Drugmaker Merck and Co. told the Supreme Court that a class-action lawsuit against it over top-selling osteoporosis drug Fosamax should be disallowed because the company informed regulators of potential adverse effects and was rebuffed.
Only eight of the court’s nine justices attended oral arguments on Jan. 7. Justice Ruth Bader Ginsburg, who turns 86 in March, is recovering at home after undergoing surgery for lung cancer on Dec. 21. She left a New York hospital on Christmas Day.
This is the first time Ginsburg, who was appointed by President Bill Clinton in 1993, has ever missed oral arguments as a member of the Supreme Court, including after two prior cancer surgeries. Chief Justice John Roberts said from the bench that Ginsburg would take part in the case at hand, “on the basis of the briefs and transcripts of oral arguments.”
Hundreds of consumers are suing the company, claiming injuries related to their use of Fosamax, sales of which brought Merck a reported $250 million in 2017 in the lucrative bisphosphonates market.
The medication is prescribed to prevent and treat osteoporosis in post-menopausal women. Some women have broken their femur bones while using the bone-strengthening drug.
In response to a question by Justice Sonia Sotomayor, the class-action litigants’ lawyer, David C. Frederick, said Merck consultant Dr. Joseph M. Lane of the Hospital for Special Surgery in New York City, previously complained that the company failed to provide “medically accurate education” to the Food and Drug Administration about fractures suffered by users of the drug.
Frederick said Lane is “the one who had coined the term ‘Fosamax fracture’ because, in all of his years of osteology, he had not encountered these kinds of fractures until he had patients coming to him who were on this drug.”
The patients claim Merck failed to provide sufficient warnings on the drug’s label, but the company, backed by the Trump administration, counters that it alerted the FDA when it discovered Fosamax could adversely affect some users.
The FDA refused the request to add the warning, saying available data didn’t support it. Merck convinced a trial judge to halt the class-action proceeding, but an appellate court reversed and allowed the lawsuits to proceed.
The FDA “thought that it is more dangerous ... to put the risk in the label than it is to leave it out,” Justice Stephen Breyer said. “And then they set up a task force and decide[d] they were wrong.”
But the company is liable even if the FDA made a mistake, Frederick said.
“The FDA clearly didn’t have ... all of the relevant information, because what the task force finds is that there are about 170 some articles that had been written on this subject. Only five had been given to the FDA, or that—that was evidence that the FDA was aware of.”
Federal law “imposes the duty on the manufacturer, because the manufacturer’s going to be tracking this all over the world,” the lawyer said, adding that in 2006, a Merck employee in Singapore “said I’ve now seen several of these specialized atypical femoral fractures, I think this could be an indication that we need a safety signal.”
Merck attorney Shay Dvoretzky said the law, which assumes that regulators are competent and do their jobs properly, is on the company’s side. The rule applying in this situation “follows from the statutory and regulatory framework governing the FDA’s conduct and from the presumption of regularity.”
“The presumption of regularity, of course, assumes that federal agencies do their jobs correctly. The FDA’s job, in this case, includes protecting the public health by working with manufacturers to revise drug labels when necessary.”
Reuters reports that a jury in San Jose, California, had awarded Merck $200 million in 2016 after determining that Gilead Sciences Inc.’s Hepatitis C drugs Sovaldi and Harvoni infringed two of its patents.
A judge later found the patents unenforceable because Merck acted in bad faith. In a similar 2016 case, Merck won a $2.54 billion verdict, reportedly the largest ever in a patent case, but a judge nixed the judgment a year ago, finding Merck’s patent invalid.
The Kenilworth, New Jersey-based company currently has a market capitalization of $196.1 billion.