By Martin Oliver
Last November, the pharmaceutical giant Pfizer was ordered by a Philadelphia court to pay US $75 million (AUD $82 million) in punitive damages to Connie Barton, an Illinois woman who developed cancer after taking the Hormone Replacement Therapy drug Prempro for five years leading up to her diagnosis in 2002. The company is also facing a US $3.75 million (AUD $4.1 million) compensatory damages payment in relation to the same case.
Prempro contains the hormones progestin and oestrogen, and was commonly used for relieving menopause symptoms such as hot flushes, night sweats, and mood swings. It was marketed by Wyeth, another drug giant that was taken over by Pfizer last October. As part of the deal, Pfizer assumed liability for Wyeth’s previous activities.
In 2002, HRT received a major setback when the Women’s Health Initiative Study, sponsored by the National Institutes of Health in the US, found a significant elevated risk of death from breast cancer or heart disease associated with drugs containing both the hormones: the study was ended prematurely out of a concern for the participants. Prior to this point, more than six million American women had been taking both pills. Today the Food and Drug Administration website recommends women who use HRT drugs to take them at the lowest dose that provides a benefit, and for the shortest time possible.
One of Barton’s lawyers claimed that Wyeth had known of the drugs’ potential to cause breast cancer as far back as the 1970s. The jury found that, as unfavourable information came to light, the company hid and ignored evidence of the potential cancer risk from HRT drugs.
Meanwhile, one of Wyeth’s lawyers admitted in court that the company engaged in various questionable practices, including ghostwriting articles for medical journals, promoting the use of drugs for conditions not listed on the packaging, and giving expensive gifts to doctors. All of these have apparently been discontinued.
This is one of four Prempro-related award rulings in the States, and in at least five other cases the company opted to settle out of court with the plaintiffs. Of nine thousand Prempro legal cases, so far eleven have made it to a hearing, and seven of these have concluded with ‘guilty’ verdicts. All of these rulings are being challenged by the company, as is the $75 million in damages.
Pfizer is no stranger to the courtroom, with a case earlier last year in which the company was found to have illegally marketed the painkiller Bextra and three other drugs. The consequent US $2.3 billion (AUD $2.5 billion) fine was the largest criminal penalty ever imposed in the US.
Martin Oliver is a writer and researcher based in Lismore, Northern NSW.