http://www.vanityfair.com/politics/2014/01/nuvaring-lethal-contraceptive-trial
Danger in the (Merck Nuva)Ring
Karen Langhart never had
the slightest doubt about her 24-year-old daughter Erika’s ability to organize
meticulously every detail of her life. For months in 2011, Erika’s Thanksgiving
plans had been locked in place. On November 23 she was set to arrive from
Washington, D.C., on U.S. Airways, landing in Phoenix, Arizona, at five P.M.
Erika and her mother would go straight to Sprouts, a local gourmet grocery
store, to shop for a turkey, corn bread, yams, and the ricotta and walnuts
needed for the signature cheesecake they served at their restaurant, the Red
Snapper, one of Durango, Colorado’s best. The Red Snapper, designed by Karen
and her husband, Rick, restaurateurs and land developers, had been, for the 25
years they owned it, the center of the family’s life.
Lanky and athletic, Erika
had a toothy smile, a raucous laugh, and a lush beauty; her long blond hair
bounced when she spoke. She carried herself like a debutante, and she made
light of her leadership awards and magna cum laude degree at Washington’s
American University. On Sundays, when the Denver Broncos played, Erika wore
their colors, orange and blue. Almost six feet tall, she often wore big hats,
short designer wrap dresses, and high heels or expensive cowboy boots, playing
her height to maximum advantage. Chosen to represent her university at
leadership conferences in China and Tibet, Erika seemed on her way to more
honors at Georgetown Law School and a career in politics.
Taking off a semester to
work on John McCain’s 2008 presidential campaign, she was quickly promoted to
be the liaison between the
Republican National Committee and the campaign on the road, a demanding
job of keeping records of travel contracts and renting venues for events. “I
was stunned when someone told me Erika was only 21,” McCain later told Karen. “She ran an entire
arm of my campaign.” All day long, Erika would pace back and forth in her heels
and wrap dresses at the candidate’s Crystal City, Virginia, headquarters, earpiece
in place, her voice cascading through the cluster of desks: “Where is the
addendum? I need the addendum. I can’t release the senator without the
addendum.” The other interns had a game, her friend Katelyn Roberts recalled:
“How many times will Erika use the word ‘addendum’ this afternoon? We didn’t
even know what an addendum was.”
The Monday before
Thanksgiving, Erika and her boyfriend, Sean Coakley, planned to stay in after
work so that Erika could pack. Coakley worked for a government agency, Erika for
a branding company not far from their apartment, in Arlington, Virginia. All
that day, they messaged back and forth. Sean was to stop at the store to pick
up dinner; Erika would already be home. When Sean arrived at 6:30, he found Erika writhing on the floor,
struggling for air. Moments later, a local emergency medical team was at
the door. Just before Erika had collapsed, she had somehow managed to call for
help.
Karen was on the golf
course when she saw Erika’s number on her cell phone. “We can’t wait to see
you!” she said. Then, she would recall, “my world stopped. It was Sean, telling
us that Erika had collapsed and that the E.M.T.’s were in the apartment.” In the ambulance Erika had two
heart attacks, and she was semi-conscious by the time they reached
Virginia Hospital Center. According to Karen, a doctor in the emergency room asked her over the phone:
“Was your daughter using birth control?” Karen said, “Yes, NuvaRing.” He
removed the device and said, “I thought so, because she’s having a pulmonary
embolism.”
Racing for the last flight
to Washington, Rick and Karen Googled “double pulmonary embolism NuvaRing.”
Dozens of results came up—“NuvaRing side effects,” “NuvaRing lawsuits.” Karen
knew little about class-action
mass-tort litigation, the battles between the tort bar—lawyers handling
cases of victims of every conceivable malady, including asbestos exposure,
diabetes, defective hip implants, arthritis, and birth-control
complications—and the law
firms specializing in defending drug and medical-device companies under
siege. Strapped into her seat on the plane, she wrote down one of the first
names that came up under “NuvaRing lawsuits,” Hunter Shkolnik, of New York’s
Napoli Bern Ripka & Shkolnik. His office was in the Empire State Building—a
fact that impressed Karen and Rick. “I never even considered that I would need
a lawyer,” Karen later told me. “But Hunter’s name kept coming up in all the articles.
It was obvious he was an expert.”
Before Karen and Rick
reached the hospital, Erika was placed on life support. She died on Thanksgiving Day. On the program for her
daughter’s memorial service, Karen stated, “Cause of Passing: Massive, Double
Pulmonary Embolism—a direct result of the NuvaRing.” She had entered,
she told me, “another phase of life. How I wish I could change places with my
daughter.” Then her voice broke. “I am living every parent’s nightmare.”
Thanksgiving 2011 was for Karen the start of the mission that now obsesses her.
“I want to warn every
mother and every daughter: do not use the product that killed my child.”
Erika’s Friend Megan
In June of this year, a
thick dossier of legal documents and e-mails was delivered to my house. The documents
came in part from Barbara Henry, the first selectman—essentially the mayor—of
Roxbury, Connecticut. She, like Karen Langhart, was on a crusade against
NuvaRing. In the folder was an e-mail she had circulated to friends about her
daughter Megan’s history with the device. “Some of you know that Megan is in the hospital
in Danbury How life changes at the flip of a switch,” she wrote soon after her
daughter was stricken, in August 2012.
A member of World Class Athletes, the army’s elite team of soldier-athletes,
Megan Henry competes in skeleton, a form of high-speed downhill sledding. The sled resembles a fiberglass baking sheet with metal
handles the athlete uses for control. Megan races at a speed close to 80 miles
per hour, achieved through a grueling daily regimen of sprints and power
lifting. In Utah, training for the 2014 Olympic Games in Russia, she found
herself, like Erika, gasping for breath. Ten days earlier, Megan had started using NuvaRing, her
first experience with birth control. “Do you smoke?” a doctor asked her.
“Of course not, I’m an athlete,” she said. “Oh well, you should be fine,” the
doctor said. In perfect health up to then, Megan could not stop fighting for
air. Her teammates blamed the altitude. “One doctor I went to told me I was under
stress, or maybe I had asthma,” she told me. “He gave me an inhaler.” On a
flight to Florida for more training, she almost collapsed. “At Urgent Care, I
was given an X-ray—it was clear. I said, ‘Could this be the NuvaRing?’ ‘Absolutely not,’ the doctor
said.”
A quick check of the Web would have shown that more than 1,000 lawsuits
had been filed against Merck & Co., the manufacturer. “Megan, you need to come home now, and I will get you
an appointment with a pulmonologist,” Barbara told her. After a second
flight—she later learned that that alone could have killed her—Megan told her
history to a Connecticut doctor, who ordered a CT scan. It revealed dozens of blood clots in her
lungs. Rushed to the hospital, she was put on blood thinners in the
E.R., and she remained hospitalized for a week. “I was told, ‘Your career as an
athlete is over,’ ” she said. “If you weren’t in the shape you are, you would be dead,” her doctor
informed her.
Friends at American
University, Megan Henry and Erika Langhart had not seen each other since
graduation. After college, Megan joined the army reserves to help pay for her
graduate studies in intelligence work. In the hospital, she learned that
Erika’s parents believed her death had been caused by NuvaRing. “This is
serious. . . . Make sure to tell this story. It may save somebody’s life. I’m
just praying for my own daughter now. I’m asking you to, too,” Barbara Henry
e-mailed friends and colleagues.
The dossier I received contained scientific
reports that detailed the hormones
used in NuvaRing, recent articles, and a fact sheet titled
“Investigation Summary.” After skimming it quickly, I highlighted one key word:
“desogestrel.” Desogestrel
and its related compounds, third-generation progestins first used in
contraceptives in the 1990s, appeared to be at the center of the legal case. A
key component of NuvaRing and several other birth-control products, these
progestins had been substituted for the ones used previously in order to lessen
side effects such as hair growth and acne. NuvaRing was the first monthly
vaginal contraceptive ring. It was acquired by Merck when the company purchased
Schering-Plough, the New Jersey-based pharmaceutical giant, in 2009. At that
time, NuvaRing was a rising star on the company’s profit sheet, earning
Schering-Plough $440 million in 2008. The ring looked like a possible blockbuster, and
it would fill a gap in Merck’s arsenal: a leading birth-control product.
Although at the time of the merger more than 100 cases had already been filed
against Schering-Plough over NuvaRing, Merck did not delay in launching a major new advertising campaign.
As Karen Langhart began her research, she studied
lawsuits previously filed against Johnson & Johnson’s patch contraceptive, Ortho Evra, and Bayer’s
popular oral contraceptives, Yasmin
and Yaz. Her immediate focus became the risks of blood clots from
birth-control drugs. While Erika was on life support, Karen spent three days in the I.C.U. with
nurses, doctors, and neurosurgeons. “Each and every one of them had personal
and professional stories to tell about birth control and pulmonary embolisms,”
she told me.
After studying Barbara Henry’s dossier, I called
my daughter, who is a few years older than Megan and Erika. “Are you on
NuvaRing?,” I asked. I then called Barbara and Karen. My first question for
both women was: If what
I’m hearing is true, why is this product still being sold? Months later, I
still do not have an acceptable answer.
This is a story I did not want to write. Not long
after I read Barbara Henry’s dossier, a box arrived from Karen Langhart. “We
hope to give you a sense of the amazing young woman Erika was,” she wrote in
the covering note. Inside were mementos from Erika’s bulletin board and
albums—photos of her and her friends in orange bikinis running into the surf in
Hawaii, of her and her younger brother, Kyle, with her 190-pound Saint Bernard,
Chewy. The box smelled like the cosmetics of a college girl. It was difficult
to look at. I had boxes of my daughter’s photographs and mementos just like these.
I closed the box quickly, but I could not get Erika’s history out of my
thoughts.
The feints
and camouflages of the pharmaceutical industry and the casino of class-action
mass-tort litigation often cloud the facts of complex drug cases. I
wondered what had happened within Merck, long considered the gold standard of
American drug companies. Spanning a decade in the 80s and 90s, the former
chairman P. Roy Vagelos, author of more than 100 scientific papers, ran a
campus of high standards. In 1987, Merck developed Mectizan, a treatment for
river blindness, a disease caused by a parasite from blackflies most often
found near rivers in more than 30 countries. Since those who could most benefit
from Mectizan could not afford it, Merck has donated more than one billion
tablets free of charge, drastically reducing the disease’s occurrences.
Like many other pharmaceutical companies, Merck has begun to outsource
much of its research and development, and it seeks to acquire drugs such
as NuvaRing and increase sales by means of ambitious advertising. In October, in an effort
“to sharpen its commercial and research and development (R&D) focus,” Merck
announced the layoff of 8,500 employees. It also announced the closing of one
of its main campuses.
With millions of prescriptions filled a year (5.5
million in 2010 alone) at a cost of between $15 and $80 per month, NuvaRing
earned Merck $623 million in 2012. All drugs come with side effects and
possible consequences, which patients and doctors are supposed to evaluate on a
risk-versus-benefit basis. Birth-control devices and hormones have long been
known to have a complicated set of possible side effects, including mood swings
and clotting. Was NuvaRing, which is inserted every four weeks to provide, as
the label states, “a continuous low dose of estrogen,” any more dangerous than
the more than 50 other birth-control products available on the market? Junk
science is filled with allegations that are later revealed to be nothing but
anecdotes. I wanted to understand if the scores of deaths and thousands of
potentially life-threatening clots—tragic as they were—were in fact merely
instances of the normal buyer-beware consequences that can occur from taking
any drug.
Why did women choose to use NuvaRing? Court
documents filed against Merck state that since the mid-1990s there have been
more than 10 studies suggesting that third-generation progestins, including the
one used in NuvaRing, are approximately twice as likely to cause blood clots as
those used in other birth-control devices that have an earlier form of
progestin. A blood clot that blocks a vein is known as a venous thromboembolism
(VTE). VTEs can occur in any vein, but they most often appear in the legs. They
can also break off and travel to the lungs. That’s what happened to Megan—and
to Erika too. A 2012 study published in B.M.J. (British Medical Journal)
found that vaginal rings
carry a 90 percent greater risk of VTE than birth-control pills with earlier
forms of progestin. (The report states that in any given year, out of
10,000 women who are not using a hormonal contraceptive, an average of 2.1
would suffer a VTE. For a woman using a vaginal ring, that risk increases 6.5
times.) A 2011 F.D.A. report found that rings could increase that risk by 56
percent. According to the lawsuits, in 2007 Organon, the Dutch pharmaceutical
company that created NuvaRing, completed a study that showed a 1.6-times
increased risk, but that study didn’t have enough participants to meet clinical standards.
(Referencing earlier studies, Merck responds, “The safety and efficacy of
NuvaRing were originally established in clinical trials involving more than
3,700 women.”)
I went to the NuvaRing Web site to see how Merck
had dealt with what was clearly well-documented risk. I found the usual disclaimers and warnings
regarding heart attacks, strokes, and smoking. I read, “The risk of getting
blood clots may be greater with the type of progestin in NuvaRing than with
some other progestins in certain low-dose birth control pills.” What did Merck
mean by saying the risk “may be greater”? Would a young woman use NuvaRing if she knew that the
F.D.A. had come up with an increased risk of 56 percent? The number of
women affected appeared to be in the thousands, and there were millions of
users.
The same dilemma drove Karen Langhart, who spent
the days after her daughter’s death in an impenetrable fog, to read every
research report she could find on the Internet. She immediately ran into a maze
of contradictions and allegations. Most drug companies have become huge
marketing machines, advertising drugs with sometimes inadequate warnings of
side effects. At Merck, the
2012 marketing-and-administration budget was 50 percent larger than the budget
for research and development.
The United
States and New Zealand are the only countries in the world that allow
prescription drugs to be advertised on television. In
1997, a change to an F.D.A. regulation set up the arena for the sideshow of
athletes, models, dancers, and aging baby-boomers who dominate ads for antidepressants,
blood thinners, and possible four-hour erections for senior males who pop a
Cialis so they’ll be ready “when the moment is right.” NuvaRing was launched in
a world of gaudy TV
huckstering, the standard for which was set by former Senate majority leader
Bob Dole, who, not long after he lost his bid to become president, began to
push Viagra in prime time.
A
Blockbuster Device
Developed by Organon in the 1990s, NuvaRing
provided a novel delivery system, an insertable plastic ring. About the time
the ring was approved in Europe, the F.D.A. signed off on it but questioned
aspects of its safety. Court documents filed against Merck show the jockeying
that went on over the labeling about the VTE risk. In the review process, the
F.D.A. said that Organon needed to toughen its warning labels, but the company
argued against that, and the two eventually negotiated a less stringent
wording.
In America, NuvaRing came on the market in 2002.
Five years later, Organon was taken over by Schering-Plough. Such acquisitions are often
driven by patents and “pipelines”—the profitable drugs owned by the company
being acquired. Those drugs—each of which can earn more than $1 billion a
year—are protected by the government’s patent office. Once a patent expires,
the F.D.A. allows generic substitutes to come onto the market; these can be 80
percent cheaper than the patented originals. A minor adjustment of a few molecules in a laboratory or
a new delivery device, therefore, can sometimes mean a renewed patent—actually
a piggyback on an existing patent—and billions of dollars added to a company’s
bottom line.
NuvaRing, which promised “the lowest dose of
estrogen” on the market, was Organon’s instrument for entering the competition
against Yasmin and Ortho Evra, which were approved by the F.D.A. the same year.
By the time NuvaRing was developed, desogestrel in pill form had gone off
patent. Organon came up with a device that would deliver the progestin in a new
way—and earned a long-running patent for it. What made NuvaRing special was its
convenience: You put it in
and “forget about it,” according to the early promotion, for a full three weeks.
It looked like a harmless bubble, and its combination of vinyls was designed to
regulate the release of third-generation progestin and ethinyl estradiol, a
form of estrogen. The
packaging recommends that the ring be kept at an optimal temperature range of
68 to 77 degrees. To this day, no test has been made of NuvaRing after it
leaves the factory. The F.D.A. has never required a test to determine what
would happen to the plastic device if it wound up sitting on a loading dock or
in the purse of a young woman vacationing where the climate was torrid.
Experts cited in the court documents submitted by the plaintiffs allege that
the ring could release a possibly life-threatening surge of estrogen. But, the
plaintiffs’ lawyers ask, were doctors and patients made aware of that?
What were
young women being told by their doctors? As part of my reporting, I
asked two college students to go to clinics in New York, inquire about using
NuvaRing, and detail their families’ histories of heart issues. Planned Parenthood, with its
distribution centers all over the country, has been a target sales market for
NuvaRing. At a clinic it operates in Brooklyn, one student mentioned to
the attending nurse practitioner that she had Googled NuvaRing and was aware of
the lawsuits alleging that it can cause blood clots. “I have a history of heart
disease and diabetes in my family,” she said. “You yourself have a history of heart
disease?” the nurse practitioner asked. “No, but my father has it. And my
mother has type 2 diabetes.” Both facts were indicators of potential problems,
but the nurse practitioner did not seem to be alarmed. “Then no. NuvaRing is
safe for healthy young women.... Of course, with all birth-control methods, there
are side effects. . . . You seem a good candidate. Would you like to try it?”
(Planned Parenthood, asked to comment, responded that the federation “does not
publicly discuss private patient matters.”)
At a university clinic in Manhattan, the other
student with a history of health issues in her family requested information
about NuvaRing. She, too, was told not to be concerned. The doctor simply
opened her desk drawer and gave her a sample. Of the clinics visited by the two students, not one
warned them about the possibility of blood clots.
Organon was holding its own with NuvaRing in
America in 2006, with an award-winning campaign: “Not Your Everyday Birth
Control.” The ring was
cleverly displayed as a halo around a woman’s midsection that followed her
throughout the day. That ad was pushed hard on Facebook and social media for a target
audience of college girls and millennials. “We weren’t trying to sell to nuns,”
Bill Drummy, the C.E.O. of Heartbeat, the digital agency hired to advertise
NuvaRing, told me.
Click on the Web site for NuvaRing and you will
see the commercial: Willowy young women warm up at a ballet barre to upbeat
music. It’s not another pill, says an ebullient voice. Another voice chimes
in, Oh! A bouncing plastic ring floats through two young women carrying
a yoga mat after class. They radiate the exuberance of perfect health. And
you don’t have to take it every day. Oh! The plastic ring bounces again as
girlfriends meet and laugh, and the voice goes on in the same lilting tone: Serious
risks include blood clots, stroke, and heart attacks… Some studies suggest that
the progestin in NuvaRing may increase the risk for blood clots… Ask your
health-care provider about a surprisingly different way to do birth control.
And all the while the score, as benign as Sesame Street’s opening tune,
fades into final girl chat and another bouncing Oh! The takeaway is:
This is a club you want to join.
The
Mass-Tort Lawyer
In the beehive of offices in the Empire State
Building, Napoli Bern
Ripka & Shkolnik occupies half of both the 74th and 75th floors.
Hunter Shkolnik has learned to avoid the Fifth Avenue entrance, where tourists
mass under the Art Deco murals on their way to the observation deck. Although
the building is world-famous, the offices in it are occupied by a hodgepodge of
lawyers, dentists, and accountants. Still, for people seeking compensation for
their scarred lungs or heart attacks, a law firm in the Empire State Building
commands attention. Shkolnik’s corner office is on the 75th floor, not far from
a glass-walled conference room crammed with assistants wearing headsets, who
are taking case histories on scores of legal cases in development. While I
waited to see Shkolnik, I read Napoli Bern’s glossy brochure: The Verdict.
HAVE YOU OR A LOVED ONE BEEN DIAGNOSED WITH MESOTHELIOMA OR LUNG CANCER? is the
front-page headline. Inside are details of the firm’s battles for victims of
the cruise ship Costa Concordia, British Petroleum’s Deepwater Horizon
oil spill, Superstorm Sandy, and the recalled DePuy knee implants made by Johnson & Johnson. Next
to me, a Hispanic family struggled with forms they were filling out. “My
husband was in 9/11,” the mother told me. “He can’t breathe very well.” Loud voices
of paralegals on the other side of the thin room divider were clearly audible: You
had a surgery done? What happened? Who was this guy? You had complications? How
are you doing now?
“You weren’t supposed to come in on the 75th
floor,” Shkolnik later told me. “Our grander lobby is one floor down—conference
rooms, reception areas. We need more space up here.” Shkolnik speaks in a
staccato New York–ese full of exclamations: You nailed it! A hundred
percent! You got that right! His clothes have the impeccable tailoring of a
man who knows he may need to make a quick appearance in court. Several times
when we were together, he jumped up as if he were rehearsing a summation for a
jury. Shkolnik showed no concern that I had seen the mass-tort boiler room. He has
become impervious to the slings and arrows that are routinely directed at the
jackals of mass-tort land and is convinced that he is practicing a version of
the people’s law. Houston plaintiff’s attorney Mark Lanier refers to “the
chicken catchers and the chicken pluckers.” Shkolnik is a plucker, who gets scores of cases from
the catchers advertising on TV. The cases do not come cheap. “Check: you
got that right,” Shkolnik confirmed. “They do not.”
The day we met, Shkolnik had just returned from
San Francisco, where he, along with other plaintiffs’ attorneys “who knew
something about aviation,” was interviewed by Chinese families who had children
and relatives on Asiana Flight 214, which had crashed in San Francisco in July.
Shkolnik was startled, he told me, by the cool poise of the Chinese parents,
with their state-of-the-art laptops and mobile phones, and the sophisticated
level of their questions. “And then it came down to the truth—money.” Right
away the families wanted to discuss fees. The split would be minuscule,
Shkolnik said, “and you could wind up trying a case in Taiwan.” In front of one
father was a stack of lawyers’ cards.
For three
years, Shkolnik’s center of attention has been NuvaRing.
According to a Merck spokesperson, “Organon, with academic and other
researchers, conducted and published well controlled clinical trials that
demonstrated the medicine’s efficacy and safety.” And yet, during a deposition taken in
Amsterdam, Shkolnik was told that, early on, Organon had launched into the
device’s marketing with a scientist’s research study that had examined only 16
women using NuvaRing. That trial, No. 34218, on the release of hormones in
different birth-control delivery systems, was so outrageous, Shkolnik told me,
that he felt it justified focusing his entire legal career on drug cases.
The expert scientific report prepared for the
plaintiffs’ legal team asserted that, during the trial, two of the women had massive spikes of estrogen
in the first days. Two other women had unexplained spikes of estrogen midway
through the trial. Those occurrences were not mentioned in the 30-page summary submitted to the F.D.A.
in 2001 for NuvaRing’s approval. The report concluded that those important data
points were eliminated from the trial’s final analysis without reasonable
explanation.
The summary prepared by Organon for the F.D.A.
was attached to thousands of pages of backup, in which were buried the risks associated with
blood clots, according to Shkolnik. There was nothing illegal in that.
“This is a standard subterfuge used by Pharma,” he said. “You bury your bad
news in one of 500 studies you have done on ease of use or lipid disorder. Then
when the F.D.A. comes back to the drug company, the drug company can say, ‘You
had it in your documents.’ If it isn’t in the 30-page summary, the F.D.A. is so understaffed
it will never be noticed.”
Under oath in a deposition, an Organon scientist
indicated that he believed the company “had satisfied the American
requirement.” That was when, Shkolnik told me, “I called my daughters and said,
‘Do not ever use any third- or fourth-generation birth control. It could kill
you.’”
Shkolnik came to the NuvaRing case slowly.
Usually, he told me, he could marshal huge enthusiasm for a project from the
outset, and that would propel him through the years of expense and research
required to go after Pharma. Shkolnik, who grew up in a ranch house in Oyster
Bay, Long Island, found his way into slip-and-fall trial work and liability
cases after graduating from Yeshiva University Law School. He always imagined
himself as a Long Island law partner, raising his daughters in Oyster Bay, but
when he was still in his 30s, he applied for a job at the famous New York City
plaintiffs’ firm started by Paul
Rheingold, a Harvard Law graduate who takes credit for the term “mass tort.” Rheingold,
Shkolnik said, has been considered “the dean of drug plaintiff law” from his first big case, which was to
challenge the safety of the birth-control device called the Dalkon Shield in
the 1970s.
Rheingold’s timing was impeccable. In Arizona in
1976, John Bates, a young former legal-aid lawyer, had advertised for clients
for his new practice in The Arizona Republic. Abraham Lincoln had also
once advertised for clients, but the practice had since been prohibited by
state bar associations, considered improper by white-shoe Harvard Law School
practitioners. Bates believed that that was unfair to the poor, and he decided
to fight the issue, with the help of one of his former law professors, on
free-speech grounds. The ultimate Supreme Court decision in the case of Bates
v. the State Bar of Arizona, which was a distinct win for him, changed
the way plaintiff law is now practiced in America. Houston plaintiff’s attorney
David Berg has observed, “Before
Bates, we looked at the law as a hallowed practice. Bates brought out
the hyenas who explode phone booths and advertise on TV. Now it is a carnival of greed.”
Shkolnik disagrees.
Shkolnik’s first assignment with Rheingold was a
bonanza: the diet drug Fen-Phen, a combination of fenfluramine or
dexfenfluramine and phentermine, manufactured by Wyeth, a division of American
Home Products. At the F.D.A., adverse-event reports suggested that the drug
could damage heart valves. “I took a lot of depositions from men and women on oxygen,
and two days later they would be dead,” Shkolnik told me.
In St. Louis another lawyer, Roger Denton, who
prided himself on his working-class roots and bulldog determination, was also
starting to focus on drugs. Denton hit his stride with Yaz, immersing himself
in the science of fourth-generation progestins as a member of the lead trial team against Bayer.
From time to time, his associates in the gleaming glass offices of Schlichter,
Bogard & Denton would hear him on the telephone, hammering defense lawyers:
Let me remind you that your product has seriously harmed and killed many who
have used it. For his clients and firm, he eventually made hundreds of
millions of dollars from the $1.6
billion Yaz and Yasmin settlements that Bayer—without admitting fault—has
been paying out over the last two years. In 2007, he was preparing cases
against Ortho Evra when he learned about NuvaRing. Denton and his associate
Kristine Kraft fielded a telephone call from the family of a deceased woman who
had collapsed on a treadmill, in front of her daughter, not long after she
started using a new birth-control device. “We thought she was on Ortho Evra,”
Denton told me. “And then we discovered it was NuvaRing.”
At the same time in New York, advertising for
Ortho Evra cases, Rheingold began to hear from women who had gotten similar
clots, which they attributed to NuvaRing. Along with a New Jersey colleague,
Steven Blau, he became convinced that that product was also potentially
dangerous. At that time,
Shkolnik was buried in a case concerning defective pacemakers, in which almost
every single device was eventually recalled. Rheingold began an Internet
marketing campaign for potential NuvaRing victims, and he was astonished when,
within months, he had registered hundreds of cases. Rheingold filed a case for
one woman in the federal court in St. Louis. Two years later, Merck came at the
firm with what Shkolnik called “the freight train”—an avalanche of some 300
individual motions to dismiss every single plaintiff. “Do you know what that costs to prepare each
motion?,” Shkolnik asked. “We are talking millions of dollars.”
For years, Shkolnik and Rheingold were like
father and son, but then their relationship turned stormy. In July 2011,
Shkolnik left to join close friends Marc Bern and Paul Napoli, whom he had
worked with when he was pursuing Fen-Phen cases. Their law firm had since
become a powerhouse.
By December 2011, two years into the NuvaRing
case, Shkolnik was in a zone of alternative reality. As he tried to fall asleep
at night, he said, “entire paragraphs of motions” would swim into his head, and
he could recite the cohort numbers of what he felt were questionable clinical
trials for NuvaRing that had somehow caused insufficient alarm at the F.D.A. He
would lie awake and think about No. 34218, stunned that NuvaRing had been
approved in Europe and in Washington.
On a flight to Amsterdam in the summer of 2011,
Shkolnik and his colleagues Roger Denton and Alex Alvarez, the Florida
mass-tort specialist, spent the entire time buried in documents of Organon’s
estrogen reports. The lawyers were focused on what Shkolnik called “the area
under the curve”—what he believed was not revealed in the final report. Denton
contended, for example, that the women using NuvaRing in 34218 had experienced
spikes of estrogen that were not fully acknowledged in the final report.
According to court documents, Organon was able to navigate around this at the
F.D.A. Every birth-control pill would create a similar spike, Shkolnik said, if
it were not for the counterbalancing progestin in it. With NuvaRing there was
no guarantee of that, he believed, claiming that the ring could not regulate
unpredictable gushes of hormones. In September 2001, as the F.D.A. was
considering the approval of the completed application, court documents
submitted by the plaintiffs claim, Organon scientists had become concerned with
“the burst release” and what they called “out-of-spec results” in “large-scale
NuvaRing batches.” One member of the regulatory-affairs team e-mailed a colleague,
“This is a very serious issue, in that FDA is very sensitive to the ‘burst
release’ phenomenon and release in general. Going to FDA to change these
specifications is absolutely the LAST thing we should consider, i.e., that’s
the worse possible scenario.”
Among Denton’s papers that day was the expert
report of Dr. Suzanne Parisian, a former chief medical officer at the F.D.A. Drug cases are often a battle of
paid witnesses, and Shkolnik and Denton had hired one of the best. In
her 132-page report, Parisian highlighted what she believed was a key fact: by
2004, after NuvaRing had been on the market for two years, Organon had begun to
receive notice that users were experiencing a type of VTE called deep-vein
thrombosis (D.V.T.), the formation of blood clots in one or more deep veins,
usually in the legs. There were enough D.V.T.’s, Parisian asserted, that
Organon should have updated the launch label with “relevant warnings” in order
to be in compliance with F.D.A. rules. Denton focused on the fact that Organon,
according to Parisian’s report, handled these thromboembolisms as separate
spontaneous events documented in annual reports scattered over several years.
It did not highlight their occurrences or recalculate the incidence rate of
VTEs until its 2006 Expert Clinical Documentation report—a possible violation
of federal safety regulations, Parisian said. (A Merck spokesperson responds:
“Merck has provided appropriate and timely information about NuvaRing to
consumers and the medical, scientific and regulatory communities.”)
“It was classic,” said Denton. “That way, they
could keep their blinders on and say, ‘Yes, we reported it.’ ” Already,
Europeans were beginning to be concerned about NuvaRing. Denton understood that
he was about to enter a fierce battle over the NuvaRing label, similar to the
one he had just been through with Yaz. That fight had stretched on for years
and was resolved only with the publication of a report by Dr. Øjvind Lidegaard,
the Danish scientist, who is a specialist in the field of hormones and
contraception. Lidegaard’s study of Yaz forced Bayer to alter its label in
order to warn of possible increased VTEs.
A special
place in Shkolnik’s hall of shame had been reserved for the marketing
executives at Schering-Plough, who appeared to know that there were problems
with D.V.T.’s. Thomas Hadley, who supervised all the marketing from 2005 until
two years ago, was apparently aware of the increasing number of reports of
D.V.T. “Do we have anything for the reps to use to help direct the conversation
away from DVT? Didn’t we create a letter for them to use reactively?” he
e-mailed a colleague in October 2009, according to court documents.
Schering-Plough had an entire campaign geared to instruct representatives on
how “to nullify concerns about blood clot risks with NuvaRing,” the documents
allege. (Hadley, who is no longer with Schering-Plough, responded: “They have
gotten everything under discovery. I have nothing to do with it anymore. I have
no comment.”)
One “Field Flash” communication to sales reps
dated July 20, 2005, came from the marketing department. It explained how to
respond to doctors who raised questions about cardiovascular risks such as
blood clots with NuvaRing. In the suggested script, the sales staff was
instructed to point out that the risks of NuvaRing were “relatively small” and
that NuvaRing, unlike Ortho Evra, produced “a low and steady daily dose of 15
mcg EE and 120 mcg etonogestrel… Based on this information are you still
confident and comfortable in prescribing NuvaRing to your patients seeking
hormonal contraception?”
For
Shkolnik, the paradigm of troubling F.D.A. officials was Dr. Susan Allen, who
had been overseeing all birth-control products before leaving the agency to
work independently as a consultant. “So, guess who decides to retire? And right
in the middle of all of it? And guess
who her first client is? NuvaRing!” Allen was then making about $150,000 a
year, Shkolnik told me, and now far more, he believes. “She was hired within
weeks of leaving the F.D.A. I took her deposition, and in my opinion it was one
of the most disgusting displays of everything that is wrong with our regulatory
system.” Shkolnik was eager to get her on the stand. He imagined himself asking
her to explain the revolving-door ethics that allowed her, as an F.D.A.
official, to oversee the very company for which she would then be paid as a
consultant on how to handle the F.D.A. He wanted his moment when he
could say: “That doesn’t stink to you?”
In their lawsuits, the plaintiffs allege that
Organon was concerned about its “failure to report the rate of VTE in their
clinical trials to the FDA.” Who would be better to testify than the very
F.D.A. official who had focused on such problems? Susan Allen was hired to
assist Organon in the summer of 2006, as Paul Rheingold was starting to detect
the first signs of adverse events with NuvaRing. Dr. Allen is now Merck’s
expert on birth-control devices, on call to testify if any NuvaRing case comes
to trial. (Dr. Allen did not respond to requests for comment.)
Culling thousands of cases, Shkolnik and his St.
Louis colleagues focused on the science as well as the individual plaintiffs.
This form of litigation takes years to develop. For example, one case that
seemed ideal had to be disallowed
because the medical examiner had reportedly failed to mention that the teenager
who had died of an embolism was using a NuvaRing. Many were rejected
owing to possible complications from family medical histories. For the entire
time her daughter was in high school, the lawyer Kris Kraft, in St. Louis,
focused on the horrors of all the young women whose case studies were taken by
her staff; for instance, the 27-year-old who had had a headache and wound up
with a massive stroke, paralyzed in a long-term-care facility. Kraft had
photographs of her with her five-year-old child in the hospice where she
eventually died.
Two cases that haunted Shkolnik were the medical
student who, while unconscious in the hospital, was allegedly raped by an
orderly, and the teacher who had been in perfect health and now would probably
have to undergo painful daily injections of the blood thinner Lovenox if she
wanted to get pregnant again. That teacher will be the bellwether plaintiff if
the case isn’t settled and goes to trial, set for federal court in St. Louis in
April.
Her case will be the first one that Shkolnik and
his partners across the nation will take to trial in a form that is used mostly
for drug cases: state-consolidated,
multi-district federal litigation (MDL). The idea is that the lawyers split the
costs and the fees and bundle the cases together if they can get a federal
court to agree to combine them. The stampede to become the lead lawyers
for these trials often resembles “the mob on Black Friday who rush into Walmart
on the day after Thanksgiving,” according to David Berg. The payoff is irresistible—often
6 percent of the settlement total, before the individual lawyers collect their
own fees. The gamble, however, is huge. “Look, we spend millions on
this,” Shkolnik told me, “and none of this can be taken as a tax loss if they
don’t work.”
The
plaintiffs are not locked into any settlement that their confederation of
lawyers may come to before a trial. They are free to choose whether or not to
settle. Plaintiffs can try their luck in a state court if they can convince
a judge that there is merit in their case. That is risky. Last April, one New Jersey state judge dismissed
the cases of seven plaintiffs, some of whom were obese. According to
Paul Rheingold, the judge’s ruling was based on the fact that, while the
doctors involved seemed aware of the possible dangers, they still believed that
NuvaRing was safe.
The
Perfect Case
On December 1, 2011, Shkolnik was in his
conference room, glazed from hours of staring at thousands of pages of reports
from the NuvaRing science team he had assembled. On his computer he noticed an
e-mail forwarded to him from a partner, headed “Our Daughter Erika.” It was
from Karen and Rick Langhart. “Our 24 year old daughter was due to come home
for Thanksgiving last week. Instead we received a phone call.” Karen went on to
detail Erika’s harrowing struggle and final moments. “Our hearts are broken for
her and the life she will not be able to live.”
She continued: “We are not going to dishonor our
beautiful, amazing daughter by not putting up a fight on this. We already have
a nationwide network of family and friends that are ready and willing to do
whatever they can to help us with this fight. We are beyond angry at the drug
company that has promoted this birth control to young women KNOWING that the
change from the 2nd generation of contraception … to a ‘new, fashionable’ but
more dangerous form of birth control … shame on them. They obviously had to
know that lawsuits would be coming and simply ‘factored this in to their cost
of doing business’ at the expense of young women … knowing it would take years
to come to light. It sickens us. We also have researched and found out that
there will be a hearing of sorts by the F.D.A. with a panel of doctors and researchers
regarding 3rd and 4th generation contraceptives next Thursday and Friday in
D.C. Can we somehow attend and listen?”
Shkolnik was missing nights with his family
because of Merck’s latest attack—a series of grenades hurled by Reed Smith, the law firm representing
Merck, which contained dozens of motions challenging the credibility of
all of the plaintiffs’ expert scientific witnesses.
In order to shake up Merck’s scorched-earth
strategy, Shkolnik needed a perfect case, preferably an attractive young woman
in excellent health who had been afflicted and whose story would stand up in a
jury trial in a federal court. Within an hour of reading Karen Langhart’s
e-mail, Shkolnik’s partner Marc Bern replied, “Please call me. My condolences
and best wishes.” Bern, who had recently lost a son, was on a plane to Phoenix
the next day. “We are going to put your case on a fast track,” he told Karen.
“A rocket docket in Virginia federal court. You are going to have to be
strong—they will come at you and Erika hard. Are you sure you are up to it?”
“We are up to it,” Karen said.
If you
turn the legal kaleidoscope in one direction, you will see lawyers like Hunter
Shkolnik who represent victims of drugs as avenging knights, riding to the
cause of social justice against a pharmaceutical industry that has a history of
covering up internal documents. Turn it in the other direction and you will see
a horde of predators, attempting to bankrupt American business, advertising
blatantly on TV for clients.
Was Hunter Shkolnik any different from the mob of
lawyers who descended on Dow Corning in 1993? Dow Corning was a manufacturer of
breast implants that were thought by some zealous scientists to be causing
auto-immune and connective-tissue disorders. In 1990, CBS aired interviews with
women who thought the implants had caused their illness. Not long after that,
the F.D.A. called for a moratorium on silicone-gel implants, except for those
used in cancer-reconstruction cases. The move was a disaster for the company.
Two years later, a Mayo Clinic study found that there was no connection between
silicone implants and connective-tissue disease. But it didn’t matter: soon
after, Dow Corning filed for bankruptcy, owing to the legal expenses it had
incurred fighting off thousands of lawsuits. Patients and lawyers divided a
$3.2 billion settlement as a shudder went through the pharmaceutical companies
and their lawyers: how to prevent another Dow Corning?
“It is now a game of count the numbers,” the author Marcia Angell told me.
The former editor of The New England Journal of Medicine,
Angell has devoted the last decade to exposing the pharmaceutical companies’
abuse of corporate responsibility. She wrote a book about Dow Corning, which
she followed with the best-selling The Truth About the Drug Companies.
Angell, a doctor, described for me what she considers “the biased literature of
clinical trials. . . . Often the trials were done by perfectly respectable
academics. I would call
them up and say, ‘You are submitting a study of a drug, and there is no side
effect?’ And they would say, ‘The sponsor would not let us include that.’
I don’t think there was any real proof until the plaintiff cases started
showing up in the courts and the discovery material revealed the internal
documents.”
She continued,
“It is criminal what they
do. And yet none of the executives are in jail. In America, corporations are
thought of as people. And the only way you can harm them is to get money out of
them. But the billions they allot for these settlements rarely harm them. They
factor it as C.D.B.—the cost of doing business.”
The
Pharmaceutical Giant
Shkolnik and his partners knew that they would be
slammed with a war of attrition like the ones Merck had waged in the past,
masterminded by the company’s current chairman, Ken Frazier. In 1999, Merck
introduced Vioxx, a painkiller for arthritis. Early studies suggested that
Vioxx could cause heart attacks, but Merck allegedly did not release that
information to the F.D.A.
By contrast, when Merck’s former chairman Roy Vagelos
learned that Vasotec, a remedy for hypertension, could cause severe allergic
reactions, he called Dr. Eve Slater, a cardiologist by training, who later
supervised product safety for the company, and said, “Eve, get to the bottom of
it.” Slater told me recently, “We sent letters to every doctor in America and
ordered rapid new tests around the world. Our reaction time was months—not
years.” After Merck brought Vioxx to market in 1999, Slater moved on to become
a U.S. assistant secretary for health. “Merck is still run in the same way,”
she told me. “I have no doubt about that. This is not a case of the big bad
drug company.”
Yet soon after Vioxx was introduced, a blizzard
of adverse-event reports from users reached the F.D.A. Still, Merck would spend
hundreds of millions of dollars on marketing campaigns, including one that
featured Olympic champion Dorothy Hamill skating into the living rooms of
America as she touted Vioxx’s gift of 24-hour pain relief. Five years passed,
and thousands of Vioxx users died. (Merck would eventually pay claims to the families of 3,468 Vioxx users
who’d died of heart attacks or strokes,
without admitting Vioxx was to blame.) Dr. David Graham, a senior drug-safety researcher at the
F.D.A., told the Senate finance committee, “I would argue that the F.D.A., as
currently configured, is incapable of protecting America against another Vioxx…
Simply put, F.D.A. and its Center for Drug Evaluation and Research are broken.”
The news made page one of The New York Times. In the years that Vioxx
remained on the market, the company sold billions of dollars’ worth of it. When
the drug was finally pulled from the market, in 2004, Merck stock plunged 40
percent.
Vioxx changed the game for how drug cases are now
fought, and it made Ken Frazier’s career. The son of a janitor from North
Philadelphia, Frazier went to Harvard Law School on a scholarship. As analysts
predicted a $50 billion break-the-company fiasco for Merck with Vioxx, Frazier,
who was then the company’s general counsel, took on the tort bar and refused to
settle. The first case resulted in a big award for the plaintiff, but Merck
ultimately prevailed in 11 of the other 16 cases that went to trial. Later,
some of the wins were reduced or reversed on appeal. Merck still settled for $4.85
billion.
Up against the mass-tort bar, Big Pharma has made
the Vioxx strategy its business plan. It is, critics say, a rigged game in
which “the lawyers are always going to insist on their ‘vig,’ ” as columnist
Joe Nocera observed in The New York Times. But who else will stand up to
the pharmaceutical giants if not the army of plaintiffs’ lawyers, who can
marshal the many experts and the tens of millions of dollars needed to bring
suits?
Mothers
in Distress
Karen and Rick Langhart’s learning curve on
Pharma hardball started in Washington, D.C., in December 2011. In the days
after Erika died, they learned of an F.D.A. drug-safety advisory-committee
meeting to discuss the risks of blood clots with third- and fourth-generation
progestins. Drugs up for discussion included Yaz, Yasmin, and Ortho Evra. Karen
thought NuvaRing would also be on the agenda. A panel of experts had been
convened to give two days of testimony on new data concerning the safety of
using drospirenone, a type of progestin. Six weeks earlier the F.D.A. had
released its own report, commissioned from Kaiser Permanente.
That report, supervised by Dr. Stephen Sidney,
was ominous: of the nearly one million women studied, those using NuvaRing
long-term were 56 percent more likely to experience clots than those using
older, low-estrogen contraceptives. Families who claimed to have lost daughters
to Yaz, Yasmin, and NuvaRing demanded to speak. The atmosphere was fraught. The
F.D.A. had been excoriated in the press over the debacle of the Ortho Evra
patch. In 2008, court papers revealed that Johnson & Johnson, in The New York Times’s
phrase, had “obscured evidence” that one of its scientists had applied a
“correction factor,” claiming that users received 40 percent less estrogen than
the trial results had indicated. A few weeks earlier, then F.D.A. commissioner Andrew C.
von Eschenbach told the National Press Club, “The F.D.A. of the 20th century is
not adequate to regulate the food and drugs of the 21st century.” In
late 2005, the F.D.A. had ordered a black-box warning—one included in the
package—and sales of the patch eventually dropped by 80 percent. A subsequent
study showed that women on the patch ran as much as twice the risk of
developing clots.
Still, two years later, Johnson & Johnson was
extolling the safety of the patch. Karen later told me she felt she had
wandered into a scene from Alice in Wonderland, a kangaroo court where reality seemed scripted by
the drug companies. Karen says she and Rick requested a chance to tell
Erika’s history, but they
were denied. “The deadline has passed,” she says a committee staffer
told them. “My daughter happened to be dying in the I.C.U. I couldn’t
register,” Karen snapped. John McCain’s office had to intercede.
Arriving at the hearing, the Langharts found
themselves in a packed auditorium of drug-company executives, lawyers, and
scientists. One member of the panel, Dr. Sidney Wolfe, the head of the Health Research Group at Public
Citizen, a powerful consumer-advocate organization, had warned the F.D.A. for
years about the possible dangers of third-generation progestins. Two days before the panel
convened, he was stripped of his voting rights on the advisory committee. Wolfe
had served on the committee for three years, but he was disqualified from
voting because of his “intellectual conflict of interest.” Not so with
the other members of the panel, doctors representing elite institutions
including Harvard’s School of Public Health. Much to Karen’s dismay, NuvaRing
was not on the agenda.
Also
excluded from discussion was a report by Dr. David Kessler, the former head of
the F.D.A., who had been hired by plaintiffs’ lawyers to study Bayer’s Yaz and Yasmin. The report was
scathing, with evidence that Bayer had not disclosed adverse-event reports
about blood clots. Kessler summarized: “Bayer violated its duties under FDA
regulations and state law by selectively presenting data as to thromboembolic
events, which did not adequately inform FDA, doctors or consumers of the ...
risks, from pre-marketing to the present.” (Bayer, which has long defended the
safety of Yaz and Yasmin, did not respond to a request for comment.)
For two days, Karen sat through hours of
testimony from doctors declaring the safety of third- and fourth-generation
progestins. Finally, she was allowed to speak. She briefly told what had happened to Erika, then was
given a two-minute extension of her time. “Why are these third- and
fourth-generation contraceptives prescribed to young women when they are known
to have risks and there are safer, second-generation contraceptives out there?
We believe that our daughter would still be alive had the third-generation
contraception not been prescribed to her.” She mentioned a doctor who had
testified that there was no reason to prescribe these drugs: “Most telling, he
stated that, as a doctor, he would not allow his daughter to take third- and
fourth-generation contraceptions… My husband and I would really like to have
each of you ask yourself that question in some private time and give yourself
honestly that answer.”
The vote was 15–11 in support of the proposition
that “the benefits of DRSP [drospirenone]-containing oral contraceptives for
prevention of pregnancy outweigh their risks.” However, there were some
peculiar things about the vote. Several of the doctors who’d voted yes
expressed real doubts about the safety of the drugs and implied that they would
not prescribe them. Not long after that, The Wall Street Journal
reported that three of the voting F.D.A. experts had had direct
ties to Bayer. In a strongly worded letter of protest to Dr.
Margaret Hamburg, the F.D.A. commissioner, Dr. Susan Wood, of the Jacobs
Institute of Women’s Health, lambasted the bias and the “financial conflicts”
in the F.D.A. Closing her letter, she declared that she strongly believed
“lives will be saved if these oral contraceptives are removed from the market.”
That May, the Langharts flew to San Diego for the
annual meeting of the
American Congress of Obstetricians and Gynecologists (ACOG). Each year,
thousands of doctors from around the country fill a convention hall to hear the
latest Pharma breakthroughs. For Karen, walking into the convention center was
excruciating; it was the first time she had seen drug companies showing their wares in the bazaar and
scores of salesmen in booths, pushing pills to the doctors. “It was our
first real understanding of how the medical community is intertwined completely
with the pharmaceutical companies.” At a Merck booth, she filmed a
representative who insisted that “NuvaRing has the lowest dose of estrogen out
there.” The booth featured a large poster with a young blonde holding a
NuvaRing in her hand. The model looked eerily like Erika Langhart. “I’ve heard
there are risks of spikes of estrogen because of the delivery system,” Karen
told the rep. “No, no, completely steady,” the rep said, and proudly informed
Karen that she had worked for the company for years.
More than 5,000 gynecologists and obstetricians
attended the meeting in San Diego, and Karen wondered if the doctor who had
prescribed the NuvaRing to her daughter in the summer of 2007 was in the crowd.
“Erika came home that day and said, ‘Mom, my doctor said that this is a product
that will be so easy. I only have to change it once a month. And he gave me samples.’
” Remembering that day, Karen wept. “I will never forgive myself for not
checking it out on the Web. It didn’t occur to me. Erika was always so
meticulous about everything she did.”
Karen wore a nametag that read: KAREN LANGHART, M.D. To everyone
she spoke with, she explained that M.D. stood for “Mother in Distress.”
Merck’s strategy at ACOG was to present its study of NuvaRing’s safety, funded
by the company in response to Kaiser Permanente’s F.D.A. study, which had
triggered the December hearing. The presenting doctor, a handsome German,
wasn’t the paper’s author. “He identified the study as paid for by Merck,”
Karen, who took careful notes, told me. “At the end of this talk, he said,
‘Therefore, a twofold risk for NuvaRing can be excluded.’ ” In fact, Merck’s
study claimed there was no increased risk of clots from NuvaRing over combined
oral contraceptives. The Merck paper won first place, Karen said.
In her hotel room in San Diego, Karen got an
e-mail from Hunter Shkolnik, who said he had navigated Erika’s case out of the
bog of St. Louis and filed it in a California state court. He had filed against
Merck and the McKesson
Corporation, the largest distributor of prescription drugs in North America.
According to the plaintiffs’ claim, McKesson, based in San Francisco, would have to show that its delivery systems
of cargo trucks and planes had kept the NuvaRing temperature-controlled.
The case had been quickly accepted by the
California Superior Court. McKesson was served first and Merck within a week.
“There will be a quiet period with nothing to report to you for months,”
Shkolnik wrote Karen. “When I have new information I will update you.” She
responded, “Thank you for this update, Hunter, we appreciate it. Do you ever
sleep?” If it goes to
trial, Erika Langhart’s case will be heard in late 2014, at the earliest. Megan
Henry’s case will be a part of the St. Louis litigation, if it ever goes to
trial. Settlement talks are now under way.
The day after he told Karen about the McKesson
suit, Shkolnik was stuck in an airport when he got a call from his St. Louis
co-lead counsel, Roger Denton. “Are you on the Web?,” Denton asked him. “Have
you seen the new study
that has just come out of Denmark?
”Independently, a group of Danish scientists, including Dr. Øjvind Lidegaard, had spent years
examining the health records of more than a million women who used patches or
NuvaRing. The results
broke in B.M.J. The statistical analysis indicated that women using
NuvaRing were more than six times as
likely to experience blood clots as those who did not use hormonal
contraceptives.
Later, Denton would look back and call this the
eureka moment. He believed, he told me, that Dr. Lidegaard was such an
impeccable researcher that finally the F.D.A. would have to get involved, as it
had when Dr. Lidegaard weighed in on Yaz. Denton knew there would be jockeying
behind the scenes, the usual arm-twisting and fighting within the F.D.A. as
Merck resisted any stricter warning that could affect sales. But surely, he
felt, the F.D.A. would do the right thing, as it had with Yaz. A label change
could also end litigation against NuvaRing. At the moment there were roughly
3,500 cases—a relatively small number compared with the more than 13,000 that
had been filed against Bayer over Yaz and Yasmin. But now, perhaps, there could
be a settlement, as well as a warning for doctors and patients.
During the summer of 2012, Karen and Rick
and Kyle, their 23-year-old son, took to the road with Erika’s Saint Bernard
and traveled more than 5,000 miles in the national parks of America. It was
Karen’s idea to try to deal with the family grief by means of long hikes in the
redwoods. Pulling into a small town in Oregon, she noticed a paperback copy of a book by
Dean Koontz on a rack in a small grocery store. The novel spoke so
directly to her that she wrote a long letter to the author, explaining how
moved she had been by it and what had happened to her daughter. Koontz promptly
responded. “I receive much fine mail from readers,” he wrote, “but none more
moving than your lovely and exceptional letter.” Koontz explained how the wife of someone close to
him had suffered two strokes. She too was on NuvaRing.
In my last conversation with Megan Henry, she
mentioned that she was almost back to normal and was training again. She will have a much higher risk
of blood clots for the rest of her life, she said, and if she gets pregnant she
will likely have to go on a painful regimen of injections of Lovenox to prevent
clots. She will never be allowed to use any kind of hormone therapy.
In the initial response to my e-mails and phone
calls requesting an interview with Merck chairman Ken Frazier or one of the
company lawyers, a pleasant Merck employee named Lainie Keller asked how the
company could be helpful. When I explained that I was focusing only on
NuvaRing, she said she understood magazine deadlines and would get back to me
soon. Two days later, I received an e-mail from her. “Ken Frazier and our other
colleagues are not available to participate in this opportunity,” she wrote,
and she directed me to several Web sites, including ACOG’s and Merck’s, “to
help provide perspective.” At the end of the e-mail, Keller included Merck’s
official statement: “Blood clots have long been known as a risk associated with
combined hormonal contraceptives. The FDA-approved patient information and
physician package labeling for NuvaRing include this information. . . . We
remain confident in the safety and efficacy profile of NuvaRing—which is
supported by extensive scientific research—and we will continue to always act
in the best interest of patients.”
All this summer and fall, the wrangling went on
behind the scenes over the Lidegaard study of NuvaRing. Early in October, as
Denton combed the Internet for developments, he got an alert that the F.D.A.
had approved changes to the NuvaRing label. Merck had included certain results
from the Kaiser study and Merck’s own study but had not included the Lidegaard
study. On his way to Ibiza for a long-delayed vacation, Shkolnik struggled to
make sense of this. Soon after he landed, he learned that Merck Canada had
indeed already changed its label and included the warnings from Lidegaard. That
was, for the plaintiffs’ team, enough to indicate that the F.D.A. had given in
to what seemed like pressure from the American drug companies. But for the
warriors of mass tort, the newest development was significant. The lack of a
stricter warning could extend the battle. In fact, the Merck Canada decision
might ironically turn out to be a plaintiff’s lawyer’s dream. Shkolnik could
hardly wait to get all that into an argument.
Thousands of cases are now being settled on
behalf of plaintiffs who say they were stricken with clots after using Yaz or
Yasmin. In the United States, more than 13,000 cases were filed against Bayer.
There have been at least 100 alleged deaths. The F.D.A. came down hard on
Bayer. “These sorts of stories usually appear in the business section,” the
mother of a 31-year-old Sony executive who had died in childbirth, allegedly of
complications from having taken Yaz, wrote me during my research. “They never
seem to have a ‘face.’ The real face is very beautiful, only 31, highly
accomplished, and will never age.”
