Carl, Actually the off-label combo story has been spread wide and far. Lawyers suing AHP in class action suits still (in today's WSJ) haven't figured out that the combo had nothing to do with the abnormal EKGs (maybe lawsuits against the lawyers are next :-)). This is in today's WSJ:
Lawyers Prepare for Deluge
Of Suits Related to Diet Drugs
By LAURA JOHANNES and RICHARD B. SCHMITT
Staff Reporters of THE WALL STREET JOURNAL
Lawsuits alleging harm from the recalled diet drugs Redux
and Pondimin are multiplying, fueling expectations of a
lengthy legal battle over the widely used treatments.
The two drugs, which alter levels of the brain chemical
serotonin to make people feel full, were withdrawn from
the market Monday at the request of the U.S. Food and
Drug Administration. The agency cited recent reports of
heart-valve abnormalities in 32% of diet-drug users given
diagnostic echocardiograms by physicians who reported
the results to the FDA.
One development that could affect the suits: American
Home Products Corp., which sells both drugs, confirmed
this week it was informed by doctors of heart-valve
problems among users as early as March, four months
before a public warning was issued by the FDA.
"We were being very cautious
and working with the FDA to
determine if these were
isolated incidents or whether
this required a higher level of
warning," says Marc Deitch,
vice president and global
medical director of
Wyeth-Ayerst, the American
Home unit in charge of
marketing Redux.
About 100 suits have been
filed already around the
country -- alleging not just
heart-valve problems, but also
brain damage and primary
pulmonary hypertension, a rare and often fatal lung
disease. Ads seeking clients are cropping up in major
newspapers. One group of lawyers is selling memberships
in a new diet-drug litigation network for $250, complete
with a regular newsletter on new developments.
"Lawyers are coming out of the woodwork," says Louis
Rubin, a specialist in pulmonary hypertension at the
University of Maryland School of Medicine in Baltimore.
"They want information. They want expert testimony. Most
of all, they want to know who knew what -- and when."
Paul Rheingold, a New York lawyer who has filed four
cases in New York state related to the diet drugs and
promises "dozens" more on the way, calls the situation "a
model for relatively easy litigation for lawyers." He predicts
"thousands of lawsuits scattered all around the country."
How such litigation will ultimately play out is difficult to
gauge, but rarely do drug companies confront liability
issues concerning so large a group. American Home
estimates that about two million people have taken Redux
since it was approved for marketing in the U.S. in April
1996, and about four million have taken Pondimin since it
hit the market in 1973.
The targets of the suits so far have been physicians who
prescribed the drugs, American Home and Interneuron
Pharmaceuticals Inc., which developed Redux.
Interneuron had no immediate comment on potential
liability. American Home said Monday it had been served
with several suits and expected further claims. In a
prepared statement Tuesday the company said it "acted
responsibly in the marketing of these products according to
FDA guidelines" and planned to defend itself against the
suits.
If the heart-valve problems turn out to be as common in
the total population of diet drug users as the early statistics
show -- and this is a large unknown -- some analysts
estimate the fat-pill liability could exceed the $4 billion
expected to be paid out in cases involving breast implants.
The diet-drug liability "has the potential for being one of the
biggest ever," says Hemant Shah, an analyst at HKS &
Co. In the breast-implant cases, large settlements were
reached despite a lack of firm data on the harmfulness of
the devices.
In this case, Mr. Shah says, "there is no question the drugs
are associated with these side effects. The question will be
what percentage of users are affected."
Compared with other recent mass-injury cases, some
lawyers say the diet debacle is off to a strong start for
plaintiffs. In cases such as those involving breast-implants,
manufacturers of the devices have continued to deny they
cause systemic disease, notwithstanding years of litigation
and settlements. While the diet-pill companies may
ultimately argue their products are safe, the withdrawal this
week, along with a July report from the Mayo Clinic about
heart side-effects, is strong evidence to the contrary, the
lawyers contend.
Ultimately, the cases will rest on what evidence the lawyers
can turn up about what the companies did or didn't do to
warn customers about dangerous side-effects, a process of
legal fact-finding that is just beginning.
Legal experts say FDA involvement in approving the drugs
would not necessarily be a bar to suits. Indeed, some
lawyers are contemplating a suit against the agency itself,
under the Federal Tort Claims Act, although the statute
customarily immunizes government officials for
"discretionary" acts, such as the handling of drug
applications.
The pulmonary side effects were well known for years --
and were in fact included on package inserts. The label
also warned that the drugs caused brain damage in animal
tests. There were no warnings, until recently, on
heart-valve complications because that information came
to light in July, after the Mayo Clinic announced it had
observed 24 cases of unusual heart-valve damage in
people using fen-phen, a combination of Pondimin
(fenfluramine) and phentermine, a stimulant.
There are now 100 known cases of people who
developed heart-valve problems after taking Redux or
Pondimin; 25 have had surgery and three have died, says
Mayo Clinic cardiologist Heidi M. Connolly, the lead
author in an article published last month in the New
England Journal of Medicine. The findings of that article,
released in early July before publication because of their
urgency, prompted the FDA to issue the public warning.
American Home got a detailed report in March from the
Mayo doctors in a four-hour meeting at the prestigious
Rochester, Minn., medical center. At the time there were
five known cases of heart-valve problems. Dr. Connolly
told the two American Home officials who visited that
she'd never seen that type of valve damage except in
patients with rare cancers or in those who had taken
ergotamine, a migraine drug that -- like the diet drugs --
affects the brain transmitter serotonin.
American Home heard about more cases later that month
in a meeting with doctors at MeritCare Medical Center in
Fargo, N.D. That group had seen more than a dozen
patients who developed heart-valve problems after taking
diet drugs. Two American Home officials were there, says
Dr. Jack L. Crary, interventional cardiologist at MeritCare.
"Their reaction was, 'This is worrisome, but we need more
information,' " says Dr. Crary. "I was very concerned
about this. I thought we needed more information, too, but
I thought until we had it we should put a moratorium" on
the drugs.
American Home was cautious about condemning the drugs
too early, in part because they had been widely sold for
decades world-wide with no reports of heart-valve
problems. The company thought it was "in the best interest
of patients and doctors to investigate before we took any
kind of drastic action," the company's Dr. Deitch says.
It isn't yet proved that diet drugs cause heart-valve
problems -- and American Home is funding a full-scale
research effort to find out. It also isn't known if the
problems go away when diet drugs are stopped, a
question that could prove key in determining legal liability.
One big potential defense for American Home: It never
endorsed the popular fen-phen combination. Boston
plaintiffs attorney Sam Pollack says that doesn't matter
because "the company knew the drugs were being
prescribed together."
The law firms involved in cases so far represent a Who's
Who of the plaintiffs' bar. Peter Angelos, the owner of the
Baltimore Orioles baseball team who made a fortune suing
asbestos companies, has filed suit over the diet pills in
Maryland state court. In San Francisco, a federal court suit
seeking class-action status has been launched by Lieff,
Cabraser Heimann & Bernstein, a firm that has been
heavily involved in suits over alleged defects with silicone
breast implants.
Lawsuits began even before the drugs were withdrawn
from the market. Rose Jonez, a 45-year-old computer
consultant from Santa Cruz, Calif., who got primary
pulmonary hypertension after several years of taking
fen-phen, received a settlement in May from A.H. Robins
Co., a part of American Home, in Richmond, Va. Her
attorney, Nancy Hersch of San Francisco, says the terms
of the settlement are confidential but called them
"extremely satisfactory."
Ms. Jonez, who had to quit her job and now is being kept
alive with a medication fed intravenously through a pump
she wears constantly, says the money from the settlement
won't replace her health. "I bought a Mercedes and when I
went to sit in it I started to cry," she says. "I'm only 45 and
I don't know how long I'm going to be around." The
disease is fatal in about 50% of people who get it,
according to Dr. Rubin of the University of Maryland. |
