Citing the corrective advertising that Bayer aired in 2009 in regard to the marketing of the oral contraceptive Yaz, the U.S. Food and Drug Administration announced in the Federal Register that it would study the “influence” of those direct-to-consumer ads, or DTC ads, designed to correct the misleading claims disseminated in previous spots.
The FDA will collect public comments through Jan. 25 on the project, which will involve the random recruitment of 6,650 subjects for “main study” interviews that will be conducted both before and after their Internet exposure to one of the following:
- “only the original ad”
- “only the corrective ad”
- “both the original and corrective ad”
- “a reminder ad for the product, to control for brand name exposure”
Input will be collected also from those who have seen neither ad.
Participants “will answer questions about their recall and understanding of the benefit and risk information, their perceptions of the benefits and risks of the drug, and their intent to ask a doctor about the medication,” consistent with the FDA’s lawful authorization “to conduct research relating to drugs and other FDA regulated products.”
Bayer has become somewhat of a federal poster child for the FDA’s request for the placement of “corrective advertising,” which is designed to douse the embers of misleading messages.
“In 2009, for example,” as the Federal Register reads, “Bayer HealthCare Pharmaceuticals produced and aired corrective DTC advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims. Despite these developments, researchers and policymakers currently lack empirical literature regarding the various influences of corrective DTC ads on prescription drug consumers. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising.”
Bayer’s Yaz ads, according to the FDA’s 2008 warning letter, were “misleading because they broaden the drug's indication (to include PMS), overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of” federal statutes and regulations.
Who knows how often the understated risks of Yaz in advertising slipped under a consumer’s radar and stimulated interest in the drug? One thing is practically gospel. There is a relationship between Yaz and the increased risk of serious conditions. The Yaz attorneys at Reich & Binstock represent clients who can attest to the severity of those risks. Yaz lawsuits have been filed to protect the rights of the injured to compensation.
Based on scientific information available at the time, the FDA in April 2012 updated the warnings and precautions for Yaz/Yasmin/ocella to include the increased risks of “thromboembolic disorders and other vascular problems,” which for too many plaintiffs in Yaz lawsuits was a tardy caveat to an unreasonable health hazard.
Yaz is a combination oral contraceptive that contains drospirenone, or DRSP, and ethinyl estradiol. In addition to pregnancy prevention, the drug is approved also to treat premenstrual dysphoric disorder, which is not the same as premenstrual syndrome, and moderate acne for patients who are at least 14 years old.
The warnings and precautions updated in April 2012 included the following language: “Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.”
Venous thromboembolism events include a deep vein thrombosis and a pulmonary embolism. As the FDA writes, “A deep vein thrombosis is a rare but serious condition where a blood clot forms inside a vein. These blood clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs. If the clot travels to the lung, it is called a pulmonary embolism, a potentially fatal condition where an artery in the lung becomes blocked.”
How serious is a pulmonary embolism? “Patients with a PE have a 30 percent to 60 percent chance of dying from it,” according to Johns Hopkins Hospital.
These are the serious risks that Yaz ads once “minimize[d],” the FDA warned.
Think about it. If any manufacturer should be held accountable for injury associated with its product, shouldn’t this one?
It is not as if Bayer brass is unaware. The German corporation has spent millions on Yaz-related settlements, according to its earnings statement for the third quarter of 2012. Referring to certain costs, Bayer Board Chairman Dr. Marijn Dekkers reported Oct. 30, “The largest item here was EUR 205 million in further accounting measures we took in connection with the oral contraceptives Yasmin and YAZ — without admission of liability — for all currently known cases involving venous clot injuries that Bayer considers to be worthy of settlement.”
The experienced Yaz litigation team at Reich & Binstock represents women who were harmed following their exposure to the unstated and unreasonable risks of Yaz. The team is comprised of pharmaceutical injury attorneys who try cases in any state so that Yaz victims nationwide may recover their damages, to include medical expenses.
Anyone who took Yaz and who since has been diagnosed with VTE may contact Reich & Binstock for a free consultation toll-free at 1-866-LAW-2400. One also may submit an electronic contact form through the national law firm’s Web site, which is www.reichandbinstock.com.