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Judith L. O'Grady

Judith L. O'Grady

Partner

Washington, DC
Phone: 202.220.1230    Fax: 202.220.1465

ogradyj@pepperlaw.com

Judy O’Grady is a partner in the Health Sciences Department, resident in the Washington office. Ms. O’Grady regularly counsels pharmaceutical and medical device companies on a wide variety of complex regulatory issues governed by the Food and Drug Administration. As part of her FDA counseling practice, she has advised clients regarding INDs, NDAs, 510ks, PMAs, facility registration, product listings, product labeling, good manufacturing practices, clinical trials, adverse event reporting and marketing and promotional claims. Ms. O’Grady has assisted clients in responding to Warning, Untitled and Complete Response Letters, 483s, and FDA import holds. Ms. O’Grady also counsels clinical laboratories regarding their compliance with the Clinical Laboratory Improvements Amendments of 1988, as well as state clinical laboratory laws and regulations. In addition to her counseling work, Ms. O’Grady leads Pepper Hamilton’s team of FDA and clinical laboratory regulatory experts in preparing SEC filings, as well as conducting due diligence in conjunction with securities offerings, mergers and acquisitions.

Ms. O’Grady leverages her deep industry knowledge to help clients mitigate risk by conducting compliance and litigation risk assessments, developing and refining compliance programs and preparing policies and procedures.  

Ms. O’Grady is an active member of the Defense Research Institute’s Medicare Secondary Payer Task Force, and 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 an extensive record 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.

Ms. O’Grady co-leads Pepper Hamilton’s Women’s Initiative and is a member of the Professional Responsibility and Alternative Work Schedule Committees.

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 gives her a strong grasp of the complex scientific issues involved in representing pharmaceutical and medical device manufacturers.

Education

  • J.D., with honors, University of Maryland Francis King Carey School of Law, 2004, Recipient of the ARC of Baltimore Outstanding Service on Behalf of Disabled Persons Award. As an intern at the National Association of the Deaf Law Center, she represented clients with disability discrimination claims. She also received her health law certificate.
  • B.A., Biological Sciences, University of Pennsylvania, 1996

Bar Admissions

  • District of Columbia
  • Maryland

Court Admissions

  • U.S. District Court, District of Columbia

Practice Areas

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