Kickas.org Forums Ankylosing Spondylitis General Discussion #1 AS Web Support Group Bisphosphonate Drugs & Osteonecrosis - law suit

In this latest case that went to trial the defence (pharma) won as they claimed that the 'facts' of the matter were that osteonecrosis of the jaw was a side effect of taking Bis drugs and was advised as such to doctors and pharmacists and to patients via leaflet information. You gotta be yor own protagonist. Read ALL the information on a drug and IF you develop 'a' side effects don't blame pharma - they 'told ya so'...!! Now looks very possible that ALL other cases re the bis drugs will likely fall apart? Ho-Hum. Culperable ignorance I suppose is the defence claim...so again, bone up on ALL the 'possible' side effects of a drug before taking as if owt goes wrong, you'll possibly have 'no' redress.

May 2011: Defense Verdict In Fourth Zometa Trial, Hogan v. Novartis
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May 2011: Defense Verdict In Fourth Zometa Trial, Hogan v. Novartis

Jury Considered Causation Issue And Label Warning About Osteonecrosis Of The Jaw (ONJ)

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late May 2011 a federal court jury sitting in New York City found in favor of the drug company Novartis in a products liability lawsuit concerning the company's bisphosphonate medication Zometa. The case is Hogan v. Novartis Pharmaceuticals Corp, which was pending in the U.S. District Court for the Eastern District of New York.

According to a May 25, 2011 Bloomberg article, "Novartis Properly Warned About Bone Drug Zometa’s Risks, Lawyer Tells Jury", in closing arguments, a defense lawyer representing Novartis argued that the drug company had done nothing wrong. In particular, the lawyer for Novartis asserted the company had properly warned about the osteonecrosis of the jaw (ONJ) side effect that has been associated with intravenous bisphosphonate medications like Zometa and Aredia as well as oral forms of the medication like Fosamax and Boniva.

A May 26, 2011 Reuters article, "U.S. jury finds Novartis not liable for jaw disease", provided some additional key facts about this Zometa lawsuit:

According to documents presented in Brooklyn federal court, Hogan was prescribed Zometa in 2003 after being diagnosed with multiple myeloma, a type of cancer that affects blood plasma cells.

In 2004, a dental surgeon discovered Hogan had developed osteonecrosis of the jaw, which causes bones in the jaw to deteriorate. The surgeon suggested a link between Zometa and the disease, the lawsuit stated.

Hogan's widow said Novartis knew about the risks of Zometa but failed to inform physicians until late 2004. As a result, she said, Hogan developed the bone disease, which left him debilitated in his final years, the lawsuit alleged.

Novartis defended itself by pointing to testimony from the physician who prescribed Zometa to Hogan, who said the potential benefits of Zometa outweighed its risks. Further testimony from Hogan's dentist indicated that he had numerous dental problems when he first came in for treatment.

Mr. Hogan died from multiple myeloma in 2005, the year before this so-called "survival action" personal injury claim was filed on his behalf by his wife.

For some information about the three earlier Zometa lawsuits that have gone to trial, see these articles:

First Zometa-ONJ Personal Injury Lawsuit Against Novartis Goes To Jury This Week (October 20, 2009)

Aredia / Zometa Jaw Injury Lawsuit In New Jersey Ends In Defense Verdict For Novartis (October 7, 2010)

North Carolina Aredia / Zometa Product Liability Federal Court Trial Jury Verdict Coming Soon (November 19, 2010)

We will continue to monitor the hundreds of Zometa and Aredia lawsuits filed against Novartis.

Unfortunately there is not a single drug or medical treatment out there that does not have some side effect or risk. The human body is so unique and we are all so slight different there will never be a completely safe drug. If we hold that standard then we basically can offer very few treatments for disease. Human suffering would increase greatly under that scenario.

we all make decisions based on our willingness to take the risk and the benefits we are looking for. tough calls indeed.

This was also a case of high dose bis drugs used to fight cancer. Risks are even greater there but some of these cancer patients had few other options back then.

i do find it rather unfortunate that we still haven't found a good osteoporosis drug that works well but without these side effects.

for awhile i heard of a few other drugs, but then noticed no mention of them; doctor said "yeh, they didn't exactly pan out.",

but he too was uncomfortable with the side effects of the bis drugs.

so for now, i am fortunate that its just osteopenia so i don't have to make the difficult choice. if it were osteoporosis, not sure how i'd handle it?

as for the strontium, have heard both sides, with the strongest advocacy of it from molly (thanks molly ).

however, when i talk to my doctors, including the ones that i respect the most, they say that the strontium may be making the bones stronger but just as likely right now is that it may just be making the bones show up denser in the dexa scans and not really be any better than the Ca/Mg/D/Zn plus exercise route.

molly, if you have scientific journal articles to back up the strontium please link, thanks.

mostly i hope that we will continue to work on osteoporosis treatments so that there are more viable options.

UC Davis have been conducting a Strontium Citrate trial - have posted several times on this trial on KA including a couple of times per your own request. Have posted additional information on S.C. on KA - also, you can google and PubMed for further information.

Would be great IF there were a files section...

Try checking this one out -

https://www.inspire.com/groups/national-...clinical-trial/

I remember when 'BoneLady' was heading up *everything pharmaceutical...and I piled in with Strontium Citrate. That must be about 5yrs ago Gotta smile, as now looks like 'she' is promoting S.C. Good, she took up the message!

Still awaiting the results of the trials. Anyways, upto people to do as they please. Me? I know what I'm doing, thanks - and that is steering well clear of ALL bis drugs.

As pointed out Sue, you can google up all the information that is available to one and all.

Yes, above is from the osteoporosis foundation site, and, last year posted this very site and its content. Nowt changed since then and subject has been closed out to further comment! Again, for further info suggest that you google it up Sue.

This isn't totally on the subject of the thread, but when Sue mentions a doc not satisfied with the side-effects of the bis drugs.... My rheumy tried me on Atelvia, which is supposed to be less likely to cause esophageal problems (swallowing difficulties). This was in response to not being able to tolerate Fosamax after 9 months. Atelvia only lasted 2 months and was causing the same issue. I saw some blurb on TV about same issue..Atelvia is supposed to alleviate that swallowing difficulty side-effect.

Told rheumy it didn't work and that I was starting SC. Gave him some of the data that I printed off. He isn't fussing about it, so in a year or so, I'll get another DXA and see how it's going. I wonder, too, if either Ca or SC just make the 'picture' look better, not the bones. So, Sue, if you find something, post it here. I'm too busy researching something more critical right now and can't do it quite yet.

well, what i find is both reports saying strontium builds stronger bones (mostly from the links molly has shared) and links saying strontium just makes things look better on the dexa scans. think that's why my doctors and i aren't sure. but if i find anything more definitive, will report back. will say most of my doctors don't like the bis drugs, that's one thing most seem to agree with.

Molly, there is no question how I am handling having Osteoporosis. I will not be taking any of the meds, at least for the time being. I am hoping my new Endo, can get me some answers and get my allergies/sensitivies settled.

Now with all the negative feed back on these meds, not sure if I want to try any of them. Hoping soon, I will be able to tolerate more calcium(lactose intolerant)- maybe they can give me vitamin D by needle form, maybe I can take it that way.

Hugs
Gerri and Makaylah

Gerri - ask yr Endo about Strontium Citrate. As SC exists in some food items then possibly you'll be able to tolerate taking?

(((HUGS))) back -