Below are some recent news stories about the birth control patch Ortho Evra:
Chief Medical Officer Blows Whistle On Johnson & Johnson
Patterson Times
PATERSON, N.J. (CN0 Johnson & Johnson subsidiary Ethicon fired its chief medical officer because of his insistence that unsafe medical products be recalled, Dr. Joel Lippman claims in Middlesex County Court. Lippman claims that during 15 years in high ranking medical positions at Ethicon and Ortho McNeil, another J&J subsidiary, Johnson & Johnson repeatedly released or refused to recall dangerous products to which he objected, including the Ortho Evra birth control patch and Intergel. Both products have spurred numerous product liability lawsuits. Lippman says he objected to the release of the Panacryl suture, "whose use resulted in numerous adverse events," but Ortho released it anyway and continued to receive reports of "adverse events." He says he objected to the release of ProCeed, a "mesh product," but Ortho released it anyway, until the FDA forced a recall. He says he told Ethicon it must inform surgeons that an endoscopic applicator leaks chromium during use, but Ethicon refused. He says he was fired less than a month after insisting that Ethicon recall a product called DFK24, used in heart bypass surgery, because its tip fell off and had to be fished out of the aorta.
Lippman has been an assistant professor of obstetrics and gynecology at Tufts, director of the clinical development division of medical affairs for Wyeth Ayerst Laboratories, and worked for Ortho McNeil from 1990 to 2000, leaving that company as vice president of clinical trials.
He worked for Ethicon from July 2000 until May 15, 2006. He got his M.D. at New York Medical College and has a Master's degree in public health from Harvard.
He claims that from 1998 to 2000, his last two years at Ortho, he "raised serious health concerns about two pharmaceutical products: Ortho Prefest, a hormonal menopausal product, which did not have adequate safety data to prove that it protected against uterine cancer as did other therapies, and the Evra patch, which released dangerously high levels of estrogen into patients."
Lippman claims, "The clinical research had revealed that the estrogen dose released by the Evra patch as a means of birth control may increase the risk of deep venous thrombosis and pulmonary embolisms."
Ortho faces hundreds of lawsuits making precisely those claims including 12 filed Tuesday in Newark Federal Court.
Lippman says he "advised Ortho that it should conduct further research to understand the impact of the hormones released by the patch and if necessary modify the package insert before introduction to the marketplace. (But) Ortho disregarded Dr. Lippman's concerns andlaunched the product. J&J transferred Dr. Lippman to Ethicon in 2000, shortly after Dr. Lippman made his complaints about the menopausal product and the Evra patch."
Soon after joining Ethicon in July 2000, Lippman says, he objected to the release of its "Corlink" device because data showed it "caused occluded arteries". He says he also objected because of the "lack of adequate studies to justify the product's release" and because a competing company had released a similar product, which had to be recalled and resulted in "numerous product liability suits." Lippman says his boss told him that "if he continued to oppose the launch of Corlink, his action could affect his bonus and standing with the company." His bonus could be as much as 50 percent of his annual salary, the suit states.
Lippman says that in 2002 he "insisted on the recall of a product known as Intergel" which "had caused serious injuries and was related to a number of deaths."
Intergel also has been the basis of numerous product liability suits, which claim the product spreads infection during surgery, rather than prevent it.
Lippman says that he demanded for more than a year that Intergel be recalled, and that after "a decision to recall the product was made," he was summoned to the officer of Michael Dormer, "Chairman of Medical Devices and Diagnostics for J&J in New York City," where Dormer and four attorneys attacked him "for the decision to recall Intergel".
Lippman claims he also objected to the release of Panacryl, "a suture whose use resulted in numerous adverse events," and ProCeed, a "mesh product." He says that despite his objections, Ethicon refused to recall Panacryl "and Ethicon continued to receive reports of adverse events." And he says, "The FDA later required Ethicon to recall ProCeed."
He says Ethicon ignored his advice, in late 2005, to warn physicians that a device called FS2 was not sterile because of two holes in it. In response, he says, "a member of Ethicon's Quality Assurance Board stated that `surgeons are like five year olds. We need to control what is said to them.'"
He says he learned in April this year that an endoscopic applicator "was leaking chromium, a toxic heavy metal," and that he "insisted that Ethicon notify physicians who had used the applicator during recent clinical usage that the applicator oozed chromium during use. (But) Ethicon ignored his objections."
And in the case that he claims led directly to his illegal firing, Lippman says that by April this year he had received three complaints that an Ethicon arterial cannula called DFK24, a life sustaining device used in heart bypass surgery, lost its tip during surgery, and had to be retrieved from the patient's aorta. He says he and the vice president of medical operations, a cardiac surgeon, decided in April that the DFK 24 must be recalled because "the risk of serious injury or intra operative death was very high." Ethicon's Quality Assurance Board decided to recall it on April 14, but Ethicon refused, and still had not recalled it when it fired him on May 15, 2006"
500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson
Evelyn Pringle
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.
Ortho Evra Birth Control Patch
Statistics do not Lie News
Dallas, TX: During one 17 month period between April 2002 and September 2003, the FDA received 9,116 adverse reaction reports on the Ortho Evra birth control patch.
In stark contrast, during a 6 year period between 1997 and September 2003, the Ortho birth control pill only generated 1,237 adverse event reports and 6 time more women were using the pill.
Since the FDA admits that it only receives adverse event reports on between 1% and 10% of the actual adverse events that occur, the death and injury rate for patch users is known to be many times higher than the numbers indicate in the FDA database.
Although patch maker, Ortho McNeil Pharmaceutical, and its parent company, Johnson and Johnson, have continuously denied any knowledge about problems with the patch, according to CBS News, documents have surfaced in litigation that show the company's own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.
During the same time frame, CBS notes, there were only 61 adverse event reports received with respect to all types of oral contraceptives. In addition, there were four times as many strokes in women using the patch compared to women using oral contraceptives even though once again, there were three times more women taking the pill.
Finally, CBS said, the evidence indicates that in medically confirmed cases the risk of blood clots was 14 times higher with the patch.
The first lawsuit involving the patch filed in Texas in October 2004, on behalf of a woman who suffered a stoke and became paralyzed after wearing the patch for only 12 days, cited FDA records that revealed that in one year, between May 1, 2002 and April 30, 2003, forty six women who were using the patch had suffered blood clot related death or injuries.
In the same time period, the lawsuit said, only half as many women on birth control pills had suffered clots even though here too, there were 6 times more women taking the pill. In addition, the lawsuit said, 11 times more fatal or life threatening clots were developed in women on the patch when compared to those taking the pill.
Notwithstanding all of the above statistics gathered over 3 years, the FDA waited until November 11, 2005, to announce an addition to the patch label warning women who were using the patch that they were being exposed to 60% more estrogen than women on birth control pills. The FDA noted that exposure to higher levels of estrogen increased the risk of serious side effects. Adverse effects of estrogen use include blood clots in the legs or lungs as well as heart attack and stroke.
"In general," according to the Mayo Clinic, "the higher the amount of estrogen you're exposed to, the greater your risk of serious side effects."
Most recently, on September 20, 2006, the FDA announced an update to the Ortho Evra patch label based on the results of two epidemiology studies, both paid for by the patch maker, Johnson and Johnson, supposedly designed to evaluate the risk of serious side effects, specifically due to venous and arterial blood clots in women using patch.
Although both studies were conducted using electronic health care claims data, the two studies produced different results.
According to the FDA, the first study found that the risk of non fatal venous thromboembolism (VTE) events associated with the use of the patch is similar to the risk associated with the use of oral contraceptive pills.
But the results of the second study, which included a review of patient charts, showed an approximate 2 fold increase in the risk of medically verified VTE events in users of the patch compared to women using of the pill.
The above statistics documenting the much larger number of cases of injury and death in women on the patch compared to the pill do not lie.
To begin with, by its own admission, J&J will not design a head to head clinical trial that might show the patch to be more dangerous than the pill. On July 18, 2005, the Associated Press, reported an internal company memo authored in 2003, that showed the company refused to fund a study comparing the Ortho patch to the company's Ortho Cyclen pill because there was "too high a chance that study may not produce a positive result for Evra" and a "risk thatOrtho Evra may be the same or worse than Ortho Cyclen."
The Associated Press also reported that company documents showed that the drug maker itself had been analyzing the FDA's death and injury reports.
Critics say the FDA's latest warning is basically meaningless. "This announcement unfortunately is too little, too late for many women who relied on this dangerous product," says Attorney John David Hart of the Law Offices of John David Hart in Fort Worth, Texas, who is handling patch related lawsuits.
"While these new warnings are a step in the right direction," he says, "the simple truth is that a lot of women are hurt today because they were not fairly warned."
According to a press release by Attorney Hart, from April 2002 to December 2004, Johnson & Johnson in fact logged 27,974 adverse events among Ortho patch users, and during that same time period, the company recorded only 5,571 adverse events for one of its oral contraceptives, even though the pill was used by three times more women than were using the patch.
Other legal experts involved in patch litigation express the same sentiments. "The notion that periodic warnings of Ortho Evra's increased risks is sufficient to protect the health of women is misguided," says Jason Mark, an attorney at Parker & Waichman, LLP who heads the firm's mass tort litigation department.
"There are many safer alternative forms of hormonal contraception than the patch," he said in a press release. "This is not a last resort, life saving medication."
"The product needs to be withdrawn from the market," he says, "so that it can no longer cause harm."
The legal team for J&J is doing everything in its power to avoid jury trials in patch cases where experts predict the juries would rule for the plaintiffs and the truth about all the suppressed adverse event reports and other damaging information would become public.
Attorneys handling the patch cases say the cause of the injuries and deaths from the patch are more clear than those in other pharma cases. "You're dealing with primarily women ages 18 to 35 who don't have a lot of pre existing conditions to begin with," a lawyer who is working with a South Carolina law firm on a dozen cases told Knight Ridder on May 12, 2006. "The reason why people are getting the blood clots," he said, "is a lot cleaner."
On April 9, 2006, the New York Post 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 wrote, "has settled a dozen lawsuits for millions of dollars in the last few months."
On May 16, 2006, the New Jersey Law Journal reported that Johnson & Johnson had "adopted a quick settlement strategy for a spate of suits charging that its Ortho Evra contraceptive patch causes blood clots due to heightened estrogen levels."
At a May 2, 2006 status conference with US District Judge David Katz in Cleveland, Ohio, where 73 cases from around the country have been consolidated, the Journal said, a J&J attorney announced that the company is prepared to settle all cases with plaintiffs who were hospitalized for stroke, heart attacks, pulmonary embolisms or deep vein thrombosis.
The same day, according to the Law Journal, J&J lawyer, Susan Sharko, wrote a letter to Superior Court Judge, Peter Bariso, in New Jersey informing him that the company had reached confidential settlements with 11 of the 12 plaintiffs who sued there.
On May 13, 2006, Bloomberg News reported that J&J had settled lawsuits with about 30 women quoting a lawyer who negotiated confidential agreements in the cases.
The tactical decision to settle cases as soon as they are filed should not be mistaken for a sign of an honest, kind, repentant drug maker. This tactic serves a much larger purpose. As long as J&J can settle cases with "confidential agreements," the plaintiffs will be legally bound to not speak about any patch related injuries and the documents from the litigation will be sealed by the court and the public will never learn the truth.
But the company had better start planning to go global to silence all the plaintiffs in the mounting cases because a class action lawsuit was filed in Canada on July 28, 2006, alleging the company failed to adequately warn Canadian patients and physicians that the patch was associated with an increased risk of developing blood clots, pulmonary emboli, strokes, heart attacks and deep vein thrombosis.
Birth-Control Patch Label To Include New Risk Data
By Jennifer Corbett Dooren
September 21, 2006
WASHINGTON -- The Food and Drug Administration said a Johnson & Johnson birth-control patch will carry information about the possibility the product might increase the risk of blood clots in women beyond that seen in typical birth-control pills.
The agency said the label will carry a discussion of two recent clinical studies of the patch that were conducted in the wake of concerns about possible increases in clot risk. The two studies show conflicting results, the FDA said.
One study suggests the birth-control patch doesn't carry a blood clot risk higher than a birth-control pill, while the other suggests an almost twofold increase in the risk of venous thromboembolism, or blood clots. Preliminary results of the studies were released in February, and the updated findings released yesterday are similar.
Agency officials said they are asking that the studies, involving nearly 500,000 women from two large insurance databases, continue for at least an additional 18 to 24 months. The Johnson & Johnson unit that makes the patch and is paying for the studies agreed to do so.
"Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women," the FDA said. "The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health-care provider about using Ortho Evra versus other contraceptive options."
Because of those concerns, Ortho Evra's label was previously updated last November to warn of a possible increased blood clot risk from the patch. The new label update will contain the information from the two studies.
"Let us be clear. We cannot conclude that there is a greater risk," said Daniel Shames, the FDA's director of the division of reproductive and urologic drug products. He said the FDA still believes that the birth-control patch carries an "acceptable" risk-benefit profile and that women and their doctors need to weigh a possible increased risk of blood clots with the risk of getting pregnant.
Dr. Shames said the typical hormone contraceptive user faces a higher risk of developing blood clots. About three to five women in 10,000 using contraception for a year would be expected to develop a blood clot compared with one in 10,000 women not on contraceptives.
Even if the patch truly does double the risk of blood clots, Dr. Shames said in actual numbers it would translate into about six women in 10,000 using contraception for a year actually getting a clot.
Some women have trouble remembering to take daily birth-control pills, thereby increasing their risk of getting pregnant. The patch, which has been used by more than five million women since it was approved in 2002, is applied to the skin and is changed once a week.
FDA Reviews Data Tied to Birth-Control Patch
By Jennifer Corbett Dooren
WASHINGTON-The Food and Drug Administration on Friday said it is reviewing new data from a unit of Johnson & Johnson that showed mixed results on the risk of blood clots associated with the company's birth-control patch.
Late Thursday, Ortho-McNeil Pharmaceutical Inc., a J&J unit based in Raritan, N.J., released preliminary data from two studies. One study showed that the risk of blood clots doubled among users of the Ortho Evra birth-control patch, compared with women on a typical birth-control pill. The other study showed no increased risk when women using the patch were compared with women using a birth-control pill.
The FDA said health-care professionals and women should be made aware of the findings but cautioned that the data are preliminary. The patch, which has been used by more than five million women since it was approved in 2002, is applied to the skin and is changed once a week. It contains estrogen and progestin, which are released into the bloodstream in doses designed to prevent pregnancy.
In November, the FDA warned that the patch might increase the risk of blood clots because it contains more estrogen than a typical birth-control pill. The company said then that it would conduct additional studies; the studies released Thursday are the first results.
Daniel Shames, the FDA's director of the division of reproductive-and urologic-drug products, said the twofold increase in the risk of blood clots seen in one of the studies could be because of chance. He said he expects more data to be submitted to the FDA by about May.
Dr. Shames said women who use hormone contraceptives face a higher risk of developing blood clots than women not using such contraceptives. About three to five women in 10,000 using hormone contraception for a year would be expected to develop a blood clot, compared with one in 10,000 women not on contraceptives. Women using the patch are exposed to about 60% more estrogen than if they were taking a typical birth-control pill containing 35 micrograms of estrogen. The increased estrogen exposure from the patch could increase the risk of blood clots.
Birth Control Patch Might Raise Clotting Risk More Than Pill
By Ricardo Alonso-Zaldivar, Times Staff Writer, February 2006
WASHINGTON — Women using the increasingly popular birth control patch may face double the risk of blood clots compared with women taking contraceptive pills, but more investigation is needed to see whether the preliminary findings are valid, federal regulators said Friday.
"We're not sure what this means clinically, but it's information that people need to know about," said Dr. Daniel Shames, who heads the Food and Drug Administration division that evaluates contraceptives.
"At this time, we do not plan on taking any specific regulatory action based on these preliminary results," he said.
FDA Updates Labeling for Ortho Evra Contraceptive Patch
FDA press release, November 10, 2005
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
Read the rest of the news release here.
Doctors back off birth-control patch
By Ann Marie Chaker, November 22, 2005
Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it.
The Ortho Evra contraceptive patch has revolutionized birth control for many women. The thin waterproof adhesive, which came on the market in 2002, is about the size of a matchbook and can be worn discreetly on the body. The biggest attraction is that it is changed only weekly and eliminates the need to remember a pill every day.
Read the entire news story here.
Doctors Wary of Birth-Control Patch
By United Press International, November 22, 2005
Doctors have become wary of a birth-control patch since the U.S. Food and Drug Administration issued a warning of increased hormone intake.
The Ortho Evra contraceptive patch, sold in the United States since 2002, outsells all brands of birth control pills, with 10 million prescriptions last year, the Wall Street Journal reported. The patch is more convenient since it only needs to be replaced once a week.
Read the entire news story here.
Family blames birth control patch in 14-year-old's death
By Ryan Foley, November 17, 2005
MADISON, Wis. (AP) - Parents of a 14-year-old Wisconsin girl who died last year are suing the makers of a popular birth control patch for failing to warn people sooner about serious side effects.
Eighth-grader Alycia Brown died of blood clots on May 7, 2004, after using Ortho Evra for about six weeks, according to the lawsuit filed this week in federal court in Madison.
Read the entire news story here.
Women Using the Ortho Evra Birth Control Patch Warned of Increased Risk of Blood Clots, Stroke, and Death
By Steven DiJoseph, November 11, 2005
Long-Time Critics of the 'Patch' See Warning as Belated and Inadequate and Yet another Vioxx-Like Example of Pharmaceutical Industry Putting Profits above Safety
After years of debate over the safety of the Ortho Evra birth control patch ("the Patch"), the drug's manufacturer Ortho-McNeil (a subsidiary of Johnson & Johnson - the world's 4 th largest drugmaker) has finally acknowledged the fact that women who use the product are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.
Maker of birth-control patch issues warning
By Associated Press, November 10, 2005
The makers of a popular birth-control patch warned millions of women Thursday that the patch exposes them to significantly higher doses of hormones and may put them at greater risk for blood clots and other serious side effects than previously disclosed.
Read the entire news story here. |
