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Generic Drugs Prove
Resistant to Damage Suits
By: Katie Thomas, New York
Times
March 20, 2012
Photo
Credit: Angela Shoemaker, New York Times
Debbie
Schork, a deli worker at a supermarket in Indiana, had
to have her hand amputated after an emergency room
nurse injected her with an anti-nausea drug, causing
gangrene. She sued the manufacturer named in the
hospital’s records for failing to warn about the risks
of injecting it. Her case was quietly thrown out of
court last fall.
That result stands in sharp contrast to the highly
publicized case of Diana Levine, a professional
musician from Vermont. Her hand and forearm were
amputated because of gangrene after a physician
assistant at a health clinic injected her with the
same drug. She sued the drug maker, Wyeth, and won
$6.8 million.
The financial outcomes were radically different for
one reason: Ms. Schork had received the generic
version of the drug, known as promethazine, while Ms.
Levine had been given the brand name, Phenergan.
“Explain the difference between the generic and the
real one — it’s just a different company making the
same thing,” Ms. Schork said.
Across the country, dozens of lawsuits against generic
pharmaceutical companies are being dismissed because
of a Supreme Court decision last year that said the
companies did not have control over what their labels
said and therefore could not be sued for failing to
alert patients about the risks of taking their drugs.
Now, what once seemed like a trivial detail — whether
to take a generic or brand-name drug — has become the
deciding factor in whether a patient can seek legal
recourse from a drug company. The cases range from
that of Ms. Schork, who wasn’t told which type of drug
she had been given when she visited the hospital, to
people like Camille Baruch, who developed a
gastrointestinal disease after taking a generic form
of the drug Accutane, as required by her health care
plan.
“Your pharmacists aren’t telling you, hey, when we
fill this with your generic, you are giving up all of
your legal remedies,” said Michael Johnson, a lawyer
who represented Gladys Mensing, one of the patients
who sued generic drug companies in last year’s Supreme
Court case, Pliva v. Mensing. “You have a disparate
impact between one class of people and another.”
The Supreme Court ruling affects potentially millions
of people: nearly 80 percent of prescriptions in the
United States are filled by a generic, and most states
permit pharmacists to dispense a generic in place of a
brand name. More than 40 judges have dismissed cases
against generic manufacturers since the Supreme Court
ruled last June, including some who dismissed dozens
of cases consolidated under one judge.
Public Citizen, a consumer advocacy group, has
petitioned the Food and Drug Administration to give
generic companies greater control over their labels, a
rule change that could allow users of generic drugs to
sue, but the agency said earlier this month that it
needed more time to decide. “Congress can make this
problem go away, and the F.D.A. could, too,” said
Allison Zieve, the director of Public Citizen
Litigation Group. “But we haven’t seen signs that
either of them is paying much attention.” A
spokeswoman for the F.D.A. declined to comment.
The Supreme Court’s ruling, which was split 5 to 4 on
ideological lines, has its roots in the Hatch-Waxman
Act, the 1984 law that opened the floodgates to
generic drugs. That law allowed companies to skip the
lengthy process required to approve new drugs if they
could prove that the generic drug was equivalent to
its brand-name counterpart.
With few exceptions, it also required generic
manufacturers to use the same labels — the lengthy
list of a drug’s uses, dosages and risks — used by the
brand names.
If a problem develops, the brand-name companies are
responsible for changing the label, and the generic
companies must follow their lead. As a result, the
court’s majority ruled, generic companies cannot be
held responsible for failing to alert patients to
problems with their drug. The dissent, which was
written by Justice Sonia Sotomayor, argued that
generic companies nevertheless have a responsibility
to report problems to the F.D.A. and should be held
liable for failing to warn patients.
The ruling came just two years after the Supreme Court
established — in Ms. Levine’s case — that, by
contrast, brand-name companies can be sued for failing
to adequately warn patients.
Ms. Levine was given an injection of Phenergan in 2000
during a visit to a clinic to treat a migraine
headache. Her hand and forearm turned black and
eventually had to be amputated. Reports had shown that
the drug can cause gangrene if it enters an artery,
especially if it is placed directly into the vein
rather than injected into the muscle or through a
diluted intravenous drip. Although the label warned
that gangrene could occur if the drug came into
contact with arterial blood, Levine argued that the
warning did not go far enough.
She sued Wyeth and a Vermont jury awarded her $6.8
million. Wyeth appealed and the Supreme Court sided
with Ms. Levine, agreeing that the company could be
held liable for failing to adequately warn about the
risks of a drug.
Ms. Schork, 52, was given the generic version of
Phenergan when she visited the hospital in 2007 with a
stomachache and nausea related to her diagnosis of
Crohn’s disease.
When a nurse injected the drug into her arm, it
entered her artery, and Ms. Schork’s right hand
developed gangrene. In asking that the case be
dismissed, lawyers for Baxter Healthcare Corporation,
which then was one of several companies that made the
drug but has since sold its injectable generics to
another company, argued that Ms. Schork could not
conclusively prove that Baxter had made the drug she
took.
The judge agreed that the question could be debated at
trial but said it was irrelevant because of the
Supreme Court’s ruling.
Ms. Schork filed a malpractice claim against the
hospital with the Indiana Department of Insurance, and
received what her lawyer described as a limited award;
the amount was confidential. She said she could not
continue to work at her supermarket job and is now
unemployed.
Soon after Ms. Levine won her case, Ms. Schork wrote
to congratulate her and to share her own story. At the
bottom of the letter, Ms. Levine recalled, Ms. Schork
apologized for her handwriting because she was writing
with her left hand. “The fact that it had happened to
her and she had this same struggle — and then to hear
now that it’s getting dismissed — is just beyond me,”
said Ms. Levine.
Ms. Schork said she and Ms. Levine later spoke on the
telephone. “I’m glad for her,” she said, “but it
didn’t help me any.”
Lawyers for generic drug companies say their clients
are able to provide low-cost drugs because their
primary task is replicating drugs. If the companies
were expected to take responsibility for updating
their labels, “we would effectively start to turn
generic companies into brand companies, and of course
the tremendous cost savings that American consumers
have benefitted from would start to wane,” said Jay
Lefkowitz, who served as the lead attorney
representing generic companies before the Supreme
Court.
The Supreme Court recognized that its decision must
make “little sense” to plaintiffs who sue generic drug
companies. However, Justice Clarence Thomas wrote for
the court, “Congress and the F.D.A. retain the
authority to change the law and regulations if they so
desire.”
Some attorneys who follow the issue have speculated
that Congress and the F.D.A. are reluctant to deal a
blow to generic companies, which are responsible for
providing cheap drugs to millions of American
consumers, especially in an election year when health
care is a hot issue.
In a statement last week, Representative Henry A.
Waxman, Democrat of California, who co-wrote the
Hatch-Waxman Act, said he was exploring ways to
address the issue, either through legislation or a
rule change.
Mr. Waxman argued in a brief opposing the generic
companies in the Supreme Court case last year that
Congress had never intended for generic companies to
be freed of all responsibility.
“Congress
did not intend for consumers’ rights to be
categorically eliminated simply because they purchased
a generic rather than a brand-name drug,” he wrote.
Camille Baruch, 18, and her family say that is
precisely what happened to her. When she was 12,
Camille, of Rockville, Md., began taking the generic
version of the antiacne drug Accutane and developed
severe gastrointestinal pain several months later. Her
diagnosis was ulcerative colitis, a type of
inflammatory bowel disease, and she had to have her
large intestine removed.
Six years and eight operations later, doctors have not
been able to stabilize her condition. Her parents said
the disease transformed their daughter from a talented
basketball and softball athlete to someone who will
struggle with debilitating physical challenges for the
rest of her life.
Thousands of patients have sued Roche, the maker of
Accutane, claiming that it caused their inflammatory
bowel disease, and several have won
multimillion-dollar verdicts against the company. In
2009, citing litigation costs and competition from
generics, Roche removed Accutane from the market. In
2010, Camille sued the makers of the three generic
versions of Accutane she took. Her lawyer, Tayjes
Shah, said lawyers for the companies have told him
they intend to ask for a dismissal. “I have very
little optimism,” Mr. Shah said.
Camille, who was in the hospital this month recovering
from another operation, said she had heard the
arguments that the generic companies had made. “It
makes me almost want to cry every time that I think
that I took something that is nearly identical” to
Accutane, yet she cannot sue, she said. “I lost
everything. That is not a reason enough that these
people aren’t to blame.”
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