Ortho Evra Patch Maker Waves A White Flag
Ortho Evra Patch Maker Johnson & Johnson Waves A White Flag
By Evelyn Pringle
On May 2, 2006, Johnson & Johnson attorney, Susan Sharko, wrote to New Jersey Superior Court Judge, Peter Bariso, to inform the court that the company had reached confidential settlements with 11 of the 12 plaintiffs involved in litigation in New Jersey.
Less than a month earlier, on April 9, 2006, the New York Post reported that women who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch were already receiving cash settlements from the manufacturer.
"Ortho-McNeil Pharmaceutical," the Post wrote, "a subsidiary of Johnson & Johnson, has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending."
With J&J waving a white flag this early in the game, the litigation period involving the Ortho Evra birth control patch may go down in history as being the shortest ever against a drug company.
However, many more cases are pending in other federal and state courts. On March 1, the Judicial Panel on Multidistrict Litigation issued a transfer order and appointed a federal judge in Ohio to oversee the consolidated pretrial proceedings of 13 federal products liability suits filed by plaintiffs in different states over the Ortho Evra patch.
The JPML assigned the 13 cases to US District Judge David Katz of the Northern District of Ohio, who was already handling the first federal lawsuit over the Ortho patch.
That case, Bernard v Ortho-McNeil Pharmaceuticals, is "progressing well," the Panel said, and the Ohio venue would provide a relatively central situs in regard to the geographic dispersal of the constituents and tag-along cases..
As of March 1, 2006, the Panel said it had been notified of 54 potentially related actions pending in the multiple federal districts and said, these actions will be treated as potential tag-along actions.
The Panel noted "that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation."
"Among other things," the Panel wrote, "these action share allegations that i) the Ortho Evra contraceptive patch was defectively designed, and ii) plaintiffs received inadequate warnings regarding Ortho Evra's side effects and safety profile."
"All actions seek damages for personal injury and/or economic damages on behalf of users of Ortho Evra," the Panel wrote, "asserting various state law claims, such as negligence, products liability, breach of warranties, and negligence and/or fraudulent misrepresentation regarding the risks of using Ortho Evra."
"Centralization," the Panel said, "is necessary in order to eliminate duplicate discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary."
However a white flag has already been waved at many of the plaintiffs in these cases as well. On May 2, 2006, at the very first status conference held by Judge Katz, Johnson & Johnson attorney, Robert Tucker, stated the company was prepared to settle suits in which plaintiffs were hospitalized for heart attacks, stroke, pulmonary embolisms or deep vein thrombosis, according Charles Toutant, in the May 16, 2006 New Jersey Law Journal.
Ellen Relkin, of Weitz & Luxenberg in South Orange, NJ, a member of the plaintiffs' executive committee for the federal suit, In re Ortho Evra Products Liability Litigation, told the Journal that "many of these cases are seven figures, many are probably substantial six-figure cases."
"It's not like a Vioxx, where you have clients in their 50s, 60s, 70s," explained David Eisenbrouch, of Balkin & Eisenbrouch, who represents plaintiffs. "You're dealing with primarily very young women, and J&J would rather cut its losses," he told the Journal.
Less than 2 weeks later, on May 13, 2006, Bloomberg News reported that J&J has settled lawsuits with about 30 women quoting Attorney, Ray Chester, the lawyer who negotiated the confidential agreements.
J&J settled state courts cases in Texas, New Jersey, and California and federal courts in North Carolina and Pennsylvania, Mr Chester said.
One settlement involved Philomena Ugochukwu, 40, who had a massive stroke after wearing the patch for 12 days, he said.
The mother of two is now a quadriplegic with brain damage and needs round-the-clock care, Mr Chester told Bloomberg. She was his first Ortho Evra client.
"Johnson & Johnson is going to lose most of these cases," he warned. "The cost to defend them and the public relations hit they would take if they tried the cases," he advised, "has tilted them toward settling."
The early settlement offers are no doubt due in large part to the damning internal documents that have surfaced that show the company was aware of the lethal dangers of the patch but kept right on selling it in pursuit of the almighty dollar.
For instance, on November 11, 2005, the Associated Press reported that 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," the report said, "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.""
According to FDA records obtained in July 2005, by the Associated Press with a freedom of information request, over a 71 month period, there were 1,237 adverse event reports by women taking the pill, but over an 18 month period, there were 9,116 adverse event reports by women using the patch, which means there were over seven times more adverse event reports with the patch.
The AP found that before the patch was approved, the FDA had already noticed that blood clots with the patch were 3 times more common than with the pill. In 2000, FDA doctors reviewing the clinical trials submitted by the company warned that blood clots could be a problem if the patch was approved. In those trials, the doctors found that 2 of the 3,300 women using the patch were treated for blood clots that traveled to their lungs.
The reviewer said "the label should clearly reflect this reviewer"s safety concern about a potential increased risk." But it didn't and there were no requirement for follow-up studies other than routine reviews of voluntary reports called in by doctors, consumers, and the drug company.
Experts say the dangers with the patch stem from how it works in that rather than digestion and metabolization of the hormones like with the pill, the patch releases the hormones directly into the blood stream, leaving a significantly high concentration of hormones in the body.
In fact, the FDA advisory in November 2005, said users of Ortho Evra are exposed to about 60% more estrogen in their blood than if they were taking a birth control pill.
According to the complaints in many of the lawsuits filed, beginning on May 1, 2002, the FDA received 44 reports of clot-related injuries or deaths caused by the Ortho patch, but only 17 similar reports during the same time period for J&J's Ortho Tri-Cyclen birth control pill, even though the pill was used by close to six times as many women.
However the statistics are known to be inaccurate because FDA officials acknowledge that as few as 1 to 10% of all serious side effects are ever reported to the agency so the number of clot related adverse events reported would have to be multiplied many times over to get an actual account of the cases.
According to a CBS news report in November 2005, based on documents that had surfaced in litigation, the drug maker's own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while only 61 reports were received on all types of birth control pills.
In addition, there were four times as many strokes in women on the patch compared to women taking the pill even though 3 times as many women were taking the pill.
Overall, in medically confirmed cases, the risk of clots was estimated to be 14 times higher with the patch.
And yet, according to the complaint filed in the California case of Thoren v Johnson and Johnson, filed on January 20, 2006: "The various sales messages sent to health care providers failed to warn that the patch carried a higher risk of blood clots than oral contraceptives and actually implied that the patch carried the same risk as a pill."
Injuries listed in many of the complaints are defined in medical terms by the National Institute of Neurological Disorders and Stroke, with thrombosis being the formation of a clot within a blood vessel of the brain or neck, and embolism defined as the movement of a clots to another part of the body such as the heart to the neck or brain and can kill depending on where they lodge in the body.
All hormonal birth control products are known to increase the risk of blood clots because estrogen promotes coagulation. Clots are semisolid masses of blood tissue that form as a result of coagulation. When clots break off into the bloodstream they can block the blood flow to other areas of the body.
Common symptoms for blood clots can include, but are not limited to, pain in the calf, shortness of breath, chest pain, or coughing blood.
If a clot is lodged in the brain, a stroke can occur when the brain does not receive an adequate amount of oxygen. Symptoms of a stroke include sudden: (1) numbness or weakness of face, arm, or leg, especially on one side of the body; (2) confusion, difficulty speaking, or understanding; (3) trouble seeing in one or both eyes; (4) difficulty walking, dizziness, or loss of coordination; and (5) severe headache with no apparent cause
Milder symptoms may include drowsiness, double vision, drowsiness, nausea, or vomiting.
Attorneys say the plaintiffs in these cases have a "signature disease," meaning a condition that is closely linked to use of the product but is otherwise rare. In this instance, blood clots are highly unusual in women of childbearing age.
The 7 lawsuits reported in the January 30, 2006 Madison St Clair Record, filed in in US District Court for the Southern District of Illinois on January 23, 2006, allege the drug maker knew about the problems with the patch but failed to warn the plaintiffs about the risk of blood clots and include the following claims and injuries by plaintiffs:
Maral Annayeva suffered from bleeding, heart pain, headaches, nausea and general malaise.
Brandy Houk suffered shortness of breath, fatigue, excessive bleeding, and passed large clots as a result of use of the patch.
Melody Miller suffered multiple blood clots which resulted in the miscarriage of her child in the fifth month of pregnancy.
Tanya Lowe suffered blood clots in her right leg that shattered and spread to her lungs.
Reannon Tutkus suffered blood clots.
Stephanie Curtis discontinued the patch and immediately became pregnant and developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.
Kristine Bailey suffered blood clots, dizziness and fatigue.
The plaintiffs in the above cases also allege that the drug maker violated the Illinois Consumer Fraud Act by the use of false and misleading misrepresentations in the marketing, promotion and sale of the patch.
The injuries described in women all across the country who have been injured by the patch mirror each other as evidenced by the following cases:
In La Cross Wisconsin, 8th grader, Alycia Brown, died of blood clots in her lower pelvis.
A woman in Maine suffered from a blood clot in her right lung.
An 18-year-old student, Zakiya Kennedy, died in a New York subway station.
In Indiana, a 12-year-old girl was diagnosed with deep-vein thrombosis.
In Missouri, Rachel Cook, 22, experienced chest pains and was hospitalized for blood clots in her lungs.
In California, doctors found a blood clot in the lung of 37-year-old Stephanie Sanchez after she experienced bad cramping in her chest.
In Glen Carbon, Illinois, Jennifer McNichols had to undergo anti-coagulant therapy and vascular surgery because of clots in her right calf and thigh.
Seventeen-year-old Laurie Swanson died after suffering a stoke in August 2004.
In Georgia, Lydia Lilly, 35, experienced pain and difficulty breathing and suffered a pulmonary embolism
In Wyoming, 25-year-old, Kathleen Thoren died when a blood clot caused a fatal amount of pressure on her brain.
In New York, a 25-year-old mother of two, Sasha Webber, died of a heart attack.
And there are bound to be thousands more suits filed because J&J reportedly sold 5 millions Ortho patches to women since the product came on the market in 2002. According to its 2005 annual report, all total J&J sold $1.1 billion in contraceptives last year.
Attorneys warn that medical professionals had better think twice before prescribing the patch because any doctor writing a prescription for it after the November 10, 2005, FDA warning, they say, could very well be considered irresponsible in terms of accepted medical practice if an otherwise healthy young patient is paralyzed or dies after using the device.
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)