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Fosamax Mistrial Hinged On Juror No. 5

Posted by Jane Akre
Monday, September 14, 2009 4:52 PM EST
Category: Major Medical
Tags: Fosamax, Actonel, Osteoporosis, Osteonecrosis, Atrial Fibrillation, Vitamin D, Shirley Boles, Dental Health, Bisphosphonates

The Fosamax trial of plaintiff, Shirley Boles, failed to come to a conclusion last Friday.

Juror No. 5

LEARN MORE

IMAGE SOURCE: New York Times Web site/ Shirley Boles, first Fosamax plaintiff

Merck and Co. shares were up almost 3% on Friday, after a federal judge declared a mistrial in the New York case considering liability issues involving the company’s osteoporosis drug, Fosamax.

The jury failed to come to a verdict in this, one of the first lawsuits to proceed against Merck, charging the company did not adequately warn the public that Fosamax can lead to permanent jaw death, known as osteonecrosis or ONJ.

Fosamax, a top-seller for Merck, lost patent protection in 2008.

U.S. District Judge John Keenan allowed for a one day "cooling-off period" which brought no agreement.

One juror holdout refused to excuse the company. She said she was physically threatened during deliberations which did not move from a seven-to-one split among the five women and three men. A note to the judge was made public Monday.

It came from Juror No. 5.

“I am being intimidated, threatened, screamed at as well as verbally insulted that I am stupid because I do not agree,” said juror No. 5, Theresa Ciccone, reports Bloomberg. “I have had 2 physical threats against me -- a chair thrown -- and a verbal threat to beat me up.”

Shouting from the jury room could be heard during the first day of deliberations, September 2.

The other jurors told Judge Keenan they found evidence that supports the risks of Fosamax, but no evidence that the drug caused Ms. Boles injury.

More To Come

Merck is facing about 900 Fosamax lawsuits, including some with multiple plaintiffs. The injured claim that taking the popular osteoporosis drug, interferes with the natural process of bone turnover, the process of bone loss and buildup that occur during a lifetime, and that Merck failed to warn doctors and patients about the condition while representing the drug was safe.

Plaintiff Shirley Boles, 71, of Fort Walton Beach, Florida said she developed the condition after taking Fosamax and before Merck said it had reports of the disease, reports Bloomberg.

In her case, a tooth extraction in 2002 triggered the condition, she said, causing the gum to fall away and leaving infections that drain through open wounds in her chin, reports the New York Times.

Her attorneys presented internal Merck e-mails showing that the company knew about the jaw problems, but failed to study the problem or warn doctors in a timely fashion.

The National Osteoporosis Foundation (NOF) says osteonecrosis occurs rarely in patients who are being treated with bisphosphonate medications, such as Fosamax or Actonel. But a study in the Journal of the American Dental Association in January reported four percent of Fosamax patients at USC School of Dentistry had active ONJ.

Dental patients should let their doctor know what medications they are taking.

Boles was seeking $1 million and Judge Keenan ruled out any punitive damages in the case.

Her lawyers from, Levin Papantonio Thomas Mitchell Echsner & Proctor P.A. of Pensacola, Florida (and IB Partner) are preparing a retrial and currently represent about 400 plaintiffs.

Two more trials are set against Fosamax scheduled for January and April. Merck had spent $7 million on legal expenses defending Fosamax by mid-year.

Sales of Fosamax, before it lost patent protection, were $3.05 billion in 2007, the year 15 million prescriptions for Fosamax were written.

Bottom Line on Bone Health

About 85 to 90 percent of your adult bone mass is acquired by the age of 18 in girls and 20 in boys, reports the National Osteoporosis Foundation.

Consuming adequate amounts of calcium, vitamin D, engaging in weight-bearing and muscle strengthening exercise, avoiding smoking, and excessive alcohol are all advised to keep bones healthy.

Fracture is the most common problem suffered by post-menopausal women with one in three over the age of 50 experiencing a fracture in her lifetime. Breaking a bone from osteoporosis has more than an eight-out-of- ten chance of breaking another one, making it difficult to walk.

One-third of men will suffer an osteoporosis-related fracture during their lifetime, according to the International Osteoporosis Foundation.

The use of bisphosphonates is also associated with an increased risk of atrial fibrillation, iinflammatory eye disease and unusual fractures. #


4 Comments

Anonymous User
Posted by Shellie B
Tuesday, September 15, 2009 5:25 AM EST

The link in here for NOF is correct but there is a HUGE misrepresent by the author who does not know her subject matter. NOF stands for National Osteonecrosis Foundation, not the Osteoporosis Foundation. They are 2 different diseases. Fosomax and like drugs are not being filed against for cause of osteoporosis, but for cause of Osteonecrosis.

Posted by Jane Akre
Tuesday, September 15, 2009 9:55 AM EST

Dear Reader-

We love the fact that our readers look at stories and comment on them- thank you!

However, respectfully, you need to research your comment/criticism topic further.

NOF stands for the osteoporosis foundation.

NONF.org stands for the osteonecrosis foundation.

We have added a link to the Learn More box so you can further explore both sites. The second paragraph of the story tells you what the trial is about.

Thanks for your input!!

Posted by Auria A
Wednesday, September 16, 2009 8:45 PM EST

Thank you so much for publishing this article, why are we outliving good bone health?
Age, I am in the late 50's and have had a fracture already, yes i do have osteoporosis. It is -3.5 on the dexascan. I read above that once a woman has had a fracture, she stands an 80% chance of another one. Presently I am taking calcitonin, do you feel this particular drug is safe?
As much as a non-medical person can, I've done my research and calicitonin seemed to be my best bet--could not tolerate actenol or fosamax, taking both resulted in horrible hives everyday. Would appreciate any information you have.

Thanks again,
Auria

Posted by Jane Akre
Wednesday, September 16, 2009 11:00 PM EST

Auria-
What a great question to pose- Why are we outliving our bones?

Bone health is of particular interest to me as well. Currently I'm reading Women's Wellness Today, "The Only Cure for Osteoporosis" by Dr. Susan Lark, who is not a huge fan of bisphosphonates. (Her work is available online- by subscription, I believe...drlark.com)

A rew things she mentions:

1) Neutralize excess acid - when the body is acidic from foods, alcohol, etc, the body pulls from bone to neutralize the acid, boost alkalinity

2) Calcium, Vitamin D, Flaxseed, magnesium, zinc, DHEA supplements she recommends among others..and tells you why...

3) I've not heard of this but EMT, electromagnetic therapy which boosts healing though increasing bioelectric energy of your body to slow bone loss. Don't expect to hear about this from your mainstream doctor, though Dr. Lark is an MD.

Perhaps we need a story on that one!!! She does the research and I think she'd good!!

Comments for this article are closed.

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