Access To Justice

Merck & Co. – maker of Fosamax – will challenge the verdict in a case where a federal jury awarded $8 million to a Florida woman who alleged the osteoporosis drug caused serious damage to her jawbone.

The Associated Press reports that the case, filed in US District Court in New York, is the first Fosamax loss for Merck, which won two prior cases brought by plaintiffs with similar claims. The company faces around 1,400 Fosamax lawsuits.

The jury awarded compensatory damages last week to plaintiff Shirley Boles, who claimed the use of Fosamax destroyed her jawbone, leaving her with serious pain and disability. Merck alleged that heavy smoking and periodontal disease are to blame for Boles’ condition. The AP reports that Merck will ask the judge to reverse the verdict or order a new trial.

Osteoporosis medications like Fosamax – part of a drug class known as bisphosphonates — are meant to strengthen bones.  We’ve blogged here about how the Food and Drug Administration is currently looking into the whether there is a link between leg fractures and long-term use of certain osteoporosis drugs. As always, do not change medications without first consulting your doctor.

News developments that we’ll be watching here at Sokolove Law:

Nursing home patients and their families are among the winners in the aftermath of the historic passage of the health care reform bill, according to a non-profit group that advocates for long-term care residents.

The new legislation will create more choices and greater transparency for consumers, according to the NCCNH (formerly the National Citizens’ Coalition for Nursing Home Reform). “The health care reform bill will give consumers more choices about where and how they receive long-term care and services, and every long-term care setting—from one’s nursing home to one’s own home—will be safer when it is implemented,” said NCCNHR executive director Sarah F. Wells in a statement.

Several bills incorporated in the new legislation – including the Nursing Home Transparency and Improvement Act, the Elder Justice Act, and the Patient Safety and Abuse Prevention Act – were championed by the NCCNHR.

Under the legislation, consumers will be able to get access to important nursing home safety data such as accurate information about staffing levels and turnover rates, sanctions against facilities, and inspection reports. It also will help improve training of nursing home staff and extend public coverage of long-term care beyond nursing homes.

Toyota warned dealers of accident risks related to improperly installed floor mats as long ago as 2007, according to a report from Reuters.  Toyota sent a “technical service bulletin” about the problem in 2007 and 2008 to its dealers and the National Highway Traffic Safety Administration. The bulletins were more explicit about the risk of a crash than any public announcements later made by the carmaker or federal regulators, writes the news service. Sending such notices to dealers to address safety problems is an industry practice that is now under scrutiny in the aftermath of the recent recalls by Toyota and other automakers, according to Reuters.

Long-term use of osteoporosis drugs such as Fosamax and Reclast does not significantly increase the risk of hip fracture, according to a study published yesterday by the New England Journal of Medicine. The study’s leader, Dr. Dennis Black of the University of California, San Francisco, told the Associated Press that the drugs prevent more fractures than they cause. The drugs, known as bisphosphonates, are taken by millions of American women. Some case reports have tied the drugs to a rare type of hip fracture, writes the AP.

Popular osteoporosis drug Fosamax may increase the risk of broken bones, such as femur fracture, in some women, according to an ABC News report.

ABC is also reporting that the FDA “will look into whether or not a link exists between the use of certain osteoporosis drugs and a particular type of leg fracture.”

Osteoporosis medications like Fosamax – part of a drug class known as bisphosphonates — are meant to strengthen bones.  Doctors prescribe them for the estimated 10 million Americans with osteoporosis, many of whom are women.  Some doctors are now worried that woman who use Fosamax or similar medications  for five years or more may increase their risk of sudden bone breaks.

Fosamax maker Merck told ABC that “a causal association has not been established” between long-term use of the drug and fractures.

However, a small observational study published in 2008 in the Journal of Orthopedic Trauma linked Fosamax to an unusual type of femur fracture. That same year the company was asked by the Food and Drug Administration (FDA) to list femur fractures on the package insert’s list of potential side effects.

A number of studies suggest the benefits of taking a bisphosphonate such as Fosamax outweigh the potential risks for women who face osteoporosis. As always, do not change medications without first consulting your doctor.