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Managing Attorney & Principal

An accomplished businesswoman, lawyer, and strategist, Jamie Kendall gets results. Jamie has a range of experience representing Fortune 500 corporations in high-stakes commercial and products liability litigation. Jamie also advises companies on a variety of regulatory, compliance, and enforcement issues, and provides a broad range of day-to-day business advice and strategic counseling. Jamie is known for finding creative solutions to challenging legal problems, and her work has led to victories in hundreds of cases. 

Clients turn to Jamie for guidance in connection with the defense of lawsuits, potential lawsuits, audits, government investigations, internal investigations, contractual arrangements, and the development, implementation, and review of several types of compliance and ethics programs. Notably, corporate executives and boards of directors seek Jamie’s counsel on matters related to a broad range of business-related topics. As part of her regulatory practice, Jamie advises on product development, marketing authorization issues, post-marketing compliance, lifecycle management, and significant enforcement matters for a diverse roster of clients, including pharmaceutical and medical device manufacturers, energy businesses, consumer electronics, and major retailers. 

Jamie’s prior legal experience includes serving as General Counsel for a U.S. pharmaceutical company that has international touchpoints. She was also an associate with Morgan Lewis & Bockius LLP in its Philadelphia Litigation Practice Group. While there, she represented pharmaceutical and medical device companies in complex civil litigation and government investigations involving products liability claims, state and federal false claims statutes, the Stark Law, fraud and abuse violations, and state and federal anti-kickback statutes. She also represented corporate clients with the defense of several consumer class action claims and government investigations and inquiries.

Jamie earned her Juris Doctorate from Rutgers University School of Law – Camden. While at Rutgers Law School, she worked as a judicial law clerk for the Honorable William C. Carpenter, Jr. of the Superior Court of Delaware, the Honorable F.J. Orlando, Jr. A.J.S.C. of the Superior Court of New Jersey, and the Honorable M. Faith Angell of the U.S. District Court for the Eastern District of Pennsylvania. Jamie earned her B.A. in Journalism from Indiana University of Pennsylvania and is admitted to practice in the state and federal courts of both Pennsylvania and New Jersey.

Notable Representations

Gadolinium Retention Contrast Dye Litigation

  • Lead counsel for Guerbet, LLC and Liebel-Flarsheim Company, LLC in nationwide litigation regarding Guerbet’s Optimark® contrast dye. Plaintiffs claim that they developed a variety of injuries as a result of retaining gadolinium in their body following the use of the companies’ gadolinium-based contrast agent Optimark® and other contrast agents during MRI procedures. Successfully secured dozens of voluntary dismissals, in addition to court-ordered dismissals, over the course of the litigation which is still ongoing.
    • In re Gadolinium-Based Products Liability Litigation (J.P.M.L.) Argued for Guerbet defendants before the Judicial Panel on Multidistrict Litigation. Defeated plaintiffs’ petition to create an MDL.
    • Davis v. McKesson Corp. (D. Ariz.); Fischer v. Bayer HealthCare Pharmaceuticals Inc. (D. Ariz.); Munnuru v. Guerbet LLC (D. Ariz.) In bellwether cases, argued and won exclusion of plaintiffs’ four general causation experts resulting in an 85-page opinion followed by full summary judgment. Plaintiffs voluntarily dismissed their appeal to the Ninth Circuit.
    • Klein v. Bayer HealthCare Pharmaceuticals Inc. (D. Nev.) Won motion to dismiss based on a novel preemption theory not previously accepted by any district court in the Ninth Circuit.
    • Simoes v. Guerbet, LLC (Cal App. Supp.) Argued against plaintiff’s Application for Complex Designation on behalf of Guerbet defendants. Defeated plaintiff’s Application for Complex Designation.
  • Representation of a mid-sized pharmaceutical company in federal and state government investigations involving the marketing and pricing of products.
  • Advise national and international retailers on matters related to regulatory compliance, data breach response, and crafting privacy-by-design policies.
  • Representation of a client in a multimillion-dollar commercial dispute involving material breaches of complex stock purchase agreement, licensing, and distribution agreements.
  • Counseling clinical-stage biotech companies on a wide variety of business/legal strategies and issues.
  • Representation of an international life sciences client in a matter involving unfair sales practices by competitors.
  • Representation of a major international pharmaceutical company in federal and state government investigations involving sales and marketing practices.
  • Representation of a pharmaceutical company in internal investigation of its business practices and compliance.
  • Day-to-day pharmaceutical and medical device company counseling on product marketing and promotion materials, including use of social media.
  • Representation of pharmaceutical company in internal investigation of its contracting protocols and procedures in its selection and use of investigators in clinical studies and scientific meetings.
  • Representation of corporate clients in internal investigations related to alleged kickbacks, off-label promotion, and reimbursement guidance.
  • Representation of a life sciences client in a Veterans Affairs Office of Inspector General (OIG) audit.
  • Representation of a life sciences client in a pharmaceutical state licensing disciplinary action.
  • Representation of a medical device company in internal investigation of its promotional business practices including surgical healthcare provider interactions.

Notable Historical Representations: Representation of a national pharmaceutical company in Pharmaceutical Industry Average Wholesale Price Litigation, Vioxx® Government Investigation and Litigation, Seroquel® Government Investigation and related Products Liability Litigation, the 2006 Hewlett-Packard Company (HP) Pre-texting United States Senate and associated internal investigations and the defense of several HP-related Consumer Class Action lawsuits, and the defense of Wal-Mart Stores Inc. in several commercial transaction-related arbitration and litigation.

Publications

  • Jamie Kendall, Brad Welsh & Paul de Vastey, FDA Preemption and Albrecht’s Progeny, 76 Food and Drug L. J. 579 (2022)
  • Jamie Kendall, Brad Welsh & Alexandra Schulz, Trump’s Push for Direct Medicare Drug Price Negotiations Addresses Only One Piece of the Industry’s Drug Pricing Puzzle, United States Biopharmaceuticals 2017, Global Business Reports, May 2017, at 25
  • Jamie Kendall & Alexandra Schulz, Why Patient Experience Data Provisions Face Elimination, Law360, (Mar. 22, 2017)
  • Jamie Kendall & Alexandra Schulz, What First Amendment? FDA Remains Unfazed By Off-Label Communication Issues, Pharm Exec.Com (Mar. 7, 2017)
  • Jamie Kendall & Noah Mallon, Does the FDA’s Draft Guidance on Responding to Unsolicited Off-Label Requests Align with the FDA’s Mission to Promote the Public Health?, The Food and Drug Law Institute Policy Forum, (Mar. 14, 2012) (Peer and FDA Reviewed)
  • Jamie Kendall, From MSL to CSL (?): The Evolving Role of the Medical Science Liaison, Health Care Compliance Association, Compliance Today, Mar. 2012.
  • Jamie Kendall, Corporate Integrity Agreements: A Look Back to the Future of OIG Investigations, Health Care Compliance Association, Compliance Today, Dec. 2011, at 38.
  • Jamie Kendall, The Value is in the Juice Not the Squeeze: Why Reprints Should Not be TOVs Under the Sunshine Act, (Published as Sunshine sheds little light on status of reprints), Medical Marketing & Media, Dec. 2011.
  • Jamie Kendall, Create a Scientific Publications Guidance Document to Ensure Continued Awareness and Compliance with Industry Best Practices, Regulations, Guidances and Laws, Presented at The International Society for Medical Publication Professionals (ISMPP), April 2011 Annual Meeting.

Speaking Engagement/Webinars

  • “Lessons Learned: Compliance and Reporting Risks Identified as a Result of Preparing State Reports,” CBI’s 4th Annual Forum on Tracking State Laws and Aggregate Spend, August 2010.
  • “Corporate Integrity Agreements Serve As Intelligible “Tea Leaves” as The Government’s Focus on Commercial-Related Activities Continues to Lead to Medical Affairs Activity Scrutiny,” FX
  • Conferences, September 2011 and CIS, October 2011.
  • “Government Enforcement on Medical Affairs and Commercial-Related Activities,” CIS, October 2011.
  • “Social Media: Changing the Way the Industry Interacts one Click at a Time,” CIS, October 2011.
  • “The UK Bribery Act is Upping the Ante on Anti-Corruption and Anti-Bribery Enforcement,” FX Conferences, February 9, 2012.

Jamie Kendall

Managing Attorney & Principal

     With two decades of extensive legal experience, Jamie Kendall is a seasoned attorney and business partner whose multifaceted career encompasses a robust blend of pre-litigation and post-litigation matters, regulatory and commercial compliance, and corporate counsel, makes her a trusted advisor to organizations navigating the complexities of U.S. legal and regulatory frameworks.

     Jamie’s expertise spans a wide array of sectors, including food, supplements, pharmaceuticals, consumer goods, medical devices, MedTech, biotech, and healthcare. Her deep understanding of industry-specific regulations enables her to provide comprehensive legal guidance that aligns with business objectives while ensuring compliance with federal and state laws. Throughout her career, Jamie has demonstrated an exceptional ability to assess legal risks and successfully defend already existing legal matters, develop strategic responses, and implement effective compliance programs tailored to the unique needs of her clients.

     In her role as corporate counsel, Jamie provides day-to-day legal support for business operations in heavily regulated environments. She works closely with executive teams and boards of directors and has an uncanny ability to connect with all levels of personnel within a client’s organization.  She offers practical, insightful advice on corporate governance, business operations, contract negotiations, and operational compliance. Her collaborative approach helps organizations establish sound policies and procedures that mitigate risk and promote ethical business practices.

     Jamie’s pre-litigation experience includes providing day-to-day legal and business counsel, conducting thorough risk assessments, facilitating internal investigations, and advising on internal matters, including advising on dispute resolution strategies. Her proactive measures have often helped clients avoid costly litigation while fostering a culture of compliance and accountability. In her post-litigation practice, she adeptly navigates the complexities of enforcement actions, settlements, and ongoing compliance obligations, ensuring that clients remain aligned with regulatory requirements. She also assists small to mid-sized companies successfully develop and commercialize products in the U.S. and in U.S. regulated industries. 

     Recognized for her exceptional legal acumen and strategic thinking, Jamie is frequently sought after to advise on matters related to pre-litigation and post-litigation, U.S. regulated entity advice and counsel – including business counsel, corporate ethics, compliance program development, implementation and overnight, and regulatory enforcement. Her ability to communicate complex legal concepts in a clear and actionable manner empowers clients to make informed decisions that drive business success.

     Throughout her career, Jamie has built a reputation as a dedicated advocate for her clients, leveraging her extensive knowledge of the legal landscape to deliver results-oriented solutions. Her commitment to excellence and integrity has earned her the trust of numerous organizations as they navigate the intricacies of operating in the U.S.

Notable Corporate Representations

 

  • Lead national defense counsel for gadolinium contrast dye manufacturer in nationwide Gadolinium Retention Contrast Dye Products litigation. Plaintiffs claimed they developed a variety of injuries because of gadolinium retaining in their bodies following use of certain gadolinium-based contrast agents during MRI procedures. Over duration of litigation 8+ years, secured dozens of voluntary dismissals, in addition to court-ordered dismissals in several state and federal courts.
  • In re Gadolinium-Based Products Liability Litigation (J.P.M.L.) Argued for gadolinium contrast dye manufacturer before the Judicial Panel on Multidistrict Litigation. Defeated plaintiffs’ petition to create MDL.
  • Davis v. McKesson Corporation (D. Ariz)
  • Fischer v. Bayer HealthCare Pharmaceuticals Inc. (D. Ariz.)
  • In bellwether cases, argued and won exclusion of plaintiffs’ four general causation experts resulting in an 85-page opinion followed by full summary judgment. Plaintiffs voluntarily dismissed their appeal to the Ninth Circuit.
  • Klein v. Bayer HealthCare Pharmaceuticals Inc. (D. Nev.) Won motion to dismiss based on a novel preemption theory not previously accepted by any district court in the Ninth Circuit.
  • Successful representation of a major international pharmaceutical company in federal and state government investigations related to marketing and pricing practices.
  • Led a multimillion-dollar commercial dispute resolution for a life sciences client involving complex breaches of stock purchase agreements.
  • Provide strategic legal and business counsel to clinical-stage biotech companies, guiding them through various business and legal challenges to enhance operational efficiency and compliance.
  • Advocate for an international life sciences client involved in unfair sales practice allegations.
  • Support a major U.S. pharmaceutical company during federal and state investigations concerning sales and marketing practices, reinforcing her expertise in regulatory compliance.
  • Conduct internal investigations for U.S. regulated industry companies to review business practices and ensure compliance with internal and external standards.
  • Offer day-to-day legal counsel to a variety of U.S. regulated companies on a wide-range of corporate, clinical, and commercial-related business operation topics.
  • Manage internal investigations involving contracting protocols, off-label promotion, and reimbursement guidance, ensuring adherence to legal and ethical standards.
  • Represent clients during audits conducted by the Veterans Affairs Office of Inspector General (OIG) and in state licensing disciplinary actions.
  • Represent and counsel multiple national and regional hospitals regarding data privacy, Stark Law, False Claims Act, U.S. compliance, pre-litigation and post-litigation matters, clinical compliance, clinical research compliance.
  • Guide medical device companies through internal investigations related to promotional practices and interactions with healthcare providers.

Individual, Start-Ups, and Small Business Representation

     With a robust background in both law and business, Jamie brings a unique perspective to her legal practice, empowering small businesses and individuals to navigate complex legal and regulatory landscapes. Her extensive experience in sophisticated legal and regulatory matters allows her to offer tailored solutions that address the specific needs of her individual and small business clients. Working with hundreds of small, mid-sized and large corporations in her career, Jamie understands the intricacies of business operations, budgets, and challenges faced. She leverages her dual expertise to provide comprehensive legal services, from strategy, contract negotiation and compliance to dispute resolution and pre-litigation protection. Committed to expanding her firm’s representation, she actively collaborates with individuals, start-ups, and smaller-sized corporate clients to build lasting relationships and foster their growth.

 

     Jamie’s prior legal experience includes serving as General Counsel for a U.S. pharmaceutical company that has international touch points. She was also an associate with Morgan Lewis & Bockius LLP in its Philadelphia Litigation Practice Group. Jamie earned her Juris Doctorate from Rutgers University School of Law – Camden. While at Rutgers Law School, she worked as a judicial law clerk for the Honorable William C. Carpenter, Jr. of the Superior Court of Delaware, the Honorable F.J. Orlando, Jr. A.J.S.C. of the Superior Court of New Jersey, and the Honorable M. Faith Angell of the U.S. District Court for the Eastern District of Pennsylvania. Jamie earned her B.A. in Journalism from Indiana University of Pennsylvania and is admitted to practice in the state and federal courts of both Pennsylvania and New Jersey. 

2022 Notable Publication

  • Jamie Kendall, Brad Welsh & Paul DeVastey, FDA Preemption and Albrecht’s Progeny, 76 Food and Drug L.J. 579 (2022).
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