Merck Wins Another Fosamax Lawsuit

Osteonecrosis of the Jaw (ONJ)

This particular lawsuit was about the use of Fosamax, an oral bisphosphonate drug, and osteonecrosis of the jaw (ONJ).

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

"We believe the company acted properly," said Chilton Varner of King & Spalding LLP, outside counsel for Merck. "Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body's ability to heal."

Today's verdict marks the fourth time a jury has found in Merck's favor on a plaintiff's product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.

At trial, Merck presented evidence that it acted responsibly in researching and developing FOSAMAX and in monitoring the medicine since it has been on the market, and that FOSAMAX is a safe and effective medication as described in the product labeling that was properly designed and did not cause the plaintiff's dental and jaw problems. The company's clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with FOSAMAX.

"Merck is pleased with the jury's verdict," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We have now won four of the first five cases that have been tried to verdict. We continue to believe that FOSAMAX is a safe and effective medication and the company provided appropriate and timely information about FOSAMAX to consumers and to the medical, scientific and regulatory communities."

U. S. District Judge John F. Keenan presided over the trial. Merck is represented by Chilton Varner of King & Spalding LLP in Atlanta, Andrew Goldman of Goldman Ismail Tomaselli Brennan & Baum LLP in Chicago and Stephen Marshall of Venable LLP in Baltimore.

This suit was all about this particular woman and her pre-existing dental condition and if Fosamax was the proximte cause of her injuries. The jury said no.

But, there is an awarenenss of ONJ occurring with patients that take oral bisphosphonates and I recommend to all dental patients to please consult with your physician and dentist, if you are taking the medication and must have teeth extractions or other surgical dental procedures.

What is the state of the many lawsuits against Merck?

This is the fifth case regarding FOSAMAX® (alendronate sodium) to go to trial. Merck won three of the first four. The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge Keenan. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010. The second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. A retrial of that case in June 2010 resulted in a plaintiff verdict, which was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried. The third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010. The fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

As of June 30, 2011, approximately 1,650 cases, which include approximately 2,050 plaintiff groups, had been filed and were pending against Merck in either federal or state court.

5 Years Enough for Use of Fosamax and Other Bisphosphonates?

Yes, according to the Food and Drug Administration staff report.

Most women who take bone-building drugs like Fosamax can safely stop taking them after five years, the Food and Drug Administration said Wednesday in a staff report leading up to a broad safety review scheduled Friday by two scientific advisory committees.

Studies show that the drugs do have proven benefits in preventing osteoporosis fractures for the first three years of treatment, but continuing beyond five years does not demonstrate such benefits over no drug use at all, the report said. And women who stop taking the drugs after five years have similar levels of increased bone density and reduced fracture risk as those who continue taking them, it said.

“These results suggest no significant advantage of continuing drug therapy beyond 5 years,” according to agency’s 45-page review of scientific evidence.

As for side effects, the report said, there is no solid evidence the drugs, called bisphosphonates, cause unusual breaks of the femur bone, a jaw injury called osteonecrosis, or esophageal cancer. At the same time, the agency said, those rare but dangerous outcomes cannot be ruled out because it has been so difficult to study them for various reasons.

“The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting,” according to the F.D.A. report.

Well, the jury is still out on the use of these drugs and the complications associated with them.

More independent study and evaluation should be conducted AND soon.

Food and Drug Administration to Consider Bisphosphonate "Drug Holidays"

The two advisory panels will consider this Friday whether bisphosphonate drugs are safe and effective in use longer than three to five years.

Two advisory panels of the Food and Drug Administration will consider on Friday whether to recommend requiring women who use popular bone drugs like Fosamax to take “drug holidays” because of rising concerns about rare side effects with long-term use, according to people involved in the review.

The panels and F.D.A. staff members are also expected to conduct a comprehensive safety review of the medical evidence to date, after 16 years of growing use of the drugs, to determine whether they have proved to be safe and effective in use longer than three to five years. The recommendation could affect many of the estimated four million women in the United States who take the drugs, called bisphosphonates. Bisphosphonates inhibit a bone renewal process called resorption, adding bone mass, but possibly causing brittleness as well.

Fosamax was first approved in 1995 to treat postmenopausal osteoporosis and Paget’s disease of the bone, conditions that weaken bones. It has also been marketed, controversially, for a pre-osteoporosis condition called osteopenia. The Fosamax patent expired in 2008 and generics have flooded the market.

The F.D.A. announced in July that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thigh bone, bone death in the jaw, and possibly esophageal cancer.

Long term use of bisphosphonate drugs has been linked to osteonecrosis if the jaw (ONJ) and hundreds of lawsuits have been filed.

More than 1,000 cases are pending against Merck and Novartis, all involving allegations that the drug makers failed to adequately warn about the risk of osteonecrosis of the jaw (ONJ) associated with their bisphosphonate drugs. A few of the cases have so far gone to court, with mixed results.

In 2009, a Montana jury awarded $3.2 million to a woman who sued Novartis, but in 2010 the company triumphed in a subsequent case.

In 2010, Merck was ordered to pay a 72-year-old plaintiff $8 million in compensatory damages after a jury concluded that the woman's use of Fosamax caused her to develop ONJ and related dental problems. That amount was later reduced to $1.5 million. Another case against Merck was thrown out in 2009, while another jury found in favor of Merck in a case decided in May 2010.

Maybe through this process, a suitable protocol will be developed to treat osteoporosis and protect patients from the harmful side effects of the drugs.

Federal Judge Narrows Fosamax - Osteonecrosis of the Jaw Lawsuit

Osteonecrosis of the Jaw (ONJ)

The patient can pursue her claim against the manufacturer Merck & Co. but within more limited guidelines.

A federal judge on Tuesday threw out part of a bellwether lawsuit against Merck & Co over claims that its osteoporosis drug Fosamax causes jaw damage.

The plaintiff, Linda Secrest, may pursue her claim that Fosamax suffered from a design defect and caused her jawbone tissue to die, a condition known as osteonecrosis of the jaw, or ONJ, District Judge John Keenan wrote.

But the judge said Secrest, a former United Airlines flight attendant living in Florida, cannot pursue punitive damages or her claim that Merck failed to warn of possible problems with Fosamax, saying no reasonable jury could rule in her favor.

The lawsuit is the fourth bellwether case over Fosamax, which generated billions of dollars in annual sales for Merck before the Whitehouse Station, New Jersey-based company lost U.S. patent protection in 2008, allowing generic sales.

Well, Merck DID have a warning label on the Fosamak and there is evidence that her physician would have discontinued the medication for her.

These lawsuits will continue to drone on for a few more years. So, stay tuned.....

Oral Bisphosphonates: Study - Absolute Risk for Femur Fracture Low with Bisphosphonates

Cross Posted from Flapsblog

I have written a number of pieces about the problems associated with bisphosphonates and osteonecrosis of the jaw. My latest post is here.

Now, there is a new study published in the New England Journal of Medicine which sheds new light on the advantages vs. risks of taking these drugs.

Almost 78% of all Swedish women aged 55 years and older who sustained an atypical femur fracture in 2008 had taken bisphosphonates, but the absolute risk for such breaks is small enough to justify prescribing the drugs, according to a study published in the May 5 issue of the New England Journal of Medicine (NEJM).

For patients taking bisphosphonates, the age-adjusted relative risk for an atypical femur fracture — a clean, horizontal break spreading from the lateral side and occurring with minimal or no trauma — was 47.3%, the study reported. The crude incidence of the fractures was 0.09 per 10,000 patient-years among women who had never taken the drug compared with 5.5 among those who had ever taken it.

These results "should be reassuring for bisphosphonate users," write lead author Jörg Schilcher, MD, from the Department of Experimental and Clinical Medicine, Faculty of Health Science, Linköping University, Linköping, Sweden, and colleagues. "With a correct indication, the benefits of fracture prevention...will greatly outweigh the risk of atypical femoral fracture."

So, in other words, the benefits of preventing fractures by taking the medications outweigh the risk of an atypical leg (femur) fracture.

So, how does this apply to dentistry?

With more and more patients taking these drugs to prevent osteoporosis, and for longer periods of time, dentists will have to be scrupulous in their medical histories. Osteonecrosis of the jaw, while rare, is a known and serious complication.

An undisplaced femoral fatigue fracture associated with bishosphonate treatment. NIH photo

This study echoes the paper published in February in the Journal of the American Medical Association which I cited a few months ago. The AMA paper is here.

Experts interviewed by Medscape Medical News call the study definitive because researchers not only studied a massive number of participants — all 1.5 million women in Sweden who were aged 55 years or older in 2008 — but also reviewed the x-rays of nearly all those who had particular kinds of femur fractures.

"It's the largest and most comprehensive study of this issue that I've seen," said Sundeep Khosla, MD, president of the American Society for Bone and Mineral Research (ASBMR) and a professor of medicine and physiology at the Mayo Clinic in Rochester, Minnesota.

The study's conclusions echo those in other recent studies on the worrisome fractures and the bone-building drugs for osteoporosis. An article published in February in the Journal of the American Medical Association, for example, reported that long-term use of bisphosphonates boosted the risk for these fractures, but those authors noted that the absolute risk for fracture is low and is outweighed by the benefits of the therapy.

And, what about drug holidays - especially since the risk of fracture declines rapidly after drug withdrawal?

Because it is not clear how long patients with osteoporosis can be safely treated with bisphosphonates, the ASBMR recommends that clinicians consider discontinuing them after 5 years. At that point, many physicians give their patients a "drug holiday" for 1 or 2 years and then resume the therapy. Dr. Shane said that the rapid decline in fracture risk after drug withdrawal helps justify a holiday.

"Now there seems to be evidence that giving patients intermittent drug holidays is appropriate to do," she said. Dr. Khosla agreed, saying the decrease in fracture risk provides "reassurance that a [drug holiday] is good clinical practice."

Again for dentists, it will be esepcially important to monitor our patients for when they are on or off the medications. Since dental visits may be episodic, and in older patients only in case of an emergency e,g. tooth extraction, proper dental/medical records are mandatory. Appropriate consultation with the patient's physician is indicated. Treatment plans for dental examination and/or treatment either prior to initial treatment or before resumption of treatment with these drugs would be beneficial to patients.

I will look forward to additional studies on the risk of dental complications using a drug holiday approach - with resumption of drug use.

In the meantime, Flap urges caution for patients taking ORAL Bisphosphonate medications. And,please patients update your health history and tell your dentist if you are using these drugs.

Previous:

Revisiting Bisphosphonates and Femur Fractures

Oral Bisphosphonates Associated with a SLIGHTLY Elevated Risk of Developing Osteonecrosis of the Jaw?

New Dentistry Cause for Alarm for Patients Who Use Bisphosphonates – Fosamax, Actonel, Boniva?

Dentistry Today: Bisphosphonates: Zometa (zoledronic acid) & Aredia (pamidronate disodium) Associated with Osteonecrosis of Jaw – REDUX

Bisphosphonates: Zometa (zoledronic acid) & Aredia (pamidronate dis odium) Associated with Osteonecrosis of Jaw