, nor is it an element of any prohibited act.”
  • However, the FDA and Department of Justice remain committed to prosecuting manufacturers who promote off-label uses. Mark Twain anticipated the government’s position:
    • “It is by the goodness of God that in our country we have those three unspeakably precious things: freedom of speech, freedom of conscience, and the prudence never to practice either.”
  • According to the government, all manufacturers who engage in off-label promotion can be prosecuted for misbranding, (or for introducing an unapproved new drug), and the manufacturers’ speech will be used as evidence of intent. Apparently, it is the government’s position that although manufacturers have the First Amendment right to speak freely about off-label uses, manufacturers cannot exercise their rights without violating the FDCA and its regulations.
  • Thus while Caronia is a landmark case in establishing that the First Amendment is not abolished by drug regulations, it is only the first of many battles.
  • Caveats: Caronia does not enable anyone to make false or misleading statements. Caronia also does not address whether the FDA can require disclaimers or the provision of additional information in order to prevent off-label promotions from being false or misleading.
  • In the end, there are two core questions, one legal and one a matter of policy.
    • When can the government forbid truthful, non-misleading statements?
    • Is the government justified in preventing manufacturers – who often have the most information about their products – from fully sharing their knowledge with the doctors who are treating patients that may benefit from unapproved uses?

SEGMENT 5:
Martin L. Seidel, Partner, 
Cadwalader, Wickersham & Taft LLP 
Recent Developments in Off-Label and On-Label Promotion

  • The Caronia decision held that prosecution for engaging in truthful promotion for off-label uses violated the First Amendment.
  • The government has indicated that it will not seek further review of the Caronia decision, and suggested that the decision will not alter its efforts to curtail off-label promotion.
    • The government has continued prosecuting pharma companies including Wyeth for off-label promotion after Caronia was issued.
    • The Caronia decision could result in forum-shopping.
  • In the BMS & Sanofi-Aventis decision, the court recently denied the defendants’ motion to dismiss False Claims Act claims even though the promotion at issue was for on-label use.
    • The court stated that “the fact that a drug is FDA-approved does not mean it is ‘reasonable and necessary’ in every instance it is prescribed.”
    • BMS & Sanofi-Aventis suggests that life science companies face potential exposure to FCA claims even for on-label promotion.

SEGMENT 1:
Nick Repucci, Manager, 
Dentons US LLP

  • The legal and regulatory issues that form the basis for the high-dollar settlements that we are seeing in the popular press have a long and deep-rooted history that dates back to the early years of the regulation of medicine in the United States.
    • The 2nd U.S. Circuit decision in United States v. Caronia may mark the tipping point of a judicial trend that could undermine the FDA’s ability to enforce the misbranding provisions of the FDCA. (This isn’t the first time we’ve seen the First Amendment used to thwart the Agency’s efforts to rein-in fraudulent promotional activities, and it certainly won’t be the last.) Still, companies should tread cautiously, as the law is not yet settled.
  • High-award, high-profile False Claims Act settlements, corporate integrity agreements, and threats of exclusion from participation in federal health care programs are ineffective strategies for deterring pharmaceutical companies from promoting their products off-label.
    • FCA prosecution (related to off-label promotion) has become an unfortunate but inevitable consequence of doing business.
    • United States v. Caronia provided the much needed incentive to the FDA to reconsider the goals of enforcement and to realize other means and incentives for achieving compliance.
  • For decades, the FDA has said that companies can respond to unsolicited requests for off-label information with “truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request,” without subjecting their products to the strict regulatory requirements for promotional labeling or advertising.
    • The FDA’s latest draft guidance, “Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (December 2011), does not deviate from the Agency’s long held position. Merely, it explains in detail the FDA’s recommendations for responding to each type of request for off-label information –”non-public” and public, including through emerging social media.
      • In summary, regardless of where the unsolicited request for off-label information was made—in a non-public or public forum—the FDA recommends that a company only provide the requested off-label information about its product to the specific individual who requested the information in a private, one-on-one communication.

SEGMENT 2:
C. Scott Jones, Partner, 
Locke Lord LLP

  • Focusing on recent state court trials under individual States’ false claims act / Medicaid fraud prevention statutes, I will discuss the anatomy of a government lawsuit involving claims and allegations of off label promotion totaling in some instances more than $1 billion in damages and penalties.
  • “Call Notes and Business Plans – The Devil’s Tool.” The methods by which plaintiffs/relators and governments attempt to marshal evidence of off-label promotion so as to construct a large multiplier which can then be applied to a statutory penalty range so as to yield staggering awards, which may also then be used to bully a defendant into settling.
    • Plaintiffs’ use of “experts” to summarily present massive volumes of call notes in a compendium format so as to support huge penalty awards.
    • Ways to attempt to exclude call notes from evidence, or to otherwise undermine an expert’s “reliance” on them in rendering his or her opinions.
    • Plaintiffs’ mischaracterization and misuse at trial of business or marketing plans – many of which may have been generated before a product’s launch,or before an anticipated label change.
    • Evaluating whether to conduct a direct examination of one’s own witnesses during a deposition (e.g., sales representatives).
    • A sales representative’s focus on a product’s “favorable” side effects – Does such communications constitute off label promotion?
  • “Wolf in Sheep’s Clothing.” With the FDA’s Guidance, there remains ambiguity as to what constitutes an “unsolicited request” for off label information. Plaintiffs have attempted to exploit this uncertainty by arguing that ostensibly non-promotional events, such as advisory boards or continuing medical education symposia, are simply “dressed up” promotional events. In addition and in the alternative, plaintiffs have argued that the nature of these events (invitees are paid an honorarium to listen to presenters discuss off label information about a product, albeit in a “non-promotional” setting) serves to eviscerate the otherwise “unsolicited” nature of any follow-up requests for information.
    • Example – prescriber attends a company-sponsored advisory board put on by a third-party. Following the presentation, that prescriber calls the company’s medical affairs / scientific liaison “hotline” to request additional off label information. Some plaintiffs have argued that this sequence of events transforms an otherwise unsolicited request into one which the company has solicited.
  • “No Good Deed Goes Unpunished.” A company’s sponsorship of treatment guidelines or similar protocols, which culminates in a sponsor’s product being placed in a “preferred” position (or culminates in the product being listed on state’s preferred drug list because it is featured on the treatment protocol) has been exploited by plaintiffs. Specifically, plaintiffs have argued that such placement is the result of the company’s financial support and/or provision of company-sponsored, off-label studies, which, plaintiffs argue in turn conveys the “false or misleading” impression that the “preferred” product is superior to other, similar products.

SEGMENT 3:
Erik W. Snapp, Partner, 
Winston & Strawn LLP 
Off-Label’s current regulatory environment: Where are we now and what to expect in the future?

  • Lessons learned from recent settlements and FDA enforcement actions
    • While some hope the Caronia decision marks an end to off-label prosecutions, FDA, DOJ and HHS do not seem to think so. An FDA official speaking at a conference in late January indicated that the Caronia decision will not change the Agency’s enforcement activities. A DOJ official speaking at the same conference stated that misbranding prosecutions remain an enforcement priority. How important are these prosecutions to the federal government? DOJ and HHS reported in February that they recovered over $3.0 billion in health care fraud settlements in their last fiscal year, the vast majority of which was a settlement with GSK of off-label promotion and other allegations.
    • FDA’s Office of Prescription Drug Promotion (“OPDP”)(formerly the Division of Drug Marketing, Advertising and Communications or “DDMAC”) oversee thousands of ads every year, and must out of necessity prioritize certain categories of ads for further review. OPDP officials have stated that its priorities include ads involving drugs with significant risks, products subject to past violations, products subject to complaints, and newly approved products. Recent enforcement letters show the types of promotional activities drawing OPDP scrutiny.
    • Perhaps due to the sheer volume of ads it oversees, the FDA in 2010 implemented a “Bad Ad” Program in 2010. Through that program, FDA encourages health care providers to report false or misleading drug advertising and promotional materials. FDA has received hundreds of reports from HCPs and has issued enforcement letters stemming from some of those reports. With thousands of medical professionals helping FDA to police promotional activities, strong compliance programs are more important than ever.
    • The government relies on the responsible corporate officer doctrine, or “Park Doctrine,” as a way of deterring violations of and encouraging compliance with the FDCA. As applied by the FDA in its Procedures Manual, corporate officers can be charged with a first time misdemeanor “without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.” Participation in the violation – or even knowledge of it – can be relevant factors in the government’s decision to prosecute, but are not a prerequisite for prosecution. Recent cases show how the government has sought to apply the Park Doctrine.
    • Recent settlements involving off-label promotion allegations demonstrate the types of promotional activities attracting government scrutiny, and illustrate new approaches to corporate integrity agreements and probation provisions.

SEGMENT 4:
Jonathan Berman, Partner, 
Jones Day 
The Caronia Case, Mark Twain, and Off-Label Promotion

  • In Caronia, the Second Circuit “construe[d] the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” Even before the decision issued, the government had conceded that “promoting an approved drug for off-label uses is not itself a prohibited act under the FDCA, nor is it an element of any prohibited act.”
  • However, the FDA and Department of Justice remain committed to prosecuting manufacturers who promote off-label uses. Mark Twain anticipated the government’s position:
    • “It is by the goodness of God that in our country we have those three unspeakably precious things: freedom of speech, freedom of conscience, and the prudence never to practice either.”
  • According to the government, all manufacturers who engage in off-label promotion can be prosecuted for misbranding, (or for introducing an unapproved new drug), and the manufacturers’ speech will be used as evidence of intent. Apparently, it is the government’s position that although manufacturers have the First Amendment right to speak freely about off-label uses, manufacturers cannot exercise their rights without violating the FDCA and its regulations.
  • Thus while Caronia is a landmark case in establishing that the First Amendment is not abolished by drug regulations, it is only the first of many battles.
  • Caveats: Caronia does not enable anyone to make false or misleading statements. Caronia also does not address whether the FDA can require disclaimers or the provision of additional information in order to prevent off-label promotions from being false or misleading.
  • In the end, there are two core questions, one legal and one a matter of policy.
    • When can the government forbid truthful, non-misleading statements?
    • Is the government justified in preventing manufacturers – who often have the most information about their products – from fully sharing their knowledge with the doctors who are treating patients that may benefit from unapproved uses?

SEGMENT 5:
Martin L. Seidel, Partner, 
Cadwalader, Wickersham & Taft LLP 
Recent Developments in Off-Label and On-Label Promotion

  • The Caronia decision held that prosecution for engaging in truthful promotion for off-label uses violated the First Amendment.
  • The government has indicated that it will not seek further review of the Caronia decision, and suggested that the decision will not alter its efforts to curtail off-label promotion.
    • The government has continued prosecuting pharma companies including Wyeth for off-label promotion after Caronia was issued.
    • The Caronia decision could result in forum-shopping.
  • In the BMS & Sanofi-Aventis decision, the court recently denied the defendants’ motion to dismiss False Claims Act claims even though the promotion at issue was for on-label use.
    • The court stated that “the fact that a drug is FDA-approved does not mean it is ‘reasonable and necessary’ in every instance it is prescribed.”
    • BMS & Sanofi-Aventis suggests that life science companies face potential exposure to FCA claims even for on-label promotion.

Nick RepucciManagerDentons US LLP

Nick Repucci is a member of Dentons’ Health Care Practice. He advises biotechnology companies, academic medical centers, community hospitals, physician groups, and other health care organizations on a variety of health research policy matters. He specializes in helping clients ensure compliance with the laws and regulations that govern the conduct of clinical trials, commercial interactions with Health Care Professionals, investigator conflicts of interest, scientific misconduct, prescription drug promotion, and federal grants and contracts administration. Mr. Repucci holds a Master in Public Health from The Dartmouth Institute for Health Policy and Clinical Practice. He can be reached atnick.repucci@dentons.com.

Jonathan BermanPartnerJones Day

Jonathan Berman splits his practice between complex commercial litigation and advising on food and drug regulatory issues.Jonathan advises on topics spanning the breadth of the Food, Drug, and Cosmetic Act and other laws administered by the FDA. These matters have involved the regulation of food labeling, food additives, clinical trials, pharmaceutical compounding, “compassionate use” of unapproved drugs, Good Manufacturing Practices, and drug advertising; FOIA requests and the availability of submitted materials; and the regulation of dietary supplements, devices, cosmetics, and radiation emitting products.Jonathan’s litigation practice has emphasized class actions and other complex disputes. Many of Jonathan’s cases have involved health care providers. He has represented, in major matters, hospitals, physician practice groups, a health insurer, manufacturers of pharmaceuticals, and a drug wholesaler.

C. Scott JonesPartnerLocke Lord LLP

Scott Jones is a partner with Locke Lord LLP in its Dallas, Texas office. As a member of his firm’s business litigation section, Mr. Jones has tried and defended cases in State and Federal courts, as well as in arbitration. Mr. Jones’s trial experience covers a range of issues with a particular focus on representing pharmaceutical manufacturers in Federal and State False Claims Act and Whistleblower Act lawsuits and investigations. These matters frequently involve allegations of “off label” promotion, the marketing and sale of “misbranded” products, and other state and federal regulatory issues. Mr. Jones’s trial experience also includes general business litigation, products liability litigation, commercial and tort litigation arising out of aviation crashes, and class action defense. Mr. Jones also provides free volunteer legal services to members of the Dallas community.

Erik W. SnappPartnerWinston & Strawn LLP

Erik Snapp is a litigation partner in the Chicago office of Winston & Strawn whose practice focuses on litigation and counseling in high-stakes product liability cases, consumer fraud class actions, internal investigations and SEC investigations. Mr. Snapp currently represents pharmaceutical and medical device companies in state and federal product liability cases, which often involve allegations regarding sales and promotional practices, and advises clients regarding application of the FDA’s off-label promotion regulations. Mr. Snapp has previously defended pharmaceutical manufacturers in False Claims Act litigation involving allegations of off-label promotion, and has defended manufacturers in federal and state criminal and civil investigations focused on sales and contracting practices.

Martin L. SeidelPartnerCadwalader, Wickersham & Taft LLP

Martin Seidel focuses on complex commercial litigation and arbitration, with an emphasis on multiparty class and derivative suits and corporate control contests. Mr. Seidel is experienced in all aspects of commercial litigation, internal corporate investigations, governmental investigations, and regulatory proceedings. Mr. Seidel has represented key players in the highest profile corporate governance and securities litigations and investigations of the past decade, including Adelphia, Enron, Interstate Bakeries, Hollinger, and HealthSouth.Mr. Seidel received his B.A., magna cum laude, from the University of Wisconsin and his J.D. from Columbia Law School, where he was managing editor of the Columbia Journal of Transnational Law and a Harlan Fiske Stone Scholar. Mr. Seidel has been recognized by New York Super Lawyers, the Legal 500 U.S. Volume III Litigation and Benchmark: Litigation. Mr. Seidel has published articles and spoken on corporate governance, securities litigation, directors’ and officers’ insurance and complex litigation.


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Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   On-demand Webcast

Prerequisite:
   NONE

Course Code:
   124373

NASBA Field of Study:
   Specialized Knowledge and Applications

NY Category of CLE Credit:
   

Total Credits:
    2.0 CLE

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About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Established by the combination of international law firm Salans, Canadian law firm Fraser Milner Casgrain (FMC) and international law firm SNR Denton, Dentons is a new global firm driven to provide our clients with a competitive edge in an increasingly complex, interconnected and global marketplace.Dentons connects clients to top tier, innovative and integrated legal talent across Europe, Canada, the UK, the US, the Middle East, Central and East Asia, Asia Pacific and Africa. Our 2,500 lawyers and professionals in 79 locations across 52 countries are dedicated to providing clients with consistent high-quality service wherever they do business. Our offices across the globe serve as portals for our clients to easily access the leading legal talent of Dentons—around the corner or around the world.In today’s rapidly changing business, legal and financial environments, Dentons offers a worldwide knowledge base that provides comprehensive industry sector expertise, local market intelligence and globally informed solutions—invaluable advantages and insights for our clients across the local, regional and international spectrums. With more than 100 lawyers, consultants and policy professionals who have spent their entire professional careers exclusively counseling healthcare life sciences organizations, Dentons is dedicated to providing strategic counsel that focuses on our clients’ success. For more information, visit www.dentons.com.

Website: http://www.dentons.com/

Jones Day is a global law firm practicing in the major centers of business and finance throughout the world. Ranked among the world’s best and most integrated law firms, and perennially ranked among the best in client service, Jones Day acts as principal outside counsel to, or provides significant legal representation for, more than half of the Fortune Global 500, Fortune 500, and FT Global 500. Jones Day is listed as one of the top litigation departments worldwide for its breadth of knowledge and depth of resources, our practice was named “Litigation Powerhouse” in a 2013 report published by BTI consulting.

Website: http://www.jonesday.com/

Locke Lord LLP is a full-service, international law firm with offices in Atlanta, Austin, Chicago, Dallas, Hong Kong, Houston, London, Los Angeles, New Orleans, New York, Sacramento, San Francisco and Washington, D.C.Our team of approximately 650 attorneys has earned a solid national reputation in complex litigation, regulatory and transactional work. We serve our clients’ interests first, and these clients range from Fortune 500 and middle market public and private companies to start-ups and emerging businesses.

Website: http://www.lockelord.com/

Winston & Strawn LLP is an international law firm with more than 900 attorneys among 15 offices in Beijing, Charlotte, Chicago, Geneva, Hong Kong, Houston, London, Los Angeles, Moscow, New York, Newark, Paris, San Francisco, Shanghai, and Washington, D.C. The exceptional depth and geographic reach of the firm’s resources enable Winston & Strawn to manage virtually every type of business-related legal issue. It serves the needs of enterprises of all types and sizes, in both the private and the public sector.Winston & Strawn understands that clients are looking for value beyond just legal expertise. With this in mind, the firm works hard to understand the level of involvement that its clients want from it. Please visit www.winston.com if you would like more information about Winston & Strawn’s legal services, experience, and the industries it serves.

Website: http://winston.com/

Cadwalader, Wickersham & Taft LLP, established in 1792, is one of the world’s leading international law firms, with offices in New York, London, Charlotte, Washington, Houston, Beijing, Hong Kong and Brussels. Cadwalader serves a diverse client base, including many of the world’s top financial institutions and corporations, undertaking business in more than 50 countries. The firm offers legal expertise in antitrust, banking, business fraud, corporate finance, corporate governance, energy, environmental, financial restructuring, healthcare, intellectual property, litigation, mergers and acquisitions, private equity, private wealth, real estate, regulation, securitization, structured finance, and tax. More information about Cadwalader can be found at

Website: http://www.cadwalader.com/

Nick Repucci is a member of Dentons’ Health Care Practice. He advises biotechnology companies, academic medical centers, community hospitals, physician groups, and other health care organizations on a variety of health research policy matters. He specializes in helping clients ensure compliance with the laws and regulations that govern the conduct of clinical trials, commercial interactions with Health Care Professionals, investigator conflicts of interest, scientific misconduct, prescription drug promotion, and federal grants and contracts administration. Mr. Repucci holds a Master in Public Health from The Dartmouth Institute for Health Policy and Clinical Practice. He can be reached atnick.repucci@dentons.com.

Jonathan Berman splits his practice between complex commercial litigation and advising on food and drug regulatory issues.Jonathan advises on topics spanning the breadth of the Food, Drug, and Cosmetic Act and other laws administered by the FDA. These matters have involved the regulation of food labeling, food additives, clinical trials, pharmaceutical compounding, “compassionate use” of unapproved drugs, Good Manufacturing Practices, and drug advertising; FOIA requests and the availability of submitted materials; and the regulation of dietary supplements, devices, cosmetics, and radiation emitting products.Jonathan’s litigation practice has emphasized class actions and other complex disputes. Many of Jonathan’s cases have involved health care providers. He has represented, in major matters, hospitals, physician practice groups, a health insurer, manufacturers of pharmaceuticals, and a drug wholesaler.

Scott Jones is a partner with Locke Lord LLP in its Dallas, Texas office. As a member of his firm’s business litigation section, Mr. Jones has tried and defended cases in State and Federal courts, as well as in arbitration. Mr. Jones’s trial experience covers a range of issues with a particular focus on representing pharmaceutical manufacturers in Federal and State False Claims Act and Whistleblower Act lawsuits and investigations. These matters frequently involve allegations of “off label” promotion, the marketing and sale of “misbranded” products, and other state and federal regulatory issues. Mr. Jones’s trial experience also includes general business litigation, products liability litigation, commercial and tort litigation arising out of aviation crashes, and class action defense. Mr. Jones also provides free volunteer legal services to members of the Dallas community.

Erik Snapp is a litigation partner in the Chicago office of Winston & Strawn whose practice focuses on litigation and counseling in high-stakes product liability cases, consumer fraud class actions, internal investigations and SEC investigations. Mr. Snapp currently represents pharmaceutical and medical device companies in state and federal product liability cases, which often involve allegations regarding sales and promotional practices, and advises clients regarding application of the FDA’s off-label promotion regulations. Mr. Snapp has previously defended pharmaceutical manufacturers in False Claims Act litigation involving allegations of off-label promotion, and has defended manufacturers in federal and state criminal and civil investigations focused on sales and contracting practices.

Martin Seidel focuses on complex commercial litigation and arbitration, with an emphasis on multiparty class and derivative suits and corporate control contests. Mr. Seidel is experienced in all aspects of commercial litigation, internal corporate investigations, governmental investigations, and regulatory proceedings. Mr. Seidel has represented key players in the highest profile corporate governance and securities litigations and investigations of the past decade, including Adelphia, Enron, Interstate Bakeries, Hollinger, and HealthSouth.Mr. Seidel received his B.A., magna cum laude, from the University of Wisconsin and his J.D. from Columbia Law School, where he was managing editor of the Columbia Journal of Transnational Law and a Harlan Fiske Stone Scholar. Mr. Seidel has been recognized by New York Super Lawyers, the Legal 500 U.S. Volume III Litigation and Benchmark: Litigation. Mr. Seidel has published articles and spoken on corporate governance, securities litigation, directors’ and officers’ insurance and complex litigation.

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