The Trouble with the Pitch: Off Label Uses of Yaz and Yasmin

Birth control pills were originally developed to do exactly as it says: prevent unwanted pregnancies. The first oral contraceptives were not always effective even with perfect use, but newer formulations have proven to be highly efficacious. Of course, as is typical with most pharmaceutical solutions, there are side effects that range from uncomfortable to potentially fatal. It is accepted that with any type of oral contraceptives, there are common side effects such as blood clotting, gallbladder complications, and possible cardiac problems.

Currently, much attention has been brought to bear on the newest crop of oral contraceptives which contain drosperinone because it is suspected that the typical risks associated with oral contraceptives may be higher with 3rd and 4th generation progestins such as drosperinone than 1st and 2nd generation ones. Among the most targeted products in this category for product liability cases are Yaz and Yasmin, both manufactured by Bayer. The most popular allegation is that Bayer knew or should have known about these elevated risks and failed to give due warning to users. Bayer continues to deny these allegations as it steadily settles thousands of cases.

But to add salt to injury, Bayer had mounted an aggressive and highly successful direct-to-cutomer (DTC) marketing campaign which touted the success of Yaz and Yasmin for off label use such as treatment of premenstrual syndrome and severe acne before the Food and Drug Administration could put a stop to it. By then, doctors had prescribed the drugs to a lot of women who would otherwise not take oral contraceptives for treatment of these conditions, believing that they were no more harmful than older formulations.

As a result, more than 12,000 women or their representatives are now waiting for the outcome of litigation or settlement offers for injuries they sustained from the use of Yaz and Yasmin. By what percentage that number would have been reduced if Bayer had not encouraged the off-label use of the product is hard to determine, but it is probably a significant number.

Organ Transplant Recipients Meet in Briarcliff

BRIARCLIFF MANOR, N.Y. – When Vikram Sharma began itching all over his body in March of 2009, he thought he had some kind of skin rash. He went to see a doctor who told him he had a problem with his liver, and a few days after that prognosis, Sharma was found in his home unconscious in a pool of blood.

Sharma, 48, of Ardsley, was diagnosed with primary biliary cirrhosis, a condition where inflammation in the bile ducts of the liver blocks the flow of bile and leads to liver scarring. Sharma was put on a waiting list to receive a liver transplant, and about six months later, he underwent a transplant operation at Columbia University Medical Center in Manhattan.

“I feel great,” said Sharma, two and a half year later at a Wednesday meeting of the Transplant Support Organization held at the Congregation Sons of Israel in Briarcliff. “In my case, the medical team could never find out the root cause of my disease. I’m a vegetarian, I rarely ate red meat. I never drank in my life and I exercised regularly. I was a volunteer soccer coach in Ardsley.”

Sharma was one out of about 20 people at the meeting who had received organ transplants of various types, including liver, kidney, heart and lung.

Sharma considers himself lucky to have received a liver from a non-living person so quickly. Unlike many others who have liver problems, Sharma never used alcohol or drugs, and that helped him to be looked on favorably as a liver recipient.

“If I had used drugs, I wouldn’t have gotten a liver,” Sharma said.

There is always a shortage of organ donors, Sharma and other members of the Transplant Support Organization said. Rudy Masry, a 72-year-old Briarcliff resident who received a kidney from his wife nine years ago, recently spent four days with a group of other transplant recipients recruiting organ donors at the U.S Military Academy at West Point. They signed up 1,114 new organ donors which was a record number of people for a single event.

“It was a lot of sales,” Masry said. “You can’t just sit behind a table and expect them to come up to you. You approach them and you attack them and you sell it.”

Over coffee and snacks, transplant recipients and their spouses listened to a talk by David Wolf, the medical director of liver transplantation at Westchester Medical Center. Wolf talked about various liver conditions and the prognosis for patients with these conditions after they receive a liver transplant.

Carol Johnson, 73, of Valhalla, who received a double lung transplant at Columbia University Medical Center 10 years ago, said the hardest thing to get used to after receiving her transplant was being able to breathe without canisters of oxygen.

“I didn’t get rid of the canisters for a couple of weeks. I couldn’t believe I wouldn’t need them,” Johnson said. “But now breathing is normal. The lung is mine now.”