Judy O’Grady is a partner with Pepper Hamilton LLP, resident in the Washington office. Ms. O’Grady is a member of the firm’s Health Sciences Department. Ms. O’Grady regularly counsels medical device and pharmaceutical companies on matters governed by the Food and Drug Administration. As part of her FDA counseling practice, she has counseled clients regarding INDs, NDAs, 510ks, PMAs, facility registration, product listings, product labeling, good manufacturing practices, clinical trials and adverse event reporting. She advises clients on risk management and marketing and promotional claims. She has performed regulatory due diligence in conjunction with SEC filings, securities offerings and acquisitions. She also has experience counseling clients regarding compliance with healthcare regulations, including fraud and abuse laws, and supervising internal company healthcare regulatory compliance investigations.
Ms. O’Grady also counsels clients regarding compliance with the Medicare Secondary Payer Act and Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007.
In addition, Ms. O’Grady has extensive experience defending pharmaceutical and medical device manufacturers in products liability actions. She has experience with all aspects of litigation including pre-litigation risk assessments, document collection and production, preparing company witnesses, developing experts and deposing key witnesses. Her experience includes work on federal multidistrict litigations, state consolidated matters and individual state and federal cases. Ms. O’Grady has appeared on behalf of pharmaceutical manufacturers in state and federal courts.
Before entering the legal profession, Ms. O’Grady served as a laboratory assistant at the Stanley Laboratory of Brain Research in Bethesda, Maryland, where she researched the normal development of the brain and the neuropathology of major mental illness. She also spent time as a laboratory technician in the Anesthesiology Department of the Hospital of the University of Pennsylvania. Ms. O’Grady’s medical research background allows her to easily analyze the complex scientific issues involved in representing pharmaceutical and medical device manufacturers.