Ortho Evra Birth Control Patch Legal Rights | Howard L. Nations National Pharmaceutical Law Firm

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The Dangers in Pre-emption
Editorial

The dangers were made clear in an article by Gardiner Harris and Alex Berenson in The Times on April 6. Their report described how Johnson & Johnson obscured the fact that its Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, thereby increasing the risk of blood clots and strokes. More than 3,000 women and their families have sued the company.

The company is arguing in court that the women can't sue because the patch and its labeling were approved by the Food and Drug Administration, the presumed authority on drug safety. But the disturbing element is that the company seems to have done its best to mislead the F.D.A., as revealed in company documents made public as a result of the lawsuits. (pdf format 22.7Kb)

Source: The New York Times
www.nytimes.com
Published April 14, 2008

Ortho-McNeil Employee Follow-up Communication

By David Y. Norton

(Note: This was posted on the J & J official blog by the Ortho-McNeil chairman)

Last Sunday, April 6th, The New York Times ran a front-page story that prominently featured ORTHO EVRA® (norelgestromin/ethinyl estradiol transdermal system), our transdermal contraceptive patch. As I said in a brief note sent to employees that same evening, while the story largely addressed a legal doctrine known as pre-emption, it also called into question our own practices and interactions with health authorities. In that communication, I mentioned that we chose to actively engage with The Times' reporters and that we answered all of their questions in a lengthy interview. Unfortunately, the article did not include many of the significant facts our representatives relayed to them during the interview, but I want to provide to you what we shared with them, to give you a more complete picture of our actions. (pdf format 17.7Kb)

Source: Johnson & Johnson Blog, "By the Way
http://jnjbtw.com
Published April 13, 2008

Drug Makers Near Old Goal: A Legal Shield

By Gardiner Harris and Alex Berenson

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released. (pdf format 37.4Kb)

Source: The New York Times
www.nytimes.com
Published April 6, 2008

Ortho-McNeil Employee Communication

By David Y. Norton

(Note: This was posted on the J & J official blog by the Ortho-McNeil chairman)

The April 6th edition of The New York Times published an article entitled, “Drug Makers Near Old Goal: A Legal Shield.” The article is about a legal doctrine, called pre-emption, and featured prominently is ORTHO EVRA® (norelgestromin/ethinyl estradiol transdermal system), the birth control patch marketed in the U.S. by Ortho-McNeil.

While the article deals predominantly with the issue of pre-emption, it also questions our commitment to patient safety and scientific integrity. And in so doing, it inaccurately depicts our actions leading up to approval of the patch by the U.S. Food and Drug Administration (FDA) in 2001, and the data reporting procedures we have followed since. I want to make sure you have our point of view, in part because some of the characterizations in the article, including references to internal company documents, are taken clearly out of context. (pdf format 11.7Kb)

Source: Johnson & Johnson Blog, “By the Way”
http://jnjbtw.com
Published April 6, 2008

FDA Approves Update to Label on Birth Control Patch

The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. (pdf format 22.1Kb)

Source: U.S. Food & Drug Administration
www.fda.gov
Published January 18, 2008

Do Not Use the Ortho Evra Birth Control Patch
Statement of Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group

More than two months ago, we warned readers ...not to use the dangerous new birth control patch, Ortho Evra ... because of the increased risk of life threatening blood clots ...

These dangers were noted by the FDA physician who reviewed the drug before the agency approved it [more from Public Citizen ...]

Public Citizen
November 15, 2005

Some Doctors Stop Prescribing Ortho Evra Birth Control Patch, After FDA Warning, Wall Street Journal Reports

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 [more from Kaiser Network ...]

Kaiser Network
November 22, 2005

Birth Control Patch Higher Risk than the Pill, FDA Says

The Food and Drug Administration approved updated labeling for the Ortho Evra contraceptive patch in November ... The labeling is being changed in order to make providers aware that it's not a 20 microgram dose method and to be aware that if you want a lower dosage method that it's not a good option [more from The Daily Illini ...]

The Daily Illini
Independent student newspaper
University of Illinois
December 5, 2005

Doctors, Women face Questions on Risks of Birth Control Patch

A patch that revolutionized hormonal birth control when it came on the market three years ago now carries a warning from the U.S. Food and Drug Administration ...

"The patch was convenient, definitely, but I'm not going to risk my life for convenience," Burrell said. [more from Pittsburgh Tribune-Review ...]

Pittsburgh Tribune-Review
November 30, 2005

The Birth Control Patch: Convenient, Yes, But it's Risky

As a scientist, I agree with Dr. Arlene Lewis that the facts about the birth control patch are not all in ... But as a husband who had to watch his wife linger on the brink of death for several days with a double pulmonary embolism after using the Ortho Evra patch, I am horrified at Dr. Lewis' off the cuff remarks. [more from The Free Lance Star Daily News ...]

The Free Lance-Star daily newspaper
November 30, 2005

Warning Issued for Birth Control Patch

Concerns are being raised about a popular birth control patch that exposes women to more hormones than previously disclosed, possibly putting them at risk of serious side effects....

Ortho McNeil says it is not pulling the Ortho Evra patch from the market [more from CTV ...]

CTV, Inc.
Toronto, Canada
November 11, 2005

Birth Control Patch Users Warned

... "I wish I had known. It's quite likely I would never have used it," said Jennifer Cowperthwaite, 26, of Broad Brook, Conn., who still suffers breathing problems after a blood clot reached her lungs two years ago after she used the patch. ...

...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" [more from CBS News ...]

CBS News/Associated Press
November 11, 2005

Birth Control Patch May Pose Health Risk

About a dozen women, most in their late teens and early 20s, died last year from blood clots believed to be related to the birth control patch Ortho Evra. ...

... The women who died were young and apparently at low risk for clots women like Zakiya Kennedy, an 18 year old Manhattan fashion student who collapsed and died in a New York subway station ...

... Kathleen Thoren died last fall, just after Thanksgiving, after days of agonizing headaches that the coroner's report said were brought on by hormones released into her system by Ortho Evra, which she had started using a few weeks earlier [more from CTV ...]

CTV, Inc./Associated Press
Toronto, Canada
July 17, 2005

FDA Updates Labeling for Ortho Evra Contraceptive Patch

The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. [more from the FDA ... pdf format 19Kb]

FDA News
U.S. Food & Drug Administration
November 10, 2005

Doctors Back off Birth-Control Patch

Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it. [more from The Pittsburgh Post Gazette ...]

The Pittsburgh Post-Gazette

By Anne Marie Chaker, The Wall Street Journal
November 22, 2005

The following articles may require a [free] subscription:

Warning on Birth-Control Patch

The makers of a popular birth control patch warned millions of women that the patch exposes them to higher doses of hormones and may put them at greater risk for blood clots and other side effects than previously disclosed. [more from The New York Times ...]

The New York Times
November 11, 2005

COMPANY NEWS; F.D.A. CLEARS JOHNSON & JOHNSON BIRTH CONTROL PATCH

The drug maker Johnson & Johnson, based in New Brunswick, N.J., has received approval from the Food and Drug Administration for a new birth control patch slightly larger than a postage stamp [more from The New York Times ...]

The New York Times
November 21, 2001

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