A battle-tested team with extensive senior-level government experience helping clients in the healthcare industry navigate and address multifaceted challenges with legal, public policy and media dimensions.


Legal challenges confronting healthcare and life science companies can quickly escalate into complex, multidisciplinary matters with enormous legal, financial and reputational consequences. WilmerHale has assembled an experienced team of lawyers within its Strategic Response Group—including a former chief legal officer of the largest health insurance company in the United States—to counsel and defend companies who face such challenges. Our lawyers bring great value to these matters, having represented clients in some of the largest and most complex legal matters during the past decade. We understand the pattern, sequence and turns that such matters typically follow.

Our ability to add value to these multifaceted actions derives from three key strengths: we understand the underlying legal frameworks; as experienced advocates, we know how to frame arguments tailored to the audience in question—be it Congress, the Administration, the business community or the public; and we have a deep bench of lawyers with significant experience across multiple disciplines and US and foreign government agencies.

Contacts

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Gorelick, Jamie

Jamie Gorelick

Chair, Regulatory and Government Affairs Department

Co-Chair, Strategic Response Group

+1 202 663 6500 (t)

jamie.gorelick@wilmerhale.com

Chugh, Madhu

Madhu Chugh

Counsel

+1 202 663 6529 (t)

madhu.chugh@wilmerhale.com

Lehman_Rob_lo

Rob Lehman

Senior Public Policy Advisor

+1 202 663 6907 (t)

rob.lehman@wilmerhale.com

Timothy Martin

Timothy G. Martin

Public Policy Attorney

+1 202 663 6539 (t)

timothy.martin@wilmerhale.com

Slavitt, Andy

Andy Slavitt

Senior Advisor, Public Policy and Healthcare

+1 202 663 6119 (t)

andy.slavitt@wilmerhaleadvisor.com

Adegbile, Debo

Debo P. Adegbile

Partner

+1 212 295 6717 (t)

debo.adegbile@wilmerhale.com

Berman, Bruce M.

Bruce M. Berman

Partner

+1 202 663 6173 (t)

bruce.berman@wilmerhale.com

Brown, Reginald J.

Reginald J. Brown

Partner

+1 202 663 6430 (t)

reginald.brown@wilmerhale.com

Chipman, Jason C.

Jason C. Chipman

Partner

+1 202 663 6195 (t)

jason.chipman@wilmerhale.com

Areas of Focus

Internal Investigations and Compliance Counseling

It may begin in any number of ways. A complaint may be logged on a pharmaceutical company’s hotline or a patient may raise concerns with an academic medical center about the practices of one of its healthcare professionals. No matter how the problem comes to light, it is critical for companies and organizations to quickly gain a comprehensive understanding of the legal and factual basis for serious allegations of unlawful activity. They must also have effective compliance programs to prevent improper activities in the first place. We have helped numerous clients, both in the United States and abroad, avoid prosecution by the government by conducting internal investigations and compliance assessments. Some recent matters include:

  • Conducting internal investigations of marketing practices involving the sale of pharmaceuticals and medical devices in the United States, China, Korea, India, Japan, Mexico, Russia and Poland.
  • Conducting an internal investigation of good manufacturing practice, good laboratory practice and promotional issues for a global pharmaceutical company marketing a product with black box warnings.
  • Conducting a post-acquisition investigation of a pharmaceutical company’s marketing practices and compliance protocols within and outside the United States.
  • Providing compliance counseling to global pharmaceutical and device manufacturers, a clinical research organization and a health insurance company regarding anti-bribery risk assessments, compliance policies and compliance training.
  • Conducting a compliance assessment of, and developing internal compliance procedures for, the research division of a European life sciences and nutrition company.

Justice Department and State Attorney General Investigations

WilmerHale has deep experience defending clients when a government investigation is launched. Whether a grand jury has been convened, a qui tam complaint has been unsealed or State Attorneys General have banded together and launched their own investigation, companies need to be prepared to respond. With a team of veteran litigators and former Justice Department lawyers, including two former US Deputy Attorneys General, we approach each matter with an informed understanding of the government’s enforcement perspective and objectives. We have obtained favorable resolution of numerous government investigations and litigation alleging false claims, kickbacks, illegal marketing practices, improper post-market studies, manufacturing violations, conspiracy and other alleged violations of laws. Our recent matters include:

  • Representing a healthcare company in a False Claims Act matter in which the DOJ was persuaded not to file suit against the company, and the company settled on favorable terms with the Department of Health and Human Services.
  • Winning dismissal of a qui tam action filed by a former employee alleging that a major pharmaceutical company misrepresented the relative potency and cost of two of its medications.
  • Obtaining a global civil resolution on behalf of a medical device manufacturer in an investigation by a US Attorney’s Office arising from a former employee’s allegations that the company had an inadequate complaint reporting system under the FDCA and misrepresented the quality of numerous medical devices to the government.
  • Representing multi-national pharmaceutical and medical device companies, as well as senior executives and sales and marketing personnel, in numerous criminal and civil FCA investigations of alleged off-label marketing and kickbacks.
  • Defending an Internet search and technology company in a grand jury investigation of alleged aiding and abetting of unlawful conduct by Canadian online pharmacies and the negotiation of a non-prosecution agreement that resulted in the closing of the investigation and a release of claims.
  • Representing a Fortune 500 pharmaceutical company in parallel criminal and civil investigations of alleged misbranding and improper payments in connection with the marketing of six drugs, in which the company globally resolved those investigations, four related qui tam actions and related administrative claims.
  • Representing a major medical device manufacturer in a six-year grand jury investigation into the distribution of an allegedly adulterated and misbranded stent delivery system that was ultimately resolved on a civil basis and without any charges being brought against any individual.
  • Defending a third-party billing company in parallel civil and criminal investigations by the US Attorney for the Southern District of New York of alleged Medicare and Medicaid fraud.
  • Defending a durable medical equipment supplier in a grand jury investigation by the US Attorney for the Southern District of Florida of alleged Medicare fraud.

Congressional Investigations and the Media

A federal or state investigation frequently prompts members of Congress to launch inquiries of their own. They may start with a letter from a Congressional committee asking for documents and quickly escalate into full-blown investigations in which corporate executives are asked to testify under oath at a hearing. These matters often involve political and media considerations that are very different from those surrounding the courtroom or administrative conference room. Our team has extensive experience representing clients engaged in such complex, high-stakes congressional investigations. We have assisted clients by drafting testimony, preparing witnesses in informal sessions, conducting mock hearings, working with committee members and staff in preparation for hearings, and helping to manage press coverage. Recent matters include:

  • Representing a major contractor in an investigation by the House Energy and Commerce Committee regarding assistance provided to the federal government in implementing aspects of the Affordable Care Act.
  • Representing a health insurance company in an investigation by the House Oversight and Government Reform Committee regarding its implementation of the Affordable Care Act.
  • Representing a major pharmaceutical company in an investigation by the House Energy and Commerce Committee regarding negotiations of aspects of the Affordable Care Act before it was enacted.
  • Representing a hospital association in an investigation by the House Energy and Commerce Committee into whether or not the association received special treatment.
  • Representing a nationwide dental company in an investigation by members of the Senate Finance Committee of practices concerning treatment of children under Medicaid.
  • Advising a director of a major US healthcare corporation in connection with an investigation by the House Energy and Commerce Committee.
  • Advising a medical device company in responding to Congressional inquiries about its marketing practices.

Collateral Consequences in the United States and Abroad

In the midst of an investigation or even as it winds down, life sciences and healthcare companies must address a wave of additional actions that flow from allegations of wrongdoing. The FDA may consider whether or not to invoke its application integrity policy, while the OIG evaluates exclusion of both the company and its senior executives. And regulatory authorities in Europe and Asia may launch their own investigations. We have extensive experience helping clients navigate and address such collateral consequences, both in the United States and abroad. Recent matters include:

  • Negotiating the terms, training, mandated disclosures, reporting requirements and ongoing compliance under Corporate Integrity Agreements for various companies.
  • Representing a senior executive from a medical device company in an OIG exclusion proceeding.
  • Assisting an Internet search and technology company with potential suspension and debarment issues arising from resolution of an investigation in the United States involving prescription drug advertising.
  • Representing a global pharmaceutical company on supply and contractual issues following issuance of an FDA warning letter for one of the company’s major manufacturing facilities outside the United States.
  • Representing a global pharmaceutical company and medical device company in commercial bribery investigations in China.
  • Representing a global infant formula manufacturer in an anti-monopoly investigation in China.