Parker & Waichman, LLP Believes New Study On Ortho Evra Provides Further Evidence That the Birth Control Patch is Associated With Higher Rates of Blood Clots
Other Study Claiming Ortho Evra's Risks Were Similar to Oral Contraceptives is Flawed Because It Did Not Examine Medical RecordsSep 21, 2006 | PrimeZone
Parker & Waichman, LLP (www.yourlawyer.com) announced that it believes a new study provides further evidence that Ortho Evra is dangerous and should be recalled from the market. The study found that women using the Ortho Evra birth control patch were twice as likely to develop blood clots compared with those using oral birth control pills. Parker & Waichman, LLP currently represents hundreds of clients who were injured while using the Ortho Evra birth control patch. The firm has cases pending in state and federal courts against Ortho-McNeil Pharmaceutical, Inc, a division of Johnson & Johnson, Inc. (NYSE:JNJ). For more information on Ortho Evra, please visit www.orthopatchlawsuit.com and www.yourlawyer.com/topics/overview/Ortho_Evra_Patch.
As a result of this study, The Food and Drug Administration updated Ortho Evra's warning language 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 FDA warning came despite a second study, which did not show an increased risk of blood clots with Ortho Evra compared to oral birth control pills. Parker & Waichman, LLP believes the data from this second study is fundamentally flawed for several reasons, including its failure to properly analyze the medical records of Ortho Evra patients.
This is not the first time there have been changes made to the warnings about Ortho Evra's risks. The first warning about the increased risks of blood clots associated with Ortho Evra was issued on November 10, 2005. In that warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen.
Parker & Waichman, LLP believes the evidence about Ortho Evra's increased safety risks strongly supports the need to have the drug permanently recalled from the market. "The notion that periodic warnings of Ortho Evra's increased risks is sufficient to protect the health of women is misguided. There are many safer alternative forms of hormonal contraception than the patch. This is not a last resort, life saving medication. The product needs to be withdrawn from the market so that it can no longer cause harm," said Jason Mark, an attorney at Parker & Waichman, LLP who heads the firm's mass tort department.
It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.
Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.
About Parker & Waichman, LLP
Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) YOURLAWYER.
Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.