Recent Articles Shed Light on Dangers of Yasmin and Yaz

On Saturday, the New York Times reported on the serious and potentially deadly health risks associated with Yasmin and Yaz. As discussed on this blog, our website, and our You Tube Video , there is and has been solid evidence that these oral contraceptives are unsafe options, that the advertisements used by Bayer to promote Yasmin/Yaz intentionally obscured the serious health risks, and that the manufacturing plants producing Yasmin/Yaz are not even properly producing the drugs in accordance with U.S. current good manufacturing practices!

You can read the New York Times story by clicking here.

There was also a posting this weekend on the Human Rights-World Affairs Blog Network that is worth reading. The article by Jessica Corsi discusses how drug companies’ greed for profit and lies about safety despite contrary scientific evidence, result in women being exposed to unnecessary health risks.

The article titled, “Yaz Birth Control Controversy: Pharmaceutical Profits, Unnecessary Risks, and the Gendered Distribution of Family Planning” is available by clicking here.

To learn more about Yasmin and Yaz, please click here.

Litigating Toxic Tort, Pharmaceutical and Medical Cases

Pamela A. Borgess, one of our partners, will act as moderator for the AAJ annual “Litigating Toxic Tort, Pharmaceutical and Medical Cases” Seminar to be held on September 24-25, 2009 in Las Vegas at the Palazzo Hotel. Ms. Borgess will also present an update on the ongoing litigation involving the tainted Chinese heparin that killed hundreds of Americans in 2007 and 2008 and participate in the meetings on Yaz, Yasmin and Ocella.

This well-regarded seminar is attended by Plaintiff Attorneys from across the country, who come to get inside information on innovative trial techniques, strategies, and practices that leading attorneys have used to take on industry giants. Agenda highlights also include the latest updates on hot topics such as Hydroxycut, Paxil Birth Defects and Avandia; Electronic Discovery, and new topics such as "Facebook and Other Social Networking—What They'll Find Out About Your Client." Attendees will also learn how to access and maximize the necessary resources to go up against negligent companies.

Plaintiff Attorneys who are interested in this seminar can get more information and register at www.justice.org/education/pharmaseminaror by calling AAJ Education at 800-622-1791 or 202-965-3500, ext. 612.

**Open Only to Plaintiff Attorneys**

Judge Moss consolidates Yaz / Yasmin cases

Yesterday I had the honor of meeting again with Judge Sandra Moss in the historic Philadelphia County Courthouse, Philadelphia, Pennsylvania, to participate in the second status conference on Yaz / Yasmin.

At the conference Judge Moss announced that she was accepting the Yaz / Yasmin cases as Mass Tort cases and consolidating them for purposes of pretrial management. The appropriate orders were issued. Bayer's attorneys announced that there were 77 cases filed to date, 14 of which are pending before Judge Moss.

We have filed one (1) case before Judge Moss and the balance of our cases in federal court, including fifteen (15) before Chief Judge James Carr in Toledo. Next week we will present argument in Richmond, Virginia on our petition to have all of the federal cases consolidated before Chief Judge Carr. There is unanimity among the parties that the cases should be consolidated. The only question is which venue is the most appropriate.

After the hearing we (myself and the other litigation leaders) met with defense counsel in an effort to work out continuing coordination of the litigation. The Parties are hopeful that the JPML Court will approve a venue that will permit close coordination between the State and Federal Courts.

In the meantime we continue to be impressed by the number of women who have suffered injury or death while on Yaz / Yasmin or Ocella. (Ocella is the generic equivalent and is actually made by Bayer). While we represent well over 100 women, we are currently only filing suit on those claims where it is necessary to do so to protect the statute of limitations. The other cases will be timely filed as soon as the location of the MDL is determined, so that we can then choose the best venue for our clients.

We will keep you posted. If you have not yet retained legal counsel and suffered serious injury from Yaz I encourage you to immediately contact a qualified attorney to review your case.

Yaz, Yasmin Manufacturer Warned Yet Again by FDA

After repeated warnings by the FDA to Bayer and its predecessor Berlex for marketing its birth control drugs, Yaz and Yasmin in a way that overstates the drugs’ benefits and minimizes the very serious and potentially deadly side effects, the drug manufacturer is being warned yet again. This time, however, the problems concern the testing and quality of the pharmaceutical ingredients used its drugs, including Yaz and Yasmin.

In a letter released on Tuesday, the FDA warned Bayer about the testing and quality of pharmaceutical ingredients made at its Germany facility that are used in U.S. drugs, including the key ingredient in Yasmin and Yaz, called drospirenone. (See 9/15/09 “FDA Warns Yaz, Yasmin Manufacturer over Testing Problems” by Matthew Perrone, AP Business Writer.)

The letter followed a March 2009 inspection of the company’s plant in Berghamen, Germany, that “revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile APls [Active pharmaceutical ingredients].”

The FDA gave Bayer 30 days to respond to the warning and advised that “failure to correct these deficiencies may result in FDA denying entry of articles manufactured by your firm into the United States.”

To view a copy of this warning letter, click here.