Life sciences companies often find themselves the target of securities fraud litigation or investigations, and our experienced, interdisciplinary team has a strong record of achieving favorable results when these challenges arise. We defend companies and their management and boards of directors in securities fraud class actions and shareholder derivative suits, counsel leadership through regulatory investigations, and advise on related governance issues. Our practitioners regularly handle matters in jurisdictions across the United States and before the Securities and Exchange Commission (SEC) and other regulatory agencies. The firm also has unmatched experience representing pharmaceutical and medical device companies in matters related to all other aspects of their business, bringing a deep understanding of clinical trials, the FDA approval process, and other crucial concerns when counseling clients on securities issues.
We have successfully defended clients in a number of federal securities fraud class action suits, derivative suits, and SEC investigations related to disclosures surrounding the progress of clinical trials, the FDA approval process, and the safety and efficacy of their products. Our experience includes:
- in the federal court for the District of Massachusetts, obtaining dismissals with prejudice of a purported derivative and securities fraud class action against a biotechnology client, its management and board of directors related to the clinical trials and FDA approval prospects of its cancer treatment drug;
- securing the dismissal with prejudice of all claims in a shareholder derivative lawsuit against a biomaterials and biotechnology client in a state trial court concerning the timing of a clinical study of a product designed to treat acute spinal cord injuries, which dismissal was affirmed on appeal in 2017;
- also achieving a victory for that same client when a federal court dismissed with prejudice all claims in a shareholder class action lawsuit alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, which dismissal was affirmed by the First Circuit Court of Appeals in 2017;
- for a medical device company headquartered in France, achieving the dismissal of a securities fraud action in the federal court in the Southern District of New York arising out of the company's failure to disclose a letter from the FDA regarding the trial of one of its products and the effect of the letter on the prospects for approval;
- obtaining dismissal by the US District Court for the District of Minnesota of a derivative suit against members of
a medical device company's board of directors, which had alleged that the defendants breached their fiduciary
duties by failing to properly oversee the company with regard to the voluntary recall of one of its products; and
- also for that same medical device company, achieving a significant victory in the US Court of Appeals for the
Eighth Circuit when the court affirmed the dismissal of a securities fraud class action that had been brought
against the company and three of its senior executives arising out of communications with the FDA related to the
safety of one of its products.