Thursday, July 29, 2010

Johnson & Johnson Knee-Deep in Birth Control Patch Litigation

Evelyn Pringle November 5, 2006

Ortho Evra birth control patch lawsuits are becoming increasingly common as very young women are suffering heart attacks, strokes, blood clots and pulmonary embolism while using the patch.

On November 1, 2006, the Associated Press reported that 43 more women have sued the makers of the patch alleging that they suffered from blood clots and other health problems after using the patch.

A second lawsuit contends that 25-year-old Kelly Bracken of Elk Ridge, Maryland, died of severe blood clots in her lungs and legs after she started using the skin patch.

The new lawsuits were filed in San Francisco Superior Court, and the named defendants include patch maker Ortho-McNeil Pharmaceutical, a New Jersey based subsidiary of Johnson & Johnson; and the San Francisco based distributor McKesson Corp.

The case titles for the lawsuits are Bracken-Hodge v Ortho-McNeil, 06-457523; and Abel v Ortho McNeil, 06-457524.

Like nearly all of the cases filed so far, these lawsuits claims that the drug company failed to adequately investigate the safety of the patch and deceived consumers about the potential dangerous side effects, including the risks of strokes and blood clots.

"This product should not be on the market," said Shawn Khorrami, an attorney for the plaintiffs, in the Associated Press article.

"When you put out a product that gives women more hormones than they need," he said, "then you're increasing their risk of developing those ailments."

New lawsuits are now being filed just about every month. In mid-October a case was filed against Ortho-McNeil in the Superior Court of New Jersey, on behalf of a 25-year-old Wisconsin woman who was diagnosed with bilateral pulmonary emboli after using the patch for six months.

On October 17, 2006, News Inferno reported that a lawsuit had been filed on behalf of a Katy McKellips Braman, an Idaho woman who was 17 when she was prescribed the patch in 2004.

Ms Braman alleges that she had been using the patch for only a little more than a month when she developed deep vein thrombosis, a serious and potentially fatal blood clot condition, in her left leg.

The month before that, on September 5, 2006, a Drug Newswire press release announced that a 24-year-old Texas woman who suffered a miscarriage and developed potentially life-threatening blood clots after using the patch had filed a federal lawsuit in Marshall, Texas.

Going back another month, in August 2006, a 36-year old Kentucky woman filed the first federal lawsuit against the patch makers in that state alleging that she experienced blood clots in her legs, spleen and lung about 5 weeks after she began wearing the patch.

The FDA approved the Ortho Evra patch in November 2001, and it quickly became one of J&J's most popular products. Once attached to the body, the patch delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

Most experts agree that the dangers of the patch stem from its delivery system. By releasing estrogen directly into the bloodstream, a woman can end up with an estrogen level of up to 60% higher than a woman taking the pill. This is partly due to the fact that the absorption rate of a pill traveling through the digestive system is much lower than the patch, which delivers estrogen 24 hours a day.

Attorneys say the death and injuries attributed to the patch in younger women are what's known as a "signature disease," meaning they are practically unheard of in women in this age group. Healthy young women, with no history of any underlying condition, are not known to suffer heart attacks and strokes.

For instance Kelly Bracken's mother says her daughter never had any health problems when she unexpectedly died from severe blood clots in her legs and lungs at the age of 25. She told ABC News on November 2, 2006, that she blames the drug company for her daughter's death.

Kelly's mother also told ABC News that she now dreads her upcoming birthday because it was 2 years ago on her birthday when her daughter collapsed and went into a coma.

She said Kelly complained of problems once she started using the patch and, "Two weeks after complaining about the back ache and head ache she was dead."

A lawsuit filed in New Jersey Superior Court by ten women who allege they experienced blood clot problems after using the patch alleges the FDA received 9,116 adverse reaction reports from patch users in a 17 month period, which averages out to well over 500 per month, compared to receiving only 1,237 adverse event reports from women using the birth control pill in six years which averages out to less than 20 a month.

Since the FDA estimates that it receives reports on only between 1% and 10% of the serious adverse drug reactions that actually occur, the death and injury rate for Ortho Evra patch users is estimated to be significantly higher than FDA numbers indicate.

In November of 2005, the FDA changed the label on the Ortho Evra patch to include a bolded warning that the patch exposes women to higher levels of estrogen than most birth control pills.

The label explained that hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth and warned that increased estrogen exposure may increase the risk of side effects.

On September 20, 2006, the FDA updated the label on the patch again, warning that women who use the patch face a higher risk of blood clots

Through litigation, information has surfaced that shows that the patch makers were aware of the mounting reports of deaths and injuries associated with the patch. On November 11, 2005, the Associated Press stated: "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 article reports, "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.'"

CBS News also reported that other documents that surfaced in litigation reveal that the company's own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while during that same time period the company only received 61 such reports on oral contraceptives.

In addition, there were 4 times as many strokes in women using the patch as in women using the pill even though there were 3 times more women taking the pill and in medically confirmed cases, the risk of blood clots was found to be 14 times higher with the patch.

Because J&J does not want to try cases related to the death and injuries that have occurred uncharacteristically in so many otherwise healthy young women, the company has been offering to settle lawsuits in record numbers in hopes of avoiding public jury trials.

The only hitch is that the check is not issued until after the plaintiff signs a confidentiality agreement and promises to keep everything about the case a secret.

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