Fosamax Osteonecrosis Lawyer
"General Hospital" Star Stricken with Osteonecrosis of the Jaw
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New York Times on Fosamax Femur Fractures: We Told You So!
Category: Fosamax News
Six years after originally writing about physicians' growing concerns over long-term Fosamax use, New York Times columnist Jane Brody has written a follow-up story detailing the recent case-control study published in the Journal of the American Medical Association. In the more recent Times piece, Brody amplifies what she originally wrote about in 2004: too many patients are on Fosamax for too long of a time. To read the full 2011 New York Times Brody column, please click here
MEDICAL SOCIETY EXPERT PANEL CALLS FOR FOSAMAX FEMUR-FRACTURE WARNING
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Researchers Find that Fosamax Doubles the Risk of Esophageal Cancer
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Doctors Advising Patients Against Long-Term Use of Fosamax and Actonel
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ABC World News Tonight Exposes Risk of Femur Fractures From Fosamax
Category: Fosamax News
The lead story on the March 8, 2010, edition of ABC World News Tonight was a major story exposing the risk of low-energy, non-traumatic femur fractures for patients who take Fosamax for extended periods of time.
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LP Client Obtains $8 Million Jury Verdict in Fosamax Injury Case
Category: Fosamax Lawsuits
New York, N.Y., June 25, 2010] A jury in the United States District Court for the Southern District of New York found that Merck's osteoporosis drug Fosamax was defectively designed and unreasonably dangerous.
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MEDICAL SOCIETY EXPERT PANEL CALLS FOR FOSAMAX FEMUR-FRACTURE WARNING
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Levin Papantonio Appointed to Lead Fosamax Case
Category: Fosamax Lawsuits
Firm Attorney Timothy O'Brien has been appointed Lead Counsel by the United States District Court for the Southern District of New York in MDL No. 1789, In re Fosamax Products Liability Litigation.
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Fosamax For Life? The FLEX Trial Says "No"
Category: Fosamax News
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
Category: Fosamax News
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
Category: Drug information
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
Category: Fosamax News
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.
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
Category: Fosamax Lawsuits
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
Category: Fosamax News
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.
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.