Louisville Woman Suing Makers of Fosamax - wave3.com-Louisville News, Weather & Sports

Louisville Woman Suing Makers of Fosamax

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By Lori Lyle

(LOUISVILLE) -- A Louisville woman is now suing the drug manufacturer of Fosamax, Merck, after doctors blame the drug for basically rotting her jawbone, with no warning. Thousands of other people are making the same claims. WAVE 3's Lori Lyle has the details.

Like millions, Joyce Raisor started taking Fosamax to strengthen bones weak from osteoporosis.

Dr. David Decker didn't think twice about writing a prescription for Fosamax. "It was absolutely amazing. Changes we would see in a 2-year period on bone density study," Decker told WAVE 3 News.

Today, however, Dr. Decker finds it a troubling decision.

For Raisor, it started with an abscessed tooth. For five months, antibiotics couldn't tackle the infection, and doctors couldn't explain the problem -- until maxillofacial surgeon Dr. Brian Alpert saw Raisor.

Alpert explained that "the bacteria was eating away the bone. Look at the holes and the moth eaten appearance."

Called osteonecrosis, Fosamax and drugs like it in a class called bisphosphonates basically stop cell turnover in bone, preventing bone loss.

"The use of bisphosphonates, particularly in cancer patients, is a godsend," said Alpert.

But in the mouth, where bacteria can actually reach the bone, Dr. Alpert says the drug makes it impossible to fight that bacteria.

In over 30 years of practice, he's seen maybe three cases.

"Then, all of a sudden, this comes along," Alpert said. "Start to see seven in the course of a year. The only common denominator in it, they're on bisphosphonate."

About 2,500 cases nationwide have been reported. With no treatment, the damage is devastating.

Raisor was told her jaw bone was going to end up in a bucket. "They took some out, took some out, kept taking more out," Raisor said.

They tried to save what they could. They used a metal plate for reinforcement.

It didn't work.

After five surgeries and days in ICU they finally reconstructed her jaw, using bone from her fibula. The end result was amazing; however, the prosthesis is bulky and unstable. And her chin is permanently numb. Raisor has had to accept that she will never be the same again.

Her family is just thankful she's here. They're now fighting for other families facing the same risk.

Her family practitioner, Dr. Decker told us that "Osteonecrosis was a word I never heard of." He says no drug rep ever mentioned the risk.

There's no mention of such a potential side effect in commercials advertising the claim.

In 2005, at the request of the FDA, Merck did add a warning. That's found on a 22-page document that prescribing pharmacies receive.

There's no mention on the box.

Dr. Alpert thinks "People have a right to know. People have a right to make an informed decision."

"My hope is that no other person would ever have to watch their mother go through this," says Raisor's daughter, Sandy Burks.

Unfortunately, Dr. Alpert believes that Raisor's case may be "just the tip of the iceberg." She was just one of seven patients he treated for the side effect in 2005. Nationwide, 2,400 cases have been reported since 2001, mostly from the IV form of the drug given to cancer patients.

Louisville law firm Bahe Cook and Cantley is handling Joyce's lawsuit against the drug's manufacturer, Merck. Bahe says "there's a lot of money at stake for Merck. It's a $3 billion a year drug."

In controlled studies of 17,000 patients, the company says there were no reports of osteonecrosis.

Bahe says the firm will argue that "if you put a dangerous product on the market -- an unreasonably dangerous product on the market -- you're liable for the consequences, regardless of what you knew or didn't know."

Raisor's family also wants to make sure Merck warns others about what could happen, and that those warnings should be more than a mention on page 13 of a 22-page report that was given only to pharmacies.

That warning is now in fine print for consumers, and on the web-page.

But Raisor wants to see the drug pulled. If that can't happen, she wants the warning to be printed on the front of the box in bold letters.

Belinda Elmore, Raisor's daughter, said the drug's side effect is much worse than the disease it was designed to treat. "I just think any broken bone would never, ever compare to this."

The lawsuit seeks both compensatory and punitive damages. And because the drug can remain in the body for up to 10 years after you stop taking it, Raisor's attorneys are also asking that a patient monitoring system be put in place.

The lawsuit was filed May 12th, and Merck has 30 days to respond.