Press / Media


Kip Petroff was the lead lawyer in a landmark case in Fen Phen litigation against American Home Products Corporation in which the jury returned a verdict for the plaintiff in excess of twenty three 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.

As a result of his work in Fen Phen litigation, Kip Petroff has been recognized as an expert in Fen Phen litigation and has been featured in print and television media around the country.

Kip Petroff is also prominently featured as a Fen Phen litigation expert in the non-fiction books: The Money Lawyers by Joseph C. Goulden; and Dispensing With The Truth, by Alicia Mundy.

Attorney Kip Petroff at his law firm in Dallas, Texas.
"He's Fen-Phenomenal"
From the article,
Ardor in the Court Texas Monthly, May 1999

Kip Petroff, Attorney At Law

Kip Petroff tells the tale of "David vs. Goliath: The First Fen Phen Case Ever Tried" in Texas Justice: The Legacy of Historical Courthouses by Martana. Click here to read more.

This is a partial list of some of the television appearances and print media related to Kip Petroff's landmark Fen Phen litigation:




Television:

  • Frontline - View video of the complete "Dangerous Prescription" program, including segments with Kip Petroff.
  • Good Morning America
  • Burden of Proof
  • The Evening News with Dan Rather
  • CNN
  • Fox News

Frontline Program: "Dangerous Prescription"

Click here to view the complete Frontline Program "Dangerous Prescriptions" or click the images below to view segments with Kip Petroff.
"The Baycol Story" Segment with Kip Petroff - from the Frontline Program "Dangerous Prescriptions"
"The Baycol Story"
Segment with Kip Petroff

From the Frontline Program
"Dangerous Prescriptions"
"The Fen Phen Tragedy" Segment with Kip Petroff - from the Frontline Program "Dangerous Prescriptions"
"The Fen Phen Tragedy"
Segment with Kip Petroff

From the Frontline Program
"Dangerous Prescriptions"

 

60 Minutes II: The Fen Phen Files. Produced by Chris Riback.

Kip Petroff appeared on 60 Minutes II to discuss the Fen Phen issues.



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

    The Money Lawyers by Joseph C. GouldenA 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

    Texas Justice: The Legacy of Historical CourthousesA 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).

The Money Lawyers by Joseph C. GouldenA 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)Texas Justice by MartanaA 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.
Kip PetroffThe 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

Dispensing With The Truth
Paperback
Dispensing With The Truth
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:

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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)


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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....

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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.

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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...

back to topTexas Monthly Magazine - May 1999

 

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.

 



Disclaimer: The information in this web site has been prepared by Petroff & Associates, Attorneys at Law, for informational purposes only and is not to be intended as legal advice. Viewing this site, receipt of information contained on the web site or the transmission of information does not constitute an attorney-client relationship. Persons receiving the information via this web site should not act upon the information without seeking professional legal advice. Kip Petroff is board certified in Personal Injury and Civil Trial Law by the Texas Board Of Legal Specialization. Stan Hudson is board certified in Personal Injury Trial Law by the Texas Board Of Legal Specialization. These lawyers are responsible for the content of these advertisements.

 

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