Category: Defective Products

Orth Evra Birth Control Patch Causing Serious Injuries and Death

 

Documents have surfaced showing that Ortho-McNeil, the manufacturer of the Ortho Evra birth-control patch and subsidiary of Johnson & Johnson, refused in 2003 to fund a study comparing the Ortho patch to the company’s Ortho-Cyclen pill because there was too high of chance that the study may not produce a positive result for the patch. To read more click here. If you have been injured by the borth control patch, contact our Connecticut personal injury lawyers representing women injured by the Ortho Evra birth control patch.

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Ortho Evra Birth Control Patch

Ortho Evra is the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy. The U.S. Food and Drug Administration approved Ortho Evra, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, in November 2001.

Ortho Evra, an alternative to birth control pills, is a one-and-three-quarter inch square patch consisting of three layers. The hormones are embedded in the adhesive layer and are slowly released when the patch is applied to the skin.

According to the FDA, women who choose to use the product should apply it to the lower abdomen, buttocks or upper body but not to the breasts. Each patch should be worn continuously for one week and should then be replaced with a new patch on the same day of the week for a total of three weeks of patch wear.

The fourth week, which is patch-free, allows a woman to have her menstrual period – similar to the regimen for birth control pills.

Like birth control pills, Ortho Evra is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.

In April 2004, an 18-year-old New York fashion student died while using the Ortho Evra patch. According to officials for the FDA and Ortho McNeil, the death is the first linked to the contraceptive patch. Information from the Medical Examiner’s Office indicates Zakiya Kennedy’s death was caused by a blood clot.

In November 2005, Ortho McNeil issued a warning to millions of women revealing that the patch exposes them to significant amounts of estrogen and may put them at greater risk of developing blood clots.

Based on an internal company memo, Ortho McNeil refused to fund a study which would have compared the Ortho Evra patch to the company’s Ortho-Cyclen birth control pill. The company was afraid that the results of such a study may not be positive for the patch. However, the company now states that it plans to conduct a study for the patch, similar to studies previously conducted with the Pill. The Ortho Evra website states that prior to marketing the patch, it had been studied on over 3,000 women.

See your doctor if you have experienced serious health problems after using the Ortho Evra patch. In addition, it may be important to contact us to determine your legal rights.

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Trasylol May Increase Risk of Kidney Failure, Heart Failure and Stroke

Trasylol® is a drug manufactured and distributed by Bayer and used during coronary artery bypass grafting surgery often called a “CABG” procedure. It is used to control bleeding and minimize the need for blood transfusions. Recent studies suggest that Trasylol® causes, among other things, an increase in the risk of serious kidney damage, resulting in dialysis or even death.On January 26, 2006 a study done by Dennis Mangano, MD and published in the New England Journal of Medicine showed that Trasylol® was associated with a doubling in risk of kidney failure requiring dialysis among patients undergoing complex coronary artery surgery or primary surgery. The study also concluded that replacing Trasylol® with one of two safe generic drugs would annually prevent as many as 11,050 dialysis complications, save $1 billion in healthcare (dialysis) costs, and reduce drug costs by $250 million. Another study published in the journal Transfusion also suggested that Trasylol® administration increased the risk for renal dysfunction or failure.

In February 2006, Bayer issued a “Dear Dr. Letter” to U.S. Healthcare Professionals notifying them of the results of the two studies and of the review of the studies by the FDA. Bayer specifically stated, “Bayer supports these actions by the FDA. We have been working and will continue to work closely with the FDA and other regulatory authorities in countries where Trasylol® is marketed to address questions regarding product safety. We share the company’s data on Trasylol® with regulatory authorities on an ongoing basis and welcome their evaluation of these published reports.”

In its Stockholders’ Newsletter First Quarter 2006, Bayer acknowledged that two separate studies reported a possible link between the use of Trasylol® and severe renal dysfunction or cardiovascular or cerebrovascular problems in patients treated with this drug. Bayer further stated that the studies were being evaluated by the FDA and the EMEA.

On September 21, 2006, the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol®. During that meeting, the committee discussed the findings from the two published observational studies.

Then, on September 27, 2006, the FDA learned of another study actually conducted by Bayer. The newly discovered studies reported that use of Trasylol® may increase the chance for death, serious kidney damage, congestive heart failure and strokes. On September 29, 2006, the FDA announced that Bayer had failed to reveal the results of the study. Consequently, the FDA released a public health advisory stating that the undisclosed study demonstrated the “use of Trasylol® may increase the chance for death, serious kidney damage, congestive heart failure and strokes.”

Contact us if you believe you have suffered kidney failure, heart failure or stroke after receiving Trasylol.

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Children’s Toys with Magnets Pose Hazards

Toys with small, removable parts, continue to pose hazards to children. Last month, Mega Brands, Inc., the maker of “Magnetix” building sets, recalled nearly 4 million of the toys. The recall was an expansion of an original recall of some of the sets, in March 2006. The building sets include magnets that are easily removed, and easily swallowed. To date, at least one death and more than 25 serious injuries, including aspiration injuries, to children, are known to be attributed to the Magnetix building sets. Although the company is still manufacturing and selling the toy, it has changed the design, so that the potentially lethal magnets are not so easily removed by children. The federal Consumer Product Safety Commission is behind the recall, and reports that Mega Brands, Inc. is cooperating with the Commission.  The common injury from the ingestion of a magnet is the perforation of the intestines which if it not surgically repaired can lead to death.

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