Merck Faces First Trial of Claim That Fosamax Attacks Jawbone

[Heidi]

Source: Bloomberg

Aug. 10 (Bloomberg) -- Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others.

The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements.

“In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it’s the first information about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University in New York and an expert on civil procedure.

Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said.

There are as many as 1,200 plaintiffs in state and federal cases, Merck says. Timothy O’Brien, a lawyer representing about 400 plaintiffs, said the number is closer to 2,000.



Read more: http://www.bloomberg.com/apps/news?pid=20601127&sid=aN.O.OLorMnc

[elleng]

1. The Fosamax plaintiffs claim

Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, or ONJ.

The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.

Merck’s Position

Merck disputes the claims, saying there’s no reliable evidence the medicine causes the bone condition.

[nc4bo]

5. Silly lawsuits from greedy, lazy people. The GOP is so right about that.

Who the hell needs their jaw damn bone? :sarcasm:

Fo$amax isn't the only pimped out drug that's freely advertised all over the teevee, newspapers and magazines.

Vioxx
Bextra
Norplant

Those are ones I can remember right off the top of my head. More here:
http://www.drugrecalls.com/index.html

I swear, I get the feeling that instead of carrying out full trials, drug companies use the general population as their own private lab rats and guinea pigs.

[TZ]

14. Umm no.

EVERY DRUG ON THE MARKET goes through 10 full years of testing in clinical trials. ITS THE LAW. What unfortunately happens is that its hard to get a large amount of people to do clinical trials and therefore sometimes all the side effects aren't found until larger populations go on the drug--this is why every drug approved for marketing is monitored in what is considered Phase 4 of the clinical trials to see if any new side effects are found. If Merck found this out either pre or post marketing and covered it up, they deserve to get their assess sued off. But clinical trials for ALL DRUGS is a very structured and lengthy process.

[CountAllVotes]

15. not if it is "fast tracked"

it gets sped right on through the old FDA. :puke:

:kick:

[Grinchie]

24. You're right, Just ask Monsanto!

Oh wait, they just create GMO food laced with pesticides, and antibiotic resistance which is consumed by 100 million people everyday, and not Pharmaceuticals...

There extensive clinical trials using BT toxic derived from a pure source and not the food itself is Substantially Equivalent right?

Who cares if these DNA strand remain intact in our digestive system long enough for the normal gut bateria to incorporate them via Horizontal Gene Transfer?

You sure have a lot of faith in the Corporate owned labs, Corporate own scientists, who are bound by Corporate Charter to maximize profits for the shareholder.

[CountAllVotes]

11. ugh

and to think, "they", meaning "them" want ME to take this crap. So far it has been a :thumbsdown: ...

:kick: & recommend.

[cosmicone]

2. Another free for all for ambulance chasing weasels ....

If you take a drug, you may sometimes get side effects. If you are so risk averse, don't take any drugs and die naturally.

[TheMadMonk]

3. The question is not whether or not there are side effects.

The point being argued is that Merck failed to provide information on a known or suspected side effect of the drug. Which makes it considerably more difficult for the patient (and possibly even the prescribing doctor) to make an informed choice.

It also means that detection of such side effects is likely to be delayed, resulting in greater injury than might otherwise be the case.

Most serious side effects such as this one, are obviously the exception rather than rule or the drug would not receive FDA approval. However, when a drug does have as serious side effect as this one, then doctors and patients need to know, so that the patient can be monitored to determine if they are one of the unlucky few to be susceptible.

[aquart]

4. Thank you for that temperate and reasoned response.

Mine would have so unpleasantly different.

[No Elephants]

7. That's analogous to saying the SEC would not have let Madoff operate if he weren't legit. FDA

approval was not all that difficult to get when Fosomax hit the market. The reality is that our federal consumer safety agencies are very stretched out, even in the best of times. And, federal regulation has been considered an enemy of all that is good and useful in America since at least Reagan.

[TheMadMonk]

12. Except in this case the FDA requested that this specific information...

...be provided in the packaging and Merck chose not to do so.

The FDA may not be perfect, but in this case it advised disclosure, and Merck instead concealed by omission, a seriously deletrous possible side effect. I presume it could only advise and not mandate, because the evidence for this side effect was suggestive but not definitive. If the example of Vioxx is anything to go by, there is every chance this evidence was "massaged" in order to get the original approval.

[No Elephants]

6. Yes. lawyers really suck, as do the media, academics and all others who expose the right and/or

the greedy.

[Heidi]

8. !

:thumnbsup:

[No Elephants]

9. Thanks. Backatcha!

[Heidi]

10. You are aware that a cause of action is needed to justify filing suit, aren't you?

I mean, I guess it's possible that evil lawyers just sit making lists of deep-pocketed companies to suit, making up "facts" to support outlandish claims, then going out and recruiting (out of 300 or so million Americans) a handful who can show medical evidence of dead jawbone tissue and just happened to be taking the drug in question, etc. Then, after all that investment of time and financial resources, _hoping_ a judge will allow the claim to go forward. I mean, it _could_ happen like that, but it strikes me as an awfully laborious way to earn (or lose) money. :eyes:

What do you have against attorneys, since you've been so bold as to characterize them as "ambulance chasing weasels"?

[DemReadingDU]

13. Osteoporosis drugs also may cause femur problems

Do you really need a drug for your bones?
by Dr. Susan E. Brown, PhD

There are several categories of drugs being prescribed in the name of bone protection. In this article we discuss the latest findings on the group known as bisphosphonates.

If you’ve turned on the TV lately, leafed through a magazine, or surfed the internet, you’ve likely seen an advertisement warning you about bone loss. And the ad most likely recommends a certain medication to prevent it. It’s true that many more people are suffering from osteoporosis today than in the past, but lots of women want to know if they really need to take Fosamax, Actonel, Boniva, or some other prescription medication to strengthen their bones.

Quite simply, my answer is no. In almost all cases, taking a prescription medication is not needed. Women from around the country come to our bone center for a natural approach to strengthening their bones — and it’s been working for more than 25 years. Osteoporosis and osteopenia medications are big business, but despite all the hype and marketing from drug companies, there is a safer, more effective, and natural approach to bone health available to you.

Prescription drugs known as bisphosphonates often do lead to initial increases in bone mineral density in those women taking them, but the osteoporosis story is much more complicated than how dense your bone appears on a bone density scan. In many cases these medications don’t add any benefit in terms of fracture, and as we’ve been seeing lately, they may even hurt bone. Several women have recently reported strange fractures after taking bisphosphonates for five years or more — something I started to see in my practice years ago.
.
.
You may have read the recent news about women taking bisphosphonates for more than five years and spontaneously fracturing their femur bones while simply walking or standing. I had a patient who had been on Fosamax for four years, then turned in her bedroom one evening and fell to the floor, breaking her leg in two separate places. Though these “low-trauma” and “nontraumatic” fractures aren’t happening in all women on bisphosphonates, they certainly serve as a warning for those considering prolonged use of these drugs as “preventative medicine.” It also points to the fact that halting bone resorption doesn’t automatically give us stronger bones, and may in fact make them more brittle over time.

more...
http://www.womentowomen.com/bonehealth/osteoporosis-drugtherapy.aspx?

Because of my small bone frame, my doctor has tried for many years to get me to take these bone drugs. I repeatedly tell her that these drugs have not been studied long enough, and I am waiting for additional statistics. In the meantime, I exercise every day, eat healthy, and take calcium.

I know several women who have jaw problems while taking Fosamax. And some dentists will not treat women who are taking these bone drugs. You would think that after the Vioxx fiasco, that Merck would have learned a valuable lesson to test these new drugs more throughly before having doctors prescribe them to so many women.

edit, spelling

[virgdem]

16. You were smart to reject your Doctor's advice...

I was diagnosed about 4 years ago with Osteopenia, which is a precursor to Osteoporosis. My GP prescribed Fosamax and I took it for exactly one year with no apparent side effects. When I found out about the side effects (Osteonecrosis), I stopped taking it. Both my GP and OB/GYN both shook their heads when I told them that I had stopped taking the drug and the reasons why. Apparently the Doctors have swallowed the drug companies line of BS on these drugs. I'm very careful about any new drug I am prescribed and I try to stay away from most of them. I would rather take natural supplements and vitamins from a health food store than play Russian roulette with my health.

[DemReadingDU]

19. I have osteopenia too

and with small bone frame, I was the 'perfect' candidate for bone drugs. The reason I didn't start the drugs 5 years ago, was because I figured the drugs could alter bone composition that maybe might lead to a bone cancer. My brain sometimes works overtime, lol.

So now we don't hear about any cancer from the bone drugs, but jaw problems, and broken femurs. There is no way anyone could pay me to take prescription bone drugs.

[leftyladyfrommo]

18. Wow.

I just remind myself of the hormone viasco. Every doctor I had tried to get me to take hormones - and the bone stuff.

Not me.

[CountAllVotes]

21. you are smart

they have NOT STUDIED these drugs long enough. They have NO long term studies re: them either. :thumbsdown: :thumbsdown:

I am so not impressed!

:kick:

[JerseygirlCT]

28. I couldn't take it long enough to notice jaw problems. One dose

left me so sick! I literally felt it going down, and within 15 minutes, I was running for the bathroom.

I do use a nasal spray - hope that's not also causing problems. And like you, watch my exercise and take calcium.

I learned I had developed osteoporosis in my mid-40s. My mom and sister (younger) have already had hip replacements, and I have several bad discs in my back. I'd definitely like to avoid future problems - but I don't want to cause more problems doing it!

[leftyladyfrommo]

17. I saw something that said 4% of users had the jaw problem

That is not an insignificant number. I have lots of friends taking that stuff.

I don't take anything just because. If I really need it that's one thing. But so many of those so called preventative things either don't really do much or are pretty untested.

Scares me.

[kestrel91316]

20. IMHO, 4% is unacceptably, astronomically high for what is a truly catastrophic

adverse reaction.

[leftyladyfrommo]

22. Yea. That is what they were saying. Its a very real possibility.

The drug companies were saying that this was a very rare side effect - and its not. And it is just awful if it happens.

I read a really interesting book by a leading teacher in one of the big medical schools and he was really down on a whole lot of tests and drugs that are just sold to the public as being totally necessary.

One was colonoscopy. Just about the same number of people that are saved by the test each year die from the side effects of the test - hemmorraegic bleeding is the main one.

He doesn't believe in mammograms, either. Way too many cancers that would never do anything are picked up and then women go through all kinds of unnecessary procedures.

He was against all the bone medicines. He said that the only people that fall and break hips are the very frail. As long as people are active they do fine. And I don't think its all that clear that what the medicine does really helps keep people from breaking hips anyway.

We just buy into this stuff wholesale - and a lot of these things don't do any good and can do a lot of harm.

[kestrel91316]

25. I had a dangerous allergic reaction to a medication 25 years ago,

and it made me very cautious about meds. I don't take ANYTHING currently. I stay active, eat right, and keep my weight down. Popping pills is not a safe alternative to adjusting one's lifestyle.

[Grinchie]

23. If Bisphosphonates are prescribed for systemic bone regrowth, then

Why would it only affect the Jawbone? They don't apply the drug to a particular bone, but it is applied as a systemic drug which until normal assumptions, work on the entire bone system.

I actually know someone who had taken Fosamax, and then needed a hip replacement. When the surgery was performed, it was found that the Hip Joint was damaged by OsteoNecrosis.

This story is creepy in that we have never heard of this issue before, yet there are quite a few people that have claims regarding this strange, relatively rare disease, and they are all seemingly linked by use of Fosamax.

[arikara]

26. I know nurses who call it "fossy jaw"

and they say that its a very common side effect. I hope merck has to pay out billions. Bastards.

[Sheltiemama]

29. What about Actonel?

Have your nurse friends said anything about Actonel? My mother is having tooth problems because of it.

[frustrated_lefty]

30. The term "fossy jaw" dates back to turn of the century matchmaking

Workers making matches were exposed to substantial amounts of phosphorous which resulted in osteonecrosis of the jaw. Pardon the tangent, just thought it should be noted that the term "fossy jaw" is an old one, not a nickname given to patients on Fosamax.

[defendandprotect]

27. Also guilty of defrauding government ....

See Bernie Sanders run down on the pharmaceutical companies --

every pharmaceutical company has been fined hundreds of millions and more for

defrauding Medicare/Medicaid.

And then we let them come back and do business under the plan again!!!

There should be permanent penalties ...