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Archive for the ‘Osteonecrosis of the jaw (ONJ)’ Category

Fosamax Case Set For Trial

Monday, February 1st, 2010

On January 29, 2010, a Manhattan federal judge refused to reject a lawsuit alleging that Merck & Co Inc’s osteoporosis drug Fosamax caused jaw damage to an Indiana woman during the nearly eight years she took the pill. According to a Reuters report, Merck submitted a motion seeking to dismiss all claims filed by the Indiana plaintiff. The trial is scheduled to begin on April 19, 2010.

U.S. District Judge John Keenan described the case involving the plaintiff Louise Maley, as one of the “bellwether” trials in nationwide litigation over Fosamax, which has spawned close to 900 lawsuits. The judge is handling many of the cases.

Keenan in November dismissed a lawsuit alleging that Fosamax causes jaw damage, two months after a jury deadlock led to a mistrial in a similar case.

Fosamax is part of the bisphosphonate family of osteoporosis drugs that include Procter & Gamble Co’s Actonel and Roche Holding AG’s Boniva. This class of drugs is designed to prevent bone fractures and help offset bone loss associated with menopause. Fosamax has been linked to Osteonecrosis of the Jawbone, which overtime the bone tissue in the jaw roots and dies.

Fosamax Trail Begins for First Plaintiff

Wednesday, August 12th, 2009

On August 11, 2009, the first of many lawsuits brought by patients who claim they suffered jaw damage from Fosamax began.  An estiamted 1280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax.

U.S. District Judge John Keenan of Manhattan Federal Court heard arguments from attorneys for Shirley Boles, a 71-year-old plaintiff from Walton Beach, Florida, who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” Merck said in a statement on August 10, 2009.

Fosamax, made by Merck, was approved in the United States in 1995, and belongs to the bisphosphonate family of osteoporosis drugs that include Actonel and Boniva. The pills prevent bone fractures particularly in postmenopausal women by helping to increase bone mineral density.

In 2003, reports initially emerged linking intravenous bisphosphonate treatments with jaw osteonecrosis, meaning death of jawbone tissue that can include symptoms such as pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth.

Intravenous bisphosphonates, which are not made by Merck, involve higher concentrations of medication that are typically used to treat patients with cancer that has spread to the bones.

Oral versions of the class of drugs were initially thought to be safe until a report came out in May 2005 showing that 7 of 63 bisphosphonate users who developed the condition had been using oral forms.

But an informal review in the Journal of the American Dental Association in early 2008 suggested that oral treatments instead reduced risk of inflammatory deterioration of the jaw in patients with osteoporosis. By contrast, the report suggested a 4-fold increase in such risk among patients taking intravenous bisphosphonates.

Merck said two other Fosamax lawsuits are slated to go to trial later this year, one in federal court and another in a state court in Alabama.

Wednesday, March 25th, 2009

On March 23, 2009, officials stated that thousands of veterans in South Florida may have been exposed to hepatitis and HIV as a result of unsanitary equipment after receiving colonoscopies at the Miami Veterans Affairs Healthcare System.

Two Florida lawmakers are asking for an inspector general’s inquiry.

“The VA is a model of the type of health care we provide our veterans, and when mistakes like this occur, it undermines the efficacy of the entire system,” said Rep. Kendrick B. Meek, D-Florida, in a news release. Meek, along with Sen. Bill Nelson, D-Florida, is requesting an official inquiry by the inspector general of the VA.

In a letter to retired Gen. Eric Shinseki, the secretary of Veterans Affairs, Nelson said he is also concerned about possible contaminated equipment at facilities in Murfreesboro, Tennessee, and Augusta, Georgia.

“I am requesting that the VA Office of Inspector General begin an investigation into the potential problems of contamination; whether any patient has contracted an infection from unsterilized equipment; and, most importantly, how we can prevent such problems from happening again,” Nelson wrote.

“Finally, I urge the VA to commit to providing ongoing medical care in cases where it is responsible for exposing someone to a disease.”

On March 23, 2009, the VA sent letters to 3,260 people who may have had colonoscopies between May 2004 and March 12, 2009. Hospital officials said a review of safety procedures found that tubing used in endoscope procedures was rinsed but not disinfected.

In the first 24 hours after the letters were released, the Miami VA got more than 2,600 calls and checked out more than 350 patients. Almost 600 more are scheduled for examinations over the next two weeks, officials at the facility said.

“What happened should not have happened. We are taking steps to change it right now,” said John Vara, the Miami VA’s chief of staff.

The problem at the Miami VA facility comes on the heels of similar problems with endoscopies at the VA clinic in Murfreesboro. In December 2008, an investigation discovered that clinic workers were not following manufacturer’s directions and switched out parts they weren’t supposed to switch out, according to investigators. Approximately 6,000 people who underwent colonoscopies at the clinic were notified and offered free testing for infections.

The Charlie Norwood VA Medica Center in Augusta, Georgia, also said it had “recently notified 1,200 veterans they may have been exposed to infection when undergoing ear, nose and throat (ENT) procedures between January and November of 2008.”

In Miami, the VA has opened “special care clinics” to test veterans who received the notice and to provide information.

“Screening is strictly precautionary and does not indicate that any patients have contracted a virus,” Mary D. Berrocal, director of the Miami VA, said in a statement on the VA’s Web site.

The special care clinics opened Tuesday morning, and officials say response from patients has been good. “They are being proactive, and we are glad. We want them to get tested,” said Susan Warren, a spokeswoman for the Miami VA facility.

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