Industries: Life Sciences

Litigation and Government Investigations

Product and Commercial Litigation

No other country is as litigious as the United States, and few companies attract as much scrutiny and criticism as those in the life sciences industry. Given 1) the risk-benefit analysis inherent in making medicines and medical devices; 2) the variability of human biology and hence of the interaction between product and end-user; 3) the intricate, pervasive, and shifting FDA regulatory scheme; and 4) the highly competitive market place, perhaps litigation is inevitable. And too often, the litigation is of "bet-the company" magnitude in part because adversaries are fiercely determined, exceedingly well-funded, highly coordinated, and very sophisticated. Manufacturers must manage each litigation matter in the context of other possible litigation and regulatory, media, and shareholder repercussions. The challenges are daunting.

The processes of manufacturing and promoting medical devices and pharmaceuticals can at times result in unique product litigation challenges for companies. When facing claims or litigation, manufacturers need counsel with FDA-related knowledge and experience to mount a comprehensive defense. History has shown that the very survival of the company may depend on it.

Many decades of experience defending products liability and toxic tort claims have established McGuireWoods as an experienced leader in this area. This experience has formed the basis for our success in working with pharmaceutical, biotechnology, and medical device firms.

We have defended companies in individual cases, served as coordinating counsel in nationwide products liability litigation, and managed class actions and multidistrict litigation.

Our lawyers have defended a wide array of devices (latex gloves, catheters, etc.), pharmaceuticals (tetra-cycline, opioids, antibiotics and other medicines) and biological products (vaccines) in courts not only in jurisdictions where we have offices but around the country. Whether the product is well-established or cutting-edge, our experience in defense of claims probably encompasses the class of product to which the device ordering belongs.

On the life science industry team, we capitalize on our people and the breadth of their knowledge and experience about FDA-regulated products. Clients who seek out our solid litigation experience typically find that together we can also develop strategies to reduce or avoid litigation.

Government, Regulatory & Criminal Investigations

Our Life Science Industry attorneys have practiced in the area of litigation with particular emphasis in the areas of white collar criminal defense, related regulatory matters, complex commercial matters and product liability defense.

Many of our attorneys have also conducted such investigations on behalf of federal and state agencies in their roles prior to joining McGuireWoods. Our ranks include Former State Attorneys General, Former DOJ Task Force Attorneys, Former U.S Securities and Exchange Commission Enforcement Attorney, and Former Assistant United States Attorneys.

In order to ensure success, our government investigations attorneys also work alongside other practice areas to prevent regulatory inquiries from becoming criminal issues. We regularly advise company management regarding the establishment of compliance programs regarding all issues.