Evelyn Pringle October 13, 2006
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 that Ortho 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.
And the plaintiffs in this class action may not be so easily silenced. The attorney handling the case, Michael Peerless, a partner in the law firm Siskinds LLP, said by filing the lawsuit the company will be "required to explain to Canadian consumers what it knew about the risks associated with Ortho Evra and when it first became aware of those risks."