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.

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.

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.

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.

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.

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.

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.

 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.

The Master Complaint is the latest step to protect consumers and follows a new journal article in NeuroToxicology and a new warning label related to zinc for Super Poligrip

The NeuroToxicology article titled “Myelopolyneuropathy and pancytopenia due to copper deficiency and high zinc levels of unknown origin II.  The denture cream is a primary source of excessive zinc” (hereinafter “NeuroToxicology Article”).  The authors of the NeuroToxicology Article, who are researchers in the field of zinc poisoning and copper deficiency, studied 11 patients who had developed significant injuries, including zinc poisoning, copper deficiency and neurological disorders for a period of years. 

The Master Complaint alleges that each of the patients in the study suffered significant neurological and/or hematological injuries like the plaintiffs in the litigation and, for example, are dependent on canes, walkers or wheelchairs for mobility because of their profound neurological injuries.  For many years, the authors and the patients’ treating doctors could not identify the origin of the high blood zinc levels in the patients.  In 2009, the authors contacted the 11 patients and found that all 11 patients used Super Poligrip and/or Fixodent. The authors confirmed through zinc and copper blood tests that each suffered from zinc poisoning and copper deficiency.  The blood levels normalized after the 11 patients ceased using Super Poligrip and/or Fixodent but the neurological conditions, unfortunately, did not improve much, largely because the neurological injuries are significant and not reversible.  The authors concluded that: “It appears the [11 patients'] disease is fully explained by denture cream use.

If you or a loved one has used Super Poligrip or Fixodent brand denture creams and suffers from neuropathy like symptoms, contact our denture cream lawyers at info@consumerinjurylawyers.com or (877) 779-1414.

At the same time as the FDA announcement last week about the quality of life program, the FDA issued warning letters to 17 Lasik sugery centers who accept walk-in patients reminding them of their obligation to report poor outcomes and any surgery-related medical complaints from patients who have Lasik surgery at their facilities.  The letters were issued after FDA inspections of the facilities found that they had no system for collecting and transmitting to the FDA data on patients’ reports of post surgical “adverse events.”

The FDA website provides a number of helpful resources about Lasik surgery, including a Lasik surgery checklist (which should help patients avoid Lasik malpractice), which includes various tips and other advice for those considering Lasik surgery, such as:

Know what makes you a poor candidate

Career impact - does your job prohibit refractive surgery?
Cost - can you really afford this procedure?
Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?
Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?
Medications - do you take steroids or other drugs that might prevent healing?
Stable refraction - has your prescription changed in the last year?
High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?
Pupil size - are your pupils extra large in dim conditions?
Corneal thickness - do you have thin corneas?
Tear production - do you have dry eyes?

Know all the risks and procedure limitations

Over-treatment or under-treatment - are you willing and able to have more than one surgery to get the desired result?
May still need reading glasses - do you have presbyopia?
Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
May permanently lose vision - do you know some patients may lose some vision or experience blindness?
Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
Patient information - have you read the patient information booklet about the laser being used for your procedure?

Know how to find the right doctor

Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
Informative - is your doctor willing to spend the time to answer all your questions?
Long-term care - does your doctor encourage follow-up and management of you as a patient?  Your preop and postop care may be provided by a doctor other than the surgeon.
Be comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?

Know preoperative, operative, and postoperative expectations

No contact lenses prior to evaluation and surgery - can you go for an extended period of time without wearing contact lenses?
Have a thorough exam - have you arranged not to drive or work after the exam?
Read and understand the informed consent - has your doctor given you an informed consent form to take home and answered all your questions?
No makeup before surgery - can you go 24-36 hours without makeup prior to surgery?
Arrange for transportation - can someone drive you home after surgery?
Plan to take a few days to recover - can you take time off to take it easy for a couple of days if necessary?
Expect not to see clearly for a few days - do you know you will not see clearly immediately?
Know sights, smells, sounds of surgery - has your doctor made you feel comfortable with the actual steps of the procedure?
Be prepared to take drops/medications - are you willing and able to put drops in your eyes at regular intervals?
Be prepared to wear an eye shield - do you know you need to protect the eye for a period of time after surgery to avoid injury?
Expect some pain/discomfort - do you know how much pain to expect?
Know when to seek help - do you understand what problems could occur and when to seek medical intervention?
Know when to expect your vision to stop changing - are you aware that final results could take months?
Make sure your refraction is stable before any further surgery - if you don’t get the desired result, do you know not to have an enhancement until the prescription stops changing?

If you have undergone Lasik surgery and believe that you may be a victim of Lasik malpractice, contact a Lasik malpractice lawyer today for a free and confidential legal evaluation at info@consumerinjurylawyers.com or (877) 779-1414.