The National Law Journal selected Shook, Hardy & Bacon’s Pharmaceutical and Medical Device Division Chair Madeleine McDonough for its inaugural class of Litigation Trailblazers & Pioneers. These 50 attorneys were chosen for their “deep passion and perseverance in pursuit of their mission, having achieved remarkable successes along the way,” according to The National Law Journal. McDonough began her professional life as a clinical pharmacist and then pursued a career in pharmaceutical litigation. She has represented more than 65 FDA-regulated companies throughout her quarter-century as an attorney.
“The ‘Litigation Trailblazers & Pioneers’ list recognizes those professionals who have acted as real agents of change in their field, elevating - and in some cases, redefining - the ways in which litigation is pursued, cases are defended or trials are handled,” said Tom Larranaga, publisher of The National Law Journal. “They have raised the bar in several meaningful ways and are establishing important new standards as the legal landscape continues to evolve.”
McDonough has resolved thousands of claims and cases, often with no or minimal payment by her clients, through establishing strong relationships with opposing counsel, educating counsel and judges about the scientific and medical hurdles the cases face, and developing creative approaches through negotiation, phased litigation techniques, targeted motion practice, and trial, whenever necessary. As she noted in an interview with The National Law Journal:
“I’ve learned that a lot of issues can be resolved before trial.” With that in mind, McDonough tries to help her clients prevent litigation through anticipatory risk management. “If you have to go to trial, we’ll do that. But it’s time-consuming, expensive and often not satisfactory—even if you win.” The litigation prevention process includes understanding the opponents, the claims, the landscape and trying to work out something that helps everybody.
McDonough is known for identifying emerging legal trends and offering practical advice for clients to navigate regulatory and litigation challenges across the entire portfolio of a client’s business:
“New technology is emerging constantly which often creates privacy and data security concerns.” McDonough sees electronic discovery as a risk factor. “You need to have those issues buttoned up so they don’t become a leverage point for your opponents.” She also views the global marketplace as a game changer in the pharmaceutical field. “International health agencies are starting to have a meaningful impact on my clients.”
Long recognized for her skill and expertise, in 2012, 2013 and 2014, McDonough was named a leading product liability attorney by Who’s Who Legal: The International Who’s Who of Business Lawyers and a Life Science Star by LMG Life Sciences, and she was listed in The Legal 500 United States in 2014.