Rachael G. Pontikes counsels compounding pharmacies in both human and animal health regarding compliance with various applicable state and federal law. She also acts as litigation counsel for compounding pharmacies in disputes with the state boards of pharmacy, the Food and Drug Administration and the Drug Enforcement Administration in administrative proceedings and federal courts. She is a nationally recognized authority in the Drug Quality Security Act (DQSA)-Compounding Quality Act (CQA), participating in various discussions with the Senate HELP Committee staffers as the law was drafted. Ms. Pontikes is frequently invited to speak on the DQSA-CQA and its implications for compounding pharmacies, most recently by the Food Drug Law Institute (FDLI) for their enforcement conference and the American Pharmacist Association (APhA) for their annual conference. Her deep experience with the laws governing compounding pharmacies stems from her role as trial and appellate counsel for two seminal cases that shaped the legal landscape. Ms. Pontikes served as trial counsel in Medical Center v. Mukasey through defeat of the motion to dismiss, and trial and appellate counsel in Wedgewood Village Pharmacy v. United States. She is a member of the Duane Morris Pharmaceutical, Medical Device, Pharmacy, and Food group.
Ms. Pontikes also has an active commercial and appellate litigation practice, acting as lead counsel in representing companies in a broad range of business disputes. Fluent in Italian and a former resident of Milan, a core focus of her commercial practice involves assisting companies in litigating or arbitrating cross-border disputes, both as counsel for international entities doing business in the United States, and also as a liaison for American companies that are sued abroad. Ms. Pontikes served as lead trial counsel for an Italian vineyard sued for $18 million in Palm Bay Int'l, Inc. v. Marchesi Di Barolo S.p.A. After a month long federal jury trial, she obtained a defense verdict of $500,000 and successfully defended this win in the Second Circuit.
In each of these contexts, Ms. Pontikes approaches client problem solving creatively, from crafting beneficial settlements to creating novel legal theories on matters of first impression. She distills complex legal theories to an essence that anyone can understand. Ms. Pontikes passionately advocates her clients' positions in a manner tailored to her audience, whether it be regulators, trial or appellate judges, or juries.
Ms. Pontikes is also highly active in her community. She serves on the Executive Committee of the Chicago Bar Association Alliance for Women, is on the board for the Chicago Alliance Against Sexual Exploitation, and is the Pro Bono Coordinator for the Chicago office. Through Chicago Bar Association Alliance for Women, Ms. Pontikes co-founded the mentoring circles program, the largest mentoring program for women attorneys in Chicago. She is also a lecturer in law at the University of Chicago, where she teaches a seminar entitled "Obscenity and Pop Culture," drawing on her experience as trial counsel for two groups of minor girls who brought civil suit based on allegations they were sexually exploited when featured in child pornography.
In 2014, 2015 and 2016, Ms. Pontikes was named an Illinois Super Lawyer. In 2012 and 2013, Ms. Pontikes was named an Illinois Rising Star, an honor reserved for approximately 2 percent of Illinois lawyers. In 2013, Ms. Pontikes was selected by the Chicago Daily Law Bulletin from over 1,300 nominees as one of the "40 Illinois Attorneys Under Forty to Watch." In 2013 she was also named an Illinois Leading Lawyer and noted as being among the 25 youngest lawyers to receive her award.
Ms. Pontikes is a 2001 graduate of the University of Chicago Law School and an honors graduate of Wesleyan University, where she was elected Phi Beta Kappa.
- Counsels compounding pharmacies specializing in both human and veterinary health on compliance with various state and federal laws including the DQSA-CQA.
- Trial counsel for a compounding pharmacy in various disputes before state boards of pharmacy.
- Trial counsel for ten compounding pharmacies in Medical Center v. Mukasey, 451 F.Supp.2d 854 (W.D. Tex. 2006) through the defeat of the motion to dismiss.
- Trial and appellate counsel for a veterinary compounding pharmacy in the trial court and Third Circuit in actions against the Food and Drug Administration in Wedgewood Village Pharmacy v. Ashcroft, 293 F.Supp.2d 462, (D.N.J. 2003), aff'd, Wedgewood Village Pharmacy v. United States, 421 F.3d 263, 269 (3d Cir. 2005).
- Trial counsel for a veterinary compounding pharmacy in an administrative hearing against the Drug Enforcement Administration.
- Lead trial counsel for an Italian vineyard on $18 million breach of the warranty of merchantability claim, obtaining a defense verdict following a month-long jury trial. Palm Bay Int'l, Inc. v. Marchesi Di Barolo S.p.A., 796 F. Supp. 2d 396 (E.D.N.Y. 2011). Lead American liaison counsel assisting with American law issues in the companion Italian matter.
- Lead trial counsel in defending a United States construction corporation against a challenge from an Italian quarry in a contract dispute. Lead American liaison counsel assisting with the American law issues in the companion Italian matter.
- Trial counsel for a United States company in a $25 million international arbitration against an Australian company.
- Lead appellate counsel (argued). Successfully defended a jury verdict. Palm Bay Int'l, Inc. v. Marchesi Di Barolo, 2012 WL 1739032 (2d Cir. May 17, 2012).
- Lead appellate counsel (argued) Overturned the district court to allow plaintiffs to proceed anonymously at trial. Plaintiff B v. Francis, 631 F.3d 1310 (11th Cir. 2011).
- Appellate counsel. Successfully defended a judgment of $3.3 million. Galindo v. Instalaciones de Tendidos Telefonicos, S.A., (2d Cir. January 28, 2013).
- Appellate counsel. Successfully defended a challenge to a district court's confirmation of a pre-hearing summary judgment. Olson v. Wexford Clearing Services Corp., 397 F.3d 448 (7th Cir. 2005).
- Trial counsel for seven girls who alleged that Joe Francis and the Girls Gone Wild companies created child pornography featuring them in Doe v. Francis.
- Trial counsel for four girls who alleged that Joe Francis and the Girls Gone Wild companies created child pornography featuring them in Plaintiff B v. Francis.
- Lead trial counsel for the general partner of a family partnership. Obtained a favorable verdict in a family dispute over the partnership assets after a bench trial.
- Trial counsel for the managing member of an LLC. Defeated summary judgment, and negotiated a settlement the client found favorable.
- Represented broker-dealer that specialized in the distribution of proprietary managed investment funds in an extensive regulatory investigation, and enabled the client to settle lesser administrative charges rather than charges alleging fraud and/or manipulation.
- Represented an online trading company in a FINRA arbitration and negotiated a settlement that the client found favorable.
- Represented pro bono a sex trafficking survivor in successfully vacating criminal convictions under Illinois' 2012 Justice for Victims of Sex Trafficking Crimes Act.
- Obtained relief for a pro bono client, while working closely with the Chicago Alliance Against Sexual Exploitation, under the Illinois Justice for Victims of Sex Crimes Trafficking Act. The Act allows state courts to vacate prostitution convictions if the person convicted can show that they were a victim of trafficking at the time of the conviction.
- Obtained political asylum for an African woman, a victim of domestic violence, after an administrative hearing for the National Immigrant Justice Center (NIJC).
- Obtained a settlement the client found favorable for a prisoner beaten by a guard in a 1983 civil rights action in federal court.
- Obtained citizenship for a seventeen year old girl beaten by her father under the Violence Against Women Act.
Compounding Pharmacy Matters
Child Pornography Civil Actions
Pro Bono Work
Areas of Practice
- Healthcare Litigation
- Cross Border Litigation
- Appellate Advocacy
- Financial Services Law
- Supreme Court of Illinois
- U.S. District Court for the Northern District of Illinois
- U.S. District Court for the Northern District of Florida
- U.S. Court of Appeals for the Second Circuit
- U.S. Court of Appeals for the Third Circuit
- U.S. Court of Appeals for the Seventh Circuit
- U.S. Court of Appeals for the Eleventh Circuit
- Trial Bar of the U.S. District Court for the Northern District of Illinois
- University of Chicago Law School, J.D., 2001
- Wesleyan University, B.A., Philosophy and Italian Studies, with honors, 1996
- Elected Phi Beta Kappa
- Duane Morris LLP
- Partner, 2010-present
- Associate, 2003-2009
- The University of Chicago Law School
- Lecturer In Law, 2011-present
- Altheimer & Gray, Chicago, Illinois
- Associate, 2002-2003
- Lovells, Chicago, Illinois
- Associate, 2001-2002
- American Bar Association
- Section of International Law
- Chicago Bar Association
- Alliance for Women
- Executive Committee, 2009-present
-- Co-Chair, Mentoring Circles Committee, 2009-2012
-- Co-Chair, Advocacy and Domestic Violence Committee, 2012-present
- Hellenic Bar Association
- University of Chicago Women's Mentoring Program
Honors and Awards
- Named an Illinois Super Lawyer, 2014-2017
- Selected as one of the "40 Illinois Attorneys Under Forty to Watch" by the Chicago Daily Law Bulletin, 2013
- Named an Illinois Leading Lawyer, 2013
- Named an Illinois Rising Star, 2012, 2013
- Selected as one of the Just the Beginning Foundation's 2012 "20 Under 40" honorees
- Chicago Alliance Against Sexual Exploitation, 2011-present
- Board Development Committee Chair, 2014-present
- Personnel Committee, 2011-present
- Lyric Opera of Chicago Guild
- Member, 2007-2012
- Vice President of Silent Auction, 2007
- Author, "FDA Form 483 Inspectional Observations Are Not Findings of Wrongdoing," Duane Morris Alert, October 24, 2016
- Author, "FDA Releases Draft Guidances on What Constitute 'Essentially Copies' of Commercially Available or Approved Drug Products," Duane Morris Alert, August 4, 2016
- Author, "FDA Solidifies Its Position on Certain Compounding Issues in New Guidance Documents," Duane Morris Alert, June 20, 2016
- Author, "FDA Clarifies Its Position on Several Compounding Issues in New Draft Guidance Documents," Duane Morris Alert, May 12, 2016
- Author, "FDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers," Duane Morris Alert, November 4, 2015
- Author, "FDA Publishes Draft Guidance Documents on Compounding Using Bulk Drug Substances," Duane Morris Alert, November 3, 2015
- Quoted in "Order Vacates Conviction Under Trafficking-Victims Act," Chicago Daily Law Bulletin, July 29, 2015
- Author, "FDA Issues New Documents Governing Drug Compounding," Duane Morris Alert, April 6, 2015
- Author, "Drug Quality and Security Act Does Not Apply to Veterinary Compounding," Duane Morris Alert, March 6, 2015
- Editor and author, The Regulation of Pharmacy Compounding: FDA Authority and the Compounding Quality Act of 2013, Food and Drug Law Institute Primer, 2014
- Author, "Compounding Pharmacy Co-Owner Pleads Guilty to Misdemeanor Criminal Violations of the Food, Drug, and Cosmetic Act," Duane Morris Alert, December 22, 2014
- Author, "FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities," Duane Morris Alert, December 9, 2014
- Author, "FDA Gives Guidance on Compounding for Human Use," Duane Morris Alert, July 14, 2014
- Author, "FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees," Duane Morris Alert, April 7, 2014
- Author, "Compounding Pharmacies Now Subject to Federal Oversight," Duane Morris Alert, December 2, 2013
- Author, "U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies," Duane Morris Alert, September 19, 2013
- Author, "Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies," Duane Morris Alert, July 30, 2013
- Author, "Compounding Legislation Goes Through Another Change: New House Bill on Federal Oversight," Duane Morris Alert, July 19, 2013
- Quoted in "Compounding Bill May Hand FDA New Power Over Health Care," Law360, April 30, 2013
- Author, "Congress Drafts Compounding Legislation -- Defines Compounded Drugs as 'New Drugs' Under the FFDCA and Creates Bright Line Between 'Traditional Compounders' and 'Compounding Manufacturers,'" Duane Morris Alert, April 29, 2013
- Author, "Compounding Animal Drugs from Bulk Ingredients," Duane Morris Alert, April 17, 2013
- "FDA Authority Over Compounding Pharmacy," FDLI Update, March/April 2013
- Author, "FDA Emphasizes Patient-Specific Prescriptions," Duane Morris Alert, March 21, 2013
- Author, "FDA Tightens Requirement for Patient-Specific Prescriptions in the Wake of the Meningitis Outbreak," Duane Morris Alert, February 25, 2013
- Author, "U.S. Government's Use of the "Park Doctrine" to Police Pharmacies," Duane Morris Alert, January 7, 2013
- Author, "FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies," Duane Morris Alert, December 21, 2012
- Author, "Lawyers See Challenges in Cross-Border Disputes," Chicago Daily Law Bulletin, November 10, 2011
- Featured in "Q&A: Rachael Pontikes" by Olivia Clarke, The Chicago Lawyer, March 2011
- Quoted in "Panel: Girls in 'Wild' video to remain anonymous," Bloomberg Businessweek, February 1, 2011
Selected Speaking Engagements
- Speaker, "Animal Drug Compounding," Food and Drug Law Institute Annual Conference, Washington, D.C., Tuesday, May 4, 2017
- Speaker, "FDA Inspections," 2016 PCCA International Seminar, Houston, TX, November 11, 2016
- Webinar, "FDA Inspections - Preparing and Protecting Your Home Infusion Pharmacy," NHIA Webinar, November 3, 2016
- Speaker, "Compounding: What's on the Horizon," NCPA 2016 Annual Convention, New Orleans, LA, October 16, 2016
- Speaker, "Revisiting the Animal Drug Compounding Debate," ACI's Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food, New York, NY, September 15, 2016
- Speaker, "Compounding Issues," AVMLA Conference, San Antonio, TX, August 6, 2016
- Speaker, "Current Issues Facing Compounding Pharmacies," FDLI Annual Conference, Washington, D.C., May 5, 2016
- Speaker, "Title I - Office Use Restrictions," FDLI Drug Quality and Security Conference, Washington, D.C., February 23, 2016
- Speaker, "Compounding Animal Drugs from Bulk Drug Substances," NYSBA Food, Drug & Cosmetics Section Annual Meeting, New York, NY, January 28, 2016
- Speaker, "Compounding Legal, Regulatory & Quality Practice Update: What Pharmacies Need to Know Now," National Community Pharmacists Association (NCPA), October 12, 2015
- Speaker, "Animal Health and Veterinary Drugs and Therapeutics," Legal, Regulatory and Compliance Forum, American Conference Institute, September 10-11, 2015
- Speaker, "Compounding: What Pharmacies Need to Know Now," NCPA webinar, July 14, 2015
- Speaker, "A Practitioner Perspective on Veterinary Compounding" and "Implementation of the Memorandum of Understanding," Compounders on Capitol Hill, June 7-8, 2015
- Speaker, "Implications of the Draft MOU," Professional Compounding Centers of America (PCCA) Legislative Conference, March 23, 2015
- Speaker, "The Regulation of Veterinary Compounding Pharmacies," National Horsemen's Benevolent & Protective Association Conference, February 2015
- Speaker, "503B Outsourcing Facilities," Food and Drug Law Institute, FDA Law: Implementation of DQSA Conference, Washington, D.C., December 3, 2014
- Speaker, "Hot Law Topics—Compounding Pharmacy," American Pharmacists Association (APhA), APhA2014 Annual Meeting & Exposition, March 28-31, 2014
- Speaker, "Pharmacy Compounding – Lessons Learned from the Interaction among the Executive, Legislative and Judicial Branches," Food Drug Law Institute, Enforcement Conference, December 10, 2013
- Speaker, "Pharmacy Compounding: Recent Developments," at Pharmacy Compounding, An FDLI Dialogue, February 12, 2013
- Guest Lecturer, "Proceeding Anonymously," The University of Chicago Law School, March 2012
- Guest Lecturer, "International Litigation: Determining Jurisdiction in Cross Border Disputes," LUISS University, Rome, Italy, November 14, 2011
- Speaker, "Legal remedies for teenage victims of child pornography," Women's Conference 2011, Wheelock College
- Speaker, "Changing the System: Enhancing Multicultural Competence in Law Firms," Indiana Lawyer's 2008 Diversity in Practice Conference, October 2008
- Speaker, "Women and Negotiation," Bayer Pharmaceutical, September 2008
- Speaker, "Current Texas Federal Litigation Against the FDA," International Academy of Compounding Pharmacies, June 2005
- Speaker on the Animal Medicinal Drug Use Clarification Act at "Fundamentals of Food and Drug Law and Regulation in California," a seminar by the Food Drug Law Institute, San Francisco, June 2005
- Presented the position of compounding pharmacies in current litigation, 48th annual conference of the Food Drug Law Institute, Washington, D.C., March 2005