A Rezulin lawsuit will proceed in Michigan, after the US Supreme Court deadlocked over a case regarding patients’ rights to sue over injuries they receive from drugs that are approved by the Food & Drug Administration (FDA). Pfizer, Inc., the maker of Rezulin, was trying to convince the Court to overturn a Michigan law that allows plaintiffs to sue drug and device makers when there is evidence that manufacturers defrauded the FDA.
Rezulin was withdrawn from the market at the request of the FDA in March 2000. Rezulin was prescribed to diabetics who took insulin but whose blood sugar was not well controlled. It was designed to help insulin (either the body’s own or injected) work better, by drawing the sugar from the blood into the cells. On March 21, 2000 the head of the FDA’s center for Drug evaluation and Research stated that the “Continued use of Rezulin” posed an “unacceptable risk” to diabetes patients. The FDA said at least 63 Rezulin users have died of liver failure. However, some patient advocates believe the total number of Rezulin deaths to be as much as ten times higher than the reported 63 cases.
Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug’s manufacturer, Warner-Lambert successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times in January of 1999. Warner-Lambert was acquired by Pfizer in 2000.
Pfizer was hoping to expand a 2001 Supreme Court ruling that said patients can’t sue companies for defrauding the FDA. Unfortunately for Pfizer, Supreme Court Chief Justice John Roberts removed himself from the case because he is a Pfizer stock-holder, setting up a scenario for a potential deadlock. In the end, the Court voted 4-4 in the a case. The ruling sets no nationwide precedent while upholding a lower court decision favoring the patients. The court issued only a one-sentence order and didn’t specify on which side of the case justices voted.
The Michigan law at issue shields drug makers from product-liability suits over approved treatments. But the measure makes an exception for companies that withhold information or deceive the FDA. In addition to allowing the Michigan law to stand, the Court’s deadlock also keeps in place similar laws in six other states, including Texas.
The Supreme Court’s ruling allows 27 plaintiffs in Michigan to move ahead with their Rezulin lawsuit. All of the plaintiffs either used Rezulin, or had a loved one who did and died as a result.