The pharmaceuticals, biotechnology and medical device industries face unique legal challenges. Claims of health care fraud and abuse, products liability and mass tort litigation, and consumer fraud class actions have put increased business pressures on corporate clients. The courts have seen an explosion of ANDA litigation, testing the strength of key pharmaceutical patents. Legislative challenges abound as state and federal governments look for ways to control health care costs.
Our lawyers have experience in a wide range of matters that help our corporate clients address these pressing issues and more. Members of the Practice include top-ranked trial lawyers and lawyers with advanced degrees in relevant sciences. We have the capability to deliver the right resources at the right time consistent with your business goals in many areas, including:
- Products liability and class action defense. — We have significant experience defending pharmaceutical companies in products liability, class action and mass tort litigation. We have been national counsel and regional counsel and lead counsel on over 100 individual cases. Our Practice puts a premium on developing the good company/ scientific defense. We also use prelitigation risk assessment and risk management analyses to help clients avoid or minimize the risk of litigation.
- Intellectual property litigation. — Our lawyers are skilled in trying intellectual property and and patent cases, including high-stakes ANDA litigation, as well as counseling, and patent and trademark prosecution.
- Fraud and abuse counseling and litigation. — Our fraud and abuse team includes two former United States Attorneys, former Assistant U.S. Attorneys and former SEC staff. We often advise about compliance issues and represent companies in criminal investigations and civil litigation involving issues such as anti-kickback violations and improper marketing of pharmaceutical products.
- Commercial Litigation and Antitrust. — Members of the group have represented clients in insurance coverage disputes, counseling and litigation over contract disputes, antitrust litigation, counseling on pricing and distributorship issues and impact of overseas laws.
- Regulatory counseling and advocacy. — Our lawyers counsel in SEC and FDA regulations and guidance, compliance with HIPAA patient privacy and security rules, new product approvals, post-approval marketing restrictions, incident reporting and advocating for changes to existing or proposed rules.
- Transactions and licensing. — We have represented U.S. and foreign companies in the pharmaceutical and biotech industries in divestitures, financings, license agreements, joint ventures and other commercial matters.
For representative engagements, click on "Transactions and Cases."
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