Jennifer Bartlett took the drug sulindac, a generic version of Clinoril, for her sore shoulder. She experienced a horrific, life-altering reaction, and sued the manufacturer. Last week, the U.S. Supreme Court told her and anybody else who could easily be in her position to go jump in a lake.
Sulindac is a nonsteroidal anti-inflammatory drug (NSAID). Its effect on Bartlett was catastrophic: She lost nearly two-thirds of her skin, had to be put into a medically induced coma and is now legally blind from the drug reaction.
As described by the New York Times, The Supreme Court ruled that generic drug manufacturers could not be sued by patients like Bartlett who claim that drugs they took were defectively designed. “The decision is a significant victory for the generic drug industry,” the paper reported, “but further narrows the recourse for people who are injured by such drugs.”
A lower court in New Hampshire had awarded Bartlett $21 million in damages.
The Supreme Court’s justification for overturning that decision was that Mutual Pharmaceutical Co., the manufacturer, was legally required to copy Clinoril, so it couldn’t be held liable for claims that the drug was unsafe.
This decision applies to a drug’s design; two years ago, another Supreme Court ruling also shielded the generic drug industry, saying that people couldn’t sue for improper labeling because generic drug makers must use the same safety label as the brand-name version.
That leaves people who take generic drugs-about 8 in 10 of all prescriptions-pretty much without legal relief if those meds cause harm. The only exception is when there are flaws in the manufacturing process, which is rare.
The civil justice blog Pop Tort was blistering in its outrage over the ruling. “When it comes to injured victims trying to seek redress in the courts, cranky old Scrooge-like Supreme Court Justices are clearly ruling the day this term.”
After Bartlett filed her lawsuit, Pop Tort recalled, she found that “there were more adverse event reports to the FDA over sulindac than any other similar nonsteroidal anti-inflammatory medications on the market; that sulindac knew its rate of life-threatening conditions was comparable to that of a drug the FDA recommended be removed from the market–but it never told the FDA this. And after a 14-day trial, the jury agrees that whatever benefits might exist for this drug, they were clearly outweighed by the risks, and awards $21 million.”
Writing in dissent of the Supreme Court ruling, Justice Sonia Sotomayor claimed that the court turned pre-emption law upside down, said Pop Tort, “for the purpose of protecting corporations from liability exposure and wiping out traditional state tort remedies. And what’s more, Congress seemingly intended to do the opposite, leading her to call the majority decision “‘frankly astonishing.'”
Sotomayor wrote that the ruling last week essentially makes a contested policy judgment about the relationship between FDA review and state tort law without justifying it and without considering whether that is the policy judgment that Congress made. That shaky premise is that the FDA is the sole guardianship of drug safety.
But in requiring premarket approval of drugs to safeguard the consumer, Sotomayor said, Congress also created a shield for drug manufacturers to avoid paying damages under state laws that are also designed to protect consumers. That is so, notwithstanding Congress’ effort to disclaim any intent to pre-empt all state law. The majority’s reasoning, she wrote, thus “has the perverse effect of granting broad immunity to an entire industry that, in the judgment of Congress, needed more stringent regulation.”
The Times noted that interested parties have asked Congress and the FDA to make generic drug companies more accountable by allowing them to change their warning labels when they become aware of a safety risk. Brand-name companies may do so now. If generic drugs labels had that permission, generic manufacturers could be sued.
“Generic drug makers now have a responsibility to mirror the safety label of the brand-name company and to alert the FDA whenever they learn of an adverse event related to their products,” The Times explained. “It is then up to the agency to decide whether to change the label.”
Not only is the current process slow, but what happens when problems arise with a drug after the brand-name manufacturer has left the market?
An FDA spokeswoman told The Times that the agency was considering permitting generic companies to change their warning labels, but wouldn’t discuss specifics.
Last week, the U.S. Supreme Court was not your friend.
Unless you’re a generic drug maker.