Fosamax Osteonecrosis Lawyer
FOSAMAX FOR LIFE? THE F.L.E.X. TRIAL SAYS "NO"
As we have mentioned previously, Fosamax has a very long half-life - - 10 to 12 years - - in the human bone. This has always presented the question: if Fosamax sticks around for so long, why is it is necessary to continue using it?
A new article published in the Journal of the American Medical Association suggests that, for many women wishing to prevent fractures, there is no reason to keep using it: "These results suggest that for many women, discontinuation of aledronate for up to 5 years does not appear to significantly increase fracture risk." JAMA, Effects of Continuing or Stopping Alendronate After 5 Years of Treatment: The Fracture Intervention Long-term Extension (FLEX): a Randomized Trial", JAMA, 2006; 296:2927-2938, at 2927.
The other shoe is beginning to drop on Merck as evidence mounts that Merck has overstated the efficacy of Fosamax and downplayed the risks.
MERCK WAS CHASTISED BY FDA FOR FOSAMAX MARKETING SCHEME
In reviewing the FDA files on Merck and Fosamax, it was interesting to learn that the FDA had on several occasions in the late 1990s sent formal letters of criticism to Merck for overstating the benefits of Fosamax and, perhaps more importantly, underemphasizing the risks associated with Fosamax use. Letters were sent on the following dates: 04/14/97; 07/02/97; 07/16/99; 06/20/01. Links to the letters can be found at the bottom of this entry.
Undoubtedly, these letters would have continued through the 2000s. However, in late 2001, after the federal administration changed hands and political appointments more friendly to Big Pharma took over, a new policy was instituted that prohibited the FDA's Division of Drug Marketing, Advertising & Communications (DDMAC) from sending out warning letters to pharmaceutical companies unless the letters were previously approved by the FDA's General Counsel.
Well, here's the problem: The employees at DDMAC are lifelong FDA employees whose sole job is to make sure that the pharmaceutical companies are telling it straight to the consuming public. The General Counsel is a political appointment who serves at the request of a politician who is largely beholden to his donating patrons at Big Pharma. This General Counsel, rather than protect the American public from defective drugs, would actually write letters to federal judges asking that they dismiss cases of injured victims before the victims even had the opportunity to present to the Court exactly what it was the pharmaceutical company did wrong.
As a result, the FDA General Counsel significantly shut down the warning letters being sent by DDMAC to pharmaceutical companies in late 2001 and now pharmaceutical companies have much greater freedom to hide the risks and overstate the benefits of their drugs.
Apparently, the FDA General Counsel was either (1) too busy writing to federal courts asking that victims of defective drugs be denied their day in court or (2) not inclined to review and approve important DDMAC warnings letters to Big Pharma. The drug companies have plenty of attorneys of their own - - they should not have the right to the have taxpayer-funded Office of General Counsel serve their fancies as well. Alas, that's where we are right now.
However, before the General Counsel's policy change, guess which company was among DDMAC's chief culprits? You guessed it. Merck. In both Vioxx and Fosamax, DDMAC sent letter after letter to Merck warning Merck to quit misleading the American public. It should come as no surprise, then, that in August 2004, when the FDA requested Merck to warn consumers about the risk of osteonecrosis of the jaw and Fosamax use, Merck felt free to not follow the FDA's request, and still have not followed the FDA's request to this day.
If you're interested, here are the FDA's warning letters which were sent before the DDMAC warning letter program was severely curtailed by the FDA General Counsel.
http://www.fda.gov/cder/warn/apr97/fosamax.pdf
http://www.fda.gov/cder/warn/july97/fosamax.pdf
http://www.fda.gov/cder/warn/july99/8086.pdf
http://www.fda.gov/cder/warn/2001/9727.pdf
At Levin Papantonio, we represent no corporations, no big political donors. We represent individual American taxpayers who happen to have been harmed by corporate wrongdoings. We will continue in our efforts representing the injured victims of Fosamax.
FDA HAS INSUFFICIENT POWER TO ENSURE DRUG SAFETY
A recent study published in the New England Journal of Medicine confirms that the FDA does not presently have sufficient power to protect the American public from the adverse effects of drugs.
As you may recall, after the late 2004 Vioxx debacle, the FDA came up with a 4 part plan to see how it can prevent future pharmaceutical catastrophes such as that with Merck's Vioxx. In typical fashion, two years later, no real changes have occurred. However, the published study provides a glimmer of hope that some brave soul in Washington will take on the pharmaceutical industry and empower the FDA to protect the American public.
One part of the plan was to charge the Institute of Medicine with the task of looking at the way FDA works and how it should be changed. The New England Journal of Medicine just published the IOM's recommendations and they are unequivocal: the Congress needs to massively overhaul the FDA.The link below will take you to a radio interview with the lead author, Dr. Bruce Psaty. Dr. Psaty's generic recommendation that the "FDA needs to develop a culture of safety" that does not presently exist.
In the 1990s, the Congress passed a law that sped up the drug approval process in the United States. The User Fee amendments required drug companies to pay application fees with each New Drug Application filed. While these revenues sped up the U.S. drug approval process, pharmaceutical lobbyists were able to have Congress include a section which specifically prohibits using any of those revenues for purposes of post-marketing safety surveillance.
As a result, whereas in the 1980s, the U.S. was the site of first launch for only 5% of drugs worldwide, in the late 1990s, it became the site of first launch for 65% of the drugs and the U.S. consumer became the world's pharmaceutical guinea pigs.
Dr. Psaty says that Congress needs to give FDA additional powers because the powers it has right now are woefully insufficient to make pharmaceutical companies do anything. At the present time, short of pulling a drug off the market, the FDA cannot force a pharmaceutical company to do anything. It has to plead and cajole for it to change its warnings. This is why Merck was able to not implement the warnings language the FDA requested for Fosamax in its August 2004 Office of Drug Safety review of the class effect of osteonecrosis of the jaw.
The attorneys at Levin Papantonio have been saying for years that the FDA is too anemic to force Big Pharma to do much for consumer safety. Dr. Psaty's panel feels the same way.
The panel concluded that the FDA needs specific authority to: (1) change labels rapidly; (2) ensure postmarketing (Phase IV) studies commence immediately upon the marketing of a drug for the specific purpose of testing the safety of the drug in the real world setting; (3) ensure that the Phase IV studies are timely complete and accurately reported; and (4) quickly require (not ask or beg) the drug companies to change labeling to accurately reflect the associated risks.
Here's a link to the interview with Dr. Psaty.
http://content.nejm.org/cgi/content/full/355/17/1753/DC1
LEVIN PAPANTONIO TELEVISION: YouTube and Fosamax
The law firm of Levin Papantonio has posted an interview on Fosamax on YouTube. This new medium is an exciting way of communicating with the public in a format that is more substantive than you can otherwise get on network television.
You can access the link as follows:http://www.youtube.com/watch?v=9bclL5i5sFI
At Levin Papantonio, we continue to research both the risks and benefits of Fosamax and continue in our endeavors to bring justice to those who have suffered the harmful effects of osteonecrosis of the jaw as a result of taking Fosamax.
-- Tim O'Brien
ICARO STUDY SHOWS CLINICAL BENEFITS OF FOSAMAX ARE OVERSTATED
Category: Fosamax News
An article recently published in the Journal of Bone & Mineral Research, Fracture Incidence & Characterization in Patients on Osteoporosis Treatment: The ICARO Study, shows that the clinical trials Merck touts overstate the actual benefit conferred by Fosamax in the clinical or practical setting. The article is published in the October 2006 edition of the Journal, at pages 1565-1570.
I found it very curious that there was poor fracture reduction response for patients on Fosamax unless they were also taken Vitamin D and calcium supplements. Could it be that the Vitamin D and calcium supplements are what is helping patients rather than the Fosamax? Studies published in the New England Journal of Medicine show that Vitamin D and calcium supplements, taken by themselves, do have a significant effect on decreasing fractures.
It would be very interesting to see a head-to-head comparison of alendronate (Fosamax) therapy by itself to Vitamin D + calcium supplements to see which one is more effective at reducing fractures.
The attorneys at Levin Papantonio will be examining these questions with Merck over the next several months.
JUDICIAL PANEL CREATES NATIONAL FOSAMAX LITIGATION CENTER
Whenever a major pharmaceutical products liability litigation project becomes a consideration of national concern, a panel of judges appointed by the United States Supreme Court can consider whether the project is worthy of pretrial consolidation pursuant to 28 U.S.C. § 1407. This statute allows the Supreme Court to organize the cases, before one United States District Court, for purposes of maximizing the efficiency of discovery and minimizing the costs of litigation to the aggrieved victims.
Recently, Fosamax received such recognition from the Judicial Panel on Multidistrict Litigation and has been centralized into MDL No. 1789, In re Fosamax Products Liability Litigation. This MDL has been sent to the United States District Court for the Southern District of New York.
The MDL is not a class action. Nor is it a vehicle from which Fosamax patients can simply apply for relief. Rather, it is a tool for Fosamax plaintiffs who have filed their cases in federal court to use to ensure that Merck faces a coordinated plaintiffs' effort on both the liability (fault) front and science (causation) front.
At Levin Papantonio, we have taken the leadership role in the Fosamax MDL and are are happy to talk with anyone interested as to what the process is and what is has to offer. You may feel free to call me at any time: 850-435-7084. If I am not available, simply ask my paralegal to set a phone conference for me to call you back and I'll be happy to do so!
ORAL SURGEONS TO CONFER ON FOSAMAX-INDUCED ONJ
In early October, the American Academy of Oral & Maxillofacial Surgeons will convene in San Diego. One of the hot topics the surgeons will discuss will be bisphosphonate-induced osteonecrosis of the jaw and how dentists and oral surgeons should handle patients, including those on Fosamax, who are at risk for ONJ.
At Levin Papantonio, we certainly applaud the efforts by AAOMS to proactively handle the increasing numbers of Fosamax patients with ONJ. The amazing thing is, even while this society is meeting, Merck still refuses to warn about the risk of ONJ associated with Fosamax. While Merck states in its Precautions that those chemotherapies containing nitrogenous bisphosphonates are associated with ONJ, nowhere does Merck come out and let physician and patient know that Fosamax, which is a nitrogenous bisphosphonate, also is associated with ONJ.
For more questions, you may contact me at http://fosamax.clarislaw.com/contact.php . At Levin Papantonio, we have been working on Fosamax-induced ONJ cases for more than one year and will continue in our efforts to fight for the rights of injured patients. Because, at the end of the day, we believe that both patients and physicians have a right to know the risks associated with a pharmaceutical product such as Fosamax.
Recent Vioxx Rulings may Affect Fosamax Cases
Category: Fosamax Lawsuits
Quote, Jude Eldon Fallon, presiding judge in the recent New Orleans Vioxx case: " All three of the Plaintiff's claims revolve around the safety risks of Vioxx; what Merck knew about any such risks, when Merck knew this information and what Merck should have done about it. ......the court concludes that the jury's findings for the Plaintiff on his negligent failure-to-warn and deceit-by-concealment claims were reasonable".
In addition, Mark P. Robinson, lead plaintiff attorney agreed with the significance of the judge's statement. "The judge ruled that the jury's findings.....that Merck negligently failed to warn and committed deceit-by-concealment with Vioxx........were reasonable findings. Though the court ruled that the compensatory damages were excessive, the judge also said he was not troubled by the punitive damages award. Further he is going to allow one jury to try both the compensatory and punitive damages award again in a single trial. All of this taken together is a very positive development for those who are victims of Vioxx".
Merck is also the manufacturer of Fosamax.
Fosamax Crisis Could be Bigger than Vioxx
Category: Fosamax Lawsuits
The one thing that is not grasped by the Market watchers, the Stock checkers and the Wall Street analysts is that Foamax cases are different from Vioxx cases. In Vioxx cases, doctors would rarely admit that the prescription caused the heart attack or stroke. In Fosamax cases, all the doctors will admit that Fosamax caused the osteonecrosis of the jaw suffered by their patients. It is a signature injury. You won't see the drug maker trying to blame the victim in these cases.
Fosamax's Huge Number Of Adverse Events
As I go through the FDA files, it truly amazes me that the Fosamax problem has flown under the radar for so long. The FDA first approved Fosamax for use in 1995. By 1996, Fosamax's first year on the market, Fosamax was the leader in the number of adverse event reports received by the FDA! Look at the following report from the FDA, specifically TABLE 4: "Postmarket ADE Reports by Top-10 Ranked Suspect Drugs": http://www.fda.gov/cder/dpe/annrep96/ You will see that, out of all the hundreds of thousands of Rx drugs on the market, Merck's Fosamax had 3.5% of all reported adverse events and, as a result, occupied the unenviable pole position for prescription AERs.
Merck Admits Knowledge Of Reports Of ONJ
Category: Fosamax News
Rather than warn patients, and despite knowledge known by Merck about the increased risk of osteonecrosis of the jaw on patients using Fosamax, Merck has yet to issue a "Dear Doctor letter" to prescribing physician, and continues to defend Fosamax by minimizing unfavorable findings through statements such as those made in the Wall Street Journal: "'The cause of osteonecrosis is not well understood and is likely to include a number of conditions.'"
Additionally, while there has been no Merck clinical study directed to the relationship of osteonecrosis of the jaw and Fosamax use, Merck infers that the fears of ONJ are unfounded by arguing "'in all our controlled clinical trials, including the 10-year data with Fosamax, which have included more than 17,000 patients, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax.'"
However, in direct contrast to that statement, Merck has informed the American Dental Association that it is aware of at least 170 reports of osteonecrosis in Fosamax users. So, how has Merck been able to avoid the problems with Fosamax that it faces with Vioxx? And will it continue to be able to do so?
When examining this issue, we should consider the following factors:
(1) The peer-reviewed literature appearing in dental and oral surgery journals clearly establishes the relationship between Fosamax and ONJ;
(2) Most physicians who prescribe Fosamax do not read dental and oral surgery journals;
(3) In its prescribers information, Merck has not issued any warnings about Fosamax and the risk of ONJ to prescribing physicians;
(4) Merck has done no "Dear Doctor" letter to prescribing physicians advising them of the risk of ONJ linked to Fosamax use;
(5) Merck has made public statements inferring to prescribing physicians that there is no risk of ONJ with Fosamax;
(6) Merck previously has been rebuked by the Food & Drug Administration for misleading the public about the risks of another Merck blockbuster drug, Vioxx.
(7) Merck has been rebuked by the FDA for overstating the efficacy of its drug Fosamax.
The time has come for Merck to acknowledge what the leading dental organizations have already acknowledged: Fosamax causes osteonecrosis of the jaw.
American Dental Ass'n: Fosamax Causes ONJ
Category: Fosamax News
An expert panel put together by and for the American Dental Association recently formally recognized that the use of Fosamax is a risk factor for osteonecrosis of the jaw. This panel was comprised of several of the leading experts in the areas of oral surgery and dentistry from around the nation.
Injury Rate Estimates
Category: Fosamax News
Because treatment can be beneficial, everyone is keeping a close eye on the rate of ONJ related to drug treatment.
About 1,600 bisphosphonate-related ONJ cases have been reported to the FDA as of Oct. 28, said the American Association of Oral and Maxillofacial Surgeons.
The condition is rare. Between 6 percent and 8 percent of those taking bisphosphonates intravenously develop ONJ at the current dosages, doctors estimated. The damage from ONJ is permanent for these intravenous bisphosphonate users.
"The damage is so severe, the bone does not recover," one doctor said.
Bisphosphonate-induced ONJ is even more uncommon for those taking the medicine orally, such as with Fosamax. One oral surgeon has estimated the frequency at .05 percent to 0.005 percent.
Fosamax Lawsuit Brings Dangers To Light
Category: Fosamax News
A recent article appeared in the Salt Lake City Tribune, detailing the struggles of a Utah Fosamax patient who is dealing with osteonecrosis of the jaw. The article was written by Carey Hamilton, who did a superb job covering the issue.
Doctors Concerned About Fosamax And Osteonecrosis
Category: Fosamax News
A recent article appeared in the New Jersey Star-Ledger detailing the concerns that physicians and patients have about Fosamax's ability to cause osteonecrosis of the jaw.
As I discuss in the article, you'd have to be the Amazing Karnac to interpret the thinly worded osteonecrosis "precaution" Merck put into its Fosamax label in late 2005.
What is the FDA Doing?
Category: Drug information
Anyone concerned about Fosamax injuries and other safety concerns attending prescription medications should check out the recent article in the New England Journal of Medicine. Written By Dr. Jerry Avorn and Dr. Wiliam Shrank, the article addresses the danger of new moves by the FDA to limit manufacturer accountability for drug products. See article online.
What Are Bisphosphonates?
Category: Drug information
Bisphosphonates are a category of drugs prescribed and taken to prevent and treat osteoporosis, or a thinning of the bones, and bone fractures. They may also be used to treat Paget's disease, a chronic skeletal disorder.
Fosamax Patients Need to Be Aware of Risks
Category: Fosamax News
With more than 44 million Americans suffering from osteoporosis, it is important to stay informed about the risks of drugs that treat this bone loss problem. A May 20 article in the South Florida Sun-Sentinel expresses the concerns many doctors have over the popular drug Fosamax for their osteoporosis patients.
Continue reading "Fosamax Patients Need to Be Aware of Risks"
NIH To Conduct Study On Fosamax's Dangers
Category: Fosamax News
I was recently interviewed by the Sun-Sentinel, the major paper in South Florida. I was pleased to learn through that process that the National Institutes of Health has decided to spend some effort and money studying Fosamax and its relationship to adverse events. If you'd like to read the article, here's the link: Fosamax dangers. We continue to file cases on behalf of injured Fosamax patients and look forward to litigating these cases to their successful conclusions.
Fosamax Firm Investigates ReNu Problems
Category: Fosamax News
As my Fosamax team is conferencing with clients, reviewing medical records, preparing lawsuits, interviewing witnesses, meeting with expert dentists and oral surgeons, I was pleased to learn that my very able partners were hard at work investigating claims relating to Bausch & Lomb's ReNu MoistureLoc contact lens solution. Levin Papantonio, has filed suits in Florida and Georgia on behalf of injured MoistureLoc users.
This contact lens solution has been linked to the potentially blinding eye infection, fusarium keratitis. This infection can lead to severe optical injuries resulting in corneal transplants and, in severe cases, blindness. The problems with the contact lens solution appears to be that the antifungal agent used by Bausch & Lomb is insufficiently powered to take care of fungal agents. MoistureLoc has not been completely withdrawn from the market.
MoistureLoc patients who believe that they have developed a problem should see a doctor immediately, preserve the product packaging, and any proof of purchase. For questions concerning your legal rights, please contact me for a free consultation.
Fosamax, Osteonecrosis, And The Net
Category: Fosamax News
It's interesting, if you look at the internet, you can see in the Wikipedia that Fosamax causes osteonecrosis of the jaw. Look at the following link: http://en.wikipedia.org/wiki/Fosamax This summary very fairly reflects the current state of the peer-reviewed medical/dental literature. . Just like with Vioxx, the common wisdom appears to have far outpaced the information provided by Merck toAt the same time, no such language appears in Merck's Fosamax warnings provided to physicians and patients. For more information about the risks of osteonecrosis and Fosamax, please feel free to contact me.
Law Radio Interview Of Tim O'Brien Re: Fosamax
Category: Fosamax News
I had the pleasure of being interviewed for 30 minutes on Law Radio's show, Coast to Coast. You can get the download at http://www.law.com. Also, you may contact me if you need further information pertaining to what we're seeing with Fosamax cases and osteonecrosis of the jaw. Understandably, there a lot of concerned patients out there. If any dentist or doctor is reading this and wants to see the literature explaining the risks, please feel free to contact me.
Cnn Reports On Fosamax Lawsuit
Category: Fosamax News
CNN MONEY recently ran a story on the Fosamax lawsuit.
Could this be another Vioxx? The plaintiffs in approximately 11,500 lawsuits blame the arthritis painkiller for causing their heart attacks, and accuse Merck of withholding information about the drug's health risks. Merck has said all along that Vioxx didn't kill anyone and denied all charges of corporate wrongdoing.So far, Merck has lost two cases, won two, and there was a split verdict in another. The next trial begins June 5, in a case involving two plaintiffs in a New Jersey state court in Atlantic City.
Fosamax's Mechanism Of Action
Category: Fosamax News
I have been interviewed by several news agencies about Fosamax and its relationship to osteonecrosis of the jaw. Time and again, the question is asked: "Why can something which helps prevent bone loss in the hips and thighs cause bone problems in the jaw?" In researching this issue, it is apparent that the same mechanism which makes an oral bisphosphonate like Fosamax an osteoporosis hero, also makes it an ONJ villain. The process by which Fosamax works in preventing osteoporosis is by the inhibition of osteoclasts; by inhibiting osteoclasts, bisphosphonates inhibit bone material from being resorbed (or removed) by osteoclasis.
Normal osteoclasis is vital to bone turnover and the ability of the bone to survive Interruption of this homeostatic cycle by inhibition of bone resorption results in micro fractures of the old mineral matrix and impairs the jawbones' ability to repair themselves. This process also impairs the growth of veins in the jaw bones which in turn inhibits the ability to heal and fight infection.
Marked inhibition of bone remodeling which occurs on bisphosphonate therapy predisposes patients to osteonecrosis, particularly since the jaw has exposed bone and the mouth is never aseptic. Because the jaw bones are the only bones in the human skeleton constantly exposed, (through the teeth), frequent "bone turnover" is imperative to the maintenance of healthy jaw bones. In other words, the jaw bones need constantly to purge the old and bring in the new bone material. Osteoclast inhibition, prevents the purging of the old - - which makes it effective for preventing osteoporosis - - but also doesn't allow the exposed bones in the jaw to bring in the new.
The question presents itself: why does a drug which helps reduce fracture rates in long bones cause such problems in the jaw bones? In his 2005 article, Bisphosphohonate Induced Expose Bone of the Jaws, University of Miami Professor Robert E. Marx answers as follows: "Because the jaws have a greater blood supply than other bones and a faster bone turnover rate related both to their daily activity and the presence of teeth (which mandates daily bone remodeling around the periodontal ligament), bisphosphonates are highly concentrated in the jaws. Coupled with chronic invasive dental diseases and treatments and the thin mucosa over the bone, this anatomic concentration of bisphosphonates causes this condition to be manifested exclusively in the jaws."
Additionally, as a result of the presence of the nitrogen atom on the alendronate chemical chain, Fosamax has a half-life of more than ten years which can result in a massive cumulative dose over the multi-year dosing cycle. Due to this long half-life and the nature of the osteonecrotic process, the progress of the disease occurs even after discontinuation of Fosamax therapy.
Unfortunately for the patient suffering from osteonecrosis, there is no known effective treatment for this drug induced osteonecrosis. Indeed, corrective oral surgery may actually exacerbate the problem. Thus, the need to prevent the disease or catch it in its early stages is apparent.
Docs Need To Understand Fosamax Risks
Category: Fosamax News
It is clear from me, based upon the calls I get from clients, that prescribing physicians usually do not know about the August 2004 FDA adverse event database review in which the FDA concluded that the risk of osteonecrosis was a class effect of nitrogenous bisphosphonates, including Fosamax. This is the problem with this particular risk factor because most of the literature appears in dental journals and oral surgery journals - - journals not usually read by the internal medicine doctors, rheumatologists, endoctrinologists, etc. who actually prescribe Fosamax. In one fo the more recent articles, authored by renowned oral surgeon Dr. Robert E. Marx reveals that this is a problem extending to Fosamax: "Given that it has a half-life of more than 10 years, the current widespread use of alendronate (Fosamax) to prevent or treat early osteoporosis in relatively young women and the likelihood of long-term use as well as the unbiquitous presence of dental disease in our society gives us cause for concern." J. Oral Maxillofac Surg. 63:1567-1575 (2005), at p. 1575. If anyone reading this blog is a prescribing M.D., please feel free to contact me and I'll be happy to share this info with you.