Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phenby Alicia Mundy
Semi-finalist for the Robert F. Kennedy Memorial Book Award
In 1996, a terrible epidemic began killing young American women. Some died quickly, literally dropping in their steps. Others took more time, from a few months to a few years. Those who weren't killed suffered damage to their lungs and hearts, much of it permanent and reparable only with/b>… See more details below
Semi-finalist for the Robert F. Kennedy Memorial Book Award
In 1996, a terrible epidemic began killing young American women. Some died quickly, literally dropping in their steps. Others took more time, from a few months to a few years. Those who weren't killed suffered damage to their lungs and hearts, much of it permanent and reparable only with major surgery. Doctors suspected what the killer was. So did the Food and Drug Administration. The culprits were the two most popular diet drugs in the United States, Pondimin, one-half of the popular drug combination Fen-Phen, and Redux, a stronger version of Pondimin. They were also two of the most profitable drugs on the market, and both were produced and sold by a powerful pharmaceutical company, Wyeth-Ayerst, a division of American Home Products.
Dispensing the Truth is the gripping storry of what the drug really knew about its drugs, the ways it kept this information from the public, doctors, and FDA, and the massive legal battles that ensued as victims and their attorneys searched for the truth behind the debacle.
It tells the story of a healthy young woman, Mary Linnen, who took the drugs for only twenty-three days to lose weight before her wedding, and then died in the arms of her fiance a few months later. Hers was the first wrongful-death suit filed amd would become the most important single suit the company would ever face.
Alicia Mundy provides a shocking and thoroughly riveting narrative. It is a stark look at the consequences of greed and a cautionary tale for the future.
"[A] sad, infuriating and important tale . . . [Mundy's] mastery of the massive scandal's legal, political and regulatory issues is impressive, her documentation comprehensive. [S]he has produced an exemplary piece of reportage on an appalling and utterly needless catastrophe."—The Washington Post
"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."—Sam Donaldson, Chief White House Correspondent for ABC News and co-anchor of This Week with Sam Donaldson and Cokie Roberts
"Absorbing . . . a read that will have you gritting your teeth."—Time
"The subject of this fascinating book is the first wrongful death suit brought against a diet drug, Fen-Phen, an event that Mundy sets in the context of drug companies' greed, publicity spinning, and power over the Food and Drug Administration. Mundy comprehensively and often grippingly details the plaintiffs' attorneys' search for facts, which ultimately accumulated millions of documents; their many depositions; their work on determining trial procedures; their practicing before mock courts that included 'jurors' selected to give feedback; and then the trial itself. "—William Beatty, Booklist
"[Mundy] admirably recounts the fen-phen fiasco of the late 1990s . . . [She] has crafted a compelling morality tale out of this huge medical and regulatory disaster."—Elle
"Dispensing with the Truth has Hollywood movie written all over it . . . Think Erin Brockovich or A Civil Action—a courtroom drama pitting presumably powerless human beings against greedy corporations."—Salon.com
"[A] medical thriller that profiles unsuspecting victims while indicting the Food and Drug Administration and pharmaceutical giant Wyeth-Ayerst Laboratories."—New York Daily News
"As Capitol Hill thrashes out the limits of a patient's right to sue health care providers, all involved should make Mundy's [book] a frequently consulted reference . . . [The book] chronicles, with passion and precision, the sequence of events that led to the Fen-Phen weight-loss drug disaster that left thousands of women dead or crippled by heart disease."—The National Journal
"Mundy's scorched-earth reporting and high-energy writing build a story that leave A Civil Action in the dust."—Ellen Goodman, The Boston Globe
"Mundy's book reads like a medical thriller . . . A readable and moving narrative."—Publishers Weekly (starred review)
"Investigative reporting at its best . . . will keep readers on the edge of their seats."—Arizona Daily Star
"This true-to-life courtroom drama reads like an edge-of-the-seat novel. It tops A Civil Action."—Barry Reed, bestselling author of The Verdict and The Deception
"Dispensing with the Truth has a huge, gratifying asset: it is so readable a story, told with such zest and saucy verve, that once you start reading, you'll be hard-pressed to stop. Remember, I warned you!"—Jack Valenti, chairman and CEO of the Motion Picture Association
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Read an Excerpt
Crusaders, Cowboys, and Cannibals
Can I look forward to my waning years signing checks for fat people who are a little afraid of some silly lung problem … ?—E-mail from a Wyeth-Ayerst administrator, Kay Anderson, to Dr. Patty
Acri, product labeling director, October 3, 1996
1Alex MacDonald had just escaped from the crowded parking lot at the Garden in Boston, where several thousand children had been screaming happily at “Disney on Ice,” when his cell phone rang. He wasn’t going to answer it.At that moment, he and his youngest daughter, Emma, were doing Daddy Time, giggling over the spectacle of Mickey and Goofy and Beauty and the Beast on skates, twirling to canned music under a hundred pounds of sequins. Alex was searching the night for snowflakes for Emma. Alex’s wife, Maureen, had their oldest girl, Nora, back at the house waiting with hot chocolate. “This’ll just take a minute,” he promised solemnly as he pressed the answer button.It was his partner, Steve Rotman. “Mary Linnen just died.”“What?” Alex briefly lost control of his Toyota Celica.“She died this afternoon,” Rotman explained. “Her father wants you to call him.”“Wait, wait,” said Alex, steering the car toward the Cambridge exit. “You must have heard him wrong. She just got out of the hospital today,” he sputtered. “I just talked with her two days ago.” And then he remembered what she told him when she called, nearly hysterical. She had foreseen her own death.As Alex turned into the driveway of his yellow clapboard home off Storrow Drive, one of Cambridge’s tony addresses, it hit him. He had never lost a client like Mary Linnen. He did divorces—calamitous, horrible ones where people certainly were injured, but nobody ever died in them. This was so, well, unfathomable. Doctors lose clients—lawyers don’t lose clients.Dialing into his office phone, Alex heard the broken voice of Thomas Linnen on his voice mail. “Alex, Mary died today.”Maureen poured Alex a drink after she put the girls to bed. He was in shock. “I thought she was getting better,” he said, starting to cry. “They said she was stabilizing.”Maureen sighed. “You know,” she explained quietly, “this is what I was trying to warn you about. Doctors can only do so much with this. Mary was in bad shape.”Maureen Strafford was a well-known cardiology anesthesiologist specializing in pediatric cases. A former med student at Boston U., she had worked alongside prominent doctors from Harvard and Yale. She’d been Alex’s sounding board on Mary’s case from the first day.When Alex was initially visited by Mary Linnen’s father, he told his wife that night about the new client with “pulmonary something.”“Pulmonary hypertension?” Maureen asked. “Oh, my God, did she take those diet drugs? Alex, she’s going to die.”But no matter how many times Maureen had said, “Alex, with severe pulmonary hypertension, they all die,” he hadn’t believed her.Maureen was well versed in lung disease problems and Fen-Phen. In fact, she had interned at Columbia with a woman who was now a leading cardiologist, Dr. Robyn Barst. Maureen had warned Alex: Once they’re on the pump—the Flolan contraption—it’s usually just a matter of “when.”After calling Mary’s distraught mother and angry father, numbly expressing sympathy, Alex sat down on the sofa and just looked at Maureen. “She was so scared of dying,” he said. Maureen nodded, “You told me.”2Lawyers always say, like some cheap cliché, that some particular client or case changed their life. After the Linnen case, Alex didn’t hesitate to say it to anyone who asked, remembering the oddity of the Disney’s sequined Alice in Wonderland skating that night, and the rabbit hole he fell down hours later. The Linnen lawsuit that followed thrust him into the strange, warring world of tort litigation on a scale neither he—nor, for that matter, anyone else—had ever seen.Not that he hadn’t yet tasted blood in massive corporate cases. As a rising star, Alex MacDonald was already the label on a file at the Boston Globe. He’d nailed five doctors at a local hospital—a major coup in Boston—in a malpractice case, at the time the largest wrongful death settlement in Massachusetts history.Not bad for a kid from Boston’s backwater. In fact, Alex was just a couple of miles short of being a Southie, like the kid in Good Will Hunting. He was working class, a blue-collar boy from Dorchester, an immigrant division that hadn’t seen much action since Moby Dick was a guppie. His father, a farmer from Nova Scotia, and his mother, an immigrant from Prince Edward Island, had met and married in Boston in 1940. His dad became a union organizer, his mom a domestic, and between them, there were only five years of formal elementary education. Their hopes that Alex would become the first in the family ever to get to college wavered when they saw him spending so much time as a teenager playing guitar in a recroom rock band that called themselves, appropriately, The Poor Boys. They didn’t comprehend fully the allure that “performing” had on their son.But talk was really Alex’s forte, and the young debater won a scholarship to Boston University. It was a joyous day in the MacDonald household when Alex was accepted at Harvard Law School; it was also a terrifying one, since nobody knew how he’d pay for it. A restricted scholarship footed part of his bill, and he worked after classes at a local mental hospital. It looked like he’d have to stretch out his last year—maybe drop out and come back, when a teacher pointed him to the book of bequests at Widner Library. It was a huge tome, dedicated mostly to the scions of Yale, Harvard, and Beacon Hill, and took hours to check. But there, on the second-to-last page, Alex found the “William Stoughton Bequest,” a 250-year-old grant solely for students from the towns of Dorchester or Milton.It was 1976, the Bicentennial Year, when he graduated, and then almost blew his chance for a job. “I wanted to do public defense work,” he said, unintentionally evoking the tradition of the “Catholic guilt career choice.” You’ve made it, now go save the world.The group of Harvard grads willing to go into legal services was quite short. Harvard may have been a hotbed of idealism in the ’60s, but these students weren’t stupid. While he watched his classmates land at swank firms in Boston, New York, Philadelphia, and Chicago, Alex was pushing for a $10,000-per-year cubicle in a public defenders’ office. Philadelphia Legal Services finally came through, about the moment that Alex’s instinct for survival kicked in. It was all well and good to want to do good. But if he couldn’t make a living, he’d never get that chance. He was about to leave for Philly when he recalled, “I looked in the mirror and said, ‘What the hell am I doing?’”He rushed to the placement office and grabbed one of the few jobs left, a firm of old blue bloods, Hemenway & Barnes. Old Alfred Hemenway had been a pal of President William McKinley.For the next five years, Alex was doing stale corporate litigation and divorce work for the rich and regrettable when he was called by a senior partner who asked him to clean up a minor matter involving their clients the Cabots, one of Boston’s First Families. Alex had been weaned on tales of the local leftovers from the Mayflower, the Lodges and the Cabots. The saying goes: The Lodges speak only to Cabots, and the Cabots speak only to God.The young caretaker on the Cabot estate, living in the carriage house, had gone to check the hot water heater, which exploded in his face. At the sound of the blast, his wife, eight months pregnant, rushed to the top of the stairs to the basement just in time to see her husband engulfed in flames. The Cabots wanted a personal injury lawyer to sue the hot-water-heater maker. Perhaps young Alex, a member of the old family retainer firm, could suggest a PI attorney to whom to refer the case.In 1981 in Boston, personal injury law was considered the proctology of the profession. Alex would be doing his firm a favor by disposing of the matter and keeping Hemenway & Barnes away from the sordid nonsense. But after interviewing the fire marshal, Alex was intrigued—the fireman indicated that the heater was definitely the culprit. Divorce and real estate work were leaving Alex stale, and this sounded different. It sounded like a real case where there were two sides and they fought each other, instead of gently negotiating into paralysis. He asked the senior partner to let him do the job.The heater, Alex learned, had been the subject of an ad in Parade magazine from the Consumer Product Safety Commission and had been involved in more than ninety other accidents. Conveniently for Alex, its maker had deep pockets.Alex went to visit the caretaker, who was holding down a bed in one wing of a local hospital while his wife, in labor, was a patient in another. In his mid-twenties, the caretaker, like Alex, had a sideline in a local rock group, and Alex told him: “I’m gonna make two predictions: You’re gonna be wealthier than you’ve ever dreamed. And your band will play at my wedding.”From his earliest days, Alex had been bulging with braggadocio. It was one of his methods to shore up confidence in himself—by backing himself into a corner, he had to deliver. He made it part of his game in major cases, bragging up front to the other side to screw with their minds.But in this case, he was trying to reassure the young caretaker, who was certain he’d die right there in the hospital, a pauper with a new baby. Fortunately for both men, both boasts came true. The large firm representing the heater’s manufacturers found itself besieged by weekly requests for documents and depositions; in August 1983 they paid a settlement almost twice what Alex had originally anticipated.Alex had been dating Maureen Strafford, a young doctor in New York with a wild laugh whom he’d met at a local wedding on Memorial Day weekend in 1980. He’d promised to call, and he did—a full twelve months later, on Memorial Day weekend. Maureen had just joined the staff at Columbia-Presbyterian Hospital as a new pediatric cardiologist and was not returning to Boston anytime soon. Come visit New York, she suggested. Alex shivered. “New York? That’s like going to the moon.”But he went anyway, unable to resist (he would tell their children later) her bold red hair, her brazen humor, her watered-blue eyes, and “her sexiest organ—her brain.” Two months after the Cabot caretaker case settled, the huge bonus for Alex provided a lavish wedding for 250 guests. The caretaker and his band, and a DJ, were joined onstage by Alex during the evening. It was the only time in its 150-year history that the elitist Harvard Club on Commonwealth Avenue received complaints from its Back Bay neighbors about the insufferable noise.Alex had switched firms in 1983 to Harrison & Maguire, which handled mostly large real estate litigation. But he couldn’t stay away from medical suits, and he’d soon taken on a client, Vincent Napolitano, who was president of Gould’s Pump Company, a New York corporation on the Fortune 500. It would become the largest wrongful death recovery case in Massachusetts.Napolitano—had Alex had a chance to know him—was Alex’s kind of guy. A blue-collar baby from New York’s backside, he’d gone to the top but never forgot being on the bottom. The multimillionaire was loved in the community and among his workers—once he sent an employee’s little boy on his corporate jet down south for leukemia treatments.One night in August 1984, at a restaurant, Napolitano got indigestion and became the victim of ambulance roulette. The emergency med techs would not take patients through the Sumner Tunnel to the closest major hosptial, and instead took him to a local clinic in Winthrop. Napolitano suffered an allergic reaction to the anesthesia administered during a minor procedure to open up his breathing tube. He died on the operating table, one day short of his fifty-fourth birthday.It was during the Napolitano case that Alex discovered the most important member of his legal team: his wife. Alex brought the medical records home one night and Maureen grabbed them—anesthesiology was her residency specialty, and she told Alex, “I know what he died from.” Maureen’s own mentor reviewed the files and told Alex, “Congratulations. This is the worst case of medical malpractice I’ve ever seen.” Over the next five years, Maureen was Alex’s medical tutor before all his depositions. Once, a defense attorney took Alex aside and confided his firm’s amazement at Alex’s ability to ask and understand a lengthy series of complicated medical questions. Alex told the lawyer, “The secret is, I’m Howdy Doody.” He explained that Maureen, his doctor wife, was like Buffalo Bob, pulling all the strings. “No one sees her lips move when I talk.”Napolitano, Alex figured, was the kind of man who deserved all the drama Alex could provide. “All trial attorneys are frustrated actors,” Alex conceded, and he was Shakespearean in his frustration. But he was also an ersatz director. Preparing for one deposition, Alex had a camera crew film the operating room as it was set up when Napolitano died. There was only silence as the camera slowly panned around to the doors, and then up an adjoining wall where hung two hundred vials of the antidote that could have saved Napolitano, if only the doctor had known what he was doing. The case settled in 1989, before the jury was impaneled, for roughly $4.6 million—a first, and an unheard-of award within Boston’s temple of medicine.In 1993, Harrison & Maguire merged with Robinson & Cole, one of the most prominent legal organizations in New England, the firm that Samuel Clemens—Mark Twain had used for literary and legal issues. With almost two hundred lawyers and offices in Connecticut and New York, it was the epitome of a staid, upper-crust firm to which Harvard students aspire. The new firm’s Massachusetts offices took up the twenty-fifth and twenty-sixth floors at One Boston Place, around the corner from the Revolutionary-era Old Christ Church, where they can be glimpsed in “B” shots of The Practice and Ally McBeal. Once again, a band of blue bloods found themselves harboring a closet medical malpractice maven, wandering incognito in the fields of the Lord.It was the perfect life. Alex and Maureen moved into a historical Adams colonial house in Cambridge that had been the home of Helen Keller and her teacher Annie Sullivan when Keller attended Radcliffe. They bought a place on the Vineyard, in Chilmark, where the elite turn “summer” into a verb. His neighbors in Cambridge and on the Vineyard included Nobel scientists, the literati, actors, politicians, and the demigod of the law, Alan Dershowitz. Alex had taken a course once from the master—now he and Dershowitz were drinking buddies; well, if drinking includes Cabernet tastings. Dershowitz had even accepted suggestions from Alex for one of his novels, and afterwards, readers of The Advocate’s Devil found a character named Alex O’Donnell from the mean streets of Dorchester.Mornings were father-daughter time, as Alex fed and dressed their two blond little girls while Maureen was in surgery at the hospital. Maureen’s practice grew and she continued teaching, her favorite aspect of the job. Alex spent off hours toying with an unfinished novel. “I’m gonna overtake Alan [Dershowitz],” he joked. “If he can sell fiction, so can I.”Alex enjoyed tweaking his Brooks Brothers colleagues and the opposition by continuing to sport the lengthy locks he had cultivated in college. Blondish brown and parted in the middle, with his thick mustache and long goatee trimmed to a point, they made Alex resemble one of those portraits of Jesus seen on the living-room walls of the rough Catholic neighborhood where he’d grown up. Hairstyle as statement, one way of saying that despite his current plush lifestyle, the idealist had not sold out.You could look down on the Charles River from Alex’s expansive office windows. His walls were cluttered with photos of himself with Dershowitz in Paris and with famous politicians, including Bill Clinton. There was a separate photo of him with Hillary Clinton, obviously lecturing her on the fine points of the law. He’d become moderately famous, and his ego had grown along with his girth, though the ego, it should be noted, was definitely in the lead. One of the photos showed him singing into a mike with a Vineyard neighbor—Carly Simon. The caption read, “You’re So Vain.”It fell to Maureen to let the air out of Alex’s balloon occasionally. She was, Dershowitz laughed, Alex’s perfect foil. When his ego ran rampant, she would put up a speed bump. If he got too pedantic at cocktail parties, she’d come up behind him, prod his side, and tweak him verbally. And she would not let him forget why he had become a lawyer.“Alex loves the fight, the good guys against the bad guys,” she explained, adding that she blamed “too many Saturdays with his brother at the movies watching westerns.” Alex just wanted a fast horse, a big gun, and a white hat. “He loves being on the ‘right’ side in a case,” she said. The Napolitano case—he was frenzied, she said. He was so upset that these people had done something so wrong. “He has to have that kind of case to keep going,” she laughed, “and then you can’t stop him.”But he hadn’t had that kind of case in several years, and he was edging perilously close to complacency, which Catholic guilt abjures.Then the Linnens walked into his office in November 1996.At the time, they thought all they needed was someone to help get Mary on worker’s comp to defray her medical costs. Mary signed the contract with Robinson & Cole and introduced herself to Alex by phone. But about a week later, Mary was back in the hospital and scheduled for surgery and the insertion of the heart catheter. She was much sicker than they had realized. In a call to Alex, Mary whispered urgently, “Do everything you can to get these drugs off the market.” That might be a little difficult, Alex thought, with hundreds of millions of dollars at stake for the pharmaceuticals. But what the hell. “Yes, I will,” he promised.But before he faced the pharmaceuticals, he’d have to face his own partners. The case would need fronting, big money to support any litigation before the verdict. In the Cabot caretaker case, the old-line firm found it distasteful to write a check for $5,000 to cover costs. Alex wondered what Robinson & Cole was going to do when he asked for $450,000 up front for experts and depositions for the Linnen case.Luckily, Robinson & Cole was flush with capital. It gave Alex what he had always wanted—the power of an old-line law firm with the resources of a megalithic corporation—enough to go toe-to-toe with any major defendant and its phalanx of retainer lawyers. “This is what I can give you,” Alex said to the Linnens. Of course, he didn’t anticipate that he’d need to call on those resources so soon.3There was much to do the morning after Mary’s death, and after a sleepless night, Alex could not focus. But after calling his partners, he zeroed in on the most urgent need: an autopsy. He hadn’t planned for one, but Maureen had several suggestions for the pathologist. An autopsy would be one of the key pieces of evidence in a wrongful death suit, and this one had to be perfect—he’d known Mary, laughed with her, let her cry to him. An autopsy would show how she died, suffocating, and might indicate why.He was kicking himself. Instead of showing how she died, he should have taped Mary herself, showing how she lived. He should have brought in the camcorder and done a “day in the life” tape, following her as she washed her tube, measured medicine with her failing eyesight, tried to insert a tube without spurting blood on herself and the furniture, and how she had to rest constantly, her hands and feet bloated up to the size of giant pillows. That’s what he should have done, dammit. Now it was too late.Mary Linnen’s cardiologist had said that PPH survival rates were about four years and Mary had developed the disease the previous summer. Alex assumed that meant she had two or three years left. He shouldn’t have assumed anything, he swore silently.But he’d make it up to her. Luck, in such short supply in Mary’s life, came through after Mary’s death. The family, which recognized the importance of an autopsy, had been prepared to pay for one that they could use in court. Still, a contracted autopsy would carry some bias—like a paid expert.The night Mary died, because of local medical interest in rising numbers of PPH cases, the Massachusetts coroner’s office became involved. They arranged the postmortem, and they drew on one of the most prominent medical examiners in the field. In essence, they were giving their stamp to a critical review that determined Mary Linnen had died of pulmonary hypertension—caused by the ingestion of diet drugs.All funerals are hell, but the tragic scene at St. Paul’s Cemetery in Hingham was the most devastating Alex had attended. Perhaps it was the terrible irony that she’d just been released from the hospital, thinking she was doing better. Her mother and father, in their early seventies, looked much older. They seemed dazed as they accompanied the casket down the aisle at the church—but Mary Jo stopped long enough to hug Alex and Steve Rotman standing at the back. Mary’s sister Nancy, who had cared for her in her last months, was nearly inconsolable and guilt-ridden; she had been in California when Mary died, having been assured by Mary, “I’ll be fine. Go on.”And Tom Caruso. He’d been crying at the wake, and by the morning of the funeral his eyes were almost too puffy to open. At the gravesite, he grabbed Alex, holding on as if for his own life; that was when Alex smelled the alcohol on Tom’s breath. Oh, God, Alex said to Maureen afterwards. I think Tom fell off the wagon, and now he’s falling down a deep, deep well.After the EMS left with Mary’s body, Tom went on a bender that lasted twenty-four hours. He’d been calling Mary’s doctors, crying, yelling, blaming, begging to die with her. Dr. Michael Landzberg had taken one of the calls and immediately telephoned a colleague who was a psychologist, trying to link him up quickly with Tom. He was concerned that Tom was so unstable at this point that he might hurt himself. But Tom didn’t take any help and went instead back to his old friend, liquor. Within days, he’d been in a car wreck and charged with driving while intoxicated.It wasn’t hard for Alex to collar a friend to take Tom’s case, but the hard part was telling Tom what would come next. Because of his juvenile record and previous DUI history, there was no way he’d avoid jail. Mary was barely in her grave when Tom called Connie Lovejoy and told her he was going away. “Come and get Dustin,” he asked her, crying loudly into the phone that he had let Mary down.The catastrophe with Tom, coming on the heels of Mary’s sudden death, presented another problem for Alex, who hadn’t even filed his suit yet. Tom would be the witness to Mary’s terrible death—and he was in prison. How would that look to a jury?The situation hit both Alex and the Linnens like the second half of a one-two punch. The final insult was the belated letter that came for Mary from the Social Security Administration, denying her disability claim and urging her to find work as a telephone solicitor. The parents quickly finished packing up their old home and moved to Florida. Alex was left with a simple standing order from Mr. Linnen: “Try this case.”Back in his offices, Alex began assembling a team to take on Wyeth-Ayerst, a division of American Home Products, the makers of Robitussin and Advil, and one of the largest pharmaceuticals in the world. But a more daunting prospect was taking on some of the elite members of the very prestigious, very closed medical community in Alex’s backyard.Two such members had already popped up in the Linnen case. One was Dr. George Blackburn, of Deaconess Hospital, part of Harvard Medical School. Blackburn was considered one of the leaders in the obesity field and a member of the board, so to speak, of what one could call “Obesity, Inc.,” the national network of drug companies, obesity interest groups, and medical consultants who pushed for pharmacological aids in weight loss.It was becoming a billion-dollar business. Blackburn had made a lucrative practice of obesity work, producing a major study called The Fenway Study on the importance of diet drugs in weight loss.Furthermore, Blackburn was one of the main reasons why Mary Linnen was even able to take Fen-Phen. As the diet drug mania was sweeping the country, he helped lead the charge to get anorexic drugs approved for prescription in Massachusetts, where they had been illegal. The drugs were approved by the commonwealth on February 9—just two and a half months before Mary Linnen began taking them. Alex heard from Maureen’s circle of friends that Blackburn had done some consulting for Wyeth and AHP. But for how long? Was his nutrition clinic at the elite Deaconess Hospital supported by Wyeth?The other prominent doctor involved was a man considered a genius among scientists in Boston, and for that matter, around the world. Dick Wurtman’s office at the Massachusetts Institute of Technology was visible from Alex’s window. Wurtman was the “father” of Pondimin’s sister drug, Redux, its inventor, and one of the founders of the Boston-based Interneuron company, which would become a defendant and involuntary witness in the diet drug lawsuits.Going after Blackburn or Wurtman, Alex knew, would involve stepping on the toes of Boston’s privileged and powerful.At this early stage, Alex couldn’t determine what the key issues of his suit would be. But starting with the critical question “What did the companies know about the link between PPH and their drugs, and when did they know it?” he zeroed in on what would be the foremost focus of his strategy. Was the disease PPH more prevalent among Fen-Phen users than patients and doctors had been told, and did the companies hide that fact from them?Maureen told Alex that doctors had been hearing increasing reports of it since the Fen-Phen craze had begun. And a joint report involving American and French doctors, called the IPPHS, had made news the previous fall, citing the increased risk of PPH with Pondimin and Redux.Fen-Phen mania had already touched Maureen. She’d received a call from one of the national diet center chains, offering her an extra couple thousand of dollars per month on the side just for signing pads of prescription slips for the Fen-Phen combo. “I wasn’t listed as a GP or a weight loss doctor; they must have been calling every doctor in the book,” she had complained to Alex.It was Maureen who suggested the next step for Alex to take in his search for an answer to the big question. Look in the Physicians’ Desk Reference—the voluminous bible of drugs that lists all components and possible side effects.Alex had the actual label from one of Mary’s boxes of Pondimin. There, in pygmy print, buried deep in the Precautions section, was a mention that the drug had been linked to “four” possible cases of PPH. But when Alex looked in Maureen’s new PDR, he was surprised. This time, PPH was the first line under the “WARNINGS” section. It went on to cite an “international study” that had linked the use of anorexigens to this rare disease at a rate nine times its average occurrence, eighteen cases per million.Where the hell did this come from? Alex flipped through a Pondimin package insert he had found in another box and saw the last line: Revised June 20, 1996. A similar warning for Redux, a nearly identical drug, was dated April 29, 1996.That was the very day that Mary had first seen Dr. Abby Landzberg—two weeks before Mary began Fen-Phen. Alex looked at the PDR publication date. January 1997. So Wyeth had changed its label and added a better, more visible warning in late spring 1996. Of course, they’d probably had to begin working on that revision earlier, so they’d probably known something much earlier. And then the new, improved warning went into the next annual edition of the PDR, which did not hit most doctors’ offices until about February the following year.In the meantime, whatever drugs they’d shipped to pharmacies with the outdated label and its minimal precaution were still sitting on shelves, ready for sale. It was those drugs Mary had bought, and her doctor, Abby Landzberg, had only the available 1996 PDR on her desk.But Wyeth had certainly known that there was a problem that warranted a major change in the warning. What exactly did they know? Alex wondered. And why didn’t they do something more radical to inform doctors about the change? He’d seen pharmaceutical companies take out full-page ads in newspapers when there was a health crisis or a major screwup with a drug or a medical device, like an IUD. And Pondimin was, after all, one of the most popular drugs on the market; millions of people taking it were relying on the outdated warning.Okay, he reasoned. We’ve got the autopsy and the label change. What do we have from Mary’s own doctor? The crucial report from her cardiologist. The record was a twofold blessing for Alex: On December 11, 1996, Michael Landzberg wrote his diagnosis—PPH—ending with the all-important words “with associated Phen-[Fen] use.” Her doctor, presumably unbiased, had entered the causation on paper, linking the drugs directly to her death. This was critical, because now Alex would be able to include Mary’s prescribing physician as a defendant. This addition would allow him to file the Linnen case in a Massachusetts state court, avoiding lengthy delays in a federal proceeding.But Alex had mixed emotions. The diagnosis was written by Michael Landzberg and the prescriber was Abby Landzberg, Mary’s doctor. By putting down what he believed was the cause of Mary’s death, Michael Landzberg had put his own wife into the middle of a malpractice case. Alex wanted to reward Michael for doing the right thing, for his integrity. But he also wanted to tell him, “I’m sorry, but I need to sue your wife.” Alex would always wonder whether Michael Landzberg wished he’d looked the other way.Armed with the cardio-pulmonology report, the PDR, and the autopsy, Alex filed the first wrongful death suit in the Fen-Phen wars on May 5, 1997.Immediately afterwards, he moved for a temporary restraining order (TRO) against the companies, demanding that Wyeth, American Home Products, and the distributors of Phentermine all protect their records, files, and e-mails. From May 6 on, they would not be permitted to destroy anything.MacDonald’s move hit Wyeth’s local attorneys like a slap in the face. How dare he! It was an insult. Within a day, they were back before the judge. A well-known Boston jurist, Judge Raymond J. Brassard was a Republican appointee and not considered particularly favorable to plaintiffs’ attorneys. But he had agreed with MacDonald that a TRO was appropriate.Now Brassard was faced with Francis Fox, one of the old “white shoe” lawyers from Boston, practically an institution unto himself. Fox was fuming on behalf of his clients, whose honesty Alex MacDonald had presumed to question.Your Honor, Fox sputtered. This is a large firm and this is a major corporation, he told Brassard, adding that his clients did not need a policeman telling them not to break the law, in order to know they shouldn’t speed.Brassard was stuck. One of Boston’s patricians had given his word that the drug company would not destroy records. The judge lifted the TRO that afternoon while Alex fretted. Fox had put on a terrific show, strutting indignantly on behalf of Wyeth. But Fox’s performance would come back to haunt him.4As the summer humidity pressed down on Boston, Alex settled in, anticipating a dull three months of preparatory paperwork. But in early July, news reports sparked a Fen-Phen scare.While Mary had lain dying in Boston, a doctor and his perspicacious medical technician in Fargo, North Dakota, were looking over a flock of unusual cardiac cases. They had discovered a new problem linked to Fen-Phen, a pattern of heart valve disease. In February, they sent their medical reports to the Mayo Clinic, prompting a series of accelerating events that by midsummer created a national uproar about the diet drugs.On September 15, Mary’s last request was fulfilled, but not exactly as Alex had planned. Citing the new heart valve disease reports from Fargo and Mayo, Pondimin and Redux were both withdrawn from the market, “voluntarily,” according to Wyeth’s press statement.Blood in the water! Shark attack! Alex was not a big fan of derogatory comparisons between the members of his profession and predators circling wounded prey, but he’d never seen anything like the feeding frenzy after Fen-Phen. Within a couple of weeks of the drugs’ withdrawal, suits were plastering the walls of courthouses from coast to coast. In New Jersey and Pennsylvania, a handful of lawyers filed a class action in both states almost simultaneously, claiming to represent about a half million people, most unidentified, who had taken the drugs in those two locales.
Alex laid out his plans for the first stage of the case, discovery. Before he began pounding on Wyeth’s door for documents, he wanted to see what the Food and Drug Administration had been told about PPH cases by Wyeth and Interneuron. “I’m sure there are some documents with the FDA,” he said. He’d already seen a few from a FOIA—Freedom of Information Act—request. They pointed to a doctor inside the agency named Leo Lutwak who had apparently been fixated on PPH. “A voice crying in the wilderness?” Alex wondered. A scattering of memos piqued his interest: They indicated that Lutwak hadn’t just run up against the drug companies but also against the hierarchy at the FDA. Who is Leo Lutwak and how do I find him?But there was one document in the four-inch stack from the FDA that almost knocked him out. It was an internal FDA memo covering a four-day period, March 23—26, 1994, written by Dr. Lisa Stockbridge, a Consumer Safety Officer, about her continuing conversations with Interneuron’s Vice President for Research and Development, Bobby Sandage.“He [Sandage] said that there were real concerns at Interneuron about the pulmonary hypertension issue. He commented ‘off the record’ that concerns might be strong enough to consider withdrawing the NDA.” He was talking about the New Drug Application for Redux, the sister drug of Pondimin.What the hell is this? Alex called a couple of colleagues into his office, waving the memo. Then he looked at the bottom where it continued.“That same day I had another conversation with Dr. Sandage [and mentioned his reference to withdrawing the NDA] … . I asked Dr. Sandage what Interneuron intended to do about the safety issues that they themselves recognized. Dr. Sandage said that withdrawal, from a financial standpoint, was really out of the question because the company would be ruined.“He asked if the NDA could be put on hold … . I told him that a hold was not an option.”Alex was still trying to get his breath back when he saw another piece of paper mentioning Sandage. Once again it was a Lisa Stockbridge memo, this time from September 1994.“Bobby Sandage recently told me that Interneuron had nothing to lose and would stop at nothing to get dexfenfluramine approved.”Alex was so stunned that for once, even he couldn’t talk. It was like someone had dug up the perfect textbook evidence from one of his law classes: Profits over Public Safety equals Punitive Damages.It would take a couple of months to sift through the entire FDA pile. But quick perusal pointed toward one more target, Wyeth’s top man, its Medical Affairs Director, Dr. Marc Deitch. Documents referring to him painted the portrait of a clever executive fighting to protect the diet drugs at all costs. Bobby Sandage seemed like a simple bull in a china shop next to the subtle Deitch. Obviously, Wyeth would want to protect him. Could they? How would they package him? How would Alex get to him?A blitzkrieg. Alex mobilized for a lightning strike against Wyeth. But since speed in any form is a surprise in product liability litigation, the lawyers for Wyeth and its parent, American Home Products, reacted with a mixture of shock and disdain when Alex hit them up for depositions that fall.AHP’s lawyer, Peter Grossi, a senior partner in the old Washington-based firm of Arnold & Porter, looked down his aquiline nose at Alex and intoned, “Arnold and Porter waits until all documents are in before we begin deposing witnesses.”Drawing on the pedigree of his own firm, Alex snapped back, “When Mr. Arnold and Mr. Porter were studying torts, Robinson and Cole had been in business seventy-five years,” a legal variation on the old “mine’s longer than yours” boast.The choice of Arnold & Porter seemed to many members of the plaintiffs bar, including Alex, a surprise. A midsized firm that was once the home of the late Supreme Court justice Abe Fortas, Arnold & Porter had cachet in the capital. But it did not have many heavy hitters among its trial lawyers—which perplexed true trial junkies like Alex. But Arnold & Porter had been partly built on pharmaceutical cases and had represented AHP in various court actions for years; another plaintiffs lawyer remarked, “I guess they want someone they’re comfortable with.”Possibly. But Arnold & Porter had something else going for it: long-term ties to FDA offices that controlled what role the FDA would play in the litigation.FDA plenipotentiaries in its legal division had a lock on what in-house documents would be turned over to the plaintiffs, such as Alex, and any access by the plaintiffs to FDA employees. And they were in positions to restrict what the plaintiffs could learn about ongoing secret meetings at the FDA with representatives from Wyeth, Interneuron, and American Home Products. Finally, this cadre alone would determine what paperwork the FDA might create during the litigation that could affect its course, such as letters of support for the drug or the company. He was aware of an earlier situation, the Norplant case, when, at a critical moment in the lawsuits, the FDA had suddenly put forth news releases reaffirming the safety of Norplant, damaging the plaintiffs’ case and saving the defendant company, American Home Products.The FDA’s role, Alex knew, would be critical in any trial or settlement negotiations. To win, he and thousands of other lawyers would have to deal with a very, very tough question: How do you sue a drug company if the Food and Drug Administration itself is the company’s main defense? “The FDA approved these drugs and their labels, so what’s the problem?”It was clear to Alex that the strategy of Wyeth’s lawyers would be: stall, stall, stall. But was it the right strategy for a major drug company on the hot seat? “Let’s turn up the heat under that seat,” said Alex to his partners, “and see what happens next.”5What a difference a recall makes. In May, Alex had been almost alone in his pursuit of Wyeth. By winter, he was one of thousands after a piece of the pharmaceutical. The Association of Trial Lawyers of America, ATLA, had taken all of one month to turn Fen-Phen suits into a cottage industry. Alex didn’t know it, but some of those suits and their lawyers were about to become players in the Mary Linnen case.The Mary Linnen suit gave Alex singular cachet. After all, he’d made the CBS Evening News with Dan Rather. Invitations to join loose coalitions of lawyers suing Wyeth and the other drug makers jammed his voice mail.Not everyone’s agendas were the same, however, and the differences struck him as humorous, tendentious, and to some degree dangerous. Wyeth, or rather American Home Products, was Gulliver, surrounded by legal Lilliputians. If they worked against each other, the giant would escape and trounce them all on his way out.That was where a behemoth MDL might prove useful.In November, the half dozen federal judges who make up a panel overseeing Multi-District Litigation (MDL) around the country convened in sunny Fort Myers, Florida, bringing together judges and lawyers who routinely pursue mass tort claims involving defective products and thousands of victims in many states. The federal MDL was created twenty years ago as a special legal proceeding to handle the skyrocketing numbers of mass tort cases against various corporations and industries. A federal panel combines hundreds, sometimes thousands, of individual cases against one defendant into one suit, based in one city, relying on one set of plaintiffs attorneys to handle all the work.The theory behind the MDL is that having one case saves both parties from duplicating document discovery, depositions, and motions. It protects corporations from multiplication of their efforts, imposes one set of federal rulings in each case, and gives one judge the chance to be immersed completely in the complex litigation. At the same time, an MDL can allow the plaintiffs to present a unified front, a scary sight for a defendant, no matter how deep its pockets. And the power of the federal court, a special federal court, to get documents and testimony from malingering corporations is a wondrous thing to behold.But the MDL is like a private club, requiring something akin to a Masonic handshake and secret code words for entry. Like an extended family, MDL regulars get together for weddings, funerals, and massive lawsuits. Indeed, an outsider observing that November meeting could have mistaken it for a family reunion, with a couple dozen lawyers on the circuit schmoozing together.But they were doing serious business in Fort Myers, plotting the next big one: Fen-Phen. There might be hundreds of thousands of cases filed over the diet drugs. It was time to set up one giant MDL cluster to manage them.Several firms in the mass tort establishment were already lobbying hard. Levin & Fishbein of Philadelphia had just come off a major settlement in an MDL involving flawed pedicle screws—surgical bone screws—and were determined to get an MDL in their hometown. They were joined by a Cincinnati lawyer, Stan Chesley, who was well connected politically and had won huge amounts in Agent Orange cases. They had a particular judge in mind, Louis Bechtle, whom they hoped would be named to the case. There was frenetic behind-the-scenes negotiating among attorneys to ingratiate themselves with Levin & Fishbein. Within a few weeks, it was a done deal. The MDL managers would turn quite a profit, and it was up to them to distribute plum positions on the management and discovery committees. But even to insiders, it seemed that the MDL’s real clients weren’t diet drug victims but other lawyers. As one MDL manager put it: “Who do we represent? We represent the situation.”6Alex MacDonald normally ran the other way when he saw lawyers whose client was “the situation.” And he wasn’t the only lawyer looking askance at the MDL. Deep in the heart of Texas, Lone Star lawyers were getting ready to make their mark on the diet drug litigation, and on the Mary Linnen case.Texas tort lawyers view MDLs as black holes that suck in lawsuits and spit out victims. They like speed in Texas, and punitive damages. But in an MDL, it can take years for all the discovery work, depositions, and motions to be completed, before all the individual cases are sent back to each federal district to get a trial date. Furthermore, the unspoken—though universally acknowledged—goal in an MDL is a mass settlement. It’s a trophy for the judge, and the preferred outcome for the MDL managers.Texas laws made it easy to eschew the MDL. The Wild West culture of the courts there is a nightmare for corporate defendants and a godsend for plaintiffs. You don’t screw around with judges in Texas. Motions move like lightning there, and the Rangers don’t hesitate to enforce discovery subpoenas. The state of Texas housed about one-fifth of all the people who had taken Fen-Phen or Redux. It would be a huge, fertile field for suits. And the Texans were damned if the MDL was gonna get any of ’em.Texans were a brash bunch. But the brashest of them was not originally from Texas. He was Kip Petroff, an Ohio boy who’d taken a shine to Dallas and set up the two-man shop of Petroff & Kisselburgh in the Turtle Creek section of the city. He was a successful “breast man,” one of hundreds of Texas lawyers winning huge awards in silicone implant cases.He and his partner, Robert Kisselburgh, were a strange pair: Kip, a younger version of Tommy Lee Jones, was a former wrestler who still worked at his physique. He aspired to studmuffin status, and from the many phone messages his office manager, Redonda, took from sweettalkin‘women, he was well on his way. Robert, burdened with the eye bags of Deputy Dawg, spent his time with Boy Scouts and the vestry of his Episcopal church. Kip still had the flat midwestern accent and preferred the luxury loafer look. Robert had been born wearing cowboy boots and breathed in a western drawl.But they had something in common: They thought “MDL” was just another term for “total paralysis,” and they did not trust the folks out East.Kip’s first job after leaving Notre Dame Law School in 1982 took him to a large Dallas firm and into the Wild West culture of the Texas bar. His hotshot style fit in well, but unlike most Lone Star immigrants, he never could get used to cowboy boots. “One of my partners gave me a $1,200 pair of hand-tooled ostrich boots after I got a million-dollar settlement a couple of years ago. I just can’t wear them,” he confessed.Robert, one year younger than Kip, had sown his wild oats in college in Oklahoma and found his way into law school through the air force, where he ran a team of drug-sniffing dogs. He’d shed most of his youthful habits, except dipping snuff, which drove Kip crazy. He had been Kip’s clerk, and he was the first person Kip sought out when Fen-Phen hit the fan in September 1997. “Join me, we’ll have a ball,” Kip had promised him.Kip’s earlier cases weren’t exactly tearjerkers. But in one instance, he inherited a moribund suit against a Dallas blood bank that had distributed plasma contaminated with the AIDS virus. Several other lawyers had refused the case, and one of his partners handed it to him apologetically just weeks before trial, deeming it a certified loser. Kip got an $800,000 judgment against the clinic from the jury. “I loved that case,” he would sigh.He won fame, fortune, and an evidence case full of plastic breasts. One of his implant clients returned to him. An ex-Fen-Phen user, she was having shortness of breath. He quickly filed suit on her behalf and called the press.“I got some publicity, stories in the Dallas Morning News, which I knew would help, and bring me other cases,” he said candidly. The woman’s health improved, but in the meantime, Kip’s media savvy paid off, and he landed two dozen more diet drug clients.Kip soon found himself at a swank resort in Albuquerque, giving a lecture on how to sue big corporations over diet drugs. In the audience was a lawyer from Little Rock, who asked for advice with a troubling case. His client’s name was Mary Perez. Kip agreed to meet her, and afterwards, surprisingly moved, he told a legal conference, “Because of this case, the law is fun for me again. We have ‘good’ on our side again. We have science on our side. I want these people to pay for what they have done to my clients and to the other women who won’t live to see their children grow up.”At Harvard Law, Alex would have called this an epiphany. In Texas, Kip’s reaction just seemed like the natural thing. But in both cases, their clients’ fate drove them to thrash out quickly against the pharmaceuticals, without waiting for the MDL to fire a starter pistol.
As Christmas approached, the drug companies entrenched, acknowledging no error, giving up no information. The plaintiff groups’ differing agendas gradually began to reveal themselves like a photo negative developing into a picture.Alex set his sights on getting justice for Mary Linnen, or at least vengeance. The Lone Star litigators, perennial outsiders, had two goals: immediate gratification in their lawsuits and, ultimately, vindication from the Establishment for their unorthodox cowboy tactics. The class action veterans in New Jersey and Pennsylvania wanted to carve out their territory so they could get a place at the MDL table. And the MDL’s leaders wanted to see their closed system function smoothly. It would be disingenuous not to acknowledge the role of greed with various members of these clans.The synergy of these competing goals initially helped the discovery process. It was propelling everyone along faster than they had anticipated, and certainly faster than Wyeth and the other defendants desired.But even at that stage Alex MacDonald could see that the plaintiff groups weren’t moving forward as one. They were like trains going in the same direction on separate tracks. In some stretches they were rolling in tandem. But eventually they’d diverge, or crash. He hoped he wouldn’t find himself hitched to more than one when they all separated.DISPENSING WITH THE TRUTH. Copyright © 2001 by Alicia Mundy. All rights reserved. No part of this book may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embodied in critical articles or reviews. For information, address St. Martin’s Press, 175 Fifth Avenue, New York, N.Y. 10010.
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