Jury Awards $72.6 Million in Hormone Replacement Therapy Cases

A North Carolina federal judge has refused to overturn a $1.3 million verdict in an Aredia/Zometa injury case known as “dead jaw lawsuit.” Previously, a jury agreed that the drug maker, Novartis, failed to appropriately warn about the risks connected to its bone strengthening medications, such as severe jaw damage.

More than 5 million Americans use oral bisphosphonates such as Fosamax, Reclast, Actonel, and Boniva annually to treat post-menopausal osteoporosis.

There have only been a few studies conducted regarding the drug’s long-term risks. In 2005, the Food and Drug Administration (FDA) ordered that labels for bisphosphonates be updated to include warnings regarding osteonecrosis of the jaw, a condition also known as dead jaw syndrome.

In 2010, warnings were added to the “Warnings and Precautions” section, indicating association with possible femur fractures. Currently, the FDA is reviewing a possible link between bisphosphonates and esophageal cancer.

Almost to the day, one year after a jury awarded $12.8 million to Rita Fussman, the ruling was issued following a 15-day trial. Her fam(January 30, 2012)  A Philadelphia Common Pleas Court jury last month awarded three women a collective $72.6 million in compensatory damages in their case against the drug manufacturer Pfizer.

The three women had alleged that they each had developed breast cancer after taking hormone therapy drugs such as Prempro, which were designed to treat their menopausal symptoms.

“Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause,” the statement said. “The FDA has regularly and thoroughly reviewed the benefits and risks of these medicines”, and states that, “hormone therapy is the most effective FDA-approved medicine for relief of hot flashes, night sweats, or vaginal dryness.”

One woman, Elfont, 66, a former Northeast Philadelphia resident, had taken hormone therapy drugs for more than two years before being diagnosed with breast cancer in 1997.  She was awarded $20 million. A second woman, Kalenkoski, 68, was diagnosed with breast cancer in 2002 and had taken the hormone therapy drug Prempro for more than four years. She was awarded $27.85 million. Mulderig, also 68, had taken both Premarin and Provera for eleven years before she received her breast cancer diagnosis.  She was awarded $24.75 million in damages.

A Women’s Health Initiative report released early last decade found that women taking hormone replacement therapy drugs experienced an increased risk in developing breast cancer.

It is truly surprising that doctors are still prescribing synthetic hormones to women for menopause symptoms such as hot flashes, despite the fact that all these dangers of synthetic hormones have been known for so many years.  These drugs also were promoted for off-label uses, including prevention of cardiovascular disease and Alzheimer’s disease.

These drugs were  never approved of by the FDA, and the drug manufacturer hid these calculated risks from thousdands of women (as well as doctors) throughout the United States just to keep up the profits.

It is important to do your own research before you take medicine prescribed by your doctor.  Sometimes, it is better to live with the uncomfortable symptoms such as hot flashes, than the possibility of developing breast cancer. Is this justice?

ly alleged that while suffering end-stage breast cancer, Rita developed jawbone damage in 2009, for which $287,000 was awarded in compensatory damages and $12.6 million in punitive damages.  However, under North Carolina law, the punitive damages award was reduced to $861,000. The court then entered a judgment of $1,258,083 in favor of the estate.

The jury found that Novartis Pharmaceutical Corp. unreasonably failed to provide adequate warning with respect to Aredia or Zometa, and that the drugs medically caused Fussman’s ONJ, and that Novartis’ failure to provide proper warning was the cause of Fussman’s injuries.

The jury also found that Novartis breached an implied warranty of merchanability made to Fussman.  Further, the jury also concluded that Novartis did not provide adequate warnings to the prescribing doctor, as well, finding Novartis liable for punitive damages for willful or wanton conduct.

It is clear, once again, that the huge pharmaceutical companies took this course of action purely for financial reasons, with no regard for human life.  Maybe this will serve as a warning to other pharmaceutical companies that greed does not pay. Is this justice?

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