The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.

Filed under: 2007, AstraZeneca, Cephalon, Eli Lilly, fen-phen, fentanyl, Fosamax, Johnson and Johnson, Merck, ONJ, Ortho, patch, PPHN, Seroquel, settlement, Vioxx, Wyeth, Zyprexa

No End in Sight for Fen-Phen Lawsuits

Evelyn Pringle January 29, 2007

On December 5, 2006, five women with ages ranging from 53 to 71, who took the appetite suppressants drugs known as fen-phen in 1996 and 1997, filed lawsuits against Wyeth Pharmaceuticals after being diagnosed with a life-threatening lung disorder.

These lawsuits demonstrate that the harm caused by fen-phen can surface many years after a person stops taking the drugs. For instance, plaintiff, Renee Tedesco, 53, of New Jersey, took fen-phen 10 years ago but was not diagnosed with primary pulmonary hypertension (PPH), until April 2006. She has undergone a double lung transplant to save her life.

In addition, studies released in November 2001, indicate that PPH in fen-phen users may be 7 times higher than originally predicted in 1997.

Fen-phen refers to a combination of the drug phentermine and the diet drugs Redux (dexfenfluramine) or Pondimin (fenfluramine). According to the FDA, these drugs were approved as appetite suppressants to be used separately in the treatment of obesity for short periods of time.

The fen-phen combination was never FDA approved for any indication so all prescriptions were written for off-label uses. Drug companies are prohibited from promoting drugs for off-label use but doctors may prescribe a drug that has been approved for one indication for any condition they deem appropriate. In recent years numerous drug makers have come under fire for illegally promoting their drugs for off-label uses.

Prescriptions written off-label for fen-phen were massive. Patients were able to get fen-phen over the internet, and Jenny Craig and Nutri-System set up weight loss programs where doctors would prescribe the drugs to patients.

Doctors prescribed fen-phen without doing a thorough examination, and in many cases without any exam at all. Most doctors prescribing the drugs had little or no training in obesity, according to One Half-Phen In the Morning/One Fen Before Dinner: A Proposal For FDA Regulation of Off-Label Uses of Drugs, by Maime Wilsker (1998).

One Illinois patient said that she obtained fen-phen from a weight-loss clinic without ever seeing a doctor and that a nurse gave her the prescriptions.

An estimated 6 million people have taken fen-phen and more than 18 million prescriptions were written for the combination in 1996 alone. From 1992 to 1997, new prescriptions for fen-phen increased by 442% for phentermine and 6390% for fenfluramine, according to a report in the March 24, 1997, Archives of Internal Medicine.

However, the run-away-train prescribing about came to a screeching halt on July 8, 1997, when the FDA issued a Public Health Advisory to 700,000 health care professionals and institutions warning that researchers at the Mayo Clinic had reported 24 cases of heart valve disease in previously healthy women who took fen-phen on average for 12 months.

Of the 24 women identified who had valve disease, eight also had moderate or severe pulmonary hypertension, which had not been previously identified.

The Advisory also noted that the agency had received additional reports of the same nature, and advised health care professionals to report any similar cases to the FDA through MedWatch. Subsequently, the FDA received 66 more reports of valve disease.

The lesions that formed on the heart valves of fen-phen users cause blood to flow backwards instead of forwards, which is called regurgitation. The Mayo Clinic study was reported in the August 28, 1997, New England Journal of Medicine and concluded by stating: “significant de-novo left-sided regurgitant valvular heart disease in a population less than 50 years old is rare. Thus, the association of valvular regurgitation with fenfluramine-phentermine is not likely due to chance.”

The researchers said that fen-phen users “should be informed about serious potential adverse effects, including pulmonary hypertension and valvular heart disease.”

Cardiologist, Dr Heidi Connolly led the study and was interviewed on PBS on August 27, 1997. At that time, she reported that five of the women in the study had required open heart surgery to repair or replace damaged heart valves.

Pulmonologist, Dr Lewis Rubin was also interviewed on the PBS program as part a member of the research team that linked PPH to fen-phen. Dr Rubin’s research found that people who took fen-phen for 3 months had a 9-fold increased risk for PPH, and 6-month users had a 23-fold increased risk of developing PPH.

After the Mayo Clinic report was published, the FDA conducted a study in five areas of the country, including Florida, Minnesota, Wisconsin, Indiana, and Pennsylvania and found a 32.8% presence of lesions causing valvular regurgitation, significantly higher than would be expected amongst the general population.

In addition to the FDA data supporting the link, Dr Mehmood Kahn performed a study in Minneapolis shortly after the July, 1997 announcement about valvular disease and found that approximately 25% of the 226 fen-phen users in his study had aortal regurgitation of mild or greater severity, compared with 1% in the 81 patients who did not take the drugs.

On August 27, 1997, acting FDA Commissioner, Dr Michael Friedman was interviewed on PBS and basically blamed the problems on the off-label prescribing explaining that “when these drugs are used in accordance with the labeled instructions, the number of side effects from pulmonary hypertension or from the valve abnormality are extremely rare.”

“When these medications are used outside of those labeled indications,” he advised, “at a higher dosage, for a longer period of time, or in combination with one another, then these side effects are seen more frequently.”

“But we’ve had very few, if any, valve abnormalities in patients who have used the products in an appropriately-labeled fashion,” Dr Friedman said in the interview.

He explained that the label indication “says to use these medications only for a short period of time, some few weeks, and in conjunction with dietary restrictions.”

On September 15, 1997, the FDA called for the removal Pondimin and Redux from the market, based on findings from patients evaluated with echocardiograms to test heart valve functioning. “These findings,” the FDA stated, “indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms.”

The injuries resulting from the fen-phen debacle are reportedly one of the largest number of adverse drug reactions that the FDA has ever dealt with.

Since American Home Products Corporation, which became Wyeth in 2002, withdrew the drugs from the market, a massive number of lawsuits have been filed against the company alleging injuries of valvular heart disease and PPH caused by the drugs.

Heart valve damage is an extremely serious medical condition that is life-threatening. Experts note that there are no medications that can reverse valve damage and valve replacement surgery is often the only option available.

In a healthy heart the valves fit tightly when closed, preventing blood from flowing backwards. But in the hearts of the patients studied at the Mayo Clinic, a waxy substance prevented the valves from closing completely.

Valvular insufficiency occurs when the valves do not close properly, which forces the heart to work harder to circulate the blood and can lead to serious problems such as heart attack or heart failure, according to WebMD.

Valve replacement requires open heart surgery, according to the Texas Heart Institute. The 2 kinds of valves used are mechanical valves made of metal or plastic, and biological valves made from animal tissue or human tissue from a donated heart.

Mechanical valves are stronger but because blood tends to stick to them and create blood clots, patients need to take blood-thinning drugs for the rest of their lives. And because these drugs increase the risk of bleeding, patients must wear a medical alert bracelet so that medical professionals will know they are taking a blood-thinning drug.

Patients with biological valves usually do not have to take blood-thinning medications but because the valves are not as strong as mechanical valves, they may need to be replaced every 10 years.

PPH is also an extremely serious condition that may require a heart-lung transplant. In its simplest form, PPH means high blood pressure in the lungs and the constriction of the vessels makes it harder for the heart to pump blood through the lungs. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

On November 22, 1999, the Philadelphia Inquirer interviewed a woman who was almost entirely housebound and on a waiting list for a double lung transplant. She was connected to oxygen tubes 24 hours a day and had an IV line connected to a pump to deliver drugs into her heart with her at all times. The woman said that as soon as she starts to move she gets weak and likened living with PPH to living on Mount Everest without oxygen.

Redux was FDA approved in April, 1996, even though there were already concerns about PPH. Reports of PPH with the drug had appeared in European literature in the 1980’s and 1990’s.

Two months after its approval, the International Primary Pulmonary Hypertension Study reported that the appetite suppressants (anorectic agents) increased the risk of PPH to between 23 and 46 cases per million, compared to the usual 1-2 cases per million. Redux and Pondimin represented 90% of the anorexigens in the study.

The IPPHS found that “the use of any anorexigen within the previous year was associated with a ten-fold risk of developing PPH, and the risk increased to more than 20-fold with use for longer than three months.”

There have also been reports of neuropsychological damage in fen-phen users that can include memory loss, behavioral changes, depression, psychotic breakdowns, and mood swings. A study reported in the September 1997, Journal of the American Medical Association, indicated that Redux and Pondimin can reduce the production of a key brain-signaling chemical and adversely affect memory, cognition and moods.

Critics say this too was a known risk at the time that Redux was FDA approved. In fact, after its approval, a group of neuroscientists sent a letter to the FDA criticizing the agency for ignoring animal tests that suggested that prolonged use of Redux damaged brain tissue.

In litigation, some plaintiffs are going after the doctors for their off-label prescribing. In a Philadelphia PPH jury trial, a doctor was held liable for half of the $8 million verdict for prescribing fen-phen for the plaintiff between 1995 and 1997.

The woman’s attorney stated that “the claim against [the prescribing doctor] was that he not only prescribed the drug beyond the two weeks recommended by the manufacturer, but he prescribed it for years . . . and he prescribed it until she [the plaintiff] called him and said that she had heard on CNN when she was in Italy touring that there were side effects,” according to Lori Litchman, in the February 24, 2000, Legal Intelligencer.

On the other hand, the drug maker can hardly argue that it was unaware of the widespread off-label use of fen-phen with record profits pouring in from the drugs.

According to one plaintiff’s attorney, Paul Rheingold, in Fen-Phen and Redux: A Tale of Two Drugs, “there is blame enough to go around.”

The doctors who set up store-front fen-phen clinics and prescribed the drugs are obvious culprits, he said, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

A national class action settlement has been reached involving claims for valvular heart disease, but the settlement did not include claims for PPH or neurological damage. Lawsuits with those claims are being tried individually.

Wyeth has reportedly allocated $21 billion to cover the costs and damages of fen-phen litigation.

Filed under: 2007, fen-phen, PPHN, Wyeth

Fen-Phen May Cause Rummage Sale of Wyeth Assets

Evelyn Pringle August 23, 2006

On August 18, 2006, Bloomberg News reported that Wyeth has faced more than 175,000 claims since fen-phen was removed from the market, and that over the past 9 years, the company has settled many claims without forcing fen-phen users to file a lawsuit.

All total, the company has set aside more than $21 billion to cover legal costs and settlements since the diet drugs were withdrawn, according to Reuters News on May 24, 2006. As for how long Wyeth can stay afloat under the tidal wave of fen-phen lawsuits, financial experts say the answer could boil down to insurance coverage.

If this is true, the future looks bleak for Wyeth shareholders because according to, “The $22 Billion Gold Rush,” by Robert Lenzner & Michael Maiello, on Forbes.com on April 10, 2006:

“Insurance covered only $400 million of the damage costs, forcing Wyeth to fund the rest by selling $8 billion in assets and giving up a merger with Warner-Lambert to get a $2 billion kill fee; it warns it may have to sell more assets to fund still more claims.”

Well then maybe its time for Wyeth to put up signs for a rummage sale because on August 10, 2006, in the most recent fen-phen trial, a jury in a Philadelphia returned a $300,000 verdict in favor of 41-year-old, Jodi Wier, after deliberating only 6 hours. Ms Wier took fen-phen for about three months starting in October 1996, and was diagnosed with primary pulmonary hypertension 5 years later.

“She has an incurable disease and has to be treated for the rest of her life,” her attorney, Edward Freidberg, told the jury in closing arguments.

The lawsuit was filed in 2004 by attorney, Theodore Holt, of the California firm of Hackard & Holt, and was the first fen-phen-related PPH case to go to trial in Philadelphia. In a July 27, 2006, press release at the onset of the trial, Mr Holt, stated that “PPH is a serious incurable disease that can take years to develop.”

“We suspect,” he said, “there are still many undiagnosed victims and that PPH litigation will continue well into the future.”

In the fall of 1997, American Home Products Corporation (renamed Wyeth in 2002), withdrew the diet drugs Pondimin and Redux, which in many cases were being prescribed together with phentermine, in the combination commonly referred to as “fen-phen.”

“Fen” is short for fenfluramine, marketed as Pondimin, since it gained FDA approval in 1973, and its chemical cousin, dexfenfluramine, marketed as Redux, since it was approved in 1996.

“Phen” is short for phentermine, which is marketed under various trade names such as Ionamin and Fastin, as well as several generic forms.

According to the FDA, phentermine and fenfluramine were approved to be used as separate appetite suppressants for short periods of time of a few weeks in the management of obesity.

Nonetheless, doctors prescribed the drugs together and for extended periods of time in what the FDA referred to as “off label” use because there have been no studies submitted to the FDA to demonstrate the effectiveness or safety of the drugs taken together or for longer than a few weeks.

It is estimated that more than 6 million people took fen-phen and Pondimin and Redux became two of the most widely prescribed drugs in the US. In 1996 alone, their sales totaled over 20 million prescriptions.

Things began to head downhill for Wyeth in July 1997, when researchers at the Mayo Clinic reported 24 cases of a rare valvular disease in women who took fen-phen. On July 8, 1997, the FDA issued a Public Health Advisory describing the Mayo findings.

The FDA also revealed that it had received additional reports of the same kind, and requested that all health care professionals report any similar cases through MedWatch or the respective drug makers. Subsequently, the FDA received 66 additional reports.

The findings of the Mayo Clinic were also reported in the August 28, 1997, New England Journal of Medicine, along with an FDA letter to the editor describing additional known cases of valve disease.

At that point, the FDA asked Wyeth to stress the risk to the heart in the drugs’ labeling and package inserts. But on September 15, 1997, citing new evidence about significant side-effects, the FDA asked the company to remove both Pondimin and Redux, from the market. The action, it said, was based on findings by doctors who had evaluated patients taking the drugs with echocardiograms, a procedure that can test the functioning of heart valves.

“These findings,” the FDA stated, “indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms.”

“The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine,” the agency warned, “present an unacceptable risk at this time to patients who take them.”

These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA’s two earlier warnings concerning fen-phen, the agency advised.

The reports of cases of heart valve disease in patients taking Pondimin or Redux alone prompted the FDA to advise patients using either of the drugs to stop taking them and contact their doctors to discuss treatment.

“These findings call for prompt action,” said Michael Friedman, MD, the Lead Deputy Commissioner of the FDA at the time.

However, internal FDA documents have since surfaced in litigation that shows the FDA could have acted much sooner. As it turns out, a doctor from Fargo, North Dakota sent the FDA reports of valve damage associated with the diet drugs in February and March of 1997, and when he got no response, the doctor called the FDA in May of 1997, and had his assistant fax 25 reports to the official he spoke with.

But the official who received the information, did not alert her superiors and in fact, did nothing about the situation for a month, until she mentioned in a routine report that there was a doctor in Fargo who discovered problems with the drugs that should be tracked.

In describing valvular disease, the FDA’s web site states: “There are four major valves controlling the flow of blood into, out of, and between the four chambers of the heart.”

“Several disease processes,” it explains, “including infection and toxicity, may damage the valves, causing them to malfunction, and may produce severe heart and/or lung disease.”

Symptoms of the condition can include shortness of breath, swelling in the legs, chest pain and heart palpitations.

In some cases, the FDA says, medication can control heart failure associated with valvular damage but in others, surgery may be necessary to replace the valves with artificial valves.

Mass litigation followed the removal of the drugs from the market and continued as more studies confirmed their association with valve damage. By 1999, Wyeth faced nearly 20,000 personal injury lawsuits in state and federal courts, and more than 100 putative class actions, with some moving quickly toward certification.

The injuries alleged by plaintiffs included: heart valve regurgitation, valvular heart disease, or an increased risk of developing these conditions.

The plaintiffs claimed that Wyeth not only failed to do the testing that would have revealed the dangers of the drugs but that the company was fully aware that the fen-phen cocktail was being prescribed and sought to profit from the pairing of the two drugs. One complaint states:

“As a result of Defendants’ promotions, there was an enormous increase in sales revenues and profits for Defendants, their affiliates, and other commercial entities involved in the manufacturing and distribution chains of these anorectic pharmaceuticals.”

The complaint also alleges that Wyeth’s gross sales of Pondimin in the US increased from $3.7 million in 1993 to $150 million in 1996.

The lawsuit charges that the defendants knew that there were at least 41 reports of PPH associated with fenfluramine by the spring of 1994, and knew that the drug’s label describing only four cases of PPH was false and misleading and that they intentionally concealed information, “in order to maximize sales and profits of Pondimin.”

By 1996, the complaint says, defendants knew of at least 71 cases of PPH, including twelve deaths, while the Pondimin PDR entry continued to falsely state that there had been only four PPH cases, and only one case was fatal.

The complaint also alleges that the defendants deliberately decided not to submit proposed labeling changes to the FDA about the risk of PPH with Pondimin, to avoid any negative impact on the New Drug Application for Redux, pending before the FDA in 1995-96.

Defendants knew, it says, that PPH risks associated with Pondimin were relevant to the FDA’s consideration of Redux because both drugs had the same active ingredient.

On December 10, 1997, the Judicial Panel on Multidistrict Litigation transferred all federal fen-phen lawsuits to the US District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings before the Honorable Louis Bechtle, Chief Judge Emeritus, and upon his retirement, on June 29, 2001, the litigation was reassigned to Judge Harvey Bartle III.

The first two fen-phen cases to go to trial turned out to be a disasters for Wyeth. One settled after several plaintiffs in Mississippi won over $100 million in compensatory damages and a Texas case resulted in a verdict that included high punitive damages.

On August 7, 1999, a Texas jury awarded 36-year-old Debbie Stone Lovett, $23 million. Legal experts said the verdict was significant being Wyeth tried the case believing that the facts were their favor. The case was reportedly settled during an appeal for $2.2 million.

In another 1999 trial in Oregon, Wyeth lost a $29.2 million verdict that eventually was settled for $15.5 million. In this case, Mary Linnen, took fen-phen for just 23 days before developing PPH.

A few months after she was diagnosed, Ms Linnen had to undergo surgery to insert a tube in her heart, so that she could inject a medication into her heart several times a day. Less than 3 months later she died and her family filed the first fen-phen wrongful death lawsuit against the company.

Legal experts say Wyeth was so alarmed over the large punitive damage awards that it was desperate to find a way to set a limit on what fen-phen litigation would cost the company.

Wyeth believed that a class action could alleviate the threat of enormous punitive damage awards providing that only a small number of patients decided to opt out of the class. Under the rules, people who rejected the class action outright could sue for punitive damages, but victims who did not opt out at the first stage, would be barred from seeking punitive damages if they later decided to sue Wyeth.

The company offered the plaintiffs a good reason to remain in the class by conceding causation so that class members who stayed would not have to prove that Pondimin or Redux caused their heart valve damage, only that they had valve damage after taking the drugs.

Wyeth also offered generous compensation to class members. At the high end of the payment schedule, plaintiffs with valve damage so severe that they had strokes, heart transplants or died could receive upwards of $1.3 million.

The low end of the schedule was about $7,500 for claimants whose medical testing showed evidence of significant valve damage but no other indication of serious heart disease.

To cover its end of the deal, Wyeth agreed to ante up $2.55 billion for claimants who qualified for the larger payments, and another $1 billion for the smaller cash benefits and medical services for people with less severe heart damage.

On May 2, 2000, the US District Court in Pennsylvania held a hearing to determine whether the proposed Settlement Agreement was fair, adequate, and reasonable and held another hearing on August 10, 2000, to hear evidence on the fairness of changes contained in the Agreement.

On August 28, 2000, Judge Bechtle issued Memorandum and Pretrial Order approving the Agreement and the four amendments. A Settlement Trust was established on September 1, 2000, to administer the provisions of the Agreement, and to process the claims of class members.

In the end, Wyeth put up $3.75 billion to manage the litigation and was forced to add another $1.3 billion to the pot in 2004.

However, before the ink even had a chance to dry on the class action agreement, a new nightmare began for Wyeth when about 50,000 victims decided to opt out. The prospect of 50,000 punitive damage awards was an extremely frightening thought for Wyeth, given the results of the jury trials in 1999.

Legal experts say this looming threat prompted Wyeth to attempt settle the opt out cases as quickly as possible for whatever amount necessary and when the word got out, the whole mess quickly turned into a feeding frenzy for litigants.

Experts say news about previous large settlements may have prompted many victims to opt out. For instance, on July 22, 1999, the Dallas Morning News reported a case where the company paid more than $3 million to settle a lawsuit with a 70-year-old Texas woman. The agreement, the newspaper said, was at least the 12th settlement involving former fen-phen users, but was the first in a Dallas County court case.

A month before the $3 million settlement was reported, the article said, the company agreed to pay between $6 and $7 million to settle a case in Harris County, Texas that linked a woman’s death to fen-phen.

Adding to the risk of trying cases before a jury, is the fact that more documents keep surfacing that prove useful in court. For instance, an internal FDA e-mail dated about a year before the agency issued the fen-phen advisory, written by former FDA reviewer, Leo Lutwak, to a colleague says the serious side effects linked to fen phen and the drugs’ marginal benefits “should be brought out.”

“The company has gotten away with much manipulation these past 3 years, of the public, of the press, of the FDA,” Mr Lutwak wrote. “I started getting upset about this drug in ’93 or ’94 and was running into a lot of blocks from the FDA and from the drug company,” he said.

Although other injuries associated with fen-phen include PPH and neuropsychological damage, only persons with heart valve damage are allowed to participate in a national class action settlement.

Persons suffering from neuropsychological damage that can include depression, mood swings, memory loss, behavioral changes, and psychotic breakdowns, must sue separately.

According to the FDA, PPH has been reported to occur in about 1 in 25,000 people using the appetite suppressants for more than 3 months. Close to half of all PPH cases result in death. The Pulmonary Hypertension Association defines the condition as:

“Pulmonary hypertension (“PH”) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening.

“Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting.

“When pulmonary hypertension occurs in the absence of a known cause, it is referred to as primary pulmonary hypertension (PPH). This term should not be construed to mean that because it has a single name it is a single disease. There are likely many unknown causes of PPH. PPH is extremely rare, occurring in about two persons per million population per year.”

“This disorder,” the FDA web site says, “results in death in about 40% of affected individuals within 4 years.”

Studies released in November 2001 suggest that the occurrence of PPH may be 7 times higher than anticipated in 1997, when the diet drug were removed from the market.

According to the FDA, the disorder can also occur in association with valvular heart disease, but the class action settlement still does not apply even in those cases. However, this ruling may turn out to be the nail in the coffin for Wyeth.

On April 27, 2004, a Texas jury awarded over $1 billion to the family members of a woman who died of PPH after taking fen-phen for about two years. The verdict included $113.4 million in compensatory damages, and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report filed with the SEC. The case was later settled for an undisclosed amount.

As of July 24, 2006, Wyeth told shareholders in its latest SEC filing, the company is listed as a defendant in 103 lawsuits that allege a claim of PPH, alone or with other injuries, and in approximately two additional lawsuits pleaded as valvular regurgitation cases, the plaintiff’s attorneys have advised the company that the plaintiffs will allege a claim of PPH.

Back in February 2006, at the Merrill Lynch health-care conference in New York, Kenneth Martin, chief financial officer of Wyeth, said he was hopeful that the remaining lawsuits may be “wrapped up” within 12 to 24 months.

However, according to Fen-Phen e-Resource, Natexis Bleichroeder analyst, Jon LeCroy, said Wyeth may be able to eliminate “the bulk” of the cases within the next 24 months, but predicted it will take at least 4 more years to eliminate cases involving serious heart-valve damage and cases involving fen-phen users who developed PPH.

“So we are assuming Wyeth will need to take another $4 billion in fen-phen charges through 2010,” Mr LeCroy said.

Jury selection for the next state court trial is set to begin on September 1, 2006, in a PPH case brought by Beverly “Kim” Tilmon of Palestine, Texas, seeking a combined total of $180 million in compensatory and punitive damages, according to the June 15, 2006 Palestine Herald.

Ms Tilmon alleges she developed PPH, after taking fen-phen for four months in 1997. This case ended in a mistrial on January 31, 2006, when Texas Judge, Jim Parsons, ruled that defense attorneys “exceeded the boundaries” during opening statements.

Filed under: 2006, fen-phen, PPHN, settlement, Wyeth

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