Gladys Mensing, a former waitress and avid bingo player from Owatonna, Minn., will have her day in court next week as her lawyers argue an important generic-drug case before the U.S. Supreme Court.
Mensing’s case, targeting the generic-drug industry for inadequate warning labels about serious side effects, has broad implications for U.S. consumers who use generics to fill more than two-thirds of all prescriptions, or 2.6 billion prescriptions every year.
In Pliva v. Mensing and Actavis, Inc. v. Demahy (consolidated),the court is being asked to decide whether generic-drug companies will be held to the same standard as manufacturers of brand-name equivalents to update warning labels when significant new risks of serious side effects emerge, and whether people injured by a generic drug can sue in state court for their injuries.
While name-brand manufactures are responsible for updating warning labels when significant new risks emerge, generic-drug manufacturers argue that they are exempt from that requirement because they follow the lead of branded manufacturers and copy not just the drug but the warning label. (Generic drugs are pharmaceutical copycats of brand-name drugs whose patent protection has expired.)
Mensing and fellow plaintiff Julie Demahy suffer from tardive dyskinesia, a neurological disorder that impairs muscle control and causes repetitive, involuntary movements. Among Mensing’s symptoms, she cannot control facial muscles and her tongue, which makes her speech difficult to understand, even by her son and granddaughter. (A video interview with Mensing and family members is here.)
Mensing and Demahy were prescribed metoclopramide, the generic equivalent of Reglan, to treat two different chronic stomach disorders. Mensing took the drug from 2001 to 2005 to treat acid reflux. Denahy, who lives in Louisiana, took the drug for four years starting in 2002 to treat gastroparesis (an inability for the stomach to empty its contents).
The then-approved label said the drug had not been tested for long-term use, but described the likelihood of developing the disorder as a rare adverse effect despite research that showed as many as one in five people who use metoclopramide long-term may develop this disorder. If the two had been given the brand name instead of the generic substitution, they would have been able to sue the drug maker, Wyeth Labs.
Neither the branded label nor the generic label was updated until 2009, when the FDA ordered a warning that the drug should not be used more than 12 weeks.
Generics recently racked up $63 billion in annual sales, about 20 percent of total pharmaceutical sales, but accounted for nearly 69 percent of all prescriptions dispensed, according to the Generic Pharmaceutical Association. Nearly 80 percent of drugs listed by the U.S. Food and Drug Administration have a generic counterpart.
Louis Bograd, senior litigation counsel at the Center for Constitutional Litigation, who will argue the case Wednesday before the Supreme Court, said the case has “enormous implications” for both the industry and U.S. consumers.
“Our entire health-care system is set up to drive consumers to generics,” Bograd said.
Employer-sponsored health-care plans and health-care reform encourage substitution of name-brand drugs with less expensive generics.
In a conference call with reporters. Bograd said that about one third of generics on the market today no longer have a brand-name equivalent on the market. “If generics are not responsible, then nobody is responsible,” he added.
He said physicians rely on label information about drug safety and not holding generics accountable would undermine that confidence. “Who would be minding the store for drug labeling… [providing] new information about the safety of products?”
The case comes at an interesting time for the court, following its unanimous decision last week that held drug companies can be sued by investors for not revealing a drug’s dangerous side effects. In that case, the court ruled that Matrixx Industries, makers of a popular over-the-counter cold remedy Zicam, can be sued by shareholders for not revealing reports of the dangerous side effects — including loss of smell.
The court ruled that drug makers should rely on FDA incident reports and published research rather than extensive in-house trials to decide when to update warning labels.
“I think [the Matrixx decision] was very helpful,” Bograd said, because generic-drug companies have argued that they don’t have access to enough information to be held responsible since they don’t conduct research themselves.”
Generics already get a free ride from the drug development efforts of brand-name manufacturers, he said.
“Now they’re looking for a free ride on liability as well. I’m optimistic the court will not give it to them,” he said.
About 800 separate cases involving metoclopramide have been brought in various state courts, he said.
Minnesota Attorney General Lori Swanson, joined by 42 other states’ AGs, filed an amicus brief in support of the plaintiffs.