Evelyn Pringle September 26, 2006
More than 500 claimants are seeking "substantial compensatory and, where available, punitive damages," from Johnson & Johnson for injuries and deaths related to the Ortho Evra birth control patch, according to the company's Second Quarter Report filed with the SEC.
However, if legal analysts are correct, J&J ain't seen nothin yet.
Based on the millions of prescriptions written for the Ortho Evra patch since it came on the market in 2002, critics say there are thousands of victims who do not yet realize that an injury or death was caused by the patch.
All total, in 2005, J&J raked in $1.1 billion in sales of contraceptives products but the company says it expects a decline in 2006 because of "labeling changes and negative media coverage concerning product safety," in the company’s 2005 annual report said.
However, in July 2006, J&J took measures to make up for the lost sales by drastically increasing the price of contraceptive products paid for by Medicaid programs.
Medicaid purchases contraceptives for low income persons covered under the public health care program. For instance, West Virginia provides contraceptives to about 59,000 low income people each year and J&J was the supplier of 75% of those products.
Suddenly and without any warning, J&J created a budget crisis in West Virginia, and many other states, by increasing the price of birth control pills 20-fold, and raising the price on the Ortho Evra patch from $12.15 to $22.46, according to the Associated Press.
When asked about the price hikes, company spokeswoman, Julie Keenan said the pricing for the pills and the patch was in line with federal Medicaid pricing formulas that change every financial quarter.
Considering the fact that Johnson & Johnson has sold patches to about 5 million women since the device came on the market in 2002, according to Bloomberg News on May 13, 2006, a $10 increase times by 5 million women would make for quite a haul.
In response to the dramatic increase in prices, family planning directors across the country began accusing the company of price gouging government funded health centers. "Nobody believes that Ortho-McNeil had any reason to increase these prices by this amount," said Lon Newman, director of Family Planning Health Services, which operates seven clinics in Wisconsin.
"It's clearly a market manipulation on Ortho's part," he stated.
The increase in costs forced many family planning agencies to stop providing Ortho products to women. In the end, rather than lose all the sales, the company dropped the price of the Ortho patch down to $15, or about $3 more than it was before July 1, 2006, when the company raised the price.
Mainly to suppress negative publicity about the Ortho patch that would have an adverse effect on sales, Johnson & Johnson attorneys have been trying to settle the Ortho Evra lawsuits almost as quickly as they are filed by offering substantial settlements that require the plaintiffs to sign a confidentiality agreement in order to keep the damaging information out of the public eye.
In addition, legal experts say J&J attorneys are fully aware that the cause of the injuries and death alleged in the lawsuits will be easy to prove because the plaintiffs have a "signature disease," described as a condition closely linked to the use of a drug that is otherwise very rare. In this instance, they point out, blood clots, heart attacks and strokes are extremely unusual in teenagers and women of childbearing years, with the only commonality among the victims being the Ortho Evra birth control patch.
Many litigants have already settled their lawsuits and J&J has made it clear to attorneys for other plaintiffs, and the various judges handling the cases, that the company is ready to negotiate settlements in many more cases.
However, the problem with this legal strategy is that J&J no sooner settles a group of lawsuits before another batch get filed. Seven lawsuits were filed in one day in January to include:
Plaintiff, Maral Annayeva, alleges she was prescribed the Ortho patch between January and May 2005, and used it for 18 days before suffering from bleeding, heart pain, headaches, nausea and general malaise.
Plaintiff, Brandy Houk, used the patch from February to October 2005, and alleges that she suffered shortness of breath, fatigue, excessive bleeding, and large clots as a result.
Plaintiff, Melody Miller, alleges that on December 21, 2003, she suffered multiple blood clots which resulted in the miscarriage of her child in the fifth month of pregnancy.
Plaintiff, Tanya Lowe, alleges that she suffered blood clots in her right leg which shattered and spread into her lungs in January 2004, while using the patch.
Plaintiff, Reannon Tutkus, charges that on December 24, 2004 and January 1, 2005, she suffered blood clots.
Plaintiff, Stephanie Curtis, alleges that in March 2004 she noticed a red spot just above the patch so discontinued the patch and immediately became pregnant. In June or July of 2004, she alleges she developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.
Plaintiff, Kristine Bailey, claims in late October to early November 2005, she suffered blood clots, dizziness and fatigue.
The plaintiffs also allege that J&J violated consumer fraud statutes with the use of false and misleading misrepresentations in the marketing, promotion and sale of the patch.
Specifically, since January 2006, Johnson & Johnson has been willing to negotiate out-of-court settlements in lawsuits that involve women who have been hospitalized for the following conditions:
* heart attacks;
* pulmonary embolisms; and
* deep vein thrombosis.
In layman's terms, all of these conditions involve injuries caused by blood clots. 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.
Hormonal birth control products are known to increase the risk of blood clots because estrogen promotes coagulation. Clots usually form in the legs and cause serious problems when they travel to the heart, lungs, or brain.
A blood clot in the lungs can cause the inability to breathe (lung embolism) and a blood clot in the heart can cause a heart attack or heart failure. A blood clot in the brain can cause stroke by interfering with the free flow of blood to the brain, according to the NINDS:
“A stroke occurs when the blood supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around the brain.
There are two types of strokes: (1) ischemic - the blockage of a blood vessel supplying the brain; and (2) hemorrhagic - the bleeding into or around the brain. According to the NINDS:
“The symptoms of a stroke include sudden numbness or weakness, especially on one side of the body; sudden confusion or trouble speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; or sudden severe headache with no known cause.”
A common disability from a stroke, NINDS says, is complete paralysis on one side of the body. A related disability that is not as debilitating is one-sided weakness. Strokes may also cause problems with thinking, awareness, attention, learning, judgment, and memory.
According to NINDS, stroke survivors also often have difficulty understanding or forming speech and may have problems controlling or expressing their emotions and many people experience depression.
Stroke survivors may also experience numbness, strange sensations, and pain in their hands and feet, made worse by movement and temperature changes, especially cold temperatures. And, about 25% of patients who recover from a first stroke, NINDS says, will have another within 5 years.
The serious health problems caused by the Ortho patch first caught public attention on January 9, 2004, when an article titled, "‘Sex Patch’ Tied To 17 Deaths," appeared in the New York Post, stating, "A trendy contraceptive patch which has been aggressively marketed using sexy ads, fashion models and Olympic athletes has been linked to the deaths of at least 17 young American women in the past two years."
Citing FDA reports, the Post said that "scores" of other women using the Ortho Evra patch have suffered complications, including 21 "life-threatening" cases of blood clots and other ailments.
Ten months later, on October 10, 2004, the New York Post published another article titled: "The Patch of 'Death,'" that stated: "A popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill," quoting a complaint filed in a Texas lawsuit by a mother of 2 who had suffered a massive stroke and was left paralyzed after using the Ortho patch for 12 days.
The lawsuit described FDA records obtained with an FOIA request, that showed that in a one-year period, at least 46 women suffered blood clot related injuries or death while using the patch and that only half that number of women taking birth control pills suffered clot related problems, even though 6 times more women used the pill.
Less than a year later, another lawsuit filed in New Jersey in September 2005, on behalf of a woman who suffered a pulmonary embolism after using the patch, disclosed that between April 2002 and September 2003, the FDA's Adverse Event Reporting System (AERS), had recorded 9,116 adverse events related to the patch, but that with the birth control bill for a period of more than 6 years, there were only 1,237 adverse reports recorded even though the pill was used by almost six times more women.
The AERS is a computerized database, designed to support the FDA's post-marketing surveillance program for all approved products, that stores and analyzes the adverse event reports that are submitted to the agency.
However, experts say, when considering the number of adverse events reports related to the Ortho patch, its important to know that according to FDA officials, only between 1% and 10% of all adverse events are reported. Which means at best, the number of adverse events reported above must be multiplied by 90%, and at worst by 99%.
Plaintiffs' attorneys maintain that J&J has long known about the serious risks of using the patch. According to a CBS New report in November 2005, citing documents obtained in a lawsuit, Johnson & Johnson's own records show the company received 500 reports of serious problems in women wearing the patch between April 2002 and December 2004. And the company records also showed that even though 3 times as many women were taking birth control pills during the same time period, only 61 similar reports were received on women taking the pill.
The records reveal that there were four times as many strokes in women using the patch, and according to the Associated Press, the medically confirmed cases indicate that the risk of blood clots was 14 times higher among women using the patch.
Many experts believe that the increase in health problems is due to the patch delivery system because the medications and dosages in the patch are the same as in the pill and prevent pregnancy by: (1) altering ovulation so that an egg is not released for fertilization; (2) thickening cervical mucus to stop sperm from entering uterus; and (3) changing the endometrium to reduce the likelihood of egg implantation.
However, a European study in 2005, measured the hormone levels among 32 women who took the pill versus those who used the patch, and determined that women who used the Ortho patch had 60% more estrogen in their blood streams than women taking the pill.
Expert say that although estrogen is important in the regulation of the reproductive cycle it provokes clotting and if too much estrogen is released via the patch it can cause excessive clotting, particularly in the arteries and veins of the lower extremities.
Estrogen in birth control pills must travel through the digestive tract before it is absorbed by the body and a great deal of the dosage is lost in the process. With the patch delivery system, full-strength estrogen is absorbed through the skin directly into the blood stream continuously for 3 weeks each month, while the dose of hormones in the once a day pill leaves the body in a matter of hours after the pill is ingested.
Experts say another problem may be that the level of hormones released increase when the patch becomes heated through exercise, or bathing in a hot tub, or a high fever. "Most people don't realize that heat is going to increase absorption rates, even to toxic levels," according to Michael Cohen, director of the Institute for Safe Medication Practices.
Studies have shown that heat has a distinct effect on medication patches. As far back as 1986, a study found that 20 minutes of bicycling while wearing a nitroglycerin heart patch increased the drug's concentration two to threefold. Similar results were found with people sitting in the sauna for 30 minutes.
Despite having first-hand knowledge of the number of women being injured and killed, the FDA did not officially alert the pubic to the high risks associated with the patch until November 10, 2005, when a "Black Box" warning was added to the product label that said the device could expose women to estrogen levels 60% higher than oral contraceptives and that the increased dosage was associated with a greater risk of blood clots.
Unfortunately for the thousands of young women who have already died or been injured, this action by the FDA represents another case where the agency charged with protecting consumers from the profit driven pharmaceutical industry has done too little to late.