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Merck victorious in first state trial of Fosamax 'jaw death' link
 
 
  World News | February 15, 2011
 
Selina McKee
 
Merck & Co has emerged victorious in the first state court case alleging a link between jaw problems and the use of its osteoporosis drug Fosamax.
 
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In a vote of confidence for US drugmaker, a state court jury in New Jersey found in its favor by rejecting the claims of a Alison Rosenberg that years of Fosamax (alendronate) use caused her to suffer osteonecrosis of the jaw, otherwise known as 'jaw death'.
 
Rosenberg said she took Fosamax, which is approved for use in postmenopausal women with osteoporosis, from 1999 to 2006, and that she suffered various jaw problems following a tooth extraction in December 2005.
 
But the court dismissed her allegations. "Unfortunately, the plaintiff had medical conditions that can cause people to develop jaw and dental problems, regardless of whether they were taking Fosamax", explained Christy Jones of Butler, Snow, O'Mara, Stevens & Cannada PLLC, outside counsel for Merck, adding: "She had an extensive history of periodontal and endodontic treatments and she took a number of powerful steroid medications that are known to suppress the body's immune system and inhibit the body's ability to heal".
 
Furthermore, Merck said it presented evidence to show it had acted responsibly in researching and developing Fosamax and monitoring the medicine following its entry onto the market, with pre- and post-approval trials involving more than 28,000 patients.
 
Rosenberg's lawyers are reportedly "deeply disappointed" by the court's decision, and are still deciding whether to lodge an appeal, according to the media.
 
The company is still facing almost 1,200 cases alleging that its drug for jaw deterioration.
 
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Atlantic County jury sides with Merck in Fosamax trial
 
By Jacqueline L. Urgo; Inquirer Staff Writer The Philadelphia Inquirer February 15, 2011
 
ATLANTIC CITY - An Atlantic County Superior Court jury on Monday rejected the claim of a Montgomery County woman who said she suffered painful jawbone loss as a result of taking the popular osteoporosis drug Fosamax.
 
The verdict, which followed a three-week trial, was the third courtroom victory for pharmaceutical giant Merck & Co. Inc., of Hunterdon County, N.J., in a case linking the drug to osteonecrosis of the jaw (ONJ). The company faces more than 1,000 similar lawsuits.
 
The jury, which deliberated seven hours over two days, had been asked to consider four questions. To the first question - whether it was more likely than not that Alison Rosenberg, 67, of Wyncote, had osteonecrosis, as she claimed in the suit - the panel answered "no."
 
As a result, the jury was not required to answer the other questions.
 
Throughout the trial, lawyers representing Merck maintained that Rosenberg's condition did not meet the medical definition for the rare condition, which is also known as "jaw death."
 
Merck attorney Christy D. Jones argued that Rosenberg had various oral-health problems. Drugs she took for those issues, not Fosamax, led to the bone degeneration, she said.
 
Jones also contended that the pharmaceutical company had acted properly and timely in informing physicians about the risks associated with taking oral bisphosphonates such as Fosamax, which are prescribed for the treatment of osteoporosis.
 
"We believe the evidence showed the company acted properly, and that Fosamax did not cause the plaintiff's dental and jaw problems," Jones, of the law firm Butler, Snow, O'Mara, Stevens & Cannada P.L.L.C., of Ridgeland, Miss., said in a statement after the verdict.
 
Lawyers representing Rosenberg said that Fosamax caused the eventual death of a portion of Rosenberg's jawbone after a tooth extraction in March 2005. She underwent five outpatient surgeries at the Hospital of the University of Pennsylvania and is in chronic pain, they said.
 
People can develop ONJ "regardless of whether they were taking Fosamax," Jones said Monday. Rosenberg had an extensive history of periodontal and endodontic treatments, and her other medications, including steroids, can "suppress the body's immune system and inhibit the body's ability to heal," she said.
 
In the product-liability case, Rosenberg's attorneys questioned when Merck altered its packaging to include warnings about the risks associated with Fosamax. Attorney Paul Sizemore of Los Angeles presented e-mail and reports by company scientists and physicians that he said showed there were in-house concerns about the drug and its possible connection to ONJ.
 
In the end, the jury appears to have found the evidence insufficient to prove that Rosenberg's use of Fosamax between 1999 and 2006 caused her jawbone problems.
 
Her attorneys said Monday that they were "deeply disappointed" with the jury's findings and were unsure whether an appeal would be filed.
 
"We would have liked for the jury to find for Mrs. Rosenberg so that Merck would know that they can't keep getting away with hiding the risks of their drugs," Marc D. Grossman, another of Rosenberg's attorneys, said in a statement.
 
Rosenberg v. Merck was the first Fosamax trial held in state court. The first three trials were held in U.S. District Court in Manhattan, where 1,200 Fosamax lawsuits have been consolidated. About 300 cases in New Jersey have been centralized for "mass tort" treatment before Judge Carol B. Higbee, who presided over the Rosenberg trial.
 
Merck also has been named in a growing number of lawsuits involving patients who used Fosamax and suffered femur fractures after low- and no-impact falls.
 
Monday's ruling came the same day that findings from a study about bisphosphonates and osteonecrosis were published in the Journal of Dental Research. The research, funded by the National Institutes of Health, indicated that such drugs are "associated with a slightly elevated risk" of developing ONJ.
 
Researchers examined the medical records of nearly 600,000 patients and called the chance of developing the condition "extremely low," occurring in less than a tenth of 1 percent of patients.
 
About 4.7 million people in the United States take bisphosphonates, according to Kaiser Permanente Centers for Health and Research and HealthPartners Research Foundation, which published the report. The drug was a multibillion-dollar product for Merck before generic versions went on the market in 2008.
 
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Merck Wins First Fosamax Osteoporosis Drug `Jaw Death' State-Court Trial
 
By Thom Weidlich - Feb 14, 2011
 
www.bloomberg.com
 
Merck & Co. won the first of hundreds of state-court lawsuits in which its Fosamax osteoporosis drug is blamed for causing so-called jaw death.
 
Fosamax didn't cause Alison Rosenberg, 67, of Pennsylvania to develop osteonecrosis of the jaw, or ONJ, a jury in Atlantic City, New Jersey, found today. Merck previously won two of three cases that went to jury verdicts in Manhattan federal court.
 
The jury answered "no" to the first question on the verdict form: Was it more likely than not that Rosenberg had the condition she claimed? The vote was 9 to 1. Because the first answer meant victory for the company, the panel didn't have to answer three other questions.
 
Rosenberg had medical conditions that cause jaw problems and took other medications that suppress immune systems, Merck maintained.
 
"There's no evidence of eight weeks of exposed, necrotic, dead bone," company attorney Christy D. Jones said Feb. 9 in her closing arguments to the jury. "Ms. Rosenberg didn't meet the definition."
 
People can develop ONJ "regardless of whether they were taking Fosamax," Jones said today after the verdict
 
"The evidence showed the company acted properly and that Fosamax did not cause the plaintiff's dental and jaw problems," she said in a statement.
 
Rosenberg's lawyers said they were "deeply disappointed" in the outcome and will decide whether to appeal.
 
'Hiding the Risks'
 
"We would have liked for the jury to find for Mrs. Rosenberg so Merck would know that they can't keep getting away with hiding the risks of their drugs," Marc D. Grossman of the firm Sanders Viener Grossman LLP in Mineola, New York, said in a statement.
 
"We're here because Fosamax killed part of Mrs. Rosenberg's jaw," J. Paul Sizemore of El Segundo, California, another of her lawyers, told the jury last week in his summation.
 
As of Sept. 30, Merck, based in Whitehouse Station, New Jersey, faced about 1,180 Fosamax cases, including suits with multiple patients, the company said in a November regulatory filing. About 300 cases filed in New Jersey are before Superior Court Judge Carol E. Higbee in Atlantic City.
 
In the one federal case Merck lost, a New York jury awarded $8 million to the plaintiff. U.S. District Judge John Keenan later reduced the award to $1.5 million. About 850 Fosamax cases are before Keenan.
 
Seven Hours
 
The Atlantic City jury deliberated about seven hours over two days, ending a trial that started Jan. 24.
 
Rosenberg used Fosamax for four years before developing the condition in which bone tissue in the jaw is killed, according to an earlier statement by her attorneys. Her husband, Herbert Rosenberg, 69, also sued, for loss of consortium.
 
Merck had Fosamax sales of $691.5 million for the first nine months of 2010, down from $814.9 million in the same period the previous year, according to the regulatory filing. The drug first faced generic competition in 2008.
 
Merck fell 19 cents to $32.88 at 11:46 a.m. in New York Stock Exchange composite trading.
 
Two more so-called bellwether trials, which may point the way to out-of-court settlements and will show each side the other's litigation strategy, are scheduled for this year in federal court in Manhattan. On Feb. 4, Keenan ordered the parties to pick two additional cases for trial.
 
The case is Rosenberg v. Merck & Co., ATL-L-3644-08, Superior Court of New Jersey (Atlantic City).
 
To contact the reporter on this story: Thom Weidlich in Atlantic City, New Jersey, Superior Court at tweidlich@bloomberg.net.
 
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Merck's Fosamax Didn't Cause Jaw Disease in Woman, New Jersey Jury Is Told
 
By Thom Weidlich - Feb 9, 2011 5:03 PM ET Bloomberg
 
Merck & Co.'s osteoporosis drug Fosamax didn't cause so-called jaw death in a Pennsylvania woman, because the drug doesn't cause the disease and the woman never had it, a lawyer for the company told a jury.
 
The company's attorney, Christy D. Jones, made her closing arguments today in Atlantic City, New Jersey, at the close of the first state-court trial over the drug. Alison Rosenberg, 67, sued claiming she developed osteonecrosis of the jaw as a result of taking Fosamax.
 
"There's no evidence of eight weeks of exposed, necrotic, dead bone," said Jones, of the law firm Butler, Snow, O'Mara, Stevens & Cannada PLLC in Ridgeland, Mississippi. "Ms. Rosenberg didn't meet the definition."
 
Merck, based in Whitehouse Station, New Jersey, as of Sept. 30 faced about 1,180 Fosamax cases, including suits with multiple patients, the company said in a November regulatory filing. About 300 cases in New Jersey have been centralized with Superior Court Judge Carol E. Higbee in Atlantic City.
 
Merck won two of the three cases that went to jury verdicts in Manhattan federal court. A jury awarded $8 million to one plaintiff. U.S. District Judge John Keenan later reduced the award to $1.5 million. About 850 Fosamax cases are before Keenan.
 
Deliberations Begin Tomorrow
 
The Rosenberg jurors are scheduled to begin their deliberations tomorrow. If they find for the plaintiff and award damages, they would then hear evidence for and against punitive damages. The Atlantic City trial started Jan. 24.
 
"We're here because Fosamax killed part of Mrs. Rosenberg's jaw," Paul Sizemore, one of her lawyers, told the jury in his summation today. "That's why we're here, because Merck knew it could happen and it didn't warn Dr. Somers."
 
One of the issues in the case is whether Merck adequately warned Rosenberg's doctor, Deborah Somers, about potential problems with Fosamax.
 
In October 2005, Merck responded to a letter from Somers requesting more information about Fosamax. Merck's letter included the same information as in its new Fosamax label released in July 2005 that said the drug could cause jaw-bone damage, Jones said.
 
'Adequate Warning'
 
"Merck indeed provided an adequate warning to Dr. Somers," Jones told jurors today.
 
Sizemore, of Los Angeles, countered that the letter said there were no reports of ONJ, as the disease is known.
 
"I didn't believe there was an association" between Fosamax and ONJ after reading the letter, Somers testified at the trial. Sizemore showed the jurors the testimony.
 
Rosenberg had medical conditions that cause jaw problems and took other medications that suppress immune systems, Merck said last month in a statement.
 
Jones said Fosamax hasn't been shown to cause ONJ. A "true cause-and-effect relationship between oral biphosphonates like Fosamax and ONJ has not been established," she said.
 
The condition has to last more than eight weeks in order to be called ONJ, according to the website of the American College of Rheumatology.
 
Rosenberg used Fosamax for four years before developing the condition in which bone tissue in the jaw is killed, according to a statement on the website of the law firm representing her. Her husband, Herbert Rosenberg, 69, is also suing for loss of consortium.
 
Generic Competition
 
Merck had Fosamax sales of $691.5 million for the first nine months of 2010, down from $814.9 million in the same period the previous year, according to the regulatory filing. The drug first faced generic competition in 2008.
 
Two more so-called bellwether trials, which may point the way to out-of-court settlements and will show each side the other's litigation strategy, are scheduled for this year in federal court in Manhattan. On Feb. 4, Keenan ordered the parties to pick an additional two cases for trial.
 
Merck fell 18 cents to $33.09 in New York Stock Exchange composite trading.
 
The case is Rosenberg v. Merck & Co., ATL-L-3644-08, Superior Court of New Jersey (Atlantic City).
 
To contact the reporter on this story: Thom Weidlich in Atlantic City, New Jersey, Superior Court At tweidlich@bloomberg.net.
 
To contact the editor responsible for this story: David E. Rovella at drovella@bloomberg.net.
 
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November 22, 2010
 
Merck Wins Third Fosamax Trial; Record Now Stands at 3-1
 
By Ashby Jones
blogs.wsj.com
 
This is how the mass-tort product-liability game is played.
 
Plaintiffs' and defense counsel typically agree on several bellwether cases to try before all the others. Based on those results, the sides can then crunch the numbers and start wrapping their heads around a settlement figure.
 
In other words, the results from the early cases often have broad ramifications - which is why Merck's lawyers on Friday likely breathed a huge sigh of relief after a Manhattan jury found in the company's favor in a case involving Judith Graves, a 67-year old woman who claimed she suffered severe jaw problems as a result of her use of the bone-thinning drug, Fosamax. Click here for the WSJ story; here for the NYT story; here, here, here and here for earlier LB posts on the Fosamax situation.
 
Graves took the drug until November 2004, and her jaw was amputated in 2006.
 
"We believe the evidence showed the company acted properly and that Fosamax did not cause the plaintiff's dental and jaw problems," said Mike Brock, a lawyer for Merck. "Unfortunately, the plaintiff had multiple medical conditions that can cause people to develop jaw and dental problems, regardless of whether they were taking Fosamax."
 
Merck is facing more than 900 cases in state and federal courts, generally alleging that use of Fosamax can cause a jaw-destroying condition known as osteonecrosis and that Merck failed to properly warn of this risk.
 
Graves's case was the third so-called bellwether case to go to trial.
 
A jury awarded $8 million to a Florida woman earlier this year, but a judge ruled in October that the award was excessive. A jury found in favor of Merck in another case in May. A fourth case was previously dismissed by a New York federal judge overseeing the Fosamax litigation.
 
Timothy O'Brien, a lawyer for Ms. Graves, said he was disappointed with the verdict and believed several rulings by the judge restricted the lawyers' ability to try their case, including a ruling excluding their expert witness. He said they plan to appeal.
 
"We'll keep fighting for Ms. Graves," Mr. O'Brien said.
 
 
 
 
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