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Plavix, an anti-platelet medication developed and marketed by Bristol-Myers, is used to reduce the risk of second heart attacks and strokes. Plavix was approved for use in the U.S. by the Food and Drug Administration (FDA) in 1997. In the late 2000s, it was theorized that Plavix might be less effective for persons of Asian or Pacific Island descent. The theory was never proven and remains a matter of debate within the scientific community. However, in 2010, the FDA requested that Bristol-Myers add a warning to the drug label indicating that it could be less effective for persons of a particular genetic makeup. Although Bristol-Myers complied with the request, the warning was criticized by leading cardiologists and medical organizations as premature and unsupported by clinical data and experience, and the FDA withdrew its labelling requirement in 2016. Despite the absence of any state investigation showing misconduct or harm to any Hawaii citizen, in 2014 the State of Hawaii—prompted and aided by private sector attorneys seeking contingency fees—sued Bristol-Myers for millions of dollars in fines, claiming that its pre-2010 failure to provide the warning constituted an unfair and deceptive trade practice.
In 2021, the state court ordered Bristol-Myers to pay over $800 million in fines and penalties. When Bristol-Myers discovered that the state had not conducted any investigation before authorizing private counsel to sue, it brought a civil rights lawsuit in federal court alleging the state court action had violated its First Amendment rights by seeking to compel its speech on a matter of unproven scientific theory. The federal courts dismissed the First Amendment lawsuit under a rule of jurisdiction that prevents federal courts from hearing claims that are related to ongoing law enforcement actions brought by state authorities. Bristol-Myers petitioned the U.S. Supreme Court to overturn the dismissal, arguing that the Hawaii state court suit was brought to serve private interests and not the law enforcement interests of the state. In their amicus brief supporting the petition, The Rutherford Institute and Cato Institute argue that federal courts must remain open to protect fundamental rights.
Attorneys with Troutman Pepper Hamilton Sanders LLP assisted The Rutherford Institute and Cato Institute in advancing the arguments in Bristol-Myers Squibb Co. v. Connors.
The amicus brief in Bristol-Myers Squibb Co. v. Connors is available at www.rutherford.org.
The Rutherford Institute, a nonprofit civil liberties organization, provides legal assistance at no charge to individuals whose constitutional rights have been threatened or violated and educates the public on a wide spectrum of issues affecting their freedoms.
Source: https://bit.ly/2QY5MXg
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