Ms. Frederick devotes much of her practice to representing pharmaceutical clients in complex products liability mass torts and antitrust putative class actions, particularly those that require specialized knowledge of the regulatory framework for the prescription pharmaceutical industry. Ms. Frederick also advises pharmaceutical companies on litigation avoidance, including assisting companies with clinical trial preparation, informed consent documentation and labeling.
Her significant matters include:
- Serves on National Defense Team for Leading Manufacturer Defending Pharmaceutical Mass Torts
Secured a number of dismissals on the basis of federal preemption, including in the U.S. Supreme Court case of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and before the Eleventh Circuit in Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013). Significant experience litigating before state coordinated proceedings in California, New Jersey, Pennsylvania, Missouri, and Massachusetts.
- Defends Leading Pharmaceutical Manufacturer in Putative Antitrust Class Actions Challenging Patent Litigation Settlements
Defends clients in putative class actions challenging patent litigation settlements on antitrust grounds, initiated after the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013). Obtained complete dismissal on the pleadings in FTC v. AbbVie Inc., 107 F. Supp. 3d 428 (E.D. Pa. 2015).
- Protects Interests of Pharmaceutical Companies in Agency Actions
Achieved victory for NDA holder in the face of a challenge to the FDA’s approval of its cutting-edge 505(b)(2) drug application. Protected interests of ANDA holders in retaining regulatory approval for the introduction of the first generic versions of drugs.
- Regularly Practices Before State and Federal Appellate Courts
Obtained reversal of adverse judgment on behalf of financial institution client in Vazquez-Robles v. CommoLoCo, Inc., 757 F.3d 1 (1st Cir. 2014). Drafted petition for certiorari to the U.S. Supreme Court on the breadth of immunity provided to financial institutions for Suspicious Activity Reporting. Drafted amicus brief on behalf of DRI – The Voice of the Defense Bar in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), available here.
- Secured Release of Pro Bono Client From Wrongful Imprisonment
Represented client in post-conviction proceedings, including in a three-day evidentiary hearing on third-party guilt. Obtained an order vacating his conviction, and represented him successfully through the State’s appeal of that decision and his release from prison.