ATLANTIC CITY, NJ – Opening statements took place Monday in a civil trial against drug manufacturer Merck & Company (NYSE: MRK) involving the widely-prescribed drug Fosamax.

The lawsuit in Atlantic County Superior Court claims the drug, which is used to treat the bone disease osteoporosis, caused serious injury to plaintiff Jo-Ann Sessner’s jaw, and that Merck failed to warn of Fosamax’s potential serious side effects.

Many patients who took Fosamax have filed lawsuits alleging the drug caused a condition called osteonecrosis of the jaw, where the actual jaw bone dies and can lead to the need for extensive surgery. Sessner’s case is the second to actually go to trial in state court and only the sixth Fosamax trial over all after four others in federal district court. One of those federal lawsuits resulted in the only plaintiff’s award to date.

Sessner’s attorney, Tim O’Brien of Levin Papantonio, told the jury during opening statements taking Fosamax ultimately hurt his client. “It did nothing for her,” he said to the court. “It only did things to her.” He went on to describe how osteonecrosis could only occur because of taking Fosamax, and that Merck intentionally withheld evidence of side effects to protect profits. “What Merck does is scare women,” he said while describing the company’s aggressive marketing of the drug to women with bone diseases like osteoporosis.

Representing Merck, attorney Christy Jones of Butler Snow told jurors Fosamax did its job and benefited Sessner. “It was a good thing Ms. Sessner was prescribed Fosamax,” said Jones. “It was a good thing because it prevented fractures, and some 10 years later Ms. Sessner has never had another fracture. Fosamax worked.” Sessner originally began taking Fosamax after suffering a hip fracture without any fall or injury due to low bone density.

Jones told jurors the evidence would show Sessner developed osteonecrosis in her jaw, after a tooth became infected and had to be removed. “This infection has nothing to do with Fosamax, but it’s that infection that ultimately led to the jaw problems and the injuries,” she said. Jones also pointed to other factors, like smoking, that put Sessner at risk for jaw problems.

Jones represented Merck at the first Fosamax trial last year in New Jersey, and the jury ultimately found Fosamax did not cause osteonecrosis in that case. With her trademark dark clothing and hypnotic southern accent, she also scored a victory for Johnson & Johnson in this same court last year at a trial involving the antibiotic Levaquin.

The current trial will run through at least mid-April, and based on prior cases Sessner’s attorneys will likely ask for millions of dollars in damages. The full trial will be webcast live via Courtroom View Network, which also webcast the first Fosamax trial in state court last year.

The case is Jo Ann Sessner v. Merck Sharp & Dohme, Corp., ATL-L-3394-11.

ATLANTIC CITY, NJ – Opening statements are scheduled for March 1st in the second lawsuit to go to trial in state court involving the widely-prescribed drug Fosamax.

Plaintiffs Amelia Flores and Jo Ann Sessner filed lawsuits against the drug’s manufacturer, Merck & Company (NYSE: MRK), alleging they suffered jawbone injuries after taking Fosamax to treat osteoporosis, a disease that causes a loss of bone density.

Merck faces a number of lawsuits after patients taking Fosamax, also known as as a bisphosphonate or alendronate sodium, developed osteonecrosis of the jaw. This condition results in death of the actual jaw bone, which can cause serious dental problems and require surgery. In New Jersey, a number of individual cases were consolidated into a mass tort overseen by Judge Carol Higbee, which also includes Teva Pharmaceuticals (NASDAQ: TEVA) and Bayer Pharmaceuticals, who marketed generic versions of the drug.

Merck denies the allegations, and during earlier trials claimed other underlying health conditions caused patient’s jaw problems, and that the company provided adequate warnings about potential side effects to physicians and patients. Last year, in the first New Jersey state court trial, the jury returned a verdict in favor of Merck, determining Fosamax did not cause osteonecrosis.

Besides the cases in state court, a number of Fosamax cases were consolidated in federal court before U.S. District Judge John Keenan in New York City. So far five cases have gone to trial, resulting in three verdicts for Merck, one plaintiff’s verdict and one mistrial. In the sole plaintiff’s victory, jurors initially awarded a Florida woman $8 million dollars, but Judge Keenan later reduced that to $1.5 million.

The current trial is scheduled to last at least three to four weeks and will be webcast live, gavel to gavel, by Courtroom View Network. CVN also recorded the only other New Jersey Fosamax trial so far, Rosenberg v. Merck in March of last year.

The cases are Jo Ann Sessner v. Merck Sharp & Dohme, Corp., ATL-L-3394-11 and Amelia Flores v. Merck Sharp & Dohme, Corp., ATL-L-744-09 in the Superior Court of New Jersey, Atlantic County.

Watch In re Fosamax live on Courtroom View Network starting February 27th for jury selection or March 1st for opening statements.

Rosenberg v. Merck — A New Jersey jury this morning found that a Fosamax user did not suffer from osteonecrosis of the jaw (ONJ), and therefore she failed to show that Fosamax caused the harm.

Allison Rosenberg’s physician prescribed for her the osteoporosis medication Fosamax (alendronate), even after she was no longer osteoporitic and was only mildly osteopenic. Ms. Rosenberg claimed that Merck knew and should have warned her physician that oral biphosphonates could cause ONJ. Ms. Rosenberg endured five operations to remove parts of her jaw.

Butler Snow’s Christy Jones argued on behalf of Merck that Merck accurately and timely warned of a risk, and that Merck did not know, and does not even now know, whether Fosamax causes ONJ, because ONJ has so many causes.

The first question to the jury was, “Has the plaintiff proven that it is more likely than not that Allison Rosenberg had ONJ?”  The jury voted “No,” by a margin of 9-1.

Three prior Fosamax trials in federal court resulted in two defense verdicts and one plaintiff verdict. Merck has now won three of the first four Fosamax trials.

CVN webcast the New Jersey Rosenberg Fosamax trial live.

Closing arguments in Rosenberg v. Merck were heard today in Atlantic City, New Jersey. Defense attorney Christy Jones, of Butler Snow, went first.

According to Ms. Jones, Merck did not know at the time of the alleged failure to warn that Fosamax posed a risk of osteonecrosis of the jaw, and still does not know whether a causal relationship exists. Merck was not even certain that Ms. Rosenberg suffered from osteonecrosis, as opposed to osteomyelitis.

Ms. Jones told the jury that Merck started studying Fosamax in 1988, and conducted 150+ studies on animals, and 125+ clinical studies in humans. 17,000 people had taken Fosamax in these studies, and there was not a single report of bone necrosis.

Some studies had even shown a favorable effect on the jaw, said Ms. Jones, so Merck actually did periodontal studies because they thought they might discover a beneficial effect. But there was no early evidence that Fosamax caused bone cells to die.

The first report of osteonecrosis was in September, 2003, which involved a cancer patient taking alendronate intravenously. It wasn’t until 2006, said Ms. Jones, that Merck received information about osteonocrosis of the jaw.

Ms. Jones challenged the jury to compare the recommended 2005 label with the label eventually approved and predicted they would conclude that removing the word “orally” did not water down the warning. Moreover, in October 2005, Merck responded to Dr. Somers’ request for information and directly advised her of the risk of ONJ while on biphosphonate therapy, and Dr. Somers continued to prescribe it.

Finally, said Ms. Jones, no causal relationship has been established between oral bisphosphonates like Fosamax and osteonecrosis of the jaw. Maybe, said Ms. Jones, some day in the future we’ll be able to understand whether there is a relationship between Fosamax and ONJ, but not now, because ONJ has many causes.

For the plaintiff, Paul Sizemore of the Sizemore Law Firm told the jury, “We’re here because Fosamax killed a piece of Ms. Rosenberg’s jaw, and Merck new it could happen, and didn’t warn about it…  Merck new that this drug could cause jaw bone death, and it did, in my client.“

According to Mr. Sizemore, Merck did not warn in 1999, when Ms. Rosenberg began her treatment, nor did they warn when Ms. Rosenberg’s prescribing physician, Dr. Debra Somers, continued prescribing Fosamax in March 2005. At that point, Ms. Rosenberg was no longer osteporitic, and was only mildly osteopenic, and should have stopped taking the drug. Dr. Somers testified that she would have warned her patient if she had known of the risk.

Merck finally “warned” Dr. Somers in October 2005, said Mr. Sizemore, because Dr. Somers found out about the risks on her own and asked a sales rep. But the rep had been instructed by Merck not to discuss the risk of osteonecrosis. Instead, Merck sent Dr. Somers a written response, but this alleged warning in October 2005 claimed that there had been no reports of ONJ associated with Fosamax use, even though Merck had internally acknowledged 80 adverse reports in June 2005.

In fact, said Mr. Sizemore, Merck had a report of bare exposed jaw bone as an adverse event as early as 1999, and there were subsequently other adverse event reports involving the jaw.

Health Canada had recommended that Merck issue an ONJ warning for oral biphosphonates in December 2004. The US FDA had also indicated a risk in 2004, and Merck’s own scientists noticed the ONJ reports in 2004 and in 2005 said that the risk of ONJ “must be there.” Moreover, said Mr. Sizemore, Merck told its own consultants in June 2005 that there was a “definite link” with osteonecrosis, and that underreporting was a certainty. Therefore, Mr. Sizemore concluded, Merck knew there was a problem with Fosamax, and nonetheles first refused to warn, and then downplayed their warning.

As for damages, Mr. Sizemore reminded the jury that Ms. Rosenberg had undergone five surgeries involving filing, scraping, and drilling away the dead bone. Bone death, he said, involved the same kind of chronic severe bone pain experienced by cancer patients. Even after the fifth surgery, said Mr. Sizemore, Ms. Rosenberg continued to suffer bone loss.

Jurors will begin deliberating Thursday morning at 9am.

CVN webcast the Rosenberg Fosamax trial live.

Opening statements were heard today in the first state court Fosamax products liability trial, Rosenberg v. Merck.

For plaintiff Allison Rosenberg, Paul Sizemore, of the The Sizemore Firm, told the jury, “We’re here because Fosamax caused harm to my client’s jaw…Jaw death and what we call osteonecrosis of the jaw doesn’t just happen…it was caused by Fosamax.”

According to Mr. Sizemore, Ms. Rosenberg’s health care providers were not warned that Fosamax could cause bone death, even though the FDA had sent warning letters to Merck. Nor were her physicians told that Fosamax’s effectiveness declined after three years; instead, said Mr. Sizemore, Merck successfully fought to delay and minimize any warning.

Mr. Sizemore predicted that Merck would claim that osteoporosis was “the worst disease in the world,” but noted that Ms. Rosenberg never suffered any fracture. Instead, her jaw died, and none of the other medications Ms. Rosenberg was taking, such as steroids, cause your jaw to die, said Mr. Sizemore — only Fosamax does that.

For Merck, Butler Snow’s Christy Jones told the jury that although Ms. Rosenberg believed that Fosamax had caused harm to her jaw, extensive studies showed Fosamax to be safe and effective. In addition, current scientific evidence does not show that Fosamax causes osteonecrosis of the jaw. Moreover, Merck timely warned doctors of the possible risk of osteonecrosis. Finally, said Ms. Jones, Fosamax did not cause Ms. Rosenberg to suffer osteonecrosis of the jaw. Instead, the harm to Ms. Rosenberg’s jaw possibly resulted from steroid use.

Merck’s FOSAMAX brand is a bisphosphonate, also referred to as alendronate, alendronic acid, or alendronic sodium. Teva manufactures a generic version.

Watch CVN’s live webcast of the Rosenberg v. Merck Fosamax trial.

Watch CVN’s live webcast of the first state-court Fosamax trial, which begins next week in Atlantic City, New Jersey, before Hon. Judge Carol Higbee.

Alendronate Sodium, sold by Merck under the brand name “FOSAMAX” since 1995, is an osteoporosis treatment for postmenopausal women. Some studies have shown that oral bisphosphonates, including Fosamax, may increase the result of osteonecrosis of the jaw (ONJ), or bone death. A generic version of alendronate is manufactured by Teva.

The Mayo Clinic’s website advises that aledronate is safe for patients who do not have cancer or active dental disease, such as a recent tooth extraction.

Plaintiff Alison Rosenberg claims that her jaw problems resulted from the use of Fosamax, and Merck’s failure to timely warn of the risks. Merck claims that the harm to Ms. Rosenberg’s jaw was caused by other health problems and medications.

Rosenberg v. Merck will be the fourth FOSAMAX trial, and the first in state court.  The prior three trials, in federal court, resulted in two defense verdicts and a plaintiff verdict.