The lawsuit alleges that J&J failed to properly test the patch before placing it on the market and knowingly misled consumers about the safety and risks associated with the patch when compared to other types of birth control products.
In the lawsuit, Katy McKellips Braman, describes the onset of the condition as a pronounced swelling in her left leg that gradually increased over the course of a few days. The condition required Ms Braman to be hospitalized and she is now forced to take anti-clotting drugs daily.She is suing J&J for damages to include all future medical expenses incurred in treating the condition.
Two days later, on October 19, 2006, the Parker & Waichman, LLP law firm announced that it had filed a lawsuit against the company in New Jersey on behalf of a 25-year-old Wisconsin women who was diagnosed with bilateral pulmonary emboli after 6 months of using the patch.
Parker & Waichman has already filed numerous patch related lawsuits and says it plans to file a "significant number" of additional cases by the end of 2006.
The lawsuit states that the injured victim in the case was taken to the emergency room on August 24, 2004, after experiencing lightheadedness, shortness of breath and chest pain, where diagnostic tests revealed bilateral pulmonary emboli.
According to the National Institute of Neurological Disorders and Stroke: (1) thrombosis is the formation of a clot within a blood vessel of the brain or neck; and (2) embolism is the movement of a clot from another part of the body to the neck or brain. Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein.
After being diagnosed, the Wisconsin woman was hospitalized and received the drugs Heparin and Coumadin, as anticoagulant therapy, and according to the lawsuit, will need anticoagulant medication for a protracted period of time and possibly for the remainder of her life.
These new lawsuits, along with the hundreds of others already filed all over the country, allege that Ortho-McNeil was aware of the increased risks of blood clots, heart attack and stroke associated with the birth control patch even before the device was approved for use in the US, and that once approved, the company failed to adequately warn potential users about the risks.
To substantiate this claim in part, attorneys point to an internal Ortho-McNeil memo that shows that in 2003, the company refused to fund a study comparing the patch to its Ortho-Cyclen pill because of concerns that 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."
The plaintiff's attorney also list Ortho-McNeil's own records obtained and made public by CBS news, that show the company received some 500 reports of serious events associated with the patch between April 2002 and December 2004, during a time when only 61 such reports were received involving all types of birth control pills.
These records also show that there were 4 times as many strokes in women using the patch and that in medically confirmed cases, the risk of blood clots was found to be 14 times higher with the patch.
Users of the Ortho adhesive patch apply it to their body and change it once a week for three weeks and then do not wear it during the fourth week. The patch is intended to release 20 micrograms of estrogen into the bloodstream every 24 hours.
It is widely known that exposure to estrogen increases the risk of blood clots. The first FDA warning about the increased risks of blood clots with the patch was issued on November 10, 2005, and for the first time, Ortho-McNeil admitted that women who used the patch may be exposed to up to 60% more estrogen than women taking a birth control pill.
"FDA is announcing a revision to the label for the drug Ortho Evra," the agency said. "This change includes a new bolded warning about higher exposure to estrogen."
"Higher levels of estrogen," the FDA warned, "may put some women at increased risk for getting blood clots."
By the time of this warning, the FDA had received more than 9,000 reports of adverse events related to the patch in a 17-month period, while the Ortho Tri-Cyclen birth control pill, only generated a little over 1,200 adverse reports in a 6-year period.
In addition, during a 12-month period, 44 serious injuries or deaths were found to be associated with the patch, while only 17 such reports were found to be linked to the birth control pill during a similar time frame.
Critics say the drastic difference in serious events is further magnified when considering that the number of women using the Ortho Tri-Cyclen pill was 6 times the number of women using the Ortho Evra patch.
According to Jason Mark, an attorney at Parker & Waichman, LLP, who heads the firm's mass tort department, "The product needs to be withdrawn from the market so that it can no longer cause harm."
"The notion that periodic warnings of Ortho Evra's increased risks is sufficient," Mr Mark said in a press release, "to protect the health of women is misguided."
"There are many safer alternative forms of hormonal contraception than the patch," he states. "This is not a last resort, life saving medication."
On September 21, 2006, the law firm announced that it believes a new study that found women using the Ortho patch were twice as likely to develop blood clots compared with those using birth control pills provides further evidence that the patch is dangerous and should be recalled from the market.
As a result of this study, the firm noted, the FDA updated Ortho Evra's warning to reflect that women using the patch faced twice the risk of blood clots as women on the pill.
"The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke," the Parker & Waichman press release stated.
According to its 2005 Annual Report, J&J sold $1.1 billion in contraceptives in 2005, but the report predicted a decline in sales for 2006 because of "labeling changes and negative media coverage concerning product safety."
Warnings to young women to stay away from the patch are growing in number. On September 29, 2006, the Editorial Board of the Exponent, a Purdue college newspaper, said women should use the birth control pill instead of the Ortho Evra birth control patch and also said the patch should be removed from the market.
The Exponent, published by the Purdue Student Publishing Foundation, is Indiana's largest collegiate daily newspaper and is primarily a student operation.
According to the Wall Street Journal, in providing health care services to 42,000 students, Pennsylvania State University is no longer writing prescriptions for the patch.
The Journal also reported that similar actions were being taken by health officials at other universities including Stanford, the University of Texas at Austin, the University of California, Berkeley, and the Connecticut College in New London.
Legal experts say the patch maker is scrambling to settle as many of these lawsuits as quickly and silently as possible with substantial monetary awards that come with the signing of confidential settlement agreements because it does not want to risk the public spectacle of a steady stream of young injured women parading before a jury.
"Ortho-McNeil Pharmaceutical," the April 9, 2006 New York Post reported "has settled a dozen lawsuits for millions of dollars in the last few months."
On May 2, 2006, a J&J attorney wrote a judge in New Jersey to say that 11 women who filed suit in that state had received settlements, although the amounts were kept confidential.
Also on May 2, 2006, a J&J attorney informed an Ohio judge that the company was prepared to settle all cases where the plaintiffs were hospitalized for pulmonary embolisms, deep vein thrombosis, heart attacks or strokes.
On May 16, 2006, the New Jersey Law Journal quoted a plaintiff's attorney who estimates that "many of these cases are seven figures, many are probably substantial six-figure cases."
However, settling these lawsuits as quickly as they are filed may not turn out to be so easy. Critics say there are likely to be tens of thousands more women spread out all over the country who do not yet realize that their health problems are caused by the patch.
Which may very well be true, because even though the FDA says it has received about 9,000 reports of adverse events related to the patch, the agency acknowledges that only between 1% and 10% of adverse events ever get reported and according to Bloomberg News on Mary 13, 2006, Johnson & Johnson has sold patches to 5 million women since the launch of the product in 2002.