Our attorneys provide solutions to a variety of life sciences clients operating in the heavily regulated health care industry. Our attorneys use their experience, understanding of complex legal requirements, knowledge of clients’ industries, and relationships with government regulators to develop effective solutions to our clients' regulatory, transactional, operational, administrative, and litigation needs.
We represent pharmaceutical, biotechnology and medical device companies, laboratories, health IT companies, clinical research organizations (CRO), drug development companies, pharmacy benefit managers, and other health care entities in all stages of development and commercialization. Our attorneys are experienced in all aspects of health care law, including regulatory compliance, state and federal agency audits and investigations, fraud and abuse, corporate compliance, coverage and reimbursement, and complex health care litigation matters. Our attorneys understand the constantly-evolving and increasingly complex laws and regulations that impact companies involved directly or indirectly in the health care space.
Our attorneys guide clients through a wide range of potential regulatory issues, including compliance with federal and state health care program laws, regulations and industry codes of conduct. This includes compliance with the following:
- AdvaMed Code of Ethics on Interactions with Health Care Professionals;
- Anti-kickback laws;
- Civil monetary penalties (CMP) law;
- Coverage and reimbursement requirements;
- Drug enforcement administration (DEA) regulations;
- Eliminating Kickbacks in Recovery Act (EKRA);
- False claims acts;
- Federal Food, Drug & Cosmetic Act (FDCA);
- Food and Drug Administration (FDA) laws and regulations;
- Health care reform laws and regulations;
- Health Insurance Portability and Accountability Act (HIPAA), privacy and cybersecurity;
- Licensure and accreditation requirements;
- Office of Inspector General (OIG) compliance guidance;
- Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code);
- Prescription Drug User Fee Act (PDUFA);
- Physician self-referral laws, including the Stark Law;
- Sunshine and transparency laws;
- Telehealth/telemedicine/mHealth laws;
- U.S. Federal Sentencing Guidelines.
We represent clients in responding to administrative, civil, criminal and grand jury subpoenas, Congressional inquiries, and agency audits or notices, including the defense of claims brought under the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), EKRA, CMP Law, and HIPAA. We also assist clients with remediation efforts, including conducting internal investigations, advising regarding self-disclosure obligations, negotiating settlement agreements, and implementing integrity obligations.
Our attorneys counsel clients on the development and implementation of corporate compliance programs consistent with U.S. Federal Sentencing Guidelines, OIG guidance, industry codes of conduct, and industry best practices. This includes advising on compliance program infrastructure; drafting policies, procedures and processes; implementation of compliance reporting systems; developing compliance training, auditing, monitoring, and risk assessment programs. We conduct internal compliance effectiveness reviews, compliance audits, and internal investigations related to regulatory and compliance matters. Our attorneys also regularly provide compliance training to boards of directors, management teams, sales representatives and other company employees regarding compliance with law and industry standards.
Our attorneys stay on top of developing regulatory and enforcement priorities, advising on key risk areas such as misbranding, pre-approval promotion, off-label promotion, patient assistance programs, kickbacks, health care professional (HCP) speakers and consultants, advisory boards, interactions between sales/marketing and medical/MSL personnel, grants and sponsorships, charitable donations, and interactions with patient organizations and charitable foundations.
Our attorneys also have extensive knowledge of federal, state and local marketing, licensure, pricing and transparency reporting laws applicable to life sciences companies and other health care entities. Our attorneys advise on implementation, tracking and reporting obligations; respond to government inquiries; provide counsel regarding audits and reviews of reported data; and assist clients with submitting comments to proposed regulations and guidance. Our attorneys also advise others impacted by these transparency laws, including academic medical centers, hospitals, and HCPs.
Our attorneys understand the pressures placed on health care entities operating in the highly-regulated health care industry. With increasing state and federal regulatory requirements, there are more ways for a company to find itself and its employees under close scrutiny. There are incentives for whistleblowers – found both inside and outside the organization – to bring any alleged wrongdoing to the government’s attention.
We conduct thorough internal investigations of potential wrongdoing or regulatory non-compliance. Through fact-gathering, document review, and interviews of employees and other witnesses, our attorneys are able to find the information the client needs to plan an effective and appropriate response. We also assess whether any individual employees might need separate representation during the investigation.
At the conclusion of each investigation, we prepare a detailed report that presents our findings and recommendations to minimize and mitigate risks. When needed, we work with our clients, to take appropriate corrective action, including making voluntary self-disclosures, returning overpayments, creating or updating compliance and governance plans, and responding to government inquiries.
False Claims Act (FCA) Defense
Our health care attorneys provide comprehensive representation in FCA matters, including:
- Counseling and/or compliance audits and assessments to prevent FCA litigation;
- Advising when and how to make voluntary disclosures or returning overpayments;
- Conducting internal investigations in response to internal whistleblower complaints or other compliance concerns;
- Responding to subpoenas, civil investigative demands, and other inquiries from federal and state agencies;
- Persuading the Department of Justice (DOJ) not to intervene in qui tam actions;
- Crafting successful motions to dismiss FCA complaints;
- Litigating intervened and non-intervened FCA cases through discovery, summary judgment, trial and appeals;
- Negotiating global settlements with the DOJ, state attorneys general, Medicaid Fraud Control Units, counsel for federal and state agencies, and relators’ counsel;
- Advising on ability to pay settlements;
- Negotiating with agency counsel to prevent suspension, exclusion or debarment, including negotiating corporate integrity agreements (CIA) and monitoring agreements; and
- Assessment of CIA-readiness and implementation.
We have represented companies in government investigations by numerous federal and state agencies, defended FCA litigation in jurisdictions across the country, obtained dismissal of FCA cases, and prevailed in appeals in FCA cases. Dinsmore also has several former DOJ attorneys to assist with FCA and white collar litigation matters.
Corporate & Transactional Matters
Our attorneys handle health care corporate and transactional matters at the national, regional and local levels. We assist health care and life sciences clients in corporate matters, including joint ventures, mergers and acquisitions, contracts and agreements, financing, regulatory matters, due diligence compliance reviews, board structure, and corporate governance. We also function as de facto general counsel for several clients, in which we draft, negotiate and review various commercial contracts relevant to our clients’ businesses. We handle a variety of health care contracting matters for our clients, including licensing, acquisitions and other affiliations, joint ventures, co-promote and co-development, marketing and promotion, supply and distribution, clinical trial, managed care, pharmacy benefit management services, specialty pharmacy, management services, consulting, speaker, scientific advisory board, grants and sponsorships, and charitable donations.
We also advise manufacturers, investment banks, private equity and venture capital firms, and individual investors regarding transactions involving health care and life sciences companies, including conducting regulatory due diligence reviews to identify and assess risks associated with target companies. We utilize our experience and knowledge of the FDA, FTC and other regulatory requirements to perform risk assessments on regulatory processes affecting product approval, evaluate commercialization and post-approval activities, assess litigation risk in product liability actions, and provide input on the regulatory issues presented in financial disclosures and other transaction documents. When necessary, we also prepare transactional filings and notices to satisfy regulatory requirements applicable to a transaction.
Our team includes attorneys who are former medical researchers/scientists, bioethicists, and policy advisors who combine their technical and practical experience with their legal knowledge to advise clients in the pharmacy, pharmaceutical, biotechnology, medical device, laboratory, and clinical research industries. We guide clients’ efforts to comply with pharmacy board, FDA, DEA and CMS regulations, 340B program requirements, USP 797 and FDA sterile compounding requirements, and Joint Commission and HFAP accreditation standards. They have deep knowledge of specialty and community pharmacy, managed care, pharmacy benefits management, and long-term care pharmacy practices.
We also provide FDA regulatory advice to medical device, drug, biotechnology and cosmetic manufacturers, and mobile health application developers. We assist clients ranging from individual entrepreneurs to Global 100 companies. Our FDA experience includes assisting clients in classifying products, navigating the 510K notification process, compliance with good manufacturing practices (GMPs), advising on all aspects of clinical trials, drafting CRO and informed consent agreements, represent companies in FDA meetings, and implementation of risk evaluation and mitigation strategies (REMS). Additionally, we provide counseling on FDA's post-marketing regulations to assist clients in understanding FDA's requirements for manufacturing, including advising on product recalls, market withdrawals, product seizures and injunctive actions; reporting adverse events; and responding to FDA enforcement actions.
Our attorneys have extensive knowledge of the FDCA and FTC regulations applicable to labeling, advertising, marketing and promotion, including social media, scientific exchange, medical information requests, and disease state awareness. Our attorneys also advise on advertising claims review, including serving on promotional review committees.
FDA Enforcement and Related Litigation
We assist clients with various types of FDA enforcement actions, including FDA inspections, responses to FDA 483 Inspectional Observations, and untitled and warning letters. We represent manufacturers in injunction and seizure actions, recalls and market withdrawals, criminal prosecutions, assessments of civil penalties, and other regulatory actions brought by the FDA, FTC and state authorities. We also provide assistance with the review, development and implementation of manufacturing policies, inspection policies and corporate compliance programs that take into account FDA requirements, including clinical Good Manufacturing Practices.
The Product Liability Practice Group within our litigation department represents pharmaceutical and medical device manufacturers in cases filed in various state and federal courts throughout the United States. Included in the group are individuals who are trained in medicine, nursing, pharmacy, x-ray technology, toxicology and engineering. With respect to pharmaceutical and device products, our litigators work on behalf of the manufacturers of such products as Bendectin, DES, Thalidomide, Accutane, Phentermine, Parlodel, Phenylpropanolamine, Oxycontin, Pyridostigmine Bromide, blood and blood products, bone screws, breast implants, food supplements, such as L-tryptophan and ephedra, neutraceuticals, orthopedic implants, over-the-counter cough, cold and sleep aid medications, pacemakers, pacemaker leads, silicone implant products, surgical gloves, tampons, and urethral stone retrieval devices.
HIPAA, Privacy & Cybersecurity
Modern health care organizations face many cyber threats. One of the most significant threats in recent years is ransomware -- a form of cyber-attack that encrypts (or locks) data until the owner pays a ransom to the attackers. Once encrypted, that data – whether it is emails, accounting information, or patient treatment information – is unavailable to the organization, often severely disrupting operations. The prevalence of these attacks in the health care sector shows that health care organizations of all sizes and types must be vigilant.
In this ever-changing health care data security and cyber landscape, we guide covered entity and business associate clients in all aspects of HIPAA compliance by:
- Creating effective governance programs;
- Implementing comprehensive compliance policies and procedures;
- Analyzing and investigating alleged security breaches;
- Conducting risk assessments and training programs; and
- Drafting customized documents tailored to our clients’ business needs and technologies.
We provide guidance to health care entities regarding HIPAA privacy rule violations and breaches. We have experience with the Office of Civil Rights (OCR) in resolving breach investigations favorably for clients. We handle breach notification risk assessments, including addressing state data breach laws and requirements, many of which have more stringent notification requirements than HIPAA that must be taken into consideration. We also conduct HIPAA breach investigations for health care clients across the country, engaging computer forensic experts and overseeing the conduct of their analyses, when required.