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On November 10, 2005, Johnson and Johnson's subsidiary Ortho McNeil, makers of Ortho Evra, acknowledged that women using the birth control patch are exposed to 60 percent more estrogen than women using typical birth-control pills because hormones from patches get into the bloodstream and are removed from the body differently than those from pills. There are reports that the Ortho Evra patch has caused life-threatening blood clots, fatal heart attacks, pulmonary embolisms, and other serious medical problems in Ortho Evra Birth Control Patch users. Our firm has unique experience in this area of litigation, having been one of the first law firms in the nation to sue Johnson & Johnson in a products liability case over the use of transdermal patches to deliver medication. The case resulted in a confidential settlement. Here is a copy of that Complaint: The Ortho Evra warning comes four months after The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill. If you are seeking an Ortho Evra attorney and you or a family member have suffered injuries (or a death has occured) from using Ortho Evra, please call us at 1.800.394.2119 or CLICK HERE to contact a lawyer for a free and confidential evaluation. What You Should Know: Approximately 4 million women have used the Ortho Evra Birth Control Patch since it went on sale in 2002. Now there are reports that the Ortho Evra patch has caused life-threatening blood clots, fatal heart attacks, pulmonary embolisms, and other serious medical problems in Ortho Evra Birth Control Patch users. If you've been harmed by the Ortho Evra Birth Control Patch, an Ortho Evra Birth Control Patch lawyer can help you file a lawsuit against the manufacturer and get compensation for your pain and suffering. Johnson and Johnson subsidiary Ortho McNeil, makers of Ortho Evra, warned millions of women 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. Citing federal death and injury reports, the AP also found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems. Ortho McNeil spokeswoman Bonnie Jacobs said Thursday that the warning speaks for itself and that the company has been cooperating with the Food and Drug Administration, which distributed the new warning to health care providers. More than 4 million women have used the patch since it went on sale in 2002. Several lawsuits have been filed by families of women who died or suffered blood clots while using the patch, and lawyers said more are planned. 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, 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." Since the Ortho Evra birth control patch was FDA approved in November of 2001, a number of dangerous side effects have been reported, including fatal heart attacks and strokes. An estimated 23 deaths have been connected with patch use, in addition to dozens of nonfatal strokes and blood clots, according to consumer reports to the FDA. Serious side effects experienced by victims included severe headaches, nausea, and vision problems. Amidst recent reports by the consumer watchdog group, Public Citizen (www.worstpills.org), as well as the Associated Press that squarely challenge the safety of the Ortho Evra birth control patch marketed by Ortho-McNeil and strongly urge women to avoid using it, several lawsuits have now been commenced around the U.S. alleging serious injuries and deaths as having been caused by the patch. Only last week, CBS News presented a significant story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid. According to that story, Ortho-McNeil records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives. In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control. Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch. An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women. Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request. The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol. Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of television ads featuring models. (CBS 11/2/05). In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million. Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive. Public citizen first listed some third-generation oral contraceptives as DO NOT USE drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year. Since the FDA estimates that it receives reports of only between 1% and !0% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher. The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA Web site. Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote: THE REVIEWER DOES NOT AGREE WITH THE SPONSOR's [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the ... group [emphasis in the original]. The FDA medical officer also included the following statement in his comments: The professional product labeling and information written specifically for women using Ortho-Evra should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate). In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing or than 198 pounds (90 kilograms). The professional product label warns that Ortho-Evra should not be used in the following circumstances:
Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed). There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); Rarely do randomized pre-approval studies, the scientific gold standard for proving safety or efficacy, present such strong evidence of a serious problem. As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: "There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives." In addition to the risks already discussed cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including ORTHO EVRA, should not smoke. Finally, litigation involving Ortho Evra has been gaining momentum in recent months and especially in light of the Associated Press investigation. The litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug. A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea. The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25 year old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch. The youngest woman to die, as reported in a recent study, was an 18 year old college student who collapsed in the New York subway. Ten other women ranging in age from 18 to 27 have also sued Ortho-McNeil. In September 2005 a major New York plaintiff personal injury law firm announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey. According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch, according to the suit. This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003. Ortho-McNeil disputes the allegations that any of these deaths and injuries were the result of Ortho Evra risk factors. It claims that the unsolicited reports it received are not reliable evidence of a problem with the drug. The company also claims its own investigation has not found any causal factor linking these deaths to Ortho Evra and relies on the absence of any reports of fatal adverse side-effects during the clinical trials as proof of the drug's safety. Nonetheless, Ortho-McNeil has notified the FDA that it has undertaken a much larger study with respect to the potential problem of blood clots, strokes, and death associated with the patch. The results of that study are expected soon according to CBS. What You Should Do If you or a member of your family suffered severe reactions after the use of Ortho Evra, it may be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced in this litigation, please call attorney David Randolph Smith at 1.800.394.2119 for a free consultation or CLICK HERE to send an email. |
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