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Gadolinium Lawsuits Increasing

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Gadolinium Lawsuits Increasing

Lawsuits over gadolinium contrast agents and their links to the painful skin and connective tissue disease NFS / NFD (Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy) are increasing. Here are some useful facts about gadolinium, its dangers and the lawsuits that have been filed.
Gadolinium facts
Here are some useful facts about gadolinium:
What is it? Gadolinium is a contrast agent, or dye, used in MRIs (Magnetic Resonance Imaging) and MRAs (Magnetic Resonance Angiography) to enhance images.
When is it dangerous? While many patients’ systems simply excrete gadolinium naturally, many others’ do not. When gadolinium stays in a patient’s system, it can lead to the potentially fatal disease called NFS / NFD (Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy).
Last year, the U.S. Food and Drug Administration (FDA) told the makers of gadolinium to include a black box warning on the drugs and warned patients with kidney disease to avoid using the drugs altogether. A black box warning is the most serious warning issued by the FDA. In addition, numerous studies from respected hospitals such as Yale and Massachusetts General have been released showing gadolinium’s link to NSF/NFD.
What are the effects of NSF/NFD? NSF/NFD, a disease that affects skin and connective tissue, can cause patients’ skin to thicken to the point that they cannot move. The condition can spread to other parts of the body and can be fatal. Unfortunately, the disease was not discovered until approximately 11 years ago and the medical community has limited information on how it can be treated – if at all. For additional information on NSF/NFD, see the FDA’s website at http://www.fda.gov/cder/drug/infopage/gcca/qa.htm.
What drugs are involved? The drugs involved are OmniScan (gadodiamide), OptiMark (gadoversetamide), Prohance (gadoteridol), Magnevist (gadopentate dimeglumine) and MultiHance (gadobenate dimeglumine).
What manufacturers are involved? The following manufacturers have been named in many of the gadolinium lawsuits across the nation: Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt.
Where does the litigation stand? According to news reports, approximately 400 lawsuits have been filed across the nation. Nearly 300 of those are pending in Multidistrict litigation, or MDL, which is different than a class action lawsuit because the individual cases will be transferred back to their original courts if the MDL doesn’t resolve the issue.
Have you been injured due to gadolinium? If so, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To speak with a lawyer about what your options are, please click here. We may be able to help.

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MRI Dye/Gadolinium Lawsuits: Attorney Provides Advice To Those Exposed

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MRI Dye/Gadolinium Lawsuits: Attorney Provides Advice To Those Exposed

Gadolinium, the contrast dye used in MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography) has been linked to a debilitating disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). We asked Dan Thornburgh, a Florida attorney whose practice focuses in drug and medical device litigation, for advice on what to do when you’ve been exposed to gadolinium.
Florida Attorney Dan Thornburgh
What should someone do if they’ve been exposed to gadolinium? Thornburgh told us:
If they’ve just been exposed but don’t have symptoms, I would advise them to consult with their doctor about any exposure that increases their risk. They should certainly be aware of the symptoms such as tightening of the skin, limited walking, contractures, reflection and tension problems. If someone with renal or kidney problems who was exposed to it starts to develop these symptoms, they should immediately contact their doctor as well as an experienced attorney.
Thornburgh says that the problem in some instances is that individuals may not know that they have renal insufficiency. He explained, “They may think they have a healthy kidney, but then start to develop these symptoms. There are tests that a doctor can do to determine if NSF is the condition causing these symptoms. Their doctor can determine if doing a punch biopsy is warranted to diagnose the condition.”
How an attorney can help
Thornburgh says an attorney can help in three ways. “First, we’ll do everything we can to make this process easy and fair for you and we will aggressively represent you against the manufacturer. The second would be that if you’ve been harmed by a manufacturer who caused your injury and knew or should have known that their product was going to hurt you, then you should let them know that this isn’t allowed and that you’re going to take a stance against a corporation who may have put profits before your safety and your health.”
Finally, an experienced drug litigation attorney will use a variety of experts to find out what caused your condition. Thornburgh’s firm will talk to nephrologists, epidemiologists and other folks that are familiar with the mechanism of action and how gadolinium can cause this condition.
Suffered harm from Gadolinium? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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MRI Dye/Gadolinium Litigation Update – 4/14/09

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MRI Dye/Gadolinium Litigation Update – 4/14/09

Dan Thornburgh, a Florida attorney whose practice focuses in drug and medical device litigation, recently sat down with us to provide an update on the nearly 400 hundred lawsuits currently filed against gadolinium manufacturers.
Most lawsuits currently in discovery process
Many of the lawsuits filed are currently in multi-district litigation, or MDL, a procedure which allows a judge to look at the similarities between cases filed throughout the nation. We asked Thornburgh to provide us with a status of the MDL. He said:
It’s currently making its way through the discovery process. Oftentimes what happens is that we have what I call generic discovery rather than case specific discovery. So, we’ll obtain expert witness depositions that were taken from both sides and those generally involve discussions of causation such as whether there is an increased risk, how this is happening and why people are being affected by it.
Incidentally, NSF (Nephrogenic Systemic Fibrosis) is caused by nothing other than gadolinium exposure. So, it’s not hard to argue that my client, whose been diagnosed with Nephrogenic Systemic Fibrosis, was caused by gadolinium exposure – because that’s the only thing that causes it.
There is some case specific discovery going on with the MDL as well and the whole thing is moving forward. What I mean by discovery is conducting interrogatories – which are questions that we get to send to the defendant. They answer or object to answering those questions and they do the same to us.
Discovery also involves requests for production of documents – which is another tool where we ask the defendant to produce documents responsive to a particular request. Finally, it also includes taking depositions – which is a process where we’re allowed to ask questions to directly to their witnesses and they’re allowed to ask our witnesses or plaintiff(s) questions.
Thornburgh says that all of these tools are used to flesh out and understand the facts on both sides and that fact finding process allows us to develop themes or theories and get ready for trial.
How has the FDA been involved?
The U.S. Food & Drug Administration has been involved with gadolinium warnings. According to Thornburgh, “The FDA has reviewed the science and ultimately required a black box warning to be added. A black box warning is the most strict warning issued and it was added to gadolinium product labels. So, that’s the first thing you see now instead of having to dig through four pages of labels to find out what some of the risks may be. This is printed at the top of the label in a black box.”
Manufacturers’ deceptive practices
There have been several reports of drug manufacturers hiding clinical studies which produced unfavorable results. We asked Thornburgh whether he’s seen this happening in his practice. He told us, “Yes, some manufacturers do hide their studies. In addition, some, and I’m not referring to any one manufacturer specifically, hire what we call ghost writers. They pay doctors, who claim to be independent, a sum of money to write an article or do a study. Then, the company will actually write the study and the ghostwriter or doctor who was paid to do it will sign his or her name to it. It’s very deceptive and very concerning.”
Suffered harm from Gadolinium? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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MRI Dye/Gadolinium Side Effects

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MRI Dye/Gadolinium Side Effects

Gadolinium is a contrast agent used to enhance the images on MRIs and MRAs. While there are several companies that manufacture gadolinium products, all of these products have the potential to lead to Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) – a serious and potentially deadly side effect of gadolinium exposure. Dan Thornburgh, a Florida attorney whose practice focuses in drug and medical device litigation, provided more information in a recent interview.
What is gadolinium?
Gadolinium is a contrast agent used to enhance the images on MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography), according to Thornburgh. “When a doctor orders an MRI to rule out or rule in certain conditions, they use a type of x-ray machine to enhance images. Gadolinium is a contrast agent used in these procedures to enhance those images. It’s a chemical or toxin that is not found in the human body.”
Who manufactures gadolinium?
There are several manufacturers, according to Thornburgh. “General Electric manufactures Omniscan, Bayer manufactures Magnivist, Tyco manufacturers OptiMark and Bracco manufactures both Multihance and Prohance.”
Potential deadly side effects
Thornburgh told us that gadolinium, when used in patients with certain health conditions such as kidney failure, kidney insufficiency and liver transplant cases, the toxic gadolinium doesn’t move through the body as fast as somebody with normal kidney functions. He explained:
As a result, some people have developed conditions called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). People with underlying kidney or liver disease are at an increased risk of developing this condition which can be life altering and can even result in death.
People with this condition develop sort of a woody hard skin, lesions on their body, dark patches on the body and have burning and itching sensations. The hardening process also causes contractures which can become so serious that individuals have a hard time moving, and in some cases, can’t ambulate at all.
Unfortunately, it doesn’t stop there. The lesions that develop on the skin can also develop in organs of the body and this can lead to organ failure. So some of the cases where we see people dying from the drug or from the condition have been from organ failure because it has moved to organs or due to falls because the contractures are so bad that their ability to move has become so limited that they fall and suffer a head injury.
No cure for NSF/NFD
There is no cure for NSF/NFD, according to Thornburgh. “NSF is a fairly new disease. There are no cures to my knowledge. There are treatments but they are limited and are really done to help alleviate the pain and the suffering that these people are going through.”
400 product liability lawsuits filed
There are approximately 400 product liability lawsuits currently pending against gadolinium manufacturers which allege that these companies knew about the risks, but failed to warn consumers. Thornburg said, “It’s terrible and again, we see the same problem in this drug as we do in all these cases. The companies who manufacture these products have a duty to find out what risks are associated with the product. Yet, they either find out what the risks are and don’t warn consumers about it or they do everything they can not to test for the risks.”
Suffered harm from Gadolinium? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Gadolinium Manufacturers Settling Lawsuits

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Gadolinium Manufacturers Settling Lawsuits

Gadolinium manufacturers such as Bayer HealthCare Pharmaceuticals, General Electric, Tyco Healthcare and Bracco Diagnostics have been sued by hundreds of injured victims alleging that they’ve contracted serious skin and organ conditions after using the companies’ products while undergoing MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography). One of those companies is now settling cases – and the others are likely to follow.
Contrast dye product liability cases are settling
That seems to be the case according to various credible news agencies. According to Bloomberg news and Reuters, Bayer HealthCare Pharmaceuticals has begun to settle gadolinium cases over its contrast dye agent, Magnevist. Hundreds of lawsuits have been filed against Bayer alone alleging that patients developed serious skin conditions known as Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD) which, according to an FDA (U.S. Food & Drug Administration) alert, symptoms may include:
For the bones, joints and muscles: joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness
For the skin: burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
For the eyes: yellow raised spots on the whites of the eyes
Other manufacturers likely to follow
While Bayer HealthCare Pharmaceuticals is the only manufacturer reportedly settling lawsuits, other manufacturers such as Bracco Diagnostics, GE Healthcare and Tyco Healthcare are likely to follow suit. Lawsuits against these companies allege that they knew about the dangers of gadolinium based contrast agents and their links to NSF/NFD for years, but failed to warn consumers.
Here’s a list of manufacturers, their products and links to additional information:
Bayer HealthCare Pharmaceuticals – Magnevist
Bracco Diagnostics Products – Prohance and Multihance
GE Healthcare – Omniscan
Tyco Healthcare – Optimark
Find out more
If you’ve been injured due to a gadolinium based contrast agent, contact an experienced products liability attorney whose practice focuses in drug litigation to discuss your situation.

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Study Reveals Kidney Disease Patients Have 27% Higher Risk Of NSF

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Study Reveals Kidney Disease Patients Have 27% Higher Risk Of NSF

A new study from the University of Pennsylvania in Philidelphia reveals that patients with advanced kidney disease who are exposed to gadolinium based contrast agents (dyes used in MRIs and MRAs) have a 27% higher risk of developing nephrogenic systemic fibrosis.
Details of the study
According to a study published in the Nephrology Dialysis Transplantation Journal, researchers at the University of Pennsylvania in Philidelphia and Doctor Rajender Agarwal reviewed data from seven previous studies on the links between advanced kidney disease patients who are exposed to gadolinium based contrast agents and nephrogenic systemic fibrosis (NSF) – a serious condition which may consist of:
Burning of the skin
Hardening or tightening of the skin
Itching
Muscle weakness
Pain deep in the hip bones or ribs
Red or dark patches on the skin
Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
Swelling
Yellow spots on the whites of the eyes
The hardening process also causes contractures which can become so serious that individuals have a hard time moving, and in some cases, can’t ambulate at all.
They concluded that patients with advanced kidney disease were 27 times more likely to develop NSF if they were exposed to gadolinium products than those that were not exposed.
Gadolinium manufactures & FDA warnings
Several companies manufacture gadolinium including Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt and the products involved are OmniScan (gadodiamide), OptiMark (gadoversetamide), Prohance (gadoteridol), Magnevist (gadopentate dimeglumine) and MultiHance (gadobenate dimeglumine).
While the U.S. Food & Drug Administration (FDA) issued a black box warning (the strongest warning given by the FDA) in 2007 on gadolinium products, these products continue to be used. Lawsuits over NSF and NFD (Nephrogenic Fibrosing Dermopathy) injuries continue to be filed alleging that manufacturers failed to 1) adequately test these products and 2) warn consumers of the possibility of contacting the disease once known.
Manufacturers rumored to be settling cases,/b>
According to news reports, gadolinium manufacturers may now be settling lawsuits. Bloomberg News and Reuters have each reported that Bayer Healthcare Pharmaceuticals has begun settling gadolinium lawsuits – and it is likely that other manufacturers will follow Bayer’s lead.
If you believe that you may have been injured due to a gadolinium based contrast agent, it’s important to see your doctor right away as tests can be done to determine whether you’ve contracted NSF/NFD. Contacting an experienced products liability attorney to discuss your situation and evaluate your options.

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Drug Warnings: Fosamax Side Effects and Risks

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Drug Warnings: Fosamax Side Effects and Risks

Merck’s drug Fosamax is used to increase bone density, but recent studies have indicated that it and other bisphosphonates may also cause Osteonecrosis of the Jaw (ONJ), a condition where the tissue of the jaw bone dies and is unable to repair itself.

The FDA (Food and Drug Administration) has known for a long time that Fosamax can cause irritation of the esophagus. The FDA issued a MedWatch alert about that in 1996. In September 2004, the FDA and Novartis, the manufacturer of another bisphosphonate, issued warnings to health professionals for another more serious problem, that there is a potential for ONJ in patients treated with bisphosphonates in chemotherapy. In 2004, the FDA found 139 bisphosphonate-related ONJ cases, mostly associated with two drugs Aredia and Zometa, but 12 cases were related to Fosamax, identifying ONJ as a possible Fosamax side effect.
Suffered harm from Fosamax? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
By October 28, 2005, 1,600 cases of bisphosphonate-related ONJ had been reported to the FDA. In January 2005, the FDA asked Merck to change the label for the drug to include a Fosamax warning about ONJ. Critics claim that the “label” in question is actually a 22-page document that is sent to pharmacies. The warning, which appears on page 13, gives no real warning to consumers.

Check out the following articles for more information about Fosamax, filing a Fosamax lawsuit and finding a Fosamax attorney.

For more information about Fosamax, see Drug Overview: Fosamax Side Effects and Claims
For more information about Fosamax side effects, see Fosamax Side Effects – Osteonecrosis of the Jaw (ONJ)
For more information about Fosamax updates, see Fosamax Information and Warnings
If you would like to learn more about Fosamax lawsuits, see Fosamax Lawsuits, Litigation & Lawyers
To learn more about Fosamax attorneys and how to find one, see Hiring a Fosamax Attorney and Lawyer

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Fosamax Side Effects – Osteonecrosis of the Jaw (ONJ)

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Fosamax Side Effects – Osteonecrosis of the Jaw (ONJ)

Fosamax, along with other bisphosphonates, can cause Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw. Fosamax’s action to prevent bone from repairing itself in the normal way can cause death of the tissue in the jawbone, and eventual disintegration of the bone itself. The first symptom of ONJ is often the exposure of discolored areas of the jawbone.
The primary risk factors for ONJ are:
1) Taking bisphosphonates, in IV form or by tablet, for a long period of time;
2) Using steroids with bisphosphonates;
3) A previous history of cancer, osteoporosis, or Paget’s disease;
4) Dental procedures such as extractions or dental implants.
Suffered harm from Fosamax? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
People who take bisphosphonates intravenously as part of chemotherapy for cancer treatment are more likely to develop ONJ, at least in the short term. The damage from ONJ in those situations is usually so severe that the bone doesn’t recover. People who take bisphosphonates orally in products like Fosamax develop ONJ less frequently, though long-term use Fosamax may result in higher rates. When ONJ develops from the bisphosphonates taken orally can sometimes be treated and reversed. It’s important to be aware of ONJ as a possible Fosamax side effect.
You should always inform your dentist if you have taken bisphosphonates in any form, particularly if you need to have an invasive treatment like an extraction. It may be best to stop taking bisphosphonates before having those procedures. You should discuss this with your dentist. It’s also important to practice very careful oral hygiene, see your dentist regularly, and get help immediately if you have pain or any difficulty with your jawbone.
Check out the following articles for more information about Fosamax, filing a Fosamax lawsuit and finding a Fosamax attorney.
For more information about Fosamax, see Drug Overview: Fosamax Side Effects and Claims
To find out more about the FDA warning, see Fosamax Side Effects and Risks
For more information about Fosamax updates, see Fosamax Information and Warnings
If you would like to learn more about Fosamax lawsuits, see Fosamax Lawsuits, Litigation & Lawyers
To learn more about Fosamax attorneys and how to find one, see Hiring a Fosamax Attorney and Lawyer
Suffered harm from Fosamax? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Drug Overview: Fosamax Side Effects and Claims

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Drug Overview: Fosamax Side Effects and Claims

Fosamax (also Fosamax Plus D), generic alenronate sodium, is manufactured by Merck. It was approved by the FDA (Food and Drug Administration) in 1995 for the treatment of post-menopausal and steroid-induced osteoporosis and Paget’s disease. Osteoporosis is a condition that can lead to bone loss and increased risks of fractures. In Paget’s disease, bone grows back soft when it is repaired and can result in deformity.
The Fosamax claim is that it increases bone density. Fosamax has been a huge success for Merck, with sales of $2.5 billion in 2003 and $3.2 billion in 2005 (with 22 million prescriptions in the United States).
Fosamax is one of a group of drugs called bisphosphonates that are used in tablet form to treat osteoporosis and Paget’s disease, and intravenously to treat the effects of cancer in bone tissue. Recent studies have linked the use of bisphosphonates with Osteonecrosis of the Jaw(ONJ), which is also called Dead Jaw, Jaw Necrosis, and Bis-Phossy Jaw. See Fosamax Information and Warnings for more information about ONJ as a Fosamax side effect.
Suffered harm from Fosamax? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.
Check out the following articles for more information about Fosamax, filing a Fosamax lawsuit and finding a Fosamax attorney.
For more information about Fosamax side effects, see Fosamax Side Effects – Osteonecrosis of the Jaw (ONJ)
To find out more about the FDA warning, see Fosamax Side Effects and Risks
For more information about Fosamax updates, see Fosamax Information and Warnings
If you would like to learn more about Fosamax lawsuits, see Fosamax Lawsuits, Litigation & Lawyers
To learn more about Fosamax attorneys and how to find one, see Hiring a Fosamax Attorney and Lawyer
Suffered harm from Fosamax? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

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Fosamax Trials Set

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Fosamax Trials Set

Three early trials regarding Merck & Company’s osteoporosis drug, Fosamax, have been set for trial. Fosamax users have been diagnosed with osteonecrosis of the jaw, an irreversible and painful condition that destroys bone tissue and hundreds of lawsuits have been filed against the pharmaceutical giant.
Over 600 lawsuits filed
Fosamax has been linked to hundreds of injuries across the nation and more than 600 lawsuits have already been filed against Merck & Company, the drug’s manufacturer. The lawsuits have been consolidated into a multi-district litigation and are centralized in the U.S. District Court for the Southern District of New York. Three early trials have been set with the first one beginning in August 2009, the second in October 2009 and the third in January 2010. The three cases will be heard by juries and will help to identify the relevant issues concerning all the pending cases. Legal experts say that more lawsuits continue to be filed by women who have been injured by the drug.
What is Fosamax?
Approved by the U.S. Food and Drug Administration (FDA) in 1995, Fosamax is manufactured by Merck & Company and is prescribed to treat postmenopausal osteoporosis. However, since that time, it has been linked to a deterioration of the jaw bone, known as osteonecrosis, and the FDA required an additional warning to be placed on the label in 2005. It has also been linked to increased rates of irregular heartbeats, or atrial fibrillation, according to the New England Journal of Medicine.
Generic versions approved
Earlier in 2008, the FDA approved generic versions of Fosamax which are now manufactured by Teva Pharmaceuticals USA of Pennsylvania and Barr Laboratories Inc. of New Jersey. The success of these generic equivalents will likely be dependant upon how the hundreds of lawsuits against Merck & Company are resolved.
If you’ve been injured due to Fosamax or any other drug, contact an experienced Fosamax attorney whose practice focuses in this area of law to discuss your situation. Consultations are free, without obligation and strictly confidential.

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