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:

• DISTRICT AND APPELLATE COURT VICTORY IN SHAREHOLDER CLASS ACTION AND SUCCESSFUL CONCLUSION OF SEC INVESTIGATION
  Securing dismissal of a federal class action lawsuit alleging that a biopharmaceutical company and its executives misled shareholders regarding whether the company manufactured its lead drug candidate using current Good Manufacturing Practices and the prospects for FDA approval. WilmerHale obtained dismissal of all claims in the trial court at the motion to dismiss stage and successfully persuaded the appellate court to affirm the district court’s judgment. WilmerHale also represented the company in a year-long SEC investigation related to these issues which the SEC concluded without recommending any action.

• DISMISSAL OF ALL CLAIMS IN SHAREHOLDER CLASS ACTION
  Obtaining dismissal of a securities fraud class action alleging a biopharmaceutical company failed properly to disclose its receipt of an FDA Form 483 letter in response to a manufacturing inspection. The case involved a company’s duty to disclose receipt of a Form 483, an issue of first impression in the Second Circuit.

• DISMISSAL OF SHAREHOLDER CLASS ACTION
  Obtaining dismissal of a federal securities fraud class action alleging pharmaceutical company concealed its alleged unlawful off-label marketing practices from the public and precluded investors from knowing the risks of investment. Following oral argument, the district court endorsed WilmerHale’s reasoning and dismissed all claims with prejudice.

• DISMISSAL OF STATE AND FEDERAL SECURITIES ACT CLAIMS
  Obtaining a well-publicized ruling that Massachusetts state courts cannot maintain nationwide class actions in Securities Act cases, leading to a stay of a state court securities case, then securing a voluntarily dismissal of both the federal and state court cases, ending all pending securities litigation.

• DISMISSAL OF ALL CLAIMS IN SHAREHOLDER CLASS ACTION
  Securing the dismissal of all claims in a class action lawsuit in which shareholders alleged securities fraud following a drop in a pharmaceutical company’s share price after its announcement of disappointing results in a Phase 3 clinical trial. The most significant portion of the ruling involved the court’s rejection of the plaintiffs’ insider trading argument.

• DISMISSAL OF DERIVATIVE AND CLASS ACTION CLAIMS
  Obtaining dismissals with prejudice of a purported derivative and securities fraud class action against a biotechnology company, its management and board of directors related to the clinical trials and FDA approval prospects of its cancer treatment drug.

• FEDERAL AND STATE TRIAL COURT AND APPELLATE VICTORIES IN DERIVATIVE AND SHAREHOLDER CLASS ACTION MATTERS
  Securing the dismissal of all claims in a shareholder derivative lawsuit against a biomaterials and biotechnology company in a state trial court concerning the timing of a clinical study of a product designed to treat acute spinal cord injuries, and also obtaining the dismissal for the same client of all claims in a federal securities class action. Both dismissals were affirmed on appeal.

• DISMISSAL OF SECURITIES CLASS ACTION
  Achieving the dismissal of a securities fraud action against a medical device company 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.