By Jan Jarvis

February 4, 2010

It began with a tingling sensation, as if her foot was going to sleep.

Then numbness set in. It crept up to Elizabeth Gilley’s calf and onto her thigh.

Over the next six months, the Mineral Wells woman grew weaker, her skin turned pale, and she could barely walk across the room without gasping for breath.

When she collapsed in 2007, Gilley was taken to a hospital.

“The doctor didn’t know how I was still conscious,” Gilley said.

At first, doctors told her that she had leukemia, but tests didn’t confirm cancer. CT scans, MRIs and blood tests followed. Still Gilley was no closer to a diagnosis.

After a year of seeing doctor after doctor, she finally found out what was causing the symptoms, but she could hardly believe what the physician was telling her.

“Within five minutes of seeing him, he asked me if I wore denture cream,” said Gilley, 26, who was forced to get dentures as a teenager after a genetic condition ruined her teeth. “I handed him the tube; he told me to stop using it.”

By then the damage was done. Gilley could no longer walk, drive a car or get around without a wheelchair. Once an active young woman who had recently gotten married, she was rarely able to leave her home.

Gilley joined a growing number of people nationwide who have filed lawsuits alleging that the makers of some denture creams knew about the health risks associated with high levels of zinc in their products and did nothing about it. Fixodent and Super Poligrip are named in class-action lawsuits filed in Tennessee last year.

Gilley’s suit against GlaxoSmithKline was recently filed in Philadelphia, where the manufacturer is located. About 20 other claimants have also filed suits in mass tort court in Pennsylvania.

GlaxoSmithKline declined to comment on the litigation. But on the Web site for Super Poligrip, the manufacturer addresses issues surrounding zinc.

Both GlaxoSmithKline, the maker of Poligrip and Super Poligrip, and Procter & Gamble, the maker of Fixodent, have said that their products contain zinc at levels recognized as safe. GlaxoSmithKline’s label now states that there have been reports of serious health effects from increased zinc intake over a long period. But the company notes that small amounts swallowed during normal use are not harmful and that consumers should not apply the product more than once a day.

In addition, the Food and Drug Administration classifies the creams as medical devices and does not require zinc to be listed as an ingredient.

But dozens of people have been permanently disabled after using the cream for years, and at least one person has died, said Ed Blizzard of Houston, Gilley’s attorney.

“I believe this is just the tip of the iceberg,” he said. “I think a lot of people out there have neuropathy and don’t know it could be connected to their dentures.”

By TRISTAN SCOTT of the Missoulian | Posted: Monday, October 19, 2009

A lawsuit against a Swiss pharmaceutical company went to trial last week in Missoula, but a verdict in the case could have national significance for hundreds of plaintiffs suing the company in a mass tort.

Peggy L. Stevens of Missoula 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.

Stevens, who has lymphoma, developed severe dental and jaw-related problems after taking Zometa, a bone-strengthening medication manufactured by Novartis. 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 root canals or tooth extractions.

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

“Instead of disclosing concerns about this relationship [between dental work and the jaw disorder] in a timely fashion, Novartis focused on obscuring the causal relationship, delaying disclosure and controlling the public relations fallout that would occur from the disclosure,” attorneys wrote in a pre-trial brief.

Stevens’ condition is incurable and will result in lifelong disability, according to the lawsuit. Her case went to trial on Oct. 13 in Missoula District Court and closing arguments will likely begin on Tuesday.

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.

Unlike a class action lawsuit, wherein a large group of plaintiffs brings a claim collectively, a mass tort means the cases are closely related but exist independently. Because the cases are so similar, the outcome of the initial few trials might set a tone and determine how the remaining cases will be resolved.

Although Stevens’ case was never part of the mass tort, her legal team is drawing expert medical testimony from the same witnesses who will be on hand during the trials in New Jersey and Tennessee.

One such witness is Dr. Robert Marx, chief of the division of oral and maxillofacial surgery at Miami University. Marx is the foremost authority on the relationship between Zometa and osteonecrosis of the jaw, and will take the stand on Monday.

Linda Morris, 60, of Anchorage, Alaska, is a plaintiff in the mass tort. She has advanced breast cancer and says she took Zometa monthly for five years.

“Now I’m losing my teeth and my mouth is always infected,” she said. “There’s no cure for it and you can’t wear dentures because your jawbone is so weak. I’ve already lost five teeth and the rest will go eventually.”

A California attorney representing Morris attended portions of Stevens’ trial last week because a jury verdict could bear on the hundreds of other cases – either by emboldening the drug company’s defense or strengthening the cases for individual plaintiffs.

“It could set precedent,” Morris said.