Ropes & Gray has a long and successful track record partnering with major pharmaceutical companies, medical device manufacturers, and others in the life sciences and health care industries on the full spectrum of internal investigations and white collar enforcement matters. Our government enforcement team has been recognized for its work in the most recent editions of Chambers, Legal 500, Benchmark Litigation, and LMG Life Sciences, among other publications. As one of the leading enforcement defense practices in the country, we have extensive experience representing companies and their executives in criminal, civil, and administrative investigations conducted by federal and state law enforcement. Clients also rely on us to conduct internal investigations and provide counseling on risk assessment, prevention and compliance.
Our representations have spanned issues relating to the Federal Food, Drug and Cosmetic Act, the False Claims Act (“FCA”), the Foreign Corrupt Practices Act (“FCPA”), the federal Anti-Kickback Statute and the Stark Law; Medicare and Medicaid fraud and abuse and pricing issues; state consumer protection matters; financial statement and disclosure matters and other securities enforcement issues; and “whistleblower” or qui tam litigation. We have also represented numerous life sciences companies in Congressional investigations, and serve as counsel to the Medical Information Working Group (MIWG), an informal coalition of pharmaceutical and medical device manufacturers that addresses issues relating to government policies on promotional practices.
Our deep understanding of the regulatory environment coupled with our appreciation for the nuances of doing business in the life sciences industry positions us to effectively partner with you in complex and multi-faceted investigations and related matters. Our team includes partners who excelled as federal prosecutors and enforcement officers at U.S. Attorney’s Offices (“USAOs”), the Department of Justice (“DOJ”), and the Securities and Exchange Commission (“SEC”), and we have experience in many foreign countries across the globe. We understand the complexities of working with government attorneys, as well as handling parallel proceedings involving simultaneous civil and criminal actions. Our ready access to corporate, securities, health care, and FDA regulatory experts means efficient, cutting-edge advocacy for our clients.
Select Representative Government Enforcement Matters:
Sales and Marketing Enforcement Experience
- In a closely watched trial involving alleged off-label marketing of a bone growth product, secured the dismissal of all 13 felony charges against Stryker Biotech following opening statements in exchange for a fine and a plea to a single misdemeanor count, and helped secure the dismissal of all charges against the former Stryker Biotech president and three sales directors.
- On behalf of a global pharmaceutical company, successfully negotiated the resolution of a multiyear criminal and civil investigation into legacy conduct of a company our client acquired regarding the company’s preacquistion promotion of a drug. We also represented the company in follow-on state Attorney General consumer protection investigations and successfully negotiated an agreement in principle between the company and the multistate coalition to resolve all claims.
- Representing an orphan drug biotechnology company in a joint SEC and DOJ investigation into allegations of securities fraud, off-label promotion and other related issues. In parallel with the SEC and DOJ investigations, we are also representing the company in negotiation of a consent decree of permanent injunction with the FDA.
- Lead counsel for a multinational pharmaceutical company in a multiyear criminal investigation into alleged off-label promotion. We successfully negotiated resolution of all criminal allegations with a civil-only settlement under Food, Drug, and Cosmetic Act.
- Obtained a judgment of acquittal for a former Associate General Counsel at GSK who was charged with obstruction of justice and making false statements in connection with an FDA inquiry into the company’s marketing practices. The case, United States v. Stevens, marked the first time that the presiding judge had ever granted a motion for judgment of acquittal without sending the case to a jury in his seven and a half years on the federal bench.
- Represented Elan Pharmaceuticals Inc., the U.S. subsidiary of Elan Corporation, plc in resolving all aspects of the DOJ’s investigation of sales and marketing practices related to an antiepileptic drug. As part of the global resolution we secured one of the first corporate FDCA misdemeanor resolutions from the Boston U.S. Attorney’s Office.
- Represented Pfizer in reaching a $2.3 billion global settlement with the federal and state governments. We led a multi-firm team working with Pfizer’s legal team in conducting an extensive internal investigation of the civil and criminal allegations and to resolve the various probes and lawsuits, and served as Pfizer’s lead outside counsel in negotiating the settlement agreement with DOJ and HHS-OIG.
- Successfully represented a nationally prominent pharmacy benefit manager (“PBM”) during a multi-year grand jury investigation into the relationships between the PBM and pharmaceutical manufacturers, and secured one of the first stand-alone deferred prosecution agreements in a health care fraud case.
False Claims Act Experience
- Won a complete grant of summary judgment for a multinational pharmaceutical company in a False Claims Act lawsuit filed by two former sales representatives (“relators”) who alleged that the company continued to promote an antipsychotic drug for a number of off-label uses and paid kickbacks to doctors following a previous settlement with the federal government. Relators also alleged the company retaliated against one of the former representatives for raising compliance concerns. Following a District Court decision granting summary judgment for the company, we successfully defended against the relators’ appeal before the First Circuit Court of Appeals.
- Lead counsel for a global pharmaceutical company in a federal investigation and related action under the False Claims Act concerning alleged off-label promotion and kickbacks to physicians. We finalized a settlement resolving the USAO’s investigation and federal qui tam action for a civil-only payment, with no Corporate Integrity Agreement with the HHS-OIG.
- Co-lead counsel for a biotechnology company in federal investigations and related civil litigation. Negotiated a settlement which resolved federal and state criminal and civil liability under the Food, Drug, and Cosmetic Act, Anti-Kickback Statute, and the False Claims Act and concluded 10 outstanding qui tam lawsuits. Also negotiated the resolution of related 49 jurisdiction consumer protection investigation.
- Representing a major pharmaceutical company in a DOJ False Claims Act investigation related to drug pricing. We responded to interrogatories and document requests, using technology-assisted-review to efficiently identify and review documents, minimizing resources expenditure.
- Representing a major pharmaceutical company in a government investigation into alleged violations of the Anti-Kickback Statute. We are handling multiple document productions and preparing employees for interviews with the government, while also conducting a thorough internal investigation of the allegations.
- Lead counsel for a pharmacy services provider in an investigation by DOJ and the U.S. Attorney’s Office in South Carolina concerning contracts with pharmaceutical manufacturers and in a qui tam action concerning alleged solicitation and receipt of kickbacks from a pharmaceutical manufacturer. Negotiated favorable resolution with DOJ, HHS-OIG, State AGs, and qui tam relators.
- Represented a major medical device manufacturer in two separate joint criminal and civil investigations conducted by the DOJ and FDA that spanned several years. Both investigations involved the alleged off-label promotion of two distinct medical devices. We persuaded the DOJ to close the investigations without taking any adverse action against the company or any associated individuals, as well as obtained the dismissal and disposition of two related qui tam actions.
- Represented a major medical device company in two separate DOJ investigations aimed at alleged kickbacks and bribes to health care professionals. The investigations focused on both classic kickback allegations, such as those related to lavish travel and entertainment, as well as more complex contractual relationships with physicians, such as wholesaling and consulting arrangements. We assisted the Company in successfully resolving both matters, including related qui tam litigation, ensuring the company could continue to serve federal health care program patients.
- Secured the dismissal of a False Claims Act suit with prejudice for a multinational medical device company. The complaint alleged that the company had violated the Anti-Kickback Statute in connection with its promotion of HIV drugs, which purportedly caused false claims for federal reimbursement. The judge dismissed all claims in the complaint.
- Successfully obtained a dismissal with prejudice of a federal False Claims Act qui tam action filed in Massachusetts against a major medical device manufacturer. The complaint asserted that the company had caused the submission of false claims for procedures involving two medical devices.
- Negotiated a comprehensive civil resolution for a diagnostic laboratory facing a wide-ranging federal civil and criminal investigation involving the DOJ, HHS-OIG, and various state agencies. Secured a favorable resolution on claims relating to alleged anti-kickback, False Claims Act, Stark Law, and other alleged violations stemming from the marketing and billing of our client’s services. The resolution includes the dismissal, with prejudice, of all claims in four qui tam lawsuits.
State Attorney General and Consumer Protection Experience
- Achieved a highly favorable settlement for two multinational pharmaceutical companies and their joint venture regarding their joint venture drug. In a widely publicized investigation, 36 state attorneys general inquired into whether the companies had intentionally delayed the release of clinical trial results and whether product promotional and other consumer claims were, as a consequence, deceptive or misleading. After thorough investigation of our clients, a settlement was reached where our clients agreed to reimburse the 35 states and Washington, D.C. for costs associated with the investigation with no additional penalty and without admitting wrongdoing. We also succeeded in closing a parallel investigation with the federal government concerning the drug.
- Lead counsel to a major pharmaceutical company in negotiating a settlement with a coalition of 42 state Attorneys General that had been investigating potential violations of their respective states’ consumer protection laws with respect to the company’s promotion of one of its drugs.
- Negotiated settlement agreements for a major pharmaceutical company resolving outstanding consumer protection allegations made by the Oregon DOJ and a Multistate Coalition led by the Texas Attorney General consisting of 32 states and the District of Columbia. The allegations concerned the promotion of certain of the company’s drug products.
- Represented a multinational medical device company in connection with two state Attorney General investigations in Massachusetts and Oregon related to a bone growth product. We settled each of the investigations, and assisted with product liability suits related to the product as well.
- Representing a major pharmaceutical company in an inquiry by the Massachusetts Attorney General’s Office relating to clinical trial reporting.
- Represented a multinational pharmaceutical company in two separate consumer protection investigations concerning direct to consumer advertising conducted by the Massachusetts Attorney General's office and the Oregon Attorney General's office.
- Represented a pharmacy benefit manager (“PBM”) in an investigation that spanned approximately four years. Pursuant to state consumer protection statutes, Attorneys General from 28 states and the District of Columbia requested information and documents responsive to Civil Investigative Demands. The investigation concerned rebates, drug interchange or “switching” programs, and non-PBM sources of revenue. The PBM entered into an Assurance of Voluntary Compliance and Discontinuance with the state attorneys general to successfully resolve this investigation.