• Actos
• Darvon/Darvocet/Propoxyphene
• Guidant Defibrillators
• Avandia
• Trasylol
• Digitek Recall
• Fosamax
• Yasmin/Yaz

Actos

Actos (pioglitazone) is manufactured by Takeda Pharmaceuticals and is a drug normally prescribed for the treatment of Type II diabetes. On June 16, 2011, the FDA issued a new warning citing increased risk of bladder cancer in patients taking Actos for more than a year. In September, 2011 the FDA began a safety review of Actos after initial data from the manufacturers ongoing study indicated that the drug may increase the risk of bladder cancer. Two European countries have already banned the use of the drug.

If you or someone you know suffered from bladder cancer while using Actos, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Darvon/Darvocet/Propoxyphene

In 2009, an outside advisory panel to the FDA recommended that Darvon and Darvocet be pulled from the market. Their review indicated that the potential side effects outweighed any benefits of these drugs. More specifically, they found that Darvon and Darvocet can cause serious and potentially fatal heart rhythm abnormalities. The FDA is not required to follow the recommendations of the panel, and both Darvon and Darvocet remained on the market.

In 2010, after electrocardiography data from a clinical study revealed QT interval abnormalities occurred in healthy individuals taking the prescribed dosage of the drug, the FDA removed Darvon and Darvocet from the market.

The QT interval is defined as the measure of time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle.

Guidant Defibrillators

In July 2005, the FDA announced the recall of implantable defibrillators and pacemakers manufactured by Guidant Corporation. These devices are implanted surgically in people who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). Some of the risks associated with the defibrillators are deterioration of the wires and its inability to deliver therapy. One of the risks associated with pacemakers is that a sealing component used in the devices may experience a gradual degradation, resulting in a higher than normal moisture content with the pacemaker case.

Avandia

Avandia is widely used to treat patients with Type II Diabetes Mellitus. Avandia has been associated with a significant increase in the risk of myocardial infarctions and an increase in the risk of death from cardiovascular causes. Criteria for an Avandia cause of action include:

• Diagnosed with Type II Diabetes
• Avandia use for at least twelve weeks
• 50 years old or younger
• Non-smoker
• Death from cardiac event
• Myocardial infarction (MI)/heart attack resulting in death or disability
• Congestive heart failure (CHF) resulting in death or disability
• Cardiomyopathy.

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Trasylol

As if patients facing heart bypass surgery did not already have enough to worry about, there is now a chance that Trasylol, a drug used to prevent blood loss, might actually increase their risk of kidney problems, heart attacks, and strokes. Patients who suffered serious injuries as a result of Trasylol are now filing lawsuits against the drug's maker, alleging it knew about the risks but failed to warn patients.

The first lawsuits against Bayer, maker of Trasylol, were filed earlier this year.

A study published in the New England Journal of Medicine, (January 26, 2007) found that Trasylol had an increased risk of kidney failure, stroke, and degenerative brain disease. The study concluded, "The association between Aprotinin (Trasylol) and serious end-organ damage indicates that continued use is not prudent. In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives."

The study found the increased risks of serious injury were significant. Trasylol was found to have a 55 percent increased risk of heart failure and a 181 percent increased risk of stroke or encephalopathy (degenerative brain disease). The research team estimated that up to 10,000 patients now require dialysis because of Trasylol.

Furthermore, a study published in the Journal of the American Medical Association found Trasylol was associated with a 48 percent increased risk of dying within five years of coronary artery bypass surgery. In fact researchers noted, as reported in The New York Times, that replacing Trasylol with other drugs for a year would prevent 10,000 deaths worldwide over the next five years.

Questions have been raised about what Bayer knew about the risks of Trasylol and when officials knew it. Allegations of withholding information from the U.S. Food and Drug Administration (FDA) have been made, although it is not clear whether the omission was intentional or erroneous. Despite a safety meeting with FDA officials, Bayer representatives failed to mention that their company had undertaken a safety study of Trasylol. Preliminary findings of that study found an increased risk of death, kidney damage, stroke, and congestive heart failure. Yet Bayer did not inform the FDA of this data at the safety meeting.

If you have suffered kidney failure, heart problems, or other permanent complications after surgery, please contact us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

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Digitek Recall

Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek (Digoxin) on April 28, 2008, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a Bertek label and by UDL Laboratories, Inc. under a UDL label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.

The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. If you have suffered kidney failure, heart problems, or other permanent complications after as a result of Digitek, please contact us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

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Fosamax

Fosamax has been widely used to prevent or treat osteoporosis. It is also used for the treatment of Paget's Disease. Fosamax has been associated with the development of bone loss in the jaw, also called osteonecrosis of the jaw (ONJ) or "jawbone death." Criteria for Fosamax cause of action include:

• Diagnosed with osteoporosis or Paget's Disease
• No kidney disease.
• Development of osteonecrosis of the jaw (ONJ)
• Long-term use of Fosamax
• Atrial Fibrillation
• Esophageal Tumors and/or cancer
• Unusual Bone Fractures
• Severe Bone, Joint and Muscle Pain

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Yasmin/Yaz

Yasmin and its newer version, Yaz, are birth control pills manufactured by Bayer Healthcare. Their generic counterpart, Ocella, is produced by Barr Laboratories.

These once-a-day oral contraceptives contain drospirenone and ethinyl estradiol and were heavily marketed without adequate warnings about the serious and potentially life-threatening side effects. Users with pre-existing kidney or liver disease could be particularly susceptible to these safety concerns, yet the manufacturers of these drugs failed to provide adequate information and warnings to consumers and healthcare providers.

Although Yaz and Yasmin contain components used in birth control pills for years, the component drospirenone is exclusive to these drugs. Drospirenone has been linked to dehydration which can then lead to an increase in potassium. This potassium increase is known as hyperkalemia. Because of the direct connection between potassium levels and heart rhythm, any disturbance in potassium levels can be serious and dangerous.

Some side effects associated with the use of Yasmin, Yaz and Ocella include:

• Blood clots and blood clot-related injuries
• Strokes
• Deep vein thrombosis
• Pulmonary embolism
• Heart attacks
• Gallbladder injuries; gallbladder removal
• Kidney stones
• Kidney failure
• Pancreatic cancer
• Death

If you or someone you know suffered from blood clots, stroke, heart attack, deep vein thrombosis, gallbladder disease or death while using Yasmin, Yaz or Ocella, contact Law Offices of Gary Green toll free at 1-888-4GARYGREEN or send us an e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it to discuss your legal options without obligation.

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Gadolinium is an FDA approved contrast agent for MRI and MRA. Gadolinium provides greater contrast between normal tissue and abnormal tissue in the brain and body. It looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see. Gadolinium is then rapidly cleared from the body by the kidneys.

On May 23, 2007—The FDA announced that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning alerting patients to the risk of a potentially fatal disease NSF (Nephrogenic Systemic Fibrosis) or NFD (Nephrogenic Fibrosing Dermopathy).

It is a condition which involves hardening of the skin, resulting in varying degrees of immobility, can damage internal organs, and is sometimes fatal. It appears to affect only those persons with impaired renal function caused by kidney disease. NSF / NFD is resistant to treatment and can be very painful and debilitating. Most importantly, NSF / NFD is entirely preventable.

The following gadolinium-based agents are implicated by the warning:

• Magnevist (gadopentetate dimeglumine)
• Omniscan (gadodiamide)
• OptiMARK (gadoversetamide)
• MultiHance (gadobenate dimeglumine)
• ProHance (gadoteridol)

The FDA has been aware of problems with gadolinium since at least June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.

If you experience any of the symptoms of NSF / NFD after MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiogram), you should seek immediate medical attention and get tested for the disease. Symptoms include:

• Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
• Thickening of the skin around the joints, restricting movement
• Skin which feels “woody” and has a texture similar to that of an orange peel
• Red or dark patches of skin
• Burning, itching, and/or sharp pains in affected areas
• Fluctuating hypertension preceding the appearance of skin lesions
• Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
• Muscle weakness
• Deep bone pain in the hips and ribs
• Calcification of soft tissues
• Yellow plaques near the eyes

If you have kidney disease or impaired renal function you should always question having a MRI / MRA with contrast to make sure the contrast being used is not one of the ones listed above. When asked if you are allergic to any medications you should say "Yes, Gadolinium!"

Currently, there are federal lawsuits pending in the United States against the drug manufacturers: Bayer Healthcare, Bracco, GE Healthcare and Mallinckrodt due to the possibility that they have not properly informed patients and doctors regarding the dangerous side effects of these drugs.

Over 250 federal lawsuits have been consolidated in a Multidistrict Litigation (MDL) in the Northern District of Ohio, and at least another 104 cases have been filed in various state courts. The purpose of the MDL is to prevent inconsistent pretrial rulings, avoid duplicity and serve the convenience of the parties, witnesses and the Court. Under the MDL rules, if the cases do not settle or resolve during pretrial, they will be returned to the court in which they were filed.

Attorneys representing persons suffering from NSF have been pushing for aggressive scheduling deadlines to move the cases quickly to trial or settlement, as most of the people are very sick and many may not survive a lengthy trial.

If you have been diagnosed with NSF or NFD you should contact Law Offices of Gary Green toll free at 1-888-442-7947 or send us an e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it to discuss your legal options without obligation.