Judge Denies Request to Use Confidential Documents to Petition to the FDA on the Dangers of Yaz

Nov. 14, 2011 - PRLog -- Last week Chief Judge David R. Herndon denied Plaintiff’s request to use certain “protected” documents from the Yaz litigation to petition the FDA and its advisory committee concerning public health issues associated with drospirenone-containing birth control pills, such as Yaz.  http://www.ilsd.uscourts.gov/Documents/mdl2100/Order45.pdf  Attorney David Ennis commented on the ruling stating, “It’s a shame that certain documents are kept confidential, especially when they may include critical information for the FDA’s determination of the safety of Yaz; however it is understandable that the certain information is protected in order to preserve the discovery process.”

Kaitlyn Dietrick, one of the women who filed a lawsuit against Bayer Healthcare for its failure to warn of the side effects of Yaz and Yasmin birth control pills, wanted to use certain confidential documents obtained during discovery in her lawsuit to present to the FDA during its advisory meeting scheduled for December 9, 2011.

Dietrick argued that it was a 1st Amendment right that allowed her to present confidential documents to the FDA Advisory Committee.  Unfortunately, though, U.S. District Judge David R. Herndon, the judge presiding over the federal Yaz Multidistrict Litigation (MDL) cases filed in the Southern District of Illinois, agreed with Bayer that the documents required confidential status pursuant to German Privacy Laws, as the information obtained is personal data that was processed in Germany.   Judge Herndon further noted that Bayer showed “good cause” that the documents constituted trade secrets and should be kept confidential.  While Bayer stipulated to de-designate 10 of the documents, there were still 48 documents at issue.

Meanwhile, three studies have been released in the past three weeks to confirm increased dangerous risks, such as venous thromboembolisms and pulmonary embolisms, associated with Yaz and Yasmin.   On October 25, 2011 The British Medical Journal released their findings http://www.bmj.com/content/343/bmj.d6423.full.pdf; on October 27, 2011 the FDA released their findings http://www.fda.gov/Drugs/DrugSafety/ucm277346.htm; and on November 7, 2011 the Canadian Medical Association Journal released their findings http://www.cmaj.ca/content/early/2011/11/07/cmaj.110463.

Attorney David Ennis recommends that women who have taken drospirenone-containing birth control pills and experienced venous thromboembolisms should seek the opinion of an experienced Yaz lawyer to explore their legal rights.  Visit www.the-yaz-lawyer.com or call toll free 1-800-856-6405 today for a free, nationwide, confidential consultation.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C.  Ennis & Ennis, P.A. concentrates its practice in mass torts and represents individuals against pharmaceutical companies worldwide, as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills and Transvaginal Mesh Devices.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.  Call today toll free 1-800-856-6405 or visit www.ennislaw.com.