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Woman with Osteonecrosis of the Jaw awarded $3.2M in lawsuit against maker of bone-strengthening drug Zometa

Jurors slapped a Swiss pharmaceutical company with a $3.2 million verdict, wrapping up a Missoula woman's lawsuit that will have bearing on hundreds of cases against the company nationwide.

The jury of six men and six women received the case Tuesday afternoon and deliberated for six hours before retiring for the evening. The panel reconvened Wednesday morning and reached a verdict after less than two hours.

The case, tried over five days, involves claims by Peggy L. Stevens, 57, of Missoula. She filed suit against Novartis Pharmaceuticals Corp. last year, alleging the company was professionally negligent when it failed to disclose health risks associated with one of its medications, a bone-strengthening drug called Zometa.

Stevens has lymphoma and developed serious dental and jaw-related problems after taking the drug for several years. Her attorneys say the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures, like a tooth extraction.

Doctors in Missoula administered the drug to Stevens intravenously for three years before she had a tooth pulled in 2007 and developed the disease. Its symptoms include pain, loosening of teeth, exposed bone and infection.

On a national level, Novartis faces lawsuits from approximately 550 plaintiffs whose cases have been consolidated in a Tennessee federal court and a New Jersey state court. The first of those cases is slated for trial in March 2010 in New Jersey.

Although Stevens' case was never part of that mass tort, the verdict in her favor sets a precedent and will influence the other cases, her attorneys said.

"I think it will have a huge significance," said Terry Treweiler, a attorney representing Stevens. "The basic facts regarding Novartis' conduct are the same in every case. In terms of Novartis' failure to adequately warn doctors, those facts are now fairly well established."

Stevens' condition is incurable and will result in lifelong disability, according to her lawsuit. Her case went to trial on Oct. 13 in District Court with Judge John Larson presiding.

At trial, Trieweiler said Novartis played down the drug's risks, and obscured and delayed the release of information to the public and the medical community.

"What they were trying to do is get the minimal amount of information out to cover themselves without in any way interfering with the marketing of their drug,"said Trieweiler, a former Montana Supreme Court justice.

Trieweiler argued that Novartis focused its efforts on "delaying disclosure and controlling the public relations fallout that would occur from the disclosure."

The jury awarded Stevens $822,000 in lost income. The remaining balance of the verdict is meant to compensate for Stevens' pain, emotional suffering and the loss of her normal course of life. Stevens worked as a professional nurse at Community Medical Center prior to being diagnosed with osteonecrosis of the jaw, and earned an income of $70,000 a year. Her lymphoma is now in remission.

Joe Hollingsworth, a Washington, D.C.-based attorney representing Novartis, said evidence at trial showed the company "flatly and specifically warned that dental surgery should be avoided," and that it began printing the warnings on labels in 2003.

"The evidence shows that our warning was adequate, make no mistake," Hollingsworth said during closing arguments. "There is no way that a different label would have altered Ms. Stevens' use of Zometa."

The labeling was not printed on the packaging itself, but included in a lengthy booklet inside the box.

"The labeling is on a little folded up piece of paper," Trieweiler said. " If you printed it in 12-point font it would be 22 pages long. You fold it out like an acordion. There are 20 folds in it at least."

Stevens' legal team also showed that Novartis knew about the drug's risks through its own extensive research. The marketing and medical research departments communicated those risks in e-mails, he said.

"We were able to introduce internal e-mails that demonstrated how they actually tried to suppress information as they received it," Trieweiler said.

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Fosamax is meant to keep your bones strong (prevent osteoporosis), but it  may do just the opposite.

It could potentially be the latest in legal trouble for the drug company Merck, which is still reeling from the Vioxx scandal. Michael Schwartz, an oral surgeon in Baltimore says most doctors aren’t even aware of the problems Fosamax can cause. It belongs to a class of drugs called bisphosphonates, which also include the pills Actonel and Boniva and the IV drugs Aredia and Zometa, which are typically used in cancer patients.

Sheldon Gottesfeld has an area of his jaw that’s literally dead. It’s called osteonecrosis of the jaw and after 11 years after being successfully treated for leukemia, Sheldon’s losing his teeth. Not from cancer, but his doctor believe from taking Fosomax and Zomata as a preventative measure. For patients like Sheldon, a simple tooth extraction can shatter the jaw. Reconstructive surgery can be disfiguring and may not heal. Sheldon is worried, he might need two teeth pulled.

Merck added a warning to its U.S. labels at the request of the FDA. That label is actually a 22-page document which is given to pharmacies that dispense Fosamax. The item on osteonecrosis of the jaw is buried in the middle of page 13. Sheldon stopped taking Fosamax and Zomata, but doctors say they can stay in the body for up to 10 years. So the worst many not be over. Drugs like Fosamax are effective against osteoporosis, so for now no one is suggesting you stop taking them. Complications like dead jaw are considered rare, but, expect to hear more about the problem as doctors and patients become more aware of this condition, as well as a class action lawsuit.

Injury and Side Effects

Fosamax (generic name Alendronate).
Fosamax, Zometa and Aredia are types of drugs known as bisphosphonates. Recently, a link has been found between bisphosphonates and a serious bone disease called osteonecrosis of the jaw ONJ. This important discovery clearly shows that Fosamax and Zometa side effects may include osteonecrosis of the jaw also known as Dead Jaw. The discovery published in the Journal of Oral and Maxillofacial Surgeons prompted both the US Food and Drug Administration FDA and Novartis the manufacturer of bisphosphonates used in cancer chemotherapy to issue a warning to health care professionals on September 24 2004. The warning letter contained information about bisphosphonates and the risks of osteonecrosis in the jaw. Bisphosphonates are commonly used in tablet form such as Fosamax Alendronate Sodium to prevent and treat osteoporosis in postmenopausal women. Stronger forms of bisphosphonates are commonly used in the management of advanced cancers that have metastasized to the bone where the disease often causes bone pain and possibly even fractures.

The pharmaceutical industry has developed and marketed numerous amounts of medications to prevent and treat these conditions, but unfortunately all of these drugs have severe side effects. Because the medications alter basic bodily functions so dramatically, the consequences of taking these medications can be sometimes be awful. Additional side effects can often include sleeplessness, nausea and fatigue.

History

Alendronate Sodium or brand name is Fosamax caused quite a bit of excitement because it was the first drug to reverse the bone loss of osteoporosis in post-menopausal women.

It is a class of drugs called diphosphate. More specifically it is an aminobisphosphonate. Phosphates are an important element in bone formation. The structure of this drug combines phosphates with what is called an amino group. Amino groups are common in human biochemistry in a variety of settings. Amino acids often carry small electrical charges, and have a unique spatial configuration depending on their structures. With this drug, the amino groups' properties help the drug attach to its intended site of action--the bone. Once there, it can decrease bone loss.
Zometa and Fosamax Associated to Atrial Fibrillation
A study conducted by the researchers from the University of Miami says that the use of osteoporosis drugs Zometa and Fosamax can increase the risk of potentially severe irregular heart beats called ‘atrial fibrillation’... Read More

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