Menopause Night Sweats & Hot Flashes

Florida case could open hidden Prempro drug records

Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard?

If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug’s manufacturer nationwide could be released for the public to inspect.

The key to the confidential company records has ended up in Pinellas-Pasco Circuit Judge Anthony Rondolino’s hands because of a clerical misstep and a unique Florida statute.

A hearing on the matter is scheduled for Monday, though attorneys were negotiating a possible resolution late Thursday.

More than 9,000 women have sued Pfizer’s Wyeth unit, the maker of Prempro and Premarin, claiming its bestselling hormone drugs caused breast cancer and stroke. The vast majority of those lawsuits have been consolidated in federal courts in Arkansas, Pennsylvania and Nevada.

But the case of Loretta Esposito, a 63-year-old Clearwater resident who died of breast cancer in 2006, slipped through the cracks, making it the only Wyeth case in a Florida court. That could subject it to the state’s Sunshine in Litigation Law, which prohibits the court from keeping papers secret if they concern a public hazard.

Citing this statute, Esposito’s attorneys have refused to agree to the confidentiality order Wyeth has required other plaintiffs’ attorneys to sign before giving them access to an estimated 16 million discovery documents.

During a hearing in the spring, James Clark, the Tampa lawyer who represents the deceased woman’s husband, Peter Esposito, said the agreement would "be asking us and enticing us and luring our client through us — and the court — to violate Florida law … because it’s our position that the product isn’t okay."

‘Misleading’ risk

Prempro, which combines estrogen and progestin, and estrogen-only Premarin were approved by the Food and Drug Administration to relieve hot flashes and night sweats  associated with menopause. More than 6 million women have taken the drugs.

Sales of the drugs, widely prescribed off-label as remedies for everything from wrinkles to weak bones, took a hit in July 2002 when a large government study showed that women on Prempro had greatly increased risk of breast cancer, heart attacks, strokes and blood clots. Two years later, similar results were seen with Premarin. Last year sales of the two drugs totaled $1.1 billion, down from a peak of about $2 billion in 2002.

Wyeth’s attorneys have argued that the drugs are safe and effective and said the lawsuits are without merit. In a motion opposing Monday’s hearing, they wrote, "Even assuming that Prempro is a ‘public hazard,’ there is no information in the underlying documents that would provide a woman taking Prempro today information about the risks of Prempro that is not already known."

After listening to a similar argument from a Wyeth attorney at a hearing last month, Judge Rondolino asked: "How can you be saying this is secret if you’re saying the public knows about it?"

Among the experts expected to be called at Monday’s hearing is a Georgetown University doctor who has reviewed the confidential Wyeth documents as a plaintiff’s witness. In an affidavit, Dr. Adriane Fugh-Berman said none of the sealed papers relate to trade secrets. Instead, she said the records contain information about marketing, sales and publication plans, including paying consultants to ghost-write articles published under a researcher’s name to downplay the risks of breast cancer.

"Women will continue to receive misleading information about the risks and benefits of hormone therapy unless Wyeth’s methods are exposed," she wrote.

Maker: Label enough

Wyeth, which was acquired by Pfizer in mid October, has said its products’ labels adequately address their risks. Plaintiffs have prevailed in four of eight cases that went to a jury; all are being appealed. Most recently, a Philadelphia jury awarded a cancer victim $3.7 million in compensatory damages and an undisclosed punitive judgment.

Esposito, a mother of three, began taking Prempro for hot flashes in 1998 and had been on the drug for more than three years when she was diagnosed with Stage 4 breast cancer.

Court documents show that her physician, Dr. Margaret Coyle, who worked for Morton Plant Primary Care, was visited more than twice a month by Wyeth sales representatives during the time she was treating Esposito with Prempro. Even so, the doctor said that after the government study was halted — just months after Esposito’s cancer was diagnosed — she would have had different advice for her patient.

"I would have suggested that the risks were greater than the benefits," speculated Coyle, who has moved her practice to North Carolina.

Times researcher Carolyn Edds contributed to this report. Kris Hundley can be reached at khundley@sptimes.com or (727)892-2996.