Evelyn Pringle April 16, 2007
Tens of millions of prescriptions have been written for Johnson & Johnson's Ortho Evra birth control patch since it arrived on the market in 2002, and medical experts say the patch has harmed thousands of young women of childbearing age.
In September 2006, the FDA warned that use of the patch, made by the Ortho-McNeil division of J&J, increases the risk of blood clots, which can lead to heart attack and stroke.
Because the patch releases hormones directly into the blood stream, medical experts say, a much higher concentration of hormones enters the body than with birth control pills. A November 2005, FDA advisory reported that patch users were exposed to about 60% more estrogen than women on the pill.
A recent study in the February 2007, journal, Obstetrics and Gynecology, of 49,000 women who used the Ortho patch, and 202,000 who used oral contraceptives, found that blood clots or "venous thromboembolism" occurred in patch users at a rate of 2.2 times higher than with women on the pill.
Legal experts says proving causation in these cases will be easy because blood clots in young women are almost unheard of. No doubt due to the recognition of this fact, when the first lawsuits were filed, J&J quickly began settling cases out of court for substantial sums of money, trying to keep a lid on the news that women were being injured by the patch.
J&J has already settled lawsuits in state courts in New Jersey, Texas, and California, and federal courts in North Carolina and Pennsylvania, according to Bloomberg on April 2, 2007.
Texas attorney, Ray Chester, told Bloomberg that one settlement involved a 40-year-old woman with 2 children, who had a massive stroke after only 12 days on the patch and is now a quadriplegic with brain damage and requires around the clock medical care.
However, as the number of lawsuits multiplied, that strategy of quietly settling out of court could not continue for obvious reasons. J&J's Annual Report filed with the SEC in February 2007, states that, as of December 31, 2006, "there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries allegedly due to ORTHO EVRA."
Documents revealed in litigation, prove that J&J knew about the high rate of blood clots because they show the company had been analyzing the FDA's reports on injuries and deaths in women using the patch, and had even compiled charts showing the higher rates of clots and deaths when compared to women taking birth-control pills.
One memo from 2003, reveals that the company refused to conduct a study to compare the rate of adverse events with the patch to its Ortho-Cyclen pill because there was "too high a chance that study may not produce a positive result for Evra" and a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen."
Newly released documents show that, instead of warning consumers and prescribing physicians about the clot problems, Johnson & Johnson has been doing everything in its power to stop the negative information about the patch from becoming public.
Documents unsealed this month by Superior Court Judge, Bryan Garruto, in a New Jersey state court proceeding involving more than 300 lawsuits, reveal that J&J bought up dozens of internet domain names related to the Ortho patch in an attempt to stop negative information from appearing on the internet.
By using the standard trick of claiming the documents contained trade secrets, J&J had previously obtained a court order to keep them sealed so the public would not learn about the extent of the company's damage control efforts.
But in granting a motion by the plaintiffs' attorneys to unseal the documents, Judge Garruto said they were not entitled to a protective order because the information did not constitute trade secrets that, if revealed, would benefit J&J's competitors.
One document released calls for, "Defensive actions to minimize impact of negative presence," to include buying internet domain names, monitoring blogs and purchasing the top key words related to the patch that would be picked up by Google and Yahoo search engines.
Apparently, drug companies do this on a regular basis. According to Kent Jarrell, a spokesman for J&J, quoted by Bloomberg News on April 2, 2007: "The purchase of the domain names is a standard and accepted business practice for companies that are trying to prevent product disparagement and to safeguard the defendant's reputation."
Legal experts view the situation differently. According to Attorney, Derek Braslow, of the Conshohocken, Pennsylvania firm of Pogust & Braslow, "While J&J's purchase of key internet search terms and domain names does not prove that the Ortho patch causes injuries," he says, "J&J's conduct, like the conduct of most drug companies, does show an intentional disregard for the victims of its deadly drug."
He does not find the drug maker's conduct surprising. "J&J has only taken the next step in the natural evolution of marketing," Mr Braslow explains, "promote the drug at all costs during the life of the patent but eliminate all marketing and promotion after the money has been made and the victims start seeking answers and advocacy."
"Purchasing the domain names has nothing to do with the merits of the litigation," he says, "it has everything to do with damage control, protecting their drug at all costs and preventing victims from seeking and finding justice."
After lives have been lost and families devastated as a result of using the patch, he states, the company is attempting to prevent the victims from finding legal counsel. "Instead of coming forward with the truth behind the patch," he notes, "the company has gone to extraordinary measures to stop victims from finding attorneys to represent them."
Attorney, Ted Chabasinski, who recently worked on a case involving the release of damaging Zyprexa documents that Eli Lilly had successfully kept hidden with a court order while settling out of court with about 26,000 litigants, agrees that J&J's conduct is standard procedure when it comes to concealing damaging information about pharmaceutical products.
"What Johnson and Johnson is doing," he says, "just reflects drug company practices in general."
"None of them want the public to know that their products are dangerous and often ineffective as well," Mr Chabasinski notes.
"America must wake up soon," he warns, "to what these greedy corporations are doing to our health."
"We need politicians," he states, "who will stand up to the drug companies, and judges who will recognize that when drug company executives approve hiding the deathly effects of their drugs, thus killing thousands of people, they should be put in prison."
"It isn't enough," he advises, "to make the companies pay damages."
"Nothing will stop these practices," he warns, "except holding the people who run these corporations personally responsible for their criminal behavior."
According to FDA records obtained by the Associated Press with a FOIA request in 2005, in one 18-month period, there were 9,116 adverse events reported by women using the patch, a rate 7 times higher than women taking oral contraceptives.
A factor that must always be considered when assessing the number of people who may have been harmed by a product is that the FDA estimates that only 1% to 10% of adverse events are ever reported, which means the number of women harmed by the patch is definitely much higher. In 2005 alone, doctors wrote more than 9.4 million prescriptions for the patch, according to the pharmaceutical industry-tracking firm, IMS Health.
The review of records by the Associated Press revealed that the FDA knew that blood clots were at least 3 times more common with the patch before the device was approved.
The records show that in 2000, FDA doctors reviewing J&J's clinical trials warned that clots could be a problem with the patch after finding that 2 women were treated for serious conditions where blood clots had traveled to their lungs.
One reviewer said, "The label should clearly reflect this reviewer's safety concern about a potential increased risk." But in the end, the label did not contain the warning, and there was no requirement for follow-up studies other than ordinary reviews of voluntary reports.