Another very important case for American consumers is now before the U.S. Supreme Court. Oral argument was heard in the case last month that will decide whether a generic drug manufacturer has the same responsibility to warn of serious side effects that a brand-name manufacturer has. If the generic companies prevail, folks who take generic drugs will be left without a remedy that is available to people who take brand-name drugs.
Gladys Mensing and Julie Demahy, the two Plaintiffs in cases before the Court, alleged that they developed the neurological disorder tardive dyskinesia from taking metoclopramide, the generic form of Reglan, to treat their stomach conditions (diabetic gastroparesis and gastroesophageal reflux) for years. They filed separate lawsuits against the manufacturers, alleging they were liable under state law for failing to warn that the drug could cause the disorder. The generic drugmakers argued that those claims were preempted by the Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act, which require a generic label to match that of its associated brand-name drug. They claimed that because their labels had to match, the generic companies could not have strengthened them.
The Fifth and Eighth circuits held that the Plaintiffs’ claims were not preempted, a ruling that was in line with the Supreme Court’s 2009 decision in Wyeth v. Levine regarding brand-name drugs. It should be noted that every court since Levine, as well as the U.S. Solicitor General, has agreed. When the High Court decided to take up the issue, it consolidated the two lawsuits. Louis Bograd, senior litigation counsel with the Center for Constitutional Litigation in Washington, D.C., who argued the case for the Plaintiffs, told the Justices: “The central issue in this case is that petitioners, in the face of considerable information that the warnings on their products were inadequate, did nothing.” Jay Lefkowitz of New York City argued the case for the generic drugmakers. In reporting adverse events to the FDA, he said, “we have done everything we are required to do.” He contended that the companies were “not obligated to ask for a label change.”
A long list of organizations submitted amicus briefs in support of the Plaintiffs. The lawyer for the Plaintiffs characterized the case as “the generic companies against the world.” The American Medical Association and a group of seven other medical associations sided with the Plaintiffs, contending that “it should be the manifest public policy of this nation that all drug manufacturers – brand and generic – have a continuing duty to conduct themselves as vigilant, active, and responsible members of the health care community in furtherance of the safety and well-being of the American public.” The powerful pharmaceutical industry is trying to escape liability and accountability for its wrongful conduct.
Rep. Henry Waxman (D-Cal.), who authored the Hatch-Waxman amendments, and the Attorneys General of 42 states and the District of Columbia, also submitted briefs supporting the Plaintiffs’ position. If the Court rules for the Plaintiffs, doctors and patients will receive adequate warnings about the prescriptions they take. Such a ruling will result in preventing a tremendous number of injuries and deaths. Hopefully, the Justices on the Highest Court in the land will do the right thing in this case and affirm the two cases.
Source: Allison Torres Burtka
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