December 2011 was not a pretty month for the nearly 10,000 women seeking justice from the birth control drug Yaz. The U.S. Food and Drug Administration (FDA) created two advisory panels earlier in the year in order to investigate the dangers of the active ingredient drospirenone, resulting in even more questions and concerns.
Drospirenone has shown in numerous clinical studies to promote clotting in the blood stream. This has caused the blood of generally healthy and active women who take birth-control pills to clot when it’s not supposed to, creating what is called “deep vein thrombosis.”
Deep vein thrombosis happens when clots form in the legs and stay there until they suddenly dislodge, travel quickly to the lungs, where they get caught and in some cases can cause victims to die of suffocation. These clots can also inhibit movement and overall blood health of the women. Depending on the size and location of the clot they have also been known to cause heart attacks, strokes, and sudden death.
However, the findings of the studies seemed to not effect the FDA advisory panels’ controversial decision to keep the drug on the market as the Yaz Lawsuits march on.
Concerns About the FDA Panel
The panel voted 15-11 that the benefits of drospirenone-containing birth control pills, such as Yaz and Yasmin, outweigh the risks. It has now been revealed in a joint investigation conducted by the Washington Monthly and the British Medical Journal (BMJ) that at least 4 members of the committee have either done work for the Bayer (the manufacturer of Yaz and Yasmin), are licensees, or received research funding from them.
Though this is not unheard of, the problem is that this is the exact margin in which the drug was approved. You see, FDA guidelines state that when advisory committee members have a financial relationship with a drug company whose product is under review, the agency can issue waivers that acknowledge the advisors’ links to industry. This frees them to vote if their expertise is needed and “no other specialists are available.”
However, investigative reports state that the FDA neglected to issue these waivers for this particular panel. According to public records, recently unsealed court documents, and interviews with some of the FDA advisors, at least four of the advisory committee members in this case have served as paid researchers, consultants, “key opinion leaders,” or speakers for Bayer.
Not only this, some have also worked for other manufacturers of drospirenone and may know that the ruling against Yaz may have ripples throughout the industry. On the same panel, it was also found that a fifth advisor agreed to serve as a consultant but never executed the agreement and sixth actually received consulting fees from a law firm that represents Bayer in drug litigation.
It seems like the FDA let everyone in on the panel vote or at some point weren’t paying attention to exactly who had a conflict of interest or not, but that’s not the case. FDA officials did bar one member of the panel from voting. Sidney Wolfe, a former researcher and consumer advocate, was barred on the grounds that he had and “intellectual conflict of interest.”
What effect does this have on the thousands of lawsuits brought by victims of Yaz and Yasmin currently in Multidistrict Litigation (MDL)?
As unscrupulous and unjust as this whole business seems, it doesn’t stop the Yaz lawsuits from happening. The growing group of women who are suing Bayer over serious injuries from Yaz and Yasmin, after the December decision, urged U.S. District Judge David Herndon to examine evidence of conflicts of interest at the FDA.
On Jan. 17, the plaintiff steering committee, overseeing the federal litigation, opposed a motion to exclude opinions of former FDA commissioner David Kessler who claims conflicts of interest had stymied a joint meeting of two advisory committees over drospirenone to at the very least issue a black box warning, the next best thing to taking the drug off the market. The black box warning is given to drugs in order to warn the public of the drug’s potential to kill them.
“Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members’ impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such,” Kessler said.
Certainly, these concerns expose the FDA to more scrutiny, however, nothing’s going to come of it because the majority of the FDA’s funding is derived from the pharmaceutical companies and it would take an act of congress to change that.
Certainly, Bayer’s lawyers will try to use this decision in an effort to slow the process or effect the cost of a settlement because the longer Yaz and Yasmin stay on the market, the longer Bayer is able to cash in on the billions of dollars those drugs pull in annually. You see, 4 million women around the world are currently taking the drug. Many of these countries use the FDA as a bellwether to determine their policy on certain drugs.
Regardless, the Yaz and Yasmin MDL soldier on. There are nearly 10,000 women involved in lawsuits that charge a series of problems caused by the drug including:
- Deep vein thrombosis
- Pulmonary embolisms
- Gall bladder damage
Because of these very different ailments, Judge Herndon has asked for 9 bellwether lawsuits to take place. These lawsuits are intended to help test the validity of each claim and examine the evidence in each case for these separate ailments.
These bellwether cases are scheduled to begin in April.
Calls for a new panel have already begun under allegations that Kessler’s investigation and opinions were not adequately reviewed as they were only allowed into evidence two days before the panel’s deliberation. Unfortunately, a new panel – if accepted – would most likely not happen until long after the bellwether trials are well on their way.
If you or someone you know are taking Yaz, Yasmin, or Ocella and have been stricken with one or more of the side effects listed above, some of the best advice you can give is to seek legal council right away to find out your legal options. Protect yourself. Call Phillips Law Firm for a consultation.