Archive for June, 2010

The retrial of Shirley Boles v. Merck entered its 11th and final day of witness testimony on Wednesday. Defense witness Dr. John Bilezikian, an endocrinologist from Columbia University, testified about the serious consequences of osteoporosis if left untreated. He also spoke about the risk factors used by physicians in deciding how to treat osteoporosis and in determining if Fosamax is appropriate.

On cross-examination, the plaintiff’s counsel alluded to the close and friendly relationship between Merck and Dr. Bilezikian. In addition, he questioned the doctor on the lack of any long-term benefit from Fosamax, and the weaknesses in the clinical trials the defense relies on. Finally, the plaintiff’s counsel introduced correspondence between Merck and the National Osteoporosis Foundation to illustrate the close partnership between the two, and the monetary support Merck provides the Foundation. The Foundation has issued a number of studies and reports on the benefits of Fosamax. The defense countered that this type of relationship is normal in the pharmaceutical industry.

Due to scheduling conflicts, the conclusion of Dr. Glickman’s testimony from the previous day took place after Dr. Bilezikian’s testimony. The plaintiff’s counsel underlined the fact that Dr. Glickman has never physically examined Ms. Boles, yet has made his own diagnosis, which is contrary to her treating physician’s diagnosis.

At 4:00 in the afternoon, the plaintiff and the defendant announced that they had each rested their case. 

Thursday will kick-off with a closed conference between the parties and Judge Keenan, followed by closing arguments set to begin at 2:00 p.m.

On June 17, 2010, the final day of the plaintiff’s case, the plaintiff started the day with two video depositions and ended with Ms. Shirley Boles taking the stand. The video depositions were of Dr. Donald B. Kimmel, a Merck employee who was the former Director of Molecular Endocrinology, and Dr. Patrick J. Anastasio, the plaintiff’s doctor who is an infectious disease specialist. Dr. Kimmel admitted he had spent 60 hours with the defense counsel preparing for the deposition, and tried to persuade the jury that there was insufficient information to prove that Fosamax causes ONJ.  In contrast, Dr. Anastasio, who treated the plaintiff in 2007, testified that he believes that Fosamax caused Ms. Boles’ ONJ.

Next, Shirley Boles, a soft-spoken, seventy-two year old women and former deputy sheriff from Fort Walton Beach, took the stand. She testified that since taking Fosamax in 1997, she has experienced excruciating mouth pain and jaw problems which have forever changed her life. Despite Ms. Boles’ other medical issues, she testified that she had only taken seven sick days from work during her twenty-seven plus years on the force. After cross-examination, a re-direct examination, a re-cross-examination, and re-re-direct examination, the plaintiff conditionally rested her case.

Monday, Merck will start presenting its case.

On June 16, 2010, the penultimate day of the plaintiff’s case, began with the continuation of Dr. Curt Furberg’s testimony, concerning Merck’s research on Fosamax.  Dr. Furberg testified that he believed the primary article upon which Merck relies to try to prove that Fosamax has benefit for women with osteopenia, authored by Dr. Qundt, was widely misleading and deceptive.

The second witness of the day was Dr. Suzanne Parisian, a former FDA medical officer. Dr. Parisian worked at the FDA for four years in the early 1990s. After her tenure there, she published a book, “FDA Inside and Out,” and has made a living explaining the workings of the FDA to outsiders. Dr. Parisian’s testimony illustrated how the FDA has no real authority, that it is basically a shadow organization primarily funded by the drug companies to approve their drugs for marketing to the American public. She testified that the FDA has no power to force a drug company, such as Merck, to change its label or recall a drug once it is on the market. She also testified that the FDA is under a mandate to approve drugs in less than ten months. She further explained that the FDA is woefully understaffed, with only five workers reading the more than 400,000 adverse event reports sent to the FDA each year. Dr. Parisian’s testimony specifically rejected defense attorney Strain’s point in his opening statement that because the FDA had approved Fosamax, it could not be defective.

Tomorrow will be the plaintiff’s final day of witnesses, and will feature the plaintiff herself, Ms. Shirley Boles.

On June 15, 2010, day five of the Fosamax retrial, the jury heard testimony from two more of the plaintiff’s witnesses, Dr. Daniel Baran and Dr. Curt Furberg.

The doctors used diagrams, charts, and tables to illustrate the proper use and benefits of Fosamax in treating osteoporosis.  According to their testimony, clinical trials have shown that Fosamax can be effective for a particular group of people for a limited period of time.  However, as the plaintiff’s counsel attempted to show the jury, Ms. Boles was not a member of that group.  The plaintiff argues that because Ms. Boles did not fit the criteria of the group in the clinical trial, Merck should not have led her to believe Fosamax would help her.  Instead of improving her health, Fosamax, as the plaintiff’s counsel argues, caused Ms. Boles’ exceedingly painful condition.  While the defense counsel attempted to discredit the doctors and limit the scope of their testimony, the plaintiff’s counsel emphasized the doctors’ credentials and the scientific results the clinical trials produced.

Tomorrow will kick-off with the conclusion of Dr. Furberg’s testimony and then proceed to testimony from the plaintiff’s remaining witnesses.

On June 14, 2010, the fourth day of the Fosamax retrial of Shirley Boles v. Merck started with a video deposition of Merck’s Executive Director of Clinical Research, Dr. Arthur Santora. Ms. Boles’ counsel questioned Dr. Santora on why Merck did not conduct a thorough study on Fosamax’s alleged link to ONJ, after he received an email from a dentist at Merck who warned him of the possible link. Dr. Santora replied that Merck had conducted a preliminary assessment for ONJ, which found that a comprehensive study singling out ONJ as a side effect was not “feasible.”

Dr. Santora was then questioned about Dr. Mucci’s FDA report, which implies 1) that Fosamax is not as effective as previously thought; and 2) that research data may have been manipulated to suggest Fosamax has beneficial effects in non-osteoporosis patients.

The next witness that Ms. Boles’ counsel examined was Shirley Boles’ gynecologist/general physician, Dr. James Mills MD, who originally prescribed Fosamax for Ms. Boles back in 1997. Dr. Mills stated that he is convinced that Fosamax caused Ms. Boles’ ONJ, which has led to her severe weight loss and depression. The defense asserted that Ms. Boles’ COPD (Chronic Obstructive Pulmonary Disease) could be a possible cause of her weight loss. Dr. Mills refused to accept this theory because he believes that COPD often causes patients to gain weight.

Next, a video deposition from Merck researcher, Dr. Daniel Baran, will be shown to the jury.

On June 10, 2010, the second full day of testimony in the Fosamax trial, Shirley Boles v. Merck, began with the video testimony of Linda Hostelli.  Ms. Hostelli is the Vice President of Product Safety and Quality Assurance at Merck.  She began by explaining Merck’s procedures for the investigation of potential side effects after a drug is approved and on the market.  If seven reports of a particular side effect are received within a six month period, a label review team made up of physicians investigates.  To establish that Merck knew or should have known about Fosamax’s alleged osteonecrosis side effects, the plaintiff’s counsel questioned Ms. Hostelli concerning various reports dealing with oral injuries by Fosamax users between the years 1996 and 2001.

The plaintiff’s next witness was Mrs. Boles’ oral surgeon, Dr. Charles Elwell, a former Air Force colonel.  On direct examination, Dr. Elwell explained how he came to the conclusion that osteonecrosis was to blame for the deterioration of Mrs. Boles’ jaw bone.    He testified that her condition did not respond to therapies that should have worked if her injuries were due to osteomyelitis alone.

On cross examination, the defense counsel pointed out that Dr. Elwell himself, as well as other doctors and dentists who examined Ms. Boles, had previously determined that Mrs. Boles suffered from osteomyelitis, caused by an infection called actinomycosis.  Dr. Elwell agreed that Ms. Boles’ injuries were consistent with osteomyelitis, but added that while her jaw problems may have begun with an infection, Fosamax was a co-morbid factor that made it impossible for the jawbone to fight off the infection.

On June 8, 2010, the first day of the Fosamax retrial of Shirley Boles v. Merck began with the plaintiff’s attorney, Timothy O’Brien, and the defense attorney, Paul Strain, giving their opening statements. Each attorney gave an hour-long multimedia presentation outlining how he intended to prove his respective case. Mr. O’Brien intends to prove that Ms. Boles, a dedicated officer of the law, has been severely injured by Fosamax, a defective drug, which caused the death of her jaw (ONJ).  Mr. Strain intends to show that Ms. Boles’ ONJ was the result of other factors and was not caused by Fosamax.

After the lunch break, the plaintiff began questioning witnesses.  The first two witnesses, Dr. Michael Goldberg, a former Senior Director of Clinical Risk Management and Safety Surveillance for Merck, and Dr. Thomas Martin Bold, the current Senior Director of Clinical Risk Management and Safety Surveillance for Merck, testified via a video-taped deposition.  The plaintiff’s third and final witness for the opening day of the trial was James Randall Hollon, plaintiff Shirley Boles’ son.  Mr. Hollon testified in person and recounted first hand what it has been like for his mother to struggle with ONJ.

On June 9, 2010 as the Fosamax retrial of Shirley Boles v. Merck geared up for the first full day of witness testimony, the plaintiff’s chief witness, Dr. Robert Marx, took the stand.  Dr. Marx is a Professor at the University of Miami School of Medicine and an Oral and Maxillofacial Surgeon who has treated upwards of 250 patients with dead jaw or ONJ. 

 Dr. Marx discussed animal studies showing a link between Fosamax and ONJ and testified that he believes Fosamax causes ONJ.  He specifically rejected defendants’ theory that plaintiff’s ONJ was caused by her prior health issues instead of her Fosamax use.  Dr. Marx further explained how Fosamax’s long half-life exposes patients to the drug’s toxic effects well after they stop using it.  The half-life of Fosamax is 11.2 years, which means that it takes 11.2 years for half the drug to leave the body.  Therefore, even after being off Fosamax for 3 years, 75% of its toxic effect remains in the body.

 Tomorrow, Ms. Boles’ oral surgeon, Dr. Charles Elwell, will take the stand.