By Diana Katz Gerstel

The first oral contraceptive—Enovid, developed by G.D. Searle & Co.—revolutionized women’s lives beginning in 1960. Some credit it with ushering in the feminist movement. Arguably, “the Pill” also ushered in an era of litigation: It has been noted that every contraceptive drug or device for the last half century has been the subject of litigation. (Alexander, E., “Another Attack on a Contraceptive Is Dismissed (For Now),” Drug & Device Law Blog, October 7, 2022.)

Women’s drugs and devices generally are overrepresented in mass tort litigation—breast cancer drugs, breast implants, oral hormone replacement therapy (HRT), contraceptives, drugs for “morning sickness” and pelvic mesh, as well as products predominantly marketed to or utilized by women, such as talcum powder, infant formula, hair relaxers and human papilloma virus (HPV) vaccines.

Some legal theorists have proposed this reflects a recklessness in the development of products for women. In 1992, Professor Joan Steinman wrote: “I do not know of a single mass tort in which men were injured by a product made for men to use or take, ostensibly to enhance their well-being.” (Steinman, J.E., Women, Medical Care, and Mass Tort Litigation. 68 Chi.-Kent L. Rev. 409, 1992.) She posited: “I strongly suspect that a disparity exists between the care invested in products for men and that invested in drugs and medical devices for women.”

Thirty years later, Professor Elizabeth Chamblee Burch echoed that sentiment: “Harm from drugs and medical devices disproportionately affect[s] females…. Women account for 67% of the FDA’s medical device adverse event reports; sex-neutral devices like hip implants and pacemakers disproportionately fail in women; and from 1997 to 2000, eight of the ten drugs pulled from the market posed greater risks to women.” (Burch, E.C., Perceptions of Justice in Multidistrict Litigation: Voices from the Crowd. 107 Cornell L Rev. 1835, 2022.)

Women are the victims, Burch and Steinman proposed, of for-profit corporations, bias in medical practice, and under-representation of women in clinical studies. On the other hand, women are also unhappy with the litigation experience. Most of the pelvic mesh plaintiffs Burch based her article on were unsatisfied with their lawyers, who enlisted them as claimants, ignored their cases, and finally convinced them to accept low settlements.

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