Posts Tagged ‘ Fosamax ’
Top 10 Drug Legal News Topics For 2012
December 24th, 2012. By AbiK
LawyersandSettlements.com recently shared its list of the hottest consumer-related pharmaceutical legal news stories during the last year. Of note is that while the top drug-related topic on the legal news website in 2011 had been Tylenol—prompted by concerns over a series of Tylenol recall notices as reported by The New York Times; for 2012, the most sought out pharmaceutical topics have shifted to women’s health.
Third-generation contraceptives such as Yasmin/Yaz, NuvaRing and Mirena top the list this year as numerous birth control lawsuits either settled, or began the process of consolidation into multi-district litigation (MDL).
Reader interest in Yaz/Yasmin rose in response to Yasmin lawsuit settlements that were announced in April (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois, East St. Louis). Bloomberg reported Bayer AG settled about 500 Yasmin lawsuits over claims of blood clots that had, in some cases, led to stroke or heart attack.
Along with Yaz, readers remained concerned about NuvaRing (etonogestrel/ethinyl estradiol) and blood clot risk even as a new study on non-oral hormonal contraception, published in the British Medical Journal (BMJ 2012;344:e2990), was presented at the annual meeting of the American College of Obstetricians and Gynecologists (May, 2012). The study, aimed at quantifying NuvaRing blood clot risk, indicated no significant difference in risk of venous thromboembolism when compared to oral contraceptives.
Still, NuvaRing lawsuits continue and have been consolidated into a federal MDL court in Missouri (In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri). As of September 5, 2012, according to the U.S. Panel on Multidistrict Litigation, more than 1,000 NuvaRing lawsuits have been filed.
Mirena IUD (levonorgestrel) saw an increase in reader interest after August 2012, as Bayer Healthcare Pharmaceuticals, Inc. submitted an Application for Centralized Management of Certain Cases involving Mirena. As FoxNews reported (11/11/12), the request seeks to create a multi-district litigation (MDL) for 16 pending Mirena lawsuits in NJ that allege Mirena caused uterine perforation, infection and hemorrhaging injuries.
After the top three women’s health-related drugs, Pradaxa (dabigatran), an alternative to warfarin, joined the list this year making the Top 5. In November 2012, the FDA issued a Drug Safety Communication regarding Pradaxa bleeding events which in turn helped drive reader interest.
Thousands of LawyersandSettlements.com monthly readers have followed the latest legal news and information on these topics, many of which have fallen from the radar of traditional media outlets.
“We believe these issues are of great importance to the public, mostly due to the life-changing impact they can have on an individual,” said Stephen King, CEO. “Some of our most interesting stories of the year related to pharmaceuticals. Many of them have pending lawsuits or have had substantial settlements related to their life-altering side effects and it’s important to get this information out to the public. While many pharmaceutical companies continue to earn significant profits, people are suffering. They may think they have no recourse but in many cases they do. By keeping these topics alive, LawyersandSettlements.com is helping people stay up-to-date on these important topics every day.”
The LawyersandSettlements.com Top 10 Pharmaceutical Topics of 2012, along with the potential side effects readers were seeking information on, are:
1. Yasmin/YAZ (gall bladder disease, blood clots, deep vein thrombosis, pulmonary embolism)
2. NuvaRing & Mirena (blood clots, infection, perforation of the uterus)
3. Pradaxa (uncontrollable bleeding, lack of an available antidote)
4. Granuflo (elevated bicarbonate levels, risk for metabolic alkalosis)
5. SSRIs (birth defects including heart defects, spina bifida, cleft palate, club foot, PPHN)
6. Actos (bladder cancer, heart failure, kidney failure, rhabdomyolysis)
7. Diethylstilbestrol/DES (cancer)
8. Crestor / Statins (diabetes, cardiomyopathy, rhabdomyolysis)
9. Fosamax (bone fractures, esophageal cancer)
10. Propecia (sexual dysfunction, erectile dysfunction, sterility, prostate cancer)
LawyersandSettlements.com readers are looking for the latest and most comprehensive legal news available. Those seeking legal help can request assistance by completing a form which is then distributed to attorneys specializing in these cases. Over two and a half million people visit the site yearly, and hundreds of thousands of request forms have been submitted by qualified readers looking for legal guidance.
Prescription Hell: When Curing Your Ill Causes More Ills
August 4th, 2011. By AbiK
True Story: I saw a comment from a reader here at LawyersandSettlements.com who had gone to the doctor to get some help for his acne. While there, the doctor noticed that this guy’s hair was starting to thin. Long story short, the guy walked out of the doctor’s office with a prescription for Propecia. He now claims he suffers sexual side effects (like erectile dysfunction and impotence). Oh, and btw, he still had his acne.
It got me thinking…
I’m not a glass-half-empty type, but it’s easy to see how, with prescription drugs, one can envision a worst-case-scenario downward spiral of things—especially given the potential side effects with some drugs that are on the market.
So then I started thinking, what if…
What if a guy goes to the doctor for acne. What could happen based on which drugs he’s been prescribed and what the side effects of those drugs could be? The graphic above depicts “The Snake Pit” (classic movie if you haven’t seen it) version of taking prescription upon prescription. A modern day Dante’s “Inferno”. Only in this little vignette, no one emerges from hell in their attempt to mitigate (via new prescriptions) the snowball effect of increasingly negative side effects.
Here’s how this plays out.
(Note, yes, it’s hypothetical, assumes various doctors/specialists involved, and yes, assumes worst case and/or rare scenarios…but still, it could happen. And before you get on me for Accutane being off the market, the drug isotretinoin is still alive and kicking…)
A guy goes to the doctor for acne. He’s given Accutane (isotretinoin). A possible side effect of Accutane is Inflammatory Bowel Disease (IBD). To treat the IBD, he’s given Cipro (antibiotic) and Prednisone (corticosteroid). Cipro has been linked to tendon rupture. Reported, though rare, side effects of Prednisone can include high blood pressure and osteoporosis. Assuming his luck is nil, he experiences these side effects and is given Lisinopril (ACE inhibitor) to combat the high blood pressure, and Fosamax to help combat the osteoporosis.
As we know, Lisinopril has been linked to liver damage (or worse, liver failure). And Fosamax has been under fire for femur fractures. Which, outside of pain meds—which have their own set of side effects—requires another form of medical intervention (surgery). So we come to a “STOP” on that path.
But between the Accutane and the Lisinopril, he begins to experience some hair loss as well—a rare side effect of both drugs, and he’s Mr. Unlucky. So next up, Propecia. Propecia side effects include sexual dyfunction. And he finds himself having some “issues” on the love-making front. Well, there’s a drug for that—Viagra! But let’s face it, between hair loss, sexual dysfunction, a broken thigh bone, a ruptured tendon, high blood pressure and some bowel problems, is it any wonder this guy’s now depressed? So, it’s time for some SSRI’s—like Prozac. And Prozac’s been linked to suicidal behavior.
And, with that, I guess it’s another “STOP”.
What is a Bellwether Trial? Take that Trial for a Test Drive, Baby!
March 4th, 2011. By Kristine B
If you’ve followed news about Fosamax lately, you’ve probably heard the term “bellwether trial” thrown around. The judge in that case has ordered two more bellwether trials in addition to the five that have either already been decided or will be decided later this year. So…
What is a Bellwether Trial?
Basically, a bellwether trial is a trial to indicate future trends in a specific litigation. They are used when a large group of plaintiffs have filed suit based on the same theory or claim and the only feasible way to handle the caseload is through a bellwether trial.
Think of it this way—NASA has flight simulators. Marketing departments have focus groups and in-home trials. Pharmaceutical companies have clinical trials. And your local car dealership hands you the keys for a test drive. Law schools 
may have mock trials, but the only way to really get a sense of how a major lawsuit is going to play out is the bellwether trial.
In a bellwether trial, a small group of plaintiffs is chosen to represent the group. Those plaintiffs are chosen because their issues are common amongst all the plaintiffs. Most large-scale lawsuits, such as asbestos or Fosamax, will run three to five bellwether trials, although the judge can order more or fewer.
Yaz Bellwether Trials
Also, because a major lawsuit can take a long time to wind its way through the legal process, the bellwether trials become a key milestone for both plaintiffs and defendants–and are, therefore, eagerly awaited by all involved. For example, talk of Yaz lawsuits (or Yasmin lawsuits for that matter) has been going on for a while. But the first Yaz bellwether trial is scheduled to take place later this year, on September 12, 2011 for pulmonary embolism side effects; that will be followed by one set for January 9, 2012 and finally a Yaz thromboembolic case on April 2, 2011. Given such a drawn out timeline, it’s no wonder everyone looks to Read the rest of this entry »
Worth a Read – Fosamax Article in More Magazine
June 7th, 2010. By AbiK
Finally got to catch up on some reading this weekend and found myself flipping through the latest More magazine. The one with Sharon Stone on the cover—looking great at 52 (not to take away from Stone’s smarts or her three adopted children, but my response to any “hot body over 40” (or 50) press is, ok, but has she gone through childbirth?—and sans plastic surgery? if so, then let’s talk; otherwise, get real.) But I digress.
What I really want to talk about is the article by Katharine Davis Fishman that’s a bit further back in the June issue. Page 119, to be exact. Title: Boning Up on Bone Drugs. It’s about Fosamax and femur fractures.
And it’s worth a read—particularly if you’re a woman, of a certain age—or nearing that age, or one who’s been taking bisphosphonates—either as a result of a diagnosis of osteoporosis, or as a preventative measure against such bone degeneration.
Fishman presents her own incredible journey through osteoporosis, Fosamax prescriptions, and then a seemingly out-of-the-blue femur fracture after tripping on a rug. Her description of the incident is enough to bring on a palpable wince in the reader. Heck, I got up mid-article and popped a Caltrate D.
The part of the article I found most interesting was the delineation of what Fosamax (and others of its ilk like Actonel, Didronel, Boniva, Aredia, Reclast, Zometa, Skelid) was initially intended to treat, and where it’s evolved to. Bisphosphonates are prescribed to help prevent the breakdown of bone—to help prevent hip fractures—which according to Fishman’s article have a harrowing statistic associated with them: Around 24 percent of elderly men and women who suffer a hip fracture die within a year of the fracture; another quarter wind up incapacitated in nursing homes; and the remainder typically never walk “right” again.
With that kind of prognosis, if I hear the word “osteoporosis” uttered in any examination room I’m in, I’m asking for a Fosamax scrip right then and there.
But wait a minute—that’s the problem. Apparently, Fosamax has been prescribed more and more as a preventative measure—it was approved for such in 1997, two years after its Read the rest of this entry »
Fosamax Femur Fractures in Media Spotlight
June 1st, 2010. By janem
I feel sorry for health officials and researchers whose warnings about adverse drug reactions fall on deaf ears; if only they could employ TV anchor Diane Sawyer to heighten public awareness. Case in point: the link between Fosamax and femur fractures.
Since 2008 researchers have suggested that patients-especially women–using Fosamax may be at risk for increased risk of bone fracture. Although the femur is the strongest and biggest bone in the body, a number of Fosamax patients have fractured their femurs simply from from walking. You can watch Diane Sawyer’s investigation and a follow-up report on ABC News here.
But not even Diane Sawyer and the media can budge the FDA. It says a warning to doctors at this point isn’t justified, but they will “seriously look into it”. That’s good news for Merck. But if the agency sends a letter to doctors, it would allow them to get data they need to have Merck slap a femur fracture warning on the drug. Merck has likely banked heavily on Fosamax profits, especially given the age of baby boomers…
Back to those researchers. In 2008 Cornell University Medical School researchers showed that Fosamax patients are more than 125 times as likely to suffer non-traumatic femur fractures than patients who have not taken Fosamax. And there have been more studies to back-up Cornell.
At first, Fosamax prevents bone loss but loss over time it may also limit the bone’s natural ability to protect itself from stress. A rheumatologist at National Rehabilitation Hospital in Washington DC said that in up to 60 cases he looked at, most patients had been taking Fosamax or another type of bisphosphonate for more than five years. Potentially, many women who have taken Fosamax for 5 years or more can be walking around with brittle bones that can fracture at any time.
Here’s the clincher: on its website, Merck, the Fosamax manufacturer, says that “…after you start taking Fosamax, even though you won’t see or feel a difference and that for fosamax to continue to work, you need to keep taking it. From what I could glean, none of Merck’s clinical trials lasted more than four years. So how long does Merck want you to take it for?
For that matter, should any drug be taken longer than indicated in clinical trials? After all, the drug was approved based on most trials from 1-2 years. When it was initially approved, Merck stated that “side effects observed in clinical trials were generally mild. The most commonly reported drug-related side effects in subjects taking Fosamax were abdominal and musculoskeletal.
Recent label changes made Merck add the following: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures. But who reads that? Thanks, Ms. Sawyer.
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