We bring value to our clients in the following ways:
- Integrated services. Our regulatory and enforcement lawyers work in tandem. We believe that the best regulatory advice is informed by an in-depth understanding of the current enforcement environment and that the best defense in enforcement matters requires a nuanced understanding of regulatory issues. Our healthcare lawyers also work closely with colleagues in our FDA, white collar, products liability, IP, and transactional practices to provide seamless advice on complex legal and business issues.
- Cross-border coordination. We serve our global clients from multiple offices across the U.S. as well as from our offices in Europe and Asia. We strive to provide coordinated, borderless advice on issues such as compliance, pricing, and privacy that require an understanding of both transnational law and regulation and local law and tradition.
- Clinical perspective. With two physicians, lawyers with public health backgrounds, a Ph.D. scientist and other lawyers with extensive experience in scientific matters, we bring a distinctive clinical perspective to a range of legal matters, including matters involving quality of care, legislative policy, coverage and reimbursement, pre-clinical and clinical research, and off-label communications.
- Deep industry experience. We are able to provide efficient and effective service because we counsel healthcare clients on an extraordinary range of regulatory issues every day and have decades of experience handling enforcement and civil litigation matters in courts throughout the country.
Regulatory Firm of the Year
LMG Life Sciences Awards 2013-2017
Our work; representative matters
Our healthcare lawyers defend clients in government investigations; try civil cases; counsel clients on pricing, reimbursement, fraud and abuse, compliance, HIPAA/HITECH privacy, transparency, and antitrust issues; advocate on behalf of clients before Congress and regulatory agencies; and help assess regulatory risk in transactions.
Representative matters include:
- We represented Genentech Inc. in connection with a lengthy government investigation regarding the company’s promotion of Rituxan, which the government ultimately declined to prosecute either criminally or civilly.
- We negotiated numerous leading corporate integrity agreements in the life sciences industry, including for GlaxoSmithKline.
- We defended St. Luke’s Health System in civil antitrust suits brought by the Federal Trade Commission, Idaho Attorney General, and competitors arising out of an affiliation with a physician practice.
- We obtained dismissals or favorable settlements on behalf of several pharmaceutical companies in class actions and Attorney General suits involving alleged false price reporting to Medicare, Medicaid, and private third party payers.
- We represented Bayer Corporation in its launch of the first alpha-emitting radiopharmaceutical, Xogifo, as a treatment for castrate resistant prostate cancer with bone metastasis. The representation included responsibility for Medicare and Medicaid reimbursement, ASP and Medicaid price reporting, Federal Supply Schedule contracting, distribution system design and Nuclear Regulatory Commission licensing requirement issues.
- We represented a U.S. pharmaceutical company in a Congressional investigation into drug pricing. We successfully dissuaded the Congressional committee from continuing its investigation of the company or requesting the company to testify at a public hearing.
- Lawyers in our European, Asian, and U.S. offices represented an international device manufacturer in implementing a global privacy program which allows the business freely to transfer health data globally while meeting national privacy law requirements.
Recognition for our practice
Our work for clients has earned us acknowledgment in numerous industry publications. Clients told The Legal 500 for its 2016 edition that Sidley is “‘ahead of most other firms in work related to life sciences’ and is relied upon by clients for its ‘high quality, commercial advice’ and its ‘deep bench knowledge and experience in healthcare regulatory issues.’” The publication ranks Sidley as a first-tier firm within its Healthcare: life sciences category. LMG Life Sciences named Sidley the “Regulatory Firm of the Year” for the past five years and and the “2016 Product Liability Firm of the Year.”
“[Sidley Austin] maintains a strong reputation for its representation of an extreme range of domestic and multinational payors, providers and life sciences companies. Also, [Sidley] fields an experienced group whose expertise includes enforcement proceedings, transactional and antitrust issues, as well as Affordable Care Act compliance,” said Chambers USA in 2018. A year earlier, Chambers stated that “[Sidley] has a “strong regulation practice, highly recommended for its strengths in litigation and government investigations. Possesses substantial experience in matters relating to HIPAA/Health Information Technology for Economic and Clinical Health privacy, fraud and abuse, False Claims Act and antitrust litigation. Particularly noted for its acclaimed work on behalf of major drug companies.” In Chambers USA 2018, clients noted that “the team as a whole is excellent and offers very good client service.” And according to Chambers USA 2016, clients noted that partners in Sidley’s Healthcare practice are “tenacious and exceedingly smart” and are “willing to make decisions and stand by them, and they’re very business oriented in their advice.”
About our team
Our team features lawyers with decades of experience as litigators, counselors or both. A number of our lawyers previously served in senior government posts, including policy advisors to both Democratic and Republican Secretaries of HHS and legal counsel to the European Commission.