This is a partial list of some of the television appearances and print media related to Kip Petroff's landmark Fen Phen litigation:
Print:
(click on any underlined article to read an excerpt)
Books:
- The
Money Lawyers: The No-Holds-Barred World Of Today's Richest And Most Powerful
Lawyers
A
non-fiction book by Joseph C. Goulden (2006, Truman Talley Books; St. Martin's
Press). This enthralling book depicts the sagas of some of today's most powerful
plaintiff's lawyers.
Kip Petroff is prominently featured in Chapter 4: The Diet Pill Wars: Meet
the Class Action Club (p. 174-243) . . .
"Two factors make Petroff sui generis. First was the audacity with which
he went after the manufacturers, and the damning evidence that he rooted from
their files, and from their executives' mouths on deposition, at the very early
stage of the litigation. Within the space of a very few months Petroff established
himself as arguably the major player in the Fen Phen saga. . . . Second, Petroff
was the first lawyer to actually try a Fen Phen case 'to verdict' - that is,
to convince a jury that a manufacturer had marketed a product that caused harm
to someone, and to win an award. It was twenty three million three hundred thousand dollars." (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
Click here to read more.
- Texas
Justice: The Legacy of Historical Courthouses
A
non-fiction book by Martana (Red Bandana Publishing). This beautiful book tells
the tales of nearly 100 of Texas' historical courthouses as told by the lawyers,
judges and Texas Rangers who walked their halls.
Kip Petroff tells the tale of "David vs. Goliath: The First Fen Phen Case
Ever Tried." (p. 212)
Click here to read more.
(Excerpts
and information about the books mentioned above)
Information
about the book, The Money Lawyers: The No-Holds-Barred
World Of Today's Richest And Most Powerful Lawyers by Joseph C. Goulden
(2006, Truman Talley Books; St. Martin's Press).
A
non-fiction book by Joseph C. Goulden (2006, Truman Talley Books; St. Martin's
Press). This enthralling book depicts the sagas of some of today's most powerful
plaintiff's lawyers.
Kip Petroff is prominently featured in Chapter 4: The Diet Pill Wars: Meet
the Class Action Club (p. 174-243) . . .
"Two factors make Petroff sui generis. First was the audacity with which
he went after the manufacturers, and the damning evidence that he rooted from
their files, and from their executives' mouths on deposition, at the very early
stage of the litigation. Within the space of a very few months Petroff established
himself as arguably the major player in the Fen Phen saga. . . . Second, Petroff
was the first lawyer to actually try a Fen Phen case 'to verdict' - that is,
to convince a jury that a manufacturer had marketed a product that caused harm
to someone, and to win an award. It was twenty three million three hundred thousand dollars." (p. 176) (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
Where
To Buy This Book:
Amazon.com
- Information
about the book, Texas Justice: The Legacy of Historical
Courthouses, by
Martana (Hardcover - November 2004)
A
non-fiction book by Martana (Red Bandana Publishing). This beautiful book tells
the tales of nearly 100 of Texas' historical courthouses as told by the lawyers,
judges and Texas Rangers who walked their halls.
Kip Petroff tells the tale of "David vs. Goliath: The First Fen Phen Case
Ever Tried." (p. 212)
Editorial
Reviews: (as
published on Amazon.com)
Harold W. Nix, Founder Nix, Patterson & Roach
L.L.P.
From horse thieves to corporate raiders, Texas legal legends pass on famous cases
from the small towns of East Texas to the big cities like Dallas and across the
state in Texas Justice.
Dale Sellers, President and CEO Phoenix I Restoration and Construction,
Ltd.
The
restoration and architecture of the Lone Star courthouses is showcased in Texas
Justice on a grand scale- a scale as big as Texas.
Toby Goodman, Texas House of Representatives
The verdict is in, the power of Texas lawmakers can be seen from the State Capitol
to Washington D.C.- Texas Justice prevails.
Louise Raggio, Raggio & Raggio, P.L.L.C., Women's Equal Rights Pioneer & Legend
Texas Justice reveals the impact of the law on Texans’ lives as precedents
are set in courtrooms everyday.
Book Description:
In the heart of every Texas county seat sits a symbol of the Texas heritage of
freedom, prosperity and protection for all Texans—Texas Courthouses. The
lawyers, Judges and Texas Rangers who walk the halls of these Lone Star beauties
tell the tales of crime and passion; love and war; murder and innocence in Texas
Justice: The Legacy of Historical Courthouses.
Texas Justice unveils nearly
100 of Texas’ 254 county courthouses, of which 234 have the distinction
of being a Historical Courthouse; and 84 of these Historic Courthouses have the
double crown of being a National Register Property.
Take a tour through Texas
heritage beginning with the early log courthouses which evolved to the European
influence by renowned architects like J. Riely Gordon and W. C. Dodson.
Gordon designed the 1902 McLennan County Beaux-Arts style Historic Courthouse,
which is said to be inspired by Saint Peter’s in Rome. The 1896 Denton
County Historic Courthouse was designed by W. C. Dodson in Romanesque
Revival style of stone with eighty pink granite columns.
Shackelford County was
the first courthouse Rededicated in the Texas Courthouse Preservation Program
in 2001 by Dale Sellers, Phoenix I Restoration & Construction.
The rough justice of a guilty verdict by hanging to the modern judicial system
of a twelve man jury is represented in famous cases told by "Texas Legal Legends."
In
the Foreword by legendary Richard "Racehorse" Haynes, he says, "Like all courtroom
veterans, Texas Justice reminds me of how far we have come from the trial of
Jack Ruby for the killing of Lee Harvey Oswald, million dollar disputes over
oil rights and the trials of serial killers like Henry Lee Lucas—to mention
just a few of the landmark trials that have taken place in Texas Courthouses
of Texas Justice."
The case of "Superman the Bull Wins Eight Million Five Hundred Thousand" is told by John O’Quinn
of Harris County; Harold Nix reveals the biggest case of Morris County, "The
Forty Year Toxic Cloud;" Roy Barrera, Sr., Bexar County, reveals a famous criminal
case "A Black Eye or Russian Roulette?;" and Frank Branson of Dallas County even
received the cufflink shooters that were worn in the Jack Ruby trial. And "Believe
it or not!" in 1897, Old Rip, the "Miracle Horny Toad," was enclosed in the Eastland
County courthouse during construction—31 years later he was found alive!
From the hanging gallows to the electric chair;
from horse thieves to corporate raiders; these Texas courthouses have been visited
by the likes of all! The verdict is in, Texas Justice: The Legacy of Historical
Courthouses has captured the lore of the past and presents the law of the twenty-first
century, petitioned with the architectural beauty and history of the belle of
the county seat, the courthouse—truly a captivating book for all!
About the Author:
Texas writer and Publisher, Martana, has been documenting Texans and the legacy
of the Lone Star State for over five years now. This sixth-generation Texan is
the author of the celebrated books Texas Men, Texas Women and Texas Justice.
Martana is currently working on her fourth book Medicine Men featuring Texas
Doctors. She is the President of Red Bandana Publishing. Martana calls Dallas
home.
Where
To Buy This Book: Martana.com
Amazon.com
- Information
about the book, Dispensing With The Truth, by
Alicia Mundy

Paperback |

Hardcover |
Critics' & Editorial
Reviews: Sam
Donaldson
A great investigative reporter tells the story of how corporate
greed and government incompetence combined to let a killer loose -- and what
happened when the truth closed in. Read it and weep. Time
Magazine
An absorbing look at how the fen/phen diet craze destroyed lives and our illusions
about drug safety... giving the tale a human face... a read that will have you
gritting your teeth.
Editorial
Review - Joan Price, Amazon.com
Mary Linnen, 29, was determined to lose 25 pounds before her wedding. In May
1996, her doctor prescribed a combination of drugs known as Fen Phen. When Linnen
complained of dizziness and shortness of breath 23 days after starting the medications,
her doctor told her to stop the drugs--but didn't examine her or order tests.
Linnen got better for a time, then the shortness of breath and exhaustion returned
worse than ever. Her legs and stomach swelled. She collapsed at work. Six months
after taking Fen Phen, Linnen was admitted to the emergency room with primary
pulmonary hypertension: the capillaries that sent oxygen to her lungs had thickened
and were closing, suffocating her. Her survival expectation after heart surgery
was less than four years. Hooked up to a tube in her chest to prevent heart failure,
she died three months later.
Dispensing with the Truth: The Battle over Fen Phen tells the story
of the legal battle against the pharmaceutical companies after Fen Phen's users
started dying--some, like Linnen, of primary pulmonary hypertension; others of
heart valve damage. Investigative reporter Alicia Mundy weaves a dramatic tale
from the development of the drugs to FDA approval to the final litigation. How
much did the pharmaceutical companies know about the risks long before most of
the deaths? Plenty, according to the evidence Mundy reveals. Although at times
the book seems overfilled with details that slow down the drama, if you want
the complete, behind-the-scenes story of one of the most famous "profits
over protection" cases, this book tells all.
Where
To Buy This Book: Barnes & NobleAmazon.com
Articles
About This Book:
back
to top
Association
of Trial Lawyers of America, July, 2001
Keep Our Families Safe: Consumer News For Families
An Inside Look At The Tragedy of Fen Phen
In
the mid-90s America was immersed in a diet craze. Fascinated by our own expanding
waistlines, we experimented with many forms of weight reduction, and we turned
to doctors and pharmaceutical companies to help us. The Fen Phen fad was spawned.
For a time, it became the hottest diet drug in America. It was a favorite of
doctors and users nationwide – but it did not come without a price. Alicia
Mundy’s new book “Dispensing With The Truth” (St. Martin’s
Press, New York) describes the horrible price we paid. The book details the activities
of four camps involved in the incident – the victims, the lawyers, the
Food and Drug Administration (FDA), and Wyeth Ayerst, a division of American
Home Products, the company that sold the drugs. Mundy shows us how we could have
avoided the disaster and how it was finally stopped.
In the book Mundy tells the story of Mary Linnen, a Boston bride to be. She took
Fen Phen for less than a month in order to shed weight for her wedding. She died
of Primary Pulmonary Hypertension in her fiancé’s arms nine months
after she stopped taking Fen Phen. Her dying wish was that no one else would
be permitted to take the drug. Alex Mc Donald, a trial lawyer and member of the
Association of Trial Lawyers of America (ATLA) represented the Linnen family
against American Home Products. Mundy explores the Linnen’s case and another,
similar case brought by Dallas trial lawyers and ATLA members Kip
Petroff and Robert Kisselburgh.
Mundy’s book reveals company documents include a company ‘body count’ of
patients who died because of Fen Phen use, as well as now famous e-mails from
an American Home employees. In one, a Wyeth Ayerst employee asked, “Can
I look forward to the rest of my waning years signing checks for fat people who
are a little afraid of some silly lung problem?” It turns out, of course,
that the “silly lung problem” – Primary Pulmonary Hypertension,
a condition which narrows the capillaries that send oxygen to the lungs, causing
death by slow suffocation – was killing Wyeth Ayerst’s customers,
as were other medical conditions associated with use of the drug, such as heart
valve damage.
But
as serious as these health issues were, the FDA (the U.S. agency in charge of
regulating drugs and medical devices) was slow to address product’s
faults. Mundy asserts that the agency did not do its job. She contends that the
problem with the FDA is systematic, and explores how FDA employees are tied to
the pharmaceutical industry through business and personal friendships, making
it hard for regulators to be objective. There are exceptions to this situation,
however. Mundy introduces us to Leo Lutwak, a whistle blower of sorts who fought
Fen Phen’s approval from the start. Lutwak warned that Fen Phen is only
the tip of the iceberg in terms of drugs that slip through the FDA’s cracks.
He makes it clear that he is still on the lookout for the next drug-related disaster,
and the next Mary Linnen.
Magazines & Newspapers:
- U.S.
News & World Report
- Time
Magazine
- Texas
Lawyer
- Facts
on File
- September
30, 1999
Jury Awards twenty three million three hundred thousand dollars in Fen/Phen Suit
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- Lawyers
Weekly USA
- September
6, 1999
Twenty three million dollar Fen Phen Verdict May Open Doors to Bigger Settlements
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- Texas
Lawyer
- The
Dallas Morning News
- August
14, 1999
One Day at a Time ~ Victor in Fen Phen lawsuit says she
would trade money for health
- August
7, 1999
Fen Phen suit jury awards twenty three million four hundred thousand dollars to E. Texan ~ Drug company
vows to appeal the decision
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- August,
1999
American Home to pay substantially lower sum
- Houston
Chronicle
- August
7, 1999
Woman wins twenty three million dollars in Fen Phen case
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- The
New York Times
- August
7, 1999
Twenty three million dollars Awarded in Suit Against Maker of Diet Drug
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- The
Los Angeles Times
- Texas
Monthly
- D
Magazine
- The
Wall Street Journal
- Canton
Herald
- August,
1999
Twenty three million three hundred thousand dollars awarded in local ‘Fen Phen’
case
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
- August,
1999
Lovett says she was
‘surprised’ by verdict
- Associated
Press
- Numerous
other newspapers around the country
- Association
of Trial Lawyers of America
Press Articles:
(Excerpts or full articles from the list of print media above)
back to top
Texas Lawyer, December 20, 1999
Leaders of the Fen Phen Pack
By Susan Borreson
They're
the dynamic duo of Fen Phen. Dallas partners Robert
Kisselburgh and Kip Petroff were
the first plaintiffs' lawyers in the nation to try a case involving the diet-drug
combination to a jury, and in August won a critical twenty three million four hundred thousand dollar verdict in
Canton that set the stage for a three billion seventy five million dollar global settlement. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
But the pair accomplished much more. They were the first lawyers in the country
to take depositions from defendant American Home Products Corp. employees. More
importantly, Kisselburgh painstakingly
compiled a treasure trove of documents that laid the foundation for the litigation
nationwide, plaintiffs lawyers say....
...Kisselburgh is the computer
whiz and document king, the only lawyer who actually wanted to pore through millions
of documents from American Home to find the smoking gun memos that trial lawyers
love.
Petroff is the science guy who
focused on medical causation and was the lead lawyer in the Canton trial, which
other plaintiffs' lawyers say was targeted by the defense as an easy win....
back
to top
Time
Magazine, Jun. 04, 2001
Bitter Pills, Bad Medicine
By Frederic Golden An absorbing look at how the fen/phen
diet craze destroyed lives and our illusions about drug safety
With
the euphoniously named diet-drug combo fen/phen all the rage in the mid-1990s,
victory finally seemed near in the war on fat. Selling by the millions, the little
pills appeared to melt away pounds without maddening diets, demanding exercise
or nasty side effects. But as investigative reporter Alicia Mundy reminds us
in her absorbing postmortem, Dispensing with the Truth (St. Martin's Press; 402
pages; $24.95), what began as a panacea for intractable obesity--and a bonanza
for the pillmakers--quickly turned into a public health disaster. For the complete
article, see the www.time.com archives.
back
to top
Facts
on File, September 30, 1999
Jury Awards twenty three million three hundred thousand Dollars in Fen/Phen Suit; Other Developments
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
A Texas jury August 6 ordered American Home
Products Corp. to pay twenty three million three hundred thousand dollars in damages to a woman who claimed that the
company had failed to warn doctors and patients of a risk of heart damage from
a diet drug it sold until, September 30, 1999 1997. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement). The case, one of at least
3,100 lawsuits against the company over two of its prescription diet drugs, was
the first to reach a verdict.
American
Home Products had reached settlements in several other suits, and was reportedly
preparing a four billion dollar proposal to settle the remaining lawsuits.
The company September 16 announced that it had reached a settlement with the
Texas plaintiff for a fraction of the jury's award. American Home Products' Wyeth-Ayerst
division in 1997 had withdrawn the two popular and closely related diet drugs,
fenfluramine and dexfenfluramine--sold as Pondimin and Redux, respectively--at
the request of the Food and Drug Administration (FDA). The recall was prompted
by evidence linking "fen/phen,"
a widely-used drug combination consisting of either
of the two drugs and another drug, phentermine, to heart-valve damage. American
Home Products distributed, but did not manufacture, phentermine.
The
Texas plaintiff, Debbie Lovett, 36, had used the Pondimin and phentermine combination
for several months in 1995 and 1996. Although her own doctor testified in the
trial that her heart problems had predated her use of the drugs, her lawyer argued
that the company's failure to disclose the risks of fen/phen had further jeopardized
her health. The lawyer, Kip Petroff, said that American Home Products had encouraged
doctors to prescribe the fen/phen combination, although the three drugs were
each approved by the FDA only for use alone. The jury, in Van Zandt County, awarded
Lovett three million three hundred thousand dollars in compensatory damages and twenty million dollars in punitive damages.
American Home Products had reportedly considered Lovett's case a relatively weak
one, leading the company to not pursue an out-of-court settlement. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
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Lawyers
Weekly USA, September 6, 1999
Twenty Three Million Dollar Fen Phen Verdict May Open Doors to Bigger Settlements
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
By Christa Zevitas
When
a Texas jury ordered American Home Products Corporation to pay more than twenty three
million dollars to a woman who alleged the diet drug Pondimin caused her to suffer heart
valve damage, news of the verdict sent the pharmaceutical company's stock down
twelve percent that same day. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
But the verdict's negative ramifications will hit the company even harder in
the courtroom, predict litigation experts the country.
That's
because the Aug. 6 verdict - the first-ever in Fen Phen litigation -
slammed the Madison, N.J.-based company with twenty million dollars in punitives for what
Fen Phen plaintiffs' lawyers nationwide considered a weak case...(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
...Because
the facts against Lovett (the plaintiff) left her lawyers with a less-than compelling
compensatory lawsuit, Petroff and Kisselburgh focused
the bulk of their case on the company's negligent conduct...
...Petroff thought
the punitive award was "surprisingly large"
because they were only asking for five million in unspecified
damages. But he believes that jurors were "justly driven by anger at the company"...
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Texas
Lawyer, August 16, 1999
Fen Phen fight has just begun
Plaintiffs Lawyers Say Verdict Sets Market Rate
By John Council
When
an East Texas jury smacked a drug manufacturer with twenty three million four hundred thousand dollars in damages
August 6 in the first Fen Phen case to reach a verdict, the message the Canton
trial sent to lawyers was clear: The price of settling America's newest mass
tort case just went up. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
From
Hawaii to New Jersey, thousands of Fen Phen suits are pending against American
Home Products Corp. So far, talks of a national settlement involving the diet
drug - taken off the market in 1997 because of its link to heart problems - have
failed. However, that may soon change...
... "I've
got a whole string of cases to try and they're all better cases ... than the
one I just tried," says Kip Petroff.
"[American Home] can always get out the checkbook."....
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The Dallas Morning News, August 14, 1999
One Day at a Time
Victor in Fen Phen lawsuit says she would trade money for health
By Jennifer Arend
GRAND SALINE - Debbie Lovett is trying to adjust
to her newfound fame as the local country girl who took on a big corporation
in an East Texas courtroom and won nearly twenty three million four hundred thousand dollars. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
Legal observers said she did it with one of the weakest cases filed against American
Home Products Corp, a maker of the diet-drug combination Fen Phen...
... "The
jury knew she was a person of good character, but I don't think she had much
to do with [the verdict]," Mr. Petroff said....
... "The
lawyers produced interoffice memos and other documents showing that the company
knew of the health risks associated with its product long before 1997 but continued
to sell it. At the end of the trial, several jurors said these documents were
what convinced them of the company's guilt...
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Houston
Chronicle, August 7, 1999
Woman wins twenty Three million Dollars in Fen Phen case
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
CANTON
(AP) - A 36-year-old woman who faces lifelong heart problems she blames on the
diet-drug combination Fen Phen was awarded twenty three million three hundred sixty thousand dollars Friday in the first
case to reach a jury...(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
...Plaintiff's attorney Robert
Kisselburgh said
[Debbie] Lovett suffers fatigue and shortness of breath and likely will need
surgery to replace two heart valves as her ailment progresses...
...But
Lovett's lawyers told jurors that American Home Products was motivated by profit
and hid evidence that its diet drugs caused valvular heart disease...
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The
New York Times, August 7, 1999
Twenty Three Million Dollars Awarded in Suit Against Maker of Diet Drug
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
In the first verdict among thousands of cases pending across
the country against makers of the diet pills popularly known as Fen Phen, an
East Texas jury today awarded more than twenty three million dollars to a woman who said she suffered
heart damage after taking the drugs to lose weight. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
Lawyers for the woman, Debbie
Stone Lovett, 36, a manicurist from Grand Saline, Tex., had accused the pharmaceutical
giant American Home Products Corporation, based in Madison, New Jersey, and its
subsidiary, Wyeth-Ayerst Laboratories of St. Davids, Pennsylvania, of failing
to warn their customers and doctors that the diet pills caused heart valve damage.
The judgment is the latest setback for American Home Products, which settled
a similar case in Houston in June for a reported six million and faces a huge
class-action lawsuit over the diet pills that began jury selection this week
in New Jersey. Ms. Lovett's lawyers said that today's verdict in Van Zandt County,
about 50 miles east of Dallas, was particularly significant because American
Home Products, which had settled several cases out of court, decided that the
facts in the Lovett case favored the company.
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The
Dallas Morning News, August 7, 1999
Fen Phen suit jury awards twenty three million four hundred thousand Dollars to E. Texan
Drug company vows to appeal the decision
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
By Charles Ornstein and Jennifer Arend
CANTON,
Texas - An east Texas jury awarded nearly twenty three million four hundred thousand dollars Friday to a woman who
took the diet-drug combination Fen Phen, saying American Home Products Corp.
acted with negligence and malice in producing and promoting the product. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
The 10-2 verdict - which was handed down in what legal observers called a weak
Fen Phen case - is a foreboding signal for American Home Products as it prepares
to defend itself in thousands of lawsuits nationwide, Wall Street analysts say...
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The
Dallas Morning News, August, 1999
American
Home to pay substantially lower sum
By Charles Ornstein
American
Home Products Corp. settled a critical Fen Phen diet-drug lawsuit Thursday for
less than a tenth of the twenty three million four hundred thousand dollars awarded by an East Texas jury in August.(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
The case was the first of at least 4,100 lawsuits to make it through trial to
a verdict and was seen as a disturbing defeat by analysts...
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Texas
Monthly, May, 1999
Ardor
in the Court
By Alicia Munday .
. .
Plaintiff's
attorney Kip Petroff is doing something
his peers around the country can't: He's bringing a major drug company to its
knees.When Dallas plaintiff's attorney Kip Petroff went
after diet-drug maker Wyeth-Ayerst, everyone said he didn't have a chance. Everyone
was wrong. Click
here for complete article (this is an image that will open in a new window
so please be patient while it loads).
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Canton
Herald, August, 1999
Twenty three million three hundred thousand Dollars awarded in local ‘Fen Phen’ case
(Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
A
jury awarded Debbie Lovett of Grand Saline twenty three million three hundred sixty two thousand dollars in total damages in the "Fen Phen" diet
drug trial against American Home Products... (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
Ms. Lovett, 36, blamed American
Home Products and subsidiary Wyeth-Ayerst Laboratories for damage she claimed
to have suffered after taking the drugs for several months, starting in October
1995.The jury's decision on the question of negligence went against AHP, makers
of fenfluramine, half of the Fen Phen diet drug combination. Also, the jury answered "yes"
to questions of whether there was a defect in the marketing of the drug and a
defect in the design of the drug. The jury also found 100 percent of
the liability issue in the case to be with AHP. Judge Wallace then announced
the compensatory awards. The jury awarded Ms. Lovett fifty thousand dollars for past physical
pain and mental anguish, five hundred thousand dollars for future physical pain and mental anguish
and three hundred thousand dollars for loss of earnings capacity in the future. The jury also awarded
Ms. Lovett five hundred thousand dollars for past physical impairment, one million dollars for future physical
impairment, twelve thousand dollars for past incurred medical expenses and one million dollars for future
incurred medical expenses. Following that, Judge Wallace read the jury's
decision on the question of malice on the part of AHP, which the jury responded
with "yes." The largest part of the award was then announced
twenty million dollars to Ms. Lovett for exemplary damages. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement). None of the 12 jury members
opted to remain in the courtroom to answer questions from attorneys and the media. The
lawsuit, filed by Ms. Lovett's attorney, Kip Petroff,
claimed that Ms. Lovett had suffered severe heart valve damage after taking fenfluramine
for a seven-month period. More than 3,100 Fen Phen cases have been filed
across the country, but Ms. Lovett’s lawsuit in Canton was the first to
reach a jury verdict. Other cases, including 13 more cases in Van Zandt
County, are pending. Other cases have been settled.The company marketed Pondimin,
the brand name for fenfluramine, the "fen" part of the Fen Phen combination,
and its chemical cousin Redux until September 1997, when the U.S. Food and Drug
Administration forced its withdrawal.
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Canton Herald, August, 1999
Lovett says she was ‘surprised’ by verdict
By Allison Hoard
In
her first newspaper interview, a 36-year-old Grand Saline woman said she was
surprised by the twenty three million three hundred thousand dollars award given to her by a Van Zandt County jury
Friday. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement). "I didn’t know what kind of impact it would have," said Debbie
Lovett, the plaintiff in the
"Fen Phen" lawsuit which came to a conclusion last week. "That
was more than I would have expected," she said, referring to the amount
awarded.
Mrs.
Lovett emphasized her gratitude for the jurors’
efficiency and dedication during deliberation. She said that even though the
trial was long and tiring for everyone involved, the jurors stayed with it until
the very end.
"Those people need to be commended,"
she said, for their hard work and all their effort to do the right thing. Mrs.
Lovett and her attorney, Kip Petroff of
Dallas, were impressed with not only the dollar amount awarded but also the persistence
of the jury in researching the evidence through even the last moments of deliberation.
"That
was the most conscientious jury I have seen in my fifteen years of practice.
We are very proud of the job they did. They did the right thing," commented Mr.
Petroff... Mrs. Lovett is proud to have been able to
blaze the trail for others who have experienced similar health problems due to
the drug they took. She hopes that now their recovery will be much easier, as
a result of her battle to prove the company’s negligence.
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Los
Angeles Times, October
8, 1999
Four
Billion Eighty Three Million Offered To Settle Fen Phen Claims; American Home Products Will Compensate
Thousands Of Patients Who May Have Suffered Heart Damage
The
maker of key ingredients in the diet-drug cocktail known as Fen Phen has agreed
to pay up to four billion eighty three million to settle thousands of claims from patients who may
have suffered heart damage from taking the once-popular weight-loss treatment.
American Home Products, maker of fenfluramine, the potent portion of the mixture,
and dexfenfluramine, a chemical cousin sometimes used instead, said Thursday
it had signed a letter of intent with lawyers representing eight thousand patients to
pay for medical monitoring, health care and some compensatory damages to those
who took the drugs before they were pulled off the market in 1997. The settlement,
which must be approved by a federal judge in Philadelphia, would be open to all
six million people who took either of the AHP drugs, marketed under the names Pondimin
and Redux.
Those
with the most serious heart damage could receive as much as one million five hundred thousand under
the terms of the deal. But payments to some patients with minimal heart damage
could be as low as six thousand, and not all conditions believed to be caused by Fen Phen
are included. For example, many doctors believe that the pills also caused a
form of heart failure called primary pulmonary hypertension, but that is not
part of the deal. Under an unusual provision of the settlement, patients accepting
the settlement can opt out later if their conditions become significantly worse
and they wish to sue instead. But company officials expressed confidence that
most affected consumers would sign on rather than risk the expense and uncertainty
of proving in court that the diet cocktail caused their disease.
Here's
how the deal would work:
- Patients
who used Fen Phen for less than 60 days and are not ill would be reimbursed for
the cost of the drug cocktail as well as the cost of a heart test called an echocardiogram. Those
who test positive for heart-valve damage would receive three thousand in cash or five thousand
in medical services;
- Those who used Fen Phen for more than 60 days will be offered the heart test
and a follow-up visit with a physician. Those who show signs of disease will
be reimbursed with an amount between six thousand and one million five hundred thousand, depending on
the severity of the condition; and;
- Patients
who accept a small settlement and then become sicker will be allowed to request
greater compensation or opt out of the settlement in order to sue. There will
be no statute of limitations on the decision to sue.
The
Fen Phen cases are the latest in a string of personal-injury cases that have
cost businesses whose products were believed to cause medical injuries hundreds
of millions of dollars. American Home Products itself has been the subject of
numerous lawsuits over its Norplant contraceptive implant, and it took over the
company that manufactured the Dalkon Shield, another birth-control device that
was linked to a number of deaths and was the subject of lawsuits.
The
company expects to pay out no more than four billion eighty three million over the next 16 years
under terms of the settlement. That works out to three billion seventy five million in current dollars.
Fen Phen became wildly popular in the mid-1990s, after doctors discovered that
combining fenfluramine with phentermine, a stimulant, helped people lose weight.
It was widely prescribed in California, Texas, Florida, New York, and other states,
and for a time the pills were almost ubiquitous among everyone from stay-at-home
mothers to busy executives.
All told, 5.8 to 6 million people took Fen Phen,
according to the company.While both drugs in the Fen Phen cocktail
were legal and had been approved individually by federal regulators, they were
not tested or approved for use in combination. In 1997, doctors at the Mayo Clinic
reported a disturbing number of cases of heart-valve problems among women patients
using the drugs.
In these women, the doctors found, the valves that
push blood forward as it is pumped out of the heart had lesions on them and did
not work well. As a result, blood that was supposed to have been pumped out to
the patient's body in fact was dribbling back into the heart. The leakage, doctors
feared, could cause the heart to deteriorate or make it easy for bacteria to
lodge there.
A much more serious heart disorder, in which the heart beats uncontrollably
fast, also appeared among users of the drugs. That rare condition, called
primary pulmonary hypertension, was noted in the required warning labels for
the products, alerting physicians to the possibility of heart failure. Although
new studies appear to suggest that the problem is not as widespread as initially
believed, the number of cases mounted.
The Food and Drug Administration asked Wyeth-Ayerst, American Home Products'
pharmaceutical subsidiary, to withdraw both Pondimin and Redux from the market,
which it did voluntarily. The "phen"
in the Fen Phen combination--short for phentermine--was
not implicated in the problem and remains on the market. In the aftermath, 6,500
lawsuits were filed, 700 of them in California, representing 11,000 Fen Phen
users. The company has quietly settled a number of the cases. A jury awarded
a Texas manicurist twenty three million three hundred thousand in the first case to go to trial, but the plaintiff
agreed to an undisclosed reduced amount after the company said it would appeal
the monetary award. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
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Texas
Lawyer, October 8, 1999
Fen Phen Fight Has Just Begun
Plaintiffs Lawyers Say Verdict Sets Market Rate
by John Council
When
an East Texas jury smacked a drug manufacturer with twenty three million four hundred thousand dollars in damages
Aug. 6 in the first Fen Phen case to reach a verdict, the message
the Canton trial sent to lawyers was clear: The price of settling America’s
newest mass tort case just went up. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement). From Hawaii to New Jersey, thousands of Fen Phen
suits are pending against American Home Products Corp. So far, talks of a national
settlement involving the diet drug — taken off the market in 1997 because
of its link to heart problems — have failed.
However,
that may soon change.But in Texas — a key battleground for Fen Phen litigation with about a dozen
cases scheduled to go to trial before year’s end — lawyers on both
sides say no one is choosing mediators just yet. Madison, N.J.-based American
Home is appealing the Canton verdict, of which punitive damages account for twenty
million dollars. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement). And they won’t be blinking at future litigation, defense lawyers
say. "You don’t settle based on one case," says Bill Sims, a
partner in the Dallas office of Vinson &
Elkins and one of the lawyers who represented American
Home in the Canton case.
"I don’t think one case sets a barometer
for anything. I think you have to have a half-dozen cases to see where you are."That
stance has Kip Petroff, one of
the lawyers who represented plaintiff Debbie Lovett in Canton, and other plaintiffs
lawyers salivating."
I’ve got a whole string of cases to try and they’re
all better cases to try than the one I just tried,"
says Petroff,
of Dallas’ Petroff & Kisselburgh. "[American Home] can always
get out the checkbook."
Petroff says
he turned down a settlement offer of far less than the reported five hundred thousand American
Home gave to a plaintiff in April in a similar case set for trial in Cleburne.
Another case in Houston settled for a reported six million in June. Those figures
seem like a bargain now, plaintiffs lawyers say."
I
think you have a yardstick to measure these cases by now," says Petroff’s co-counsel, Robert
Kisselburgh.
Defense
lawyers pushed for a trial in conservative Van Zandt County, a venue that seemed
to favor their case. American Home lawyers believe that cases such as Lovett’s are the type they are most likely to
win.
While
it’s too soon to tell whether the verdict is a sign of things
to come, there will be plenty of chances to test the damage value of such cases.
Her claims are the most common and the most likely to be taken to a jury, lawyers
on both sides say.
The
Food and Drug Administration asked drug companies to withdraw fenfluramine, the "fen" part of the diet drug combo, and
the related drug dexfenfluramine, or Redux, from the market in September 1997.
Of the three varieties of Fen Phen cases, so-called "regurgitation"
cases make up the majority, Kisselburgh says. Such
cases involve claims that Fen Phen damaged the heart valves, preventing them
from sealing properly.
Defense
lawyers have been encouraged to try regurgitation cases for two reasons: They
present causation problems for the plaintiff and it’s tough to show that the plaintiff has suffered life-altering damage
because of the drug. "If you have mild regurgitation, you can fly to the
moon, you can play football," Sims says. "It’s a lab finding.
It’s something, but it’s not life adjusting. That’s why I think
we’ll be trying lots of regurgitation cases."
And
in Lovett’s
case, proving that her heart damage was the result of American Home’s drug
was especially difficult. "Causation was a huge issue," Petroff says. "Her
own cardiologist testified that the drugs didn’t cause this problem." Like
asbestos cases, defense attorneys made much of the fact that Lovett smoked cigarettes
for eight years, which may have caused her heart damage. Petroff says
documents turned the case around. Company memos introduced as evidence showed
that American Home allegedly knew of people who took the drug and developed heart
damage, but resisted putting warning labels on the product, Petroff says.
Bob
Schick, a Vinson & Elkins partner who defended American Home in the Canton
trial, says the company acted responsibly. "There simply is no scientific
study that has established a causal link between the use of Pondimin [an ingredient
in Redux, which is manufactured by American Home] and the heart problems claimed
by Mrs. Lovett,"
Schick says in a statement."
I’d like to say it’s the
lawyering, but it’s the documents," Petroff says. "They
need to be explained, but this jury figured it out for themselves."The
hot document tactic is common in litigation where causation is in dispute, says
Robert Thackston, a partner in Dallas’ Jenkens & Gilchrist and a veteran
asbestos defense attorney. "It makes them very hard to defend. What they
try to do is get the bad corporate documents that get the juries mad and try
to gloss over those distinctions,"
he says. Going Global Plaintiffs lawyers believe American Home may soon restart
national settlement talks that shut down a few months ago, especially since the
company’s stock prices dropped after the Canton verdict.
Even
if talks resume, it won’t have much of an effect on gung-ho Texas plaintiffs lawyers,
some of whom have invested millions in pretrial preparations for individual Fen Phen
cases. "You’re going to see the emphasis placed on the national settlement,"
says Thomas Pirtle, a partner in Houston’s O’Quinn
& Laminack who has several Fen Phen cases. "What [effect] that has on
Texas, I don’t know. We don’t tend to go along with that."
Both
plaintiffs and defense lawyers agree that the company is more likely to settle
the severe types of Fen Phen cases — those with illnesses that include
primary pulmonary hypertension (PPH), a fatal disease that has been connected
to the drug, or cases in which the Fen Phen users have had to have heart surgery.
The company has settled some PPH cases.The next Fen Phen case in Texas is scheduled
to begin Aug. 23 in Fort Worth state district court —
a PPH case in which a 34-year-old woman died after allegedly using the drug.
Sims, a defense lawyer in the case, says the woman signed a consent form acknowledging
that taking the drug could cause PPH. The plaintiffs’
lawyer in that case, Michael McGartland, says that despite the recent verdict,
a settlement doesn’t look likely in Fort Worth. "Based upon the conversations
thus far . . . we’re going to trial," says McGartland, a partner in
Fort Worth’s McDonald, Clay, Crow & McGartland. "Hopefully cooler
heads will prevail."
Copyright
1999, Texas Lawyer. All rights reserved.
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Associated
Press, February 12, 1999
Lawyers
sue diet drug company
DALLAS
(AP) - The maker of the now-recalled diet drug fenfluramine withheld information
about cases of potentially fatal side effects and delayed stronger warning labels
until it had rolled out another weight-loss drug, say lawyers suing the pharmaceutical
company. Fenfluramine - which was half of the diet-drug combination Fen Phen
and was sold by the drug company Wyeth-Ayerst as Pondimin - carried labels starting
in 1988 warning that in rare instances, it caused pulmonary hypertension, a potentially
fatal illness. In June 1994, Wyeth's medical monitor, Dr. Frederick Wilson, told
executives that he knew of 37 PPH cases, even though Wyeth-Ayerst had notified
federal regulators of only four, according to internal documents acquired by Kip
Petroff, a lawyer for 100 people suing Wyeth-Ayerst.
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Wall
Street Journal - Interactive Edition,
September 28, 1999
American Home Seeks Settlement As Holes in Fen Phen Defense
Show
By LAURA JOHANNES and ROBERT LANGRETH
Staff Reporters of THE WALL STREET JOURNAL
Richard B. Schmitt contributed to this article
American
Home Products Corp. stands ready to spend about four billion to settle much of
the litigation over its diet drugs. Although final terms have yet to be worked
out -- meaning a deal could still elude the company -- the settlement under negotiation
would be the biggest ever over hazardous medicine.
Part
of the reason the sum is so big is the sheer number of people involved. Six million
Americans took Pondimin, the "fen"
in the Fen Phen cocktail, or its chemical cousin Redux before American Home Products
withdrew them two years ago amid links to heart-valve disease.
But
American Home may also be interested in reaching a settlement because its strategic
position has eroded in recent weeks. For one thing, the Federal Bureau of Investigation
has begun, in a preliminary way, to look into Redux's 1996 approval by the U.S.
Food and Drug Administration; any new revelations could hurt American Home's
defenses in civil trials. The company says that it isn't aware of any FBI inquiry
and that all its actions with respect to diet drugs have been lawful.
First
Verdict
More
important, the first of 4,000-plus diet-drug lawsuits to reach a verdict went
badly for American Home last month. In Canton, Texas, a jury voted to award twenty three million four hundred thousand dollars to Debbie Lovett, who developed heart-valve leaks after she took Fen Phen. (Twenty million dollars of this verdict was for punitive damages and three million three hundred thousand dollars was awarded for pain and suffering and medical expenses. The client's alleged damages were for injury to her aortic and mitral heart valves. The client did not actually receive any money after the initial verdict. Due largely to the uncertainty of this verdict being upheld on appeal, the client settled her case on September 30, 1999, before a Judgment was entered on the verdict. On that date, the client settled her case for one million nine hundred ninety seven dollars plus Court Costs in the amount of eleven thousand four hundred eighty five dollars. Attorney's fees in the amount of seven hundred ninety eight thousand eight hundred dollars and litigation expenses in the amount of one hundred sixty five thousand eight hundred twenty nine dollars were withheld from the settlement. Therefore, the client received one million forty three thousand eight hundred and fifty six dollars as a result of the settlement).
The
case was settled for less, but the evidence presented revealed a record of monitoring
patient safety that struck some jurors as callous. "They
were looking at the dollars and at how to please their stockholders, and not
at how to protect the public," says one, Ronnie Wilson Jones.
The
proposed four billion settlement would affect only litigation involving heart-valve
damage. American Home would still face suits based on primary pulmonary hypertension,
a rare but often-fatal lung disease also associated with the drugs. Further complicating
the picture: Monday a judge rejected a proposed one hundred million settlement involving
the small firm that developed Redux, Interneuron Pharmaceuticals Inc. of Lexington,
Mass.
'Adverse Events'
Federal
rules require pharmaceutical companies to collect and quickly send to the FDA
any reports of "adverse
events" involving users. But in both the Texas trial -- in federal court
-- and an ongoing one in state superior court in New Brunswick, N.J., the effectiveness
and staffing of American Home's safety department were central issues.
There
was testimony that at critical junctures, American Home was receiving reports
of heart-valve problems but not passing them on immediately to the FDA. Other
testimony portrayed the company as resistant to stiffening package-insert warnings
about side effects.
Plaintiffs'
assertion that American Home gave short shrift to safety "is just so wrong," says Robert Essner, executive vice president
of the company. "American Home puts the highest possible standards on integrity,
safety and regulatory compliance. We don't cut corners."
The
company says the evidence didn't support the outcome of the Texas case. "There are those
that have taken sections of selected company memoranda out of context to argue
that AHP disregarded safety in the pursuit of profits. That argument is absolutely
baseless,"
American Home says.
Hair Loss
Much
of the evidence in the Texas case came from company insiders. At one point, a
plaintiff's attorney asked company executive Axel Olsen why Pondimin's label
warned of possible hair loss but not of heart-valve problems. Weren't heart-valve
problems worse than hair loss?
"One
would really need to have more information than simply the term in order to say
one was more serious than the other," Dr. Olsen said, in a reply that angered
Mr. Jones, the juror. "How could he not know that? A human life is worth
more than hair damage," the juror says.
Another
setback came when Bernard Poussot, president of global pharmaceuticals at American
Home's Wyeth-Ayerst unit, testified that
"similar issues" to the heart-valve problems had been seen "as
early as 1960." He couldn't be reached for comment, but American Home says
he was referring to reports about Aminorex, a diet drug sold in Europe. Although
testimony presented no specific link between the 1960 date and Pondimin or Redux,
Mr. Jones says the long history of red flags helped persuade him as a juror to
support the plaintiff's side.
In
the New Jersey suit -- a class action seeking medical monitoring for those who
took the drugs -- current and former American Home employees testified that the
company was hard-pressed to keep up with its growing responsibility of monitoring
side-effect reports. First, the company's workload increased in 1994 with American
Home's acquisition of American Cyanamid Co. and its Lederle drug unit. Then,
sales of Pondimin took off. Pondimin had been a minor drug since the 1970s, becoming
a product of American Home via its 1989 acquisition of A.H. Robins. The drug
became a big seller after a report on how to use Pondimin -- technically, fenfluramine
-- with a drug called phentermine to create Fen Phen, the appetite-dulling combo
that ignited a craze.
An
official testified to a 30% rise during the first half of 1996 in reports of "adverse
events" problems with American Home's drugs, the more serious of which went
into red folders. "Will this flood of red folders never end," employee
Mary Frances Moeller wrote to a colleague in an October 1996 memo involving Pondimin
reports. "We are in desperate need of a lull." American Home says Ms.
Moeller nonetheless completed her work on time.
The
company relied heavily on temporary employees to monitor and process side-effect
reports. Marc Deitch, former global medical director for Wyeth-Ayerst, testified
that as of July 1996, soon after Redux won FDA approval, 33% of safety staffers
were temps.
One
monitor, Amy Myers, testified that she repeatedly complained to her boss about
the burgeoning workload, including time spent training short-term temps. The
FDA, during a 1997 FDA inspection, found deficiencies in American Home's safety-monitoring
computer system. According to an internal company summary of the inspection,
Dr. Deitch told the FDA the problem was due to rapid growth. "He said that he wasn't
making excuses, but offering this as an explanation; Ayerst, Robins, Lederle,
Cyanamid, and the system simply could not accommodate the growth," the summary
read.
Dr.
Deitch, who has left the company, declines to comment. American Home says it
has always allocated adequate resources to safety surveillance. A spokesman,
noting there may have been "a little turmoil" following its acquisitions,
says the company has upgraded its computers and substantially increased its safety
staff.
Valve Problems in Europe
A
major trial issue was why American Home didn't warn the public after receiving
reports of several dozen cases of heart-valve problems involving Pondimin in
Europe, well before valve problems arose in the U.S. in the spring of 1997.
Fredrick
S. Wilson, one of American Home's medical monitors for Pondimin, testified via
deposition in the Texas trial that he took a month-long vacation in February
1995, the same time that several reports of heart-valve problems from Belgium
reached the company. Dr. Wilson's deposition said that when he returned to work
part-time in March, he didn't review the valve reports that had arrived during
his vacation.
American
Home says another staffer reviewed the reports in his absence. Its defense was
that the European reports it got weren't alarming because the heart valve leaks
were very mild, of a kind that isn't uncommon in the population at large. And
it said the Belgian cases -- the bulk of the reports -- were complicated by the
fact that many patients also took a concoction of Chinese herbs to lose weight.
One
juror, Peggy L. Jacobs of Edgewood, Texas, says she was willing to give American
Home the benefit of the doubt on the Chinese herbs. But she says she couldn't
forgive the company's repeated efforts to avoid putting prominent warnings on
the the drug's package insert.
Pulmonary Hypertension
The
first trial evidence about the warnings dated back to June 1994, when Dr. Wilson
found out that the company had reports of 41 Pondimin users coming down with
primary pulmonary hypertension, while the package insert was showing just four,
according to his testimony. Dr. Wilson testified that he proposed updating the
warning to reflect additional cases of the dangerous disorder and that company
officials initially agreed to a draft change. But the warning wasn't strengthened
until two years later, according to Ms. Myers's testimony in the New Jersey case.
That
was in July 1996, about two months after Pondimin's chemical cousin, Redux, won
FDA approval in a close vote, in the wake of considerable debate over side effects.
Lawyers for American Home Products say the company didn't update the package
insert sooner because it was waiting for results of a large-scale study on the
incidence of the lung disorder. The company adds that the FDA told it in 1994
that the warning didn't need to be updated.
But
Mr. Jones, the Texas juror, says the delay seemed like an attempt to sweep the
issue under the rug until Redux won approval. And in the New Jersey case, Dr.
Deitch, who was responsible for the label at the time, testified that it was
a "mistake" not to update
the Pondimin label's reference to just four pulmonary-hypertension cases. "I'm
not saying we shouldn't have changed the number four. We should have," he
testified.
'Black Box'
During
the approval process for Redux, the company argued against a "black box" warning
for pulmonary hypertension on the package insert, which is sent to pharmacies
and printed in doctors' reference manuals. In these warnings, the cautionary
information is set off in a bordered box to draw attention. Lawyers for Ms. Lovett produced
a document circulating at American Home showing a consultant had said Redux sales
could be as much as 50% lower if there was a black-box warning.
The
memo was solely for "informational purposes"
for the marketing department and didn't have "any impact" on the company's
labeling negotiations with FDA on Redux, a spokesman says.
On
Feb. 27, 1996, Wyeth-Ayerst official JoAlene Dolan wrote to the group assigned
to help her prepare a presentation opposing the black box. "The meeting with FDA yesterday was
a tremendous success!"
she wrote to this SWAT group (Special WyethAyerst Team). "No black box!" Ms.
Dolan, has left the company and couldn't be reached for comment.
Marc
Farley, a lawyer for American Home in the New Jersey case, says the Dolan memo "is
a classic example of an out-of-context memo" used by plaintiffs' lawyers
to assert misleadingly that the company wasn't concerned about safety. Since
the company's top medical experts thought a black box wasn't necessary, it was
natural for Ms. Dolan to be pleased when the FDA agreed, he says. Redux won FDA
approval in April 1996 without the black box.
(It
is unclear what elements of the approval have piqued the FBI's curiosity. Its
agents are still trying to determine whether there is evidence warranting a criminal
investigation, according to people familiar with the matter. Plaintiffs' attorneys
are eagerly aiding the probe.)
Damage Control
Four
months later came some bad news: A study published in the New England Journal
of Medicine provided further evidence linking primary pulmonary hypertension
to diet-drug use.
One
of American Home's immediate reactions was to strategize on how to prevent the
paper from scaring off customers. Kelly Davis, a doctor in charge of monitoring
the drugs' safety for American Home, wrote to Ginger Constantine, a high-ranking
doctor at the company: "In order to be truly convincing that the risk of primary pulmonary
hypertension is worth taking, I would recommend making a comparison of risks
for another drug or medical risk that physicians are more comfortable with, such
as the risk of dying from an anaphylactic reaction associated with the use of
an antibiotic." American Home declines to comment on this memo or on whether
it took any safety steps in reaction to the New England Journal of Medicine paper.
Other
testimony told of employees being instructed to delay processing new heart-valve
reports. Ms. Myers, the safety monitor, testified in Texas that the company received
reports of heart-valve problems from a doctor in Fargo, N.D., on March 6, 1997;
she said that soon afterward she entered about 14 cases into the firm's computer
system and gave them identifying "manufacturer control numbers."
But
when Ms. Myers updated her superiors on the cases five days later at a safety-surveillance
meeting, Dr. Constantine told her she shouldn't have entered the cases into the
computer because the information the Fargo doctor gave on the phone wasn't detailed
enough. "I basically told her that I thought she had jumped the gun," Dr.
Constantine testified.
Files Overwritten
Dr.
Olsen, vice president of global medical operations at the Wyeth-Ayerst unit,
suggested at the same meeting that "the cases could be canceled," Ms. Myers testified. In
his own deposition, Dr. Olsen denied telling her to "erase" the entries
and replace them with other reports; reached by phone, he declined to comment.
Dr. Constantine couldn't be reached.
Following
the meeting, Ms. Myers testified, she overwrote the files and reused numbers
she had given to diet-drug reports. According to records at the FDA, American
Home didn't inform the agency of the North Dakota incidents until April 11, after
sending officials to Fargo and the Mayo Clinic in Minnesota, which was working
with the Fargo doctor.
The
FDA, in a Dec. 4, 1997, inspection report, told American Home that it had improperly
reused the manufacturer's control numbers. The FDA also alleged that American
Home was 11 business days late in reporting the Fargo problems. Drug firms are
required to inform the agency of any serious safety problems "as soon as
possible,"
but no later than 15 days after hearing of them.
"It did seem like they
were trying to buy some time, stretch it out as long they could and keep selling" the
diet drugs, says Ms. Jacobs, the Texas juror.
The
company says it believes it "reported
everything according to FDA guidelines." Mr. Farley, its lawyer, says the
original reports opened by Ms. Myers
"were not complete, and they would not have provided the FDA with meaningful
information." He acknowledges that it was a mistake for her to overwrite
the manufacturer's control numbers.
Lars
Noah, a food-and-drug-law expert at the University of Florida in Gainesville,
says that even a company that has an incomplete report from the field should
be able to get enough to file a report to the FDA within in a day or two. "The obligation to file the 15-day report
kicks in immediately," he said.
"If there's going to be follow-up ... that's a subsequent report to FDA.
You
don't decide internally, 'Let's get all our facts straight and only when we're
sure there's a problem here do we raise the red flag with the FDA.' " American
Home has said that it has resolved the FDA concerns in the inspection report,
in part by a computer-system overhaul that makes it impossible to overwrite a
report once it is entered.
Quadruple-Urgent
By
July 1997, evidence of heart-valve problems was growing. A Mayo Clinic study
on the subject, set for publication late in August, was instead released by Mayo
at a July 8 news briefing.
American
Home heard about the plan for an accelerated release. In an internal memo dated
July 1 and headed "URGENT URGENT URGENT URGENT," marketing
employee Gerald V. Burr warned officials that the Mayo report might leak before
the news conference and provided a "standby statement" for responding
to inquiries.
"Well,
does it say anywhere under the four urgents here that there's one iota of concern
for the people who have the heart-valve problems?" Kip
Petroff, an attorney for Ms. Lovett in Texas, asked Carrie Smith-Cox,
formerly vice president for women's health at Wyeth-Ayerst, during a video deposition
played during the trial.
"This memo does not refer to that," Ms. Smith-Cox
replied.
"However, that would also not have been within
the responsibilities of the people charged with writing the standby statement
to look at the overall plan."
American Home says Mr. Burr's memo was "simply
a heads-up" to prepare for questions from the media.
Meanwhile,
although Redux had been approved without a black-box warning, documents and testimony
from a former FDA official show that the idea of a black-box warning for the
newly discovered heart-valve problem was under discussion at the agency in July
1997. American Home initially argued against it, and in succeeding weeks, relations
with the agency grew tense. In a Sept. 5 internal FDA memo introduced at the
Texas trial, FDA scientist David J. Graham wrote that he and colleague Lanh Green
had "have become concerned about the diligence of Wyeth-Ayerst in pursuing
leads and obtaining and reporting full clinical details of cases to FDA."
American
Home says it never heard such criticism from the FDA. It also says the scientific
evidence at the time didn't warrant a black-box warning because the heart-valve
incidents were "anecdotal case reports" that needed evaluation.
About
a week later, according to testimony, the FDA asked American Home officials to
come to agency headquarters. At the meeting, the FDA says, it asked the officials
to recall the drugs. American Home says that it would have withdrawn the drugs
from the market even if the FDA hadn't asked it to.
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In addition to the numerous articles presented above, a comprehensive web site on Products Law has an excellent list of Fen Phen related news: www.productslaw.com/fenphen.html. For more information on AHP's Diet Drug Settlement Trust, see AHP's Diet Drugs Claims Administration Web Site
Past successes cannot be an assurance of future successes since each case must
be decided on its own merits.