Evelyn Pringle September 22, 2006
According to Johnson & Johnson's latest SEC filing for the Second Quarter of 2006, the company is currently facing 500 claimants in lawsuits related to deaths and injuries caused by the Ortho Evra birth control patch.
"These claimants," the filing notes, "seek substantial compensatory and, where available, punitive damages.
However, the company's filing does not disclose any of the settlements of cases reported over the past nine months in the press, and does not identify any financial reserves that are set aside to pay the settlements.
Legal analysts say the 500 claims are just the tip of the iceberg, because there are thousands of young women all over the country who have suffered blood clots, heart attacks and strokes who are still unaware of the culprit. And it logically follows, they say, that many families have lost a daughter, sister, wife, or mother who also do not know that the patch is to blame.
In 2005 alone, doctors wrote more than 9.4 million prescriptions for the Ortho Evra patch, according to IMS Health, a pharmaceutical industry-tracking firm.
Attorneys handling these lawsuits say J&J knows these cases are easily winnable because unlike most other cases involving a specific drug, there are no preexisting conditions with women in this age group and the kind of deaths and injuries brought on by the Ortho patch are virtually unheard of in teenagers and young women of childbearing age.
For that reason, J&J has adopted a strategy to settle as many lawsuits as quickly and quietly as possible. The company has obviously taken the position that the deaths, injuries and settlements with these women are just a necessary expense of doing business in the name of profits.
One thing's for sure, the company is not about to remove the mega-buck patch from the market and lose billions of dollars in future sales.
In fact, many of the lawsuits have already ended in confidential settlements with barely a peep of coverage in the mainstream media. And for others cases, Johnson & Johnson has made it abundantly clear to opposing attorneys that the company is eager to cut a deal.
The New York Post was about the only major newspaper to cover the story about the payoffs. On April 9, 2006, it reported that women "who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch are receiving cash settlements from the manufacturer."
"Ortho-McNeil Pharmaceutical," the Post said, "has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending."
One lawyer who asked not to be identified told the Post that the company had been "approaching everyone" representing women, and that lawyers had begun submitting cases for settlement.
During its investigation, the Post used the FOIA to obtain FDA records that showed that 17 women between the ages of 17 and 30, who had used the patch, had died from unlikely causes in view of their age group, of heart attacks, blood clots, and possible strokes, since August 2002.
Scores of other women on the patch, the Post reported, had suffered other complications including 21 life-threatening cases of blood clots and other ailments.
Doctors who reviewed the reports voiced alarm over the number of fatalities. "This is a cause for concern," warned Dr John Quagliarello, a professor of obstetrics and gynecology at NYU Medical Center.
He and other doctors said that the discovery by the Post was the first they had ever heard of multiple deaths linked to the Ortho patch.
Critics also point out that these records do not accurately portray the number of women injured by the patch because according to the FDA, at best, only 10% of all adverse events get reported to the agency.
In attempt to manage the mounting number of lawsuits filed in federal courts, on March 1, 2006, the Judicial Panel on Multidistrict Litigation issued a transfer order to consolidated the pre-trial proceedings of 13 federal lawsuits filed by plaintiffs in different states, along with 54 potentially related actions pending in multiple federal districts.
The Panel assigned the cases to US District Judge, David Katz, of the Northern District of Ohio, in part, because he was already handling the first federal Ortho patch related lawsuit.
That move seemed to push J&J toward settling even more cases out-of-court. On May 2, 2006, at the very first status conference in the Ohio court, Johnson & Johnson attorney, Robert Tucker, informed Judge Katz that the company was prepared to settle cases with plaintiffs who were hospitalized for heart attacks, stroke, pulmonary embolisms or deep vein thrombosis, according Charles Toutant, in the May 16, 2006 New Jersey Law Journal.
Attorney, Ellen Relkin, a member of the plaintiffs' executive committee for the federal case, told the Journal "many of these cases are seven figures, many are probably substantial six-figure cases."
"It's not like a Vioxx, where you have clients in their 50s, 60s, 70s," said attorney, David Eisenbrouch, who represents plaintiffs. "You're dealing with primarily very young women, and J&J would rather cut its losses," he told the Journal.
Also on May 2, 2006, in a coordinated blitz, another Johnson & Johnson attorney, Susan Sharko, sent a letter to New Jersey Judge, Peter Bariso, to inform him that she had reached confidential settlements with 11 of the 12 plaintiffs involved in litigation in New Jersey.
An important point to keep in mind according to legal experts, is that as J&J quietly settles all these cases out-of-court with little or no fanfare, by design, the time limits for filing a lawsuit are slowly but surely ticking away for many persons who may have no idea that the Ortho Evra patch is the cause of an injury or death.
The applicable statute of limitation vary from state to state and in some states a personal injury claim might need to be filed within 3 years from the date an injury is diagnosed, while a wrongful death claim might need to be filed within 2 years from the date of a death. In some states, experts say, the time may be as short as 1 year from the date of diagnosis or death.
On May 13, 2006, the LA Times did get around to reporting that J&J had entered into confidential settlement agreements with about 30 women, quoting a plaintiff's attorney, Ray Chester, who negotiated the agreements in cases filed in state courts in New Jersey, Texas and California, and federal courts in North Carolina and Pennsylvania.
"Johnson & Johnson is going to lose most of these cases," Mr Chester said in the Times. "The cost to defend them and the public relations hit they would take if they tried the cases," he stated, "has tilted them toward settling."
"It is abundantly clear," Mr Chester added, "that the patch causes more clots than the pill."
Its all good and well that the Times published this story but the reporting is old news, because according to Mr Chester, J&J began settling these cases back in January which means the company was somehow able to conceal the fact that it was in essence admitting guilt in 30 cases, for about 5 months.
One case that was settled with a confidentiality agreement involved the first fatality attributed to the patch in the media which occurred on April 2, 2004, when 18-year-old Zakiya Kennedy collapsed in New York City while waiting for the subway.
The people who did catch the story about this 18-year-old dying so suddenly the few times it appeared were not surprisingly shocked. An autopsy revealed the cause of death was a blood clot called a pulmonary embolism that had moved to the lung as a direct result of using the Ortho Evra patch, the coroner ruled.
The New York Post was about the only major newspaper that covered the story in-depth.
But several months after the event, on September 23, 2004, Ms Kennedy's father and grandmother were interviewed by ABC News and said the young woman had experienced symptoms but did connect them to the patch or take them seriously. "She was complaining about her head was hurting - she felt pain in her leg and she had felt dizzy," her father recalled.
"She was complaining about pains in her leg or in her shoulder," he said. "She thought it was from her exercising."
Roberta Alloway, Ms Kennedy's grandmother, said the drug company should be warning people about the lethal side effects of the patch. "They need to really let people know that my granddaughter and other people have died from this patch," she told ABC news.
"I can't bring her back," she said. "But I want something to bring attention to these young women."
Notwithstanding the high statistics of death and serious injuries revealed by the New York Post based on the FDA's own database, it would take nearly 20 more months for the FDA to force J&J to add a warning to the label of the Ortho patch to alert women about the risk of blood clots, strokes, and heart attacks.
On November 11, 2005, the day after the waning was announced, Dr Sanjay Gupta, CNN's senior medical correspondent, predicted on CNN that the warnings would probably, at a minimum, "mean a complete redesign of the patch so it doesn't deliver as much estrogen and doesn't put women at greater risk for blood clots."
"Or," he stated, "it could mean the demise of the patch altogether."
Unfortunately, neither occurred and as a result, thousands more young women have died or been injured needlessly.
According to J&J at the time, the injuries and deaths with women on the patch were "consistent with the health risks" of the birth control pill, which "kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29."
However, that assertion was proven to be a bold-faced lie on the part of Johnson & Johnson, by FDA reports obtained by the Associated Press under the FOIA, that showed that in 2004, when 800,000 women were using the patch, the risk of a woman dying or suffering a survivable clot while on the patch was three times higher than women using birth control pills.
In fact, the records show that back in 2000, the FDA scientist in charge of reviewing the pre-approval clinical trials submitted on the patch, warned FDA officials that blood clots could be a problem if the device was approved.
While reviewing the trials, the scientist discovered that two of the 3,300 women using the Ortho Evra patch had been treated for blood clots that had traveled to their lungs. J&J argued that one of the two women should not be counted because she had underwent surgery, but the FDA reviewer, using capital letters to emphasize the point, disputed that argument stating:
“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases...” “The incidence rates quoted by the sponsor may be misleading.”
The reviewer also said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.”
The official specifically said the professional product labeling and information written for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”
In addition, he expressed concern about the fact that 211 women out of 3,088 had gained 10 or more pounds during the trials and noted that the effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds.
The scientist also said that it would be important to study patch users for clot problems after the patch came on the market.
The reviewer might as well have been talking to himself, because when the device was approved, there was no warning on the label about the risks he identified and no requirements for post-surveillance studies other than routine monitoring of the adverse event reports from consumers, doctors and the drug makers.
The Associated Press also reviewed what had happened since the Ortho Evra patch arrived on the market in 2002, and determined that deaths of women on the patch appeared to be at least 3 times higher than women on the pill.
Under the FOIA request, the FDA released approximately 16,000 adverse event reports associated with the patch ranging from a mild rash to death. Within these reports, the AP found 23 different deaths associated with the patch and the doctors who reviewed the 23 deaths, found about 17 to be clot related.
But even after these reports became public, J&J continued to claim that none of the deaths could be directly attributed to the patch.
Nine months after the article in the Post about the 18-year-old women dying in the subway, a glimpse at the truth about the patch occurred in October 2004, when the first lawsuit was filed in Austin, Texas, on behalf of a paralyzed woman who suffered a stoke after only 12 days on the patch.
The lawsuit listed FDA records that showed forty-six women who were on the patch had suffered blood clot related injuries or death in a 1-year period between May 1, 2002 and April 30, 2003.
In the same 12 months, the lawsuit said, only half as many women taking birth control pills had developed clots even though there were six times more women on birth control pills.
Comparatively, the lawsuit alleged, 11 times more fatal or life-threatening clots were suffered by women on the patch when compared to women taking the pill.
On July 25, 2005, CNN reported on a lawsuit filed in New Jersey, on behalf of 10 women, who alleged the Ortho Evra patch had caused them to suffer blood clots and strokes.
The plaintiff's attorney told CNN that the women listed in the lawsuit were all between 18 and 47-years-old, from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma.
The plaintiffs had all suffered debilitating long-term health problems as a result of using the patch. Plaintiff, Amanda Bianchi, 19, developed a 10-inch blood clot in her brain, which doctors said was a direct result of the patch she used for 3 months in 2004, and according to the complaint she had suffered two strokes.
"I don't want any other woman to have to go through what I'm going through," Ms Bianchi told CNN. "It's not fun to have to get up and not be able to go to school and live the life that you were living," she said.
When contacted by CNN, sticking to its guns, J&J repeated its usual mantra of denial in a written statement saying, "The types of adverse event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra product level."
And a spokeswoman for the industry owned FDA, did the same. She totally ignored the FDA's own database statistics to the contrary and told CNN:
"The risks of using this product are similar to the risks of using birth control pills, including an increased risk of blood clots, heart attack, and stroke. The data is not precise enough to tell whether there is an increased incidence (with the patch)."
In September 2005, a federal lawsuit filed in New Jersey on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the patch for seven months, laid out the facts as to what J&J knew and when and exactly what the FDA knew and when as well.
The public filing of the information contained in this lawsuit, and more of the same that soon followed, no doubt contributed greatly to J&J's desire to quickly and quietly settle as many cases possible as soon as they were filed.
Lydia Lilly, a Georgia woman, claimed J&J marketed the Ortho Evra patch for financial gain while failing to warn consumers and doctors about the company's known risks of blood clots and other injuries.
According to the complaint, before the patch was approved on November 20, 2001, the only studies specifically conducted to examine the effect of the patch on humans were Phase III clinical trials funded and conducted by the drug makers.
As it turns out, the incidence of embolisms and thrombotic injuries in those trials was about six times greater with the patch than the incidence of similar adverse events in women who used a widely prescribed class of oral contraceptives.
Yet the package insert that accompanied the Ortho patch when it was placed on the market stated, "the contraceptive patch is expected to be associated with similar risks" to those of other hormonal contraceptives.
The package insert also stated "there is no epidemiological data available to determine whether safety and efficacy with the transdermal route of administration would be different than the oral route."
And as far as what the FDA knew first-hand, according to the lawsuit's complaint, during a 17-month period between April 2002 and September 2003, the FDA logged 9,116 reports of adverse events due to of the patch.
A number significant, the lawsuit states, because over the 6-year time period between November 1997 and September 2003, there were only 1,237 adverse event reports from women taking the leading oral contraceptive. The number is also highly significant because almost six times more women when used the pill.
In addition, according to the complaint, around the time J&J introduced the Ortho Evra patch to the market, the patent for its oral contraceptive, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue by getting the patch on the market.
More news of J&J's intentional suppression of the facts related to the dangers of the patch hit the airwaves on November 2, 2005, when CBS News broke the story that the company's own records revealed during litigation showed that between April 2002 and December 2004, the company had received some 500 reports of serious problems associated with the patch.
The records also showed that during the same time frame, the company had only received 61 adverse event reports for women on birth control pills.
In addition, CBC reported that there were four times as many strokes in women using the patch even though there were three times as many women taking the pill.
Overall, CBS said, the evidence indicated that in medically confirmed cases the risk of blood clots was 14 times higher with women using the patch.
On November 11, 2005, the Associated Press dropped another bomb by reporting that J&J knew about the higher death and injury rates of women on the patch all the long and had in fact, had refused to conduct additional testing on the patch because it was afraid of the results.
AP reported that documents "released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill."
"In addition," the AP said, "an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was 'too high a chance that study may not produce a positive result for Evra' and there was a 'risk that Ortho Evra may be the same or worse than Ortho-Cyclen.'"
From that point on, lawsuits filed included this newly reported information.
In light of all the damaging stories in the press during the fall of 2005, critics say its not that difficult to figure out why Johnson & Johnson was in a rush to start settling cases in January 2006, but at the same time, they say, the stories also made many more women aware of the type of injuries that are associated with the patch.
While J&J may have settled 30 cases in January as reported by the media, any sense of relief was short-lived because on January 30, 2006, the Madison St Clair Record, reported that J&J had been hit with seven brand new federal lawsuits on January 23, 2006, in the Southern District of Illinois, each seeking damages in excess of $75,000.
And since January 2006, the steady filing of lawsuits has continued unabated, with each new case usually accompanied by a press release.
On May 12, 2006, Knight Ridder reported the case of 20-year-old nursing student, Kristin Ribakusky-Templin, who experienced what started as a dull ache in her leg that within two weeks turned into shooting pains leaving her unable to walk and sent her to the emergency room where doctors found multiple blood clots deep in the veins of her lungs and leg.
The culprit, the doctors told her later, was the birth control patch she had been dutifully sticking to her body once a week for less than two months.
"The patch is still on the market," Knight Ridder noted.
In New Jersey, where 37 cases have been filed, the articles states, "the stories are hauntingly similar: An otherwise healthy Georgia woman develops a pulmonary embolism; a Maine woman suffers from a blood clot in her right lung; a 12-year-old girl in Indiana is diagnosed with deep-vein thrombosis, just like Ribakusky-Templin."
On May 18, 2006, a lawsuit was filed in New Jersey, on behalf of the family of a 17-year-old who suffered a stroke and died in August 2004 after using the Ortho Evra patch for approximately four months.
In a press release, an attorney from the firm handling the case said, "This is one of the saddest cases I've been involved with."
"This was a sweet 17 year old girl," he stated, "This shouldn't have happened and Johnson & Johnson and Ortho McNeil must be held accountable."
On September 5, 2006, a Drug Newswire press release reported the latest federal lawsuit filed in Texas by a 24-year-old woman who suffered a miscarriage and developed life-threatening blood clots after using the patch.
According to the lawsuit, in 2004, Elizabeth Barroso, began experiencing chest pains and difficulty breathing after using the patch for three weeks and spent eight days in the hospital where doctors treated her for blood clots in her lungs.
Upon release from the hospital, Ms Barroso was placed on blood thinning drugs for 10 months. She became pregnant in October 2004, but later suffered a miscarriage.
In 2005, she became pregnant again and was forced to endure daily injections of blood thinners to prevent another miscarriage. Due to her injuries, all of Ms Barroso's future pregnancies will carry a risk of miscarriage and will require similar treatment.
"This young lady's life was put in jeopardy by a company that made a harmful product," her attorney said in the press release. "And the tragic thing," he stated, "is the company continues to market and sell this product even today."
An interesting statistical allegation in this latest lawsuit, says that from April 2002 to December 2004, Johnson & Johnson logged 27,974 adverse events among Ortho Evra patch users when during that same time period, the company noted only 5,571 adverse events for one of its oral contraceptives, even though the pill was used three times more than Ortho patch.
Patch related lawsuits are also being filed in other countries. On July 28, 2006, a class action was filed in Canada alleging that the drug makers failed to adequately warn consumers and doctors that the Ortho Evra patch was associated with an increased risk of developing blood clots, pulmonary emboli, strokes, heart attacks and deep vein thrombosis.
With any luck, now that the media has come out of hibernation, all of the women who have been injured by the birth control patch will hopefully at least know what happened.