McNeil knew of the Ortho Evra risks
November 18, 2005 08:45

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

Doctors have become wary of a birth-control patch since the U.S. Food and Drug Administration
issued a warning of increased hormone intake. The Ortho Evra contraceptive patch, sold in the United States since 2002, outsells all brands of birth control pills, with 10 million prescriptions last year, the Wall Street Journal reported. The patch is more convenient since it only needs to be
replaced once a week.

On November 10, 2005 the FDA announced that the popular Ortho Evra birth control patch can release up to 60% greater levels of estrogen than found in the pill. The medical community has known for decades that high levels of estrogen can cause blood clots, leading to serious medical conditions such as deep vein thrombosis, pulmonary embolism, stroke, heart attack and even death in young, healthy women. Because the product labeling for the Ortho Evra patch included claims that it was just as safe as the pill, the FDA required Johnson & Johnson to add a warning in November 2005 about the increased risk of injury due to high levels of estrogen released from the Ortho Evra patch.

Our co-counsel in the Ortho Evra litigation, the law firm of Lopez, Hodes, Restaino, Milman & Skikos, has been actively representing women seriously injured due to blood clots caused by the Ortho Evra birth control patch, and filed in April of 2005 what is believed to be among the first of many cases we anticipate will be filed in the country against the makers of the Ortho Evra patch. As a result of this early filing, Lopez Hodes has taken a leading role in developing the case against Johnson & Johnson and its Ortho-McNeil subsidiary. Lopez Hodes has already had several status conferences in the United States District Court in the Northern District of Ohio, before the Honorable Judge Katz. A protective order has been entered, discovery responses provided, and nearly two million pages of documents have been produced to Lopez Hodes. The Defendant has agreed to consolidate discovery in other Lopez Hodes cases with the lead case in Ohio.

Last week, the law firm of Lopez Hodes filed a wrongful death action on behalf of a family in Wisconsin, who lost their 14 year old daughter due to pulmonary emboli caused by the Ortho Evra patch. The Lopez Hodes law firm has several other cases filed on behalf of women who have suffered serious personal injury due to use of the Ortho Evra patch, including recent filings in California and Massachusetts.

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NEW YORK, November 22, 2005 (LifeSiteNews.com) - The recent flurry of publicity surrounding the Ortho Evra contraceptive patch has resulted in some doctors refusing to prescribe the deadly drug. The Wall Street Journal reported yesterday that some doctors do not want to take chances after the manufacturer began including warnings of fatalities and stroke related to the patch.

Some doctors are no longer writing prescriptions for Johnson & Johnson's Ortho Evra contraceptive patch after FDA issued a warning earlier this month regarding possible health risks for women using the patch, the Wall Street Journal reports (Chaker, Wall Street Journal, 11/22). FDA on Nov. 8 warned that women who use the patch have a higher risk of experiencing blood clots and other side effects than previously stated because the patch exposes users to about 60% more estrogen than standard birth control pills.
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=33884

Alycia Brown was an eighth-grader in La Crosse, Wisconsin when she died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.

The FDA is studying the dangers of Ortho Evra and other birth control methods.

The FDA has approved a measure to update warning labels for the Ortho Evra contraceptive patch because of potential risks related to increased estrogen exposure. The action, taken on Nov. 10, followed an analysis by the FDA and Ortho McNeil Pharmaceuticals to compare estrogen and progestin hormones in the birth control patch Ortho Evra to typical birth control pills.

Today, the first Massachusetts lawsuit alleging injury from the Ortho Evra Patch was filed in the U.S. District Court in Boston, by Michael R. Hugo of the Firm, Lopez, Hodes, Restaino, Milman & Skikos. The case is Poltrack v. Johnson & Johnson, et al USDC Civil Action No: 05 CA 12345, alleges that the plaintiff, a 25 year old woman, suffered a stroke while on the contraceptive patch.

http://www.thebostonchannel.com/news/5386019/detail.html

The Associated Press has published a number of reports on problems caused by the patch. Using federal death and injury reports, it found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch. Dozens more survived strokes and other clot-related problems.
http://www.zenit.org/english/visualizza.phtml?sid=80231

The Ortho Evra contraceptive birth control patch, sold in the United States since 2002, outsells all brands of birth control pills, with 10 million prescriptions last year, the Wall Street Journal reported. The birth control patch is more convenient since it only needs to be replaced once a week.

The Food and Drug Administration issued a warning last week that users of the Ortha Evra birth control patch are at a higher risk for blood clots and other serious side effects.

Leigh Zaleski of Temple News reports that the FDA has approved a measure to update warning labels for the Ortho Evra contraceptive patch because of potential risks related to increased estrogen exposure.

Leigh Zaleski can be reached at leigh.zaleski@temple.edu.

Health Canada is advising consumers that it is currently reviewing whether any product labelling changes are required for the Canadian version of the Ortho Evra contraceptive skin patch. It is important to note that the dosages and the manufacturing processes for the Canadian version are different than the patch approved in the United States.

On November 10, 2005, the U.S. Food and Drug Administration approved revised labelling for the Ortho Evra contraceptive skin patch that includes a new, bolded warning alerting health care providers that the amount of estrogen delivered through the skin produces a higher estrogen exposure than when taking the typical birth control pill. Greater exposure to estrogen may increase the risk of blood clots. The full Food and Drug Administration advisory is located at:
www.fda.gov/bbs/topics/news/2005/NEW01262.html