Concerns Over Birth Control Patch Gather SteamSep 28, 2005 | Lawyers Weekly USA So far, there is only a smattering of lawsuits alleging that Ortho-McNeil Pharmaceutical failed to adequately warn women of the high risk of blood clots from its popular birth control patch but plaintiffs' lawyers say there is the potential for many more.
Since its introduction in April 2002, more than 5 million women have used the Ortho Evra transdermal contraceptive patch. It's considered as reliable as oral contraceptives in preventing pregnancy, but is more convenient since it doesn't require women to take a pill each day.
The patch is worn on the upper arm, upper torso, stomach or buttocks. Users put on a new patch once a week for three weeks, then go patch-free in the fourth week during menstruation.
Print and TV ads marketing the patch directly to women tout Ortho Evra as a safe and effective form of birth control.
But an investigative report by the Associated Press in July found that among the 800,000 women were using the patch last year, the risk of dying or suffering a major blood clot was three times as high compared as that for women taking birth control pills.
Ortho-McNeil, a Raritan, N.J. subsidiary of Johnson & Johnson defends the patch's safety. But the company also told Lawyers Weekly USA it is conducting a new study in conjunction with the Food and Drug Administration to investigate reports of thrombotic injuries: clots, strokes and heart attacks caused by the patch.
"We take all adverse event reports seriously," Ortho-McNeil communications manager Gloria Vanderham said in a statement.
Vanderham said the company was undertaking the epidemiological study "pro-actively to further characterize the safety of this product and to add to information received from ongoing spontaneous reports."
The statement noted that "the types of adverse events reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra label."
David Logan, a dean and professor at Roger Williams University School of Law in Bristol, R.I., said reports about the high risk of blood clots from the use of the patch points to the same concern that has played out in the Vioxx litigation "the enormous profits [that can] be made before comprehensive clinical trials are completed to test the long-term effects of these drugs.
"I think there has been in the United States for 20, 30 years a sense that we're taking an awful lot of medications that have an awful lot of risks, and maybe we as consumers don't know all we should before making an informed decision," he said.
Headaches And Strokes
Larissa Griffin-Sponsler, 33, of Minneapolis had been using the Ortho Evra birth control patch for about a year when she began experiencing splitting headaches.
A MRI scan revealed that Griffin-Sponsler who was prescribed Ortho Evra to control her menstrual cycles had suffered a stroke and a massive cerebral hemorrhage.
She filed suit in New Jersey Superior Court on Aug. 26, alleging that the patch's manufacturer knew about the increased risks associated with the drug before it was approved by the FDA in November 2001, and that it failed to adequately warn patients about the risks.
Jason Mark, an attorney with Parker & Waichman in New York who is representing Griffin-Sponsler, said that his firm has also filed four other suits against Ortho-McNeil and Johnson & Johnson on behalf of women who developed blood clots and thrombotic injuries after using the patch. Two have been filed in state court and twoinfederal court in New Jersey, where Ortho-McNeil and parent company Johnson & Johnson have their headquarters.
In Parker & Waichman's most recent suit, filed in federal court in Newark on Sept. 12, a 37-year-old Georgia woman is blaming Ortho Evra for a pulmonary embolism she suffered after using the contraceptive patch for seven months.
The firm is also evaluating other claims, according to Mark.
"We believe there are a significant number of claimants that have a wide range of thrombotic injuries: clots, pulmonary emboli, deep vein thrombosis, heart attacks and strokes," he said.
Parker & Waichman has requested that pharmaceutical liability suits involving the Ortho Evra patch that have been filed or will be filed in state court in New Jersey be designated as mass-tort litigation.
In Marks view, "the issue with the patch relates to the increased risks. The information we have reviewed indicates that the risks associated with the patch exceed the risks with the birth control pill."
Unlike a birth control pill, which is metabolized by the body's digestive system, the progestin and estrogen in the Ortho Evra patch are released directly into the bloodstream. Parker & Waichman is claiming that this unique delivery method can result in dangerously higher concentrations of medications in the body and higher rates of blood clots.
In July, a similar lawsuit was filed in another New Jersey county by Austin, Texas attorney Amy Clark-Meachum. That suit claims the patch is "defectively designed" and "unreasonably dangerous" and caused 10 women across the country to suffer strokes and blood clots.
Plaintiffs named in the suit include women from ages 18 to 47 from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma.
The suit claims that the introduction of the patch three and a half years ago was intended to offset the fact that Ortho-McNeil's best-selling oral contraceptive was going off-patent and facing competition from generic birth control pills.
During clinical trials of Ortho Evra with 3,000 women,the patch caused or contributed to two major cases of pulmonary embolism and several other minor to moderate thrombotic injuries, six times the clotting rate associated with oral contraceptives, the suit alleges.
The suit further claims that Ortho-McNeil's massive marketing and advertising campaign for the patch "downplays the safety risks of the drug."
A Dozen Deaths
The AP investigation found that about a dozen women most in their late teens and early 20s died last year from blood clots believed to be related to the birth control patch.
The report which was based on federal drug safety reports obtained under the Freedom of Information Act said that the women who died were young and apparently at low risk for clots.
Logan complained that the AP did what "the FDA should be doing which is compiling information about adverse reactions from drugs."
While AP's finding that the patch apparently triples the risk of blood clots requires further study, Logan said, it is likely to trigger increased public concern about the safety of the patch.
"The vast majority of drugs cure a condition," he noted. "Birth control, almost by definition, starts with people who are healthy, so when something goes wrong, the perception of outrage is pretty significant."
While it's too early to tell whether litigation over the patch will be significant in terms of damages, Logan pointed out that most women using the drug are young, and if a jury considers future earnings as a factor in awarding damages, the verdict for a young, female professional who suffered a stroke as a result of the patch could be "astronomical."
When Vioxx came under similar public scrutiny last year, Merck & Co. pulled the painkiller off the market.
With the birth control patch, there are other ways to respond to public concerns, said Logan, such as further epidemiological studies. But if there is an unusually high risk of clots from the patch, doctors need to tell their patients about it and "let the consumer make that choice," he said.