Use of gadolinium-based contrast agents in MRI’s causes nephrogenic systemic fibrosis (NSF)

A magnetic resonance imaging scan, commonly called an MRI, gives doctors a detailed view of the soft tissues of the body and is especially helpful in neurological, musculoskeletal, cardiovascular and oncological (cancer) imaging. A contrast agent, similar to a dye, is often used during MRI’s in order to enhance the quality of imaging. These contrast dyes may also be used during magnetic resonance angiography scans (MRA’s) and “CT” scans. One type of contrast agent which uses the toxic substance gadolinium has been linked to causing those with kidney problems to develop a disease called nephrogenic systemic fibrosis (NSF), formerly called nephrogenic fibrosing dermopathy (NFD). NSF/NFD is characterized by the formation of thick, hard skin on the extremities and the fibrosis of organs. The symptoms of this debilitating disease include:

• Burning, itching, swelling, or hardening of the skin
• Red or dark patches on the skin
• Yellow spots on the whites of the eyes
• Stiff joints and trouble moving the limbs
• Hypertension
• Deep bone pain in the hips and ribs
• Symmetrical skin lesions

According to the FDA, patients usually experience these symptoms between 2 days and 18 months after being exposed to gadolinium. In 2006, researchers found that NSF/NFD is directly caused by the use of gadolinium-based contrast agents during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) in those with kidney problems. Patients with properly functioning kidneys can quickly expel gadolinium from their bodies, but patients with kidney problems cannot and therefore the toxic substance remains in their bodies and causes harm. A recent study revealed that 2.4% of the time that a patient with advanced kidney disease was exposed to gadolinium they developed NSF/NFD. There are 5 gadolinium-based contrast agents approved for use in the U.S.:

1. Omniscan (gadodiamide)
2. MultiHance (gadobenate dimeglumine)
3. Magnevist (gadopentetate dimeglumine)
4. ProHance (gadoteridol)
5. OptiMARK (gadoversetamide)

Of these, the majority of all reported NSF/NFD cases involve Omniscan, with 5 out of 9 patients diagnosed with the disease having received an MRI involving Omniscan. There is no current cure for NSF/NFD but the most effective treatment option is often a kidney transplant. Many lawsuits have already been filed against GE Healthcare, the company who manufactures Omniscan, for failing to warn of the risk that the contrasts pose for patients with kidney problems. It is also crucial that doctors administering gadolinium-based contrast agents use the lowest dosage possible. Although no recall has been ordered and gadolinium-based contrast agents are still in use, the FDA has ordered that warnings be placed on these contrast agents in order to alert patients and healthcare professionals of the risks. If you or a loved one has developed NSF or NFD after having undergone an MRI or MRA involving a gadolinium-based contrast agent, you may be entitled to compensation. Please call us for a free initial consultation at (727)781-3433 or submit a simple case form.

Shoulder pain pumps and post-arthroscopic glenohumeral chondrolysis (PAGCL)

The use of intra-articular shoulder pain pumps for pain management after arthroscopic surgery has been favored over oral painkillers because the medication is delivered immediately. These pain pumps involve the insertion of a catheter which emits local anesthesia directly into the surgical site and are often used for 2-3 days after surgery. However, the use of these pain pumps, such as the Stryker pain pump or the I-Flow On-Q pump, has now been linked to the development of a condition called post-arthroscopic glenohumeral chondrolysis (PAGCL). This condition involves the deterioration of the cartilage in the shoulder joint resulting in the following symptoms:

• Shoulder pain and stiffness
• Clicking, popping, and grinding of the shoulder
• Shoulder weakness
• Decreased range of motion
• Shrunken shoulder joint (visible on X-ray)

These symptoms typically manifest within 3-12 months after surgery. Those diagnosed with PAGCL often report that the symptoms of this condition are worse than the symptoms that they originally sought surgery for. Many individuals require a joint replacement surgery to reduce the pain caused by the bone-to-bone contact in the shoulder that results from the loss of cartilage. Recent studies have established that there is a definite risk of developing PAGCL after using shoulder pain pumps. One study conducted by Dr. Charles Beck which was published in the American Journal of Sports Medicine found that 63% of subjects who used a pain pump after surgery developed PAGCL. This recent medical information suggests that shoulder pain pumps should be avoided, especially those administering bupivacaine and epinephrine. Despite studies conducted in 2006 and 2007, the manufacturers of shoulder pain pumps (including Stryker, DJO Inc., I-Flow and BREG Inc.) failed to warn about the risk of developing PAGCL after using their pain pumps. Pain pumps continue to be used and have no warning against pointing the catheter into the joint space, although this is what research cites as the cause of developing PAGCL. PAGCL is a serious condition which can result in the need for shoulder replacement surgery, life-long pain, and/or lost mobility. If you or a loved one has sustained injury after using an intra-articular shoulder pain pump, you may be entitled to compensation from the manufacturers who failed to warn consumers and the medical community about the risk of developing PAGCL. Please call us at (727)781-3433 for a free initial consultation or submit a simple case form.

Mesothelioma and wrongful death

Since the early 1940’s, the collective group of minerals known as asbestos has been used extensively in the construction, shipbuilding and heating industries. Asbestos can be found in homes built between 1930 and 1970, paint compounds used prior to 1977, some vinyl floor tiles, cement pipes and roofing shingles. However, it is not until more recently that people who were previously exposed to asbestos (the Mesothelioma and Asbestos Disease Society estimates that 27,000,000 Americans have been exposed) have suffered from diseases that directly resulted from their exposure to this substance. The most deadly of these asbestos-related diseases is mesothelioma, a form of cancer found in the lining of the chest, abdomen and heart. The National Institute of Cancer lists working with asbestos as the #1 risk factor for mesothelioma and reports that there are 2,000 new cases of mesothelioma diagnosed in the U.S. each year. Mesothelioma is almost always fatal, with the survival rate averaging 11 months. The Health and Safety Executive reported 2,037 deaths caused by mesothelioma in the year 2005 alone. Common symptoms of mesothelioma include:

• Fluid build-up around the chest-lining or abdomen
• Coughing
• Anemia
• Tumors
• Nausea
• Fever
• Sweating
• Shortness of breath

Those who have been exposed to high levels of asbestos are most at risk for mesothelioma. This includes construction workers, plumbers, carpenters, drywall removers, firefighters, electricians and those living within close proximity to industries that make or use asbestos products. Additionally, paraoccupational, or family, exposure occurs when someone is exposed to asbestos fibers brought home on the clothes, skin or hair of a family member who comes into frequent contact with asbestos. Death caused by mesothelioma often warrants a wrongful death case because the manufacturers producing products containing asbestos and the companies requiring employees to work in conditions involving asbestos have known about the dangers of this substance for years. If you have sustained any asbestos-related diseases (including mesothelioma and asbestosis) or a loved one has died due to an asbestos-related disease caused by the negligence of another, please call us for a free initial consultation at (727)781-3433 or submit a simple case form.

Chantix’s suicide side-effects

Chantix, a medication manufactured by Pfizer and first introduced in 2006, once offered smokers hope that they could successfully quit smoking and prolong their lives. The once-daily pill is part of a 12-week program that has been hailed as the most successful smoking cessation drug available thus far and works because the active ingredient, varenicline tartrate, attaches to nicotine receptors in the brain and thereby blocks nicotine from reaching them. As a result, the pleasurable feelings formerly felt after lighting up disappear and the urge to smoke soon follows. However, Chantix has now been cited by the FDA for the serious side effects associated with its use. As of February of this year, the FDA registered 491 cases involving suicide attempts associated with Chantix, out of which 37 people committed suicide while taking Chantix. Recent class-action and individual lawsuits are blaming the manufacturer for failing to list these potentially fatal side effects on the warning label. Normal side effects while taking Chantix include nausea, dizziness, headache, loss of taste, changes in dreaming, constipation and gas. However, some of the serious side effects to look out for include:

• Depression
• Suicidal thoughts
• Aggression
• Hallucinations
• Anxiety
• Abusive behavior

If you or a loved one has experienced physical injury or death as a result of a suicide or suicide attempt while taking the drug Chantix or after having recently taken Chantix, compensation may be available through an individual Chantix lawsuit. Please call us at the Law Offices of Hensley|Chalfant for a free initial consultation at (727)781-3433 or submit a simple case form.

Baxter Heparin recall

The medication Heparin is a blood thinner, or anti-coagulant, which is used during surgery and dialysis to prevent blood clots. However, this drug has recently been linked to up to 81 deaths and 800 adverse reactions as reported by the Federal Drug Administration. The company Baxter International, who manufactures about 50% of the Heparin vials used in the U.S., recalled 9 lots of its 1000/unit mL multi-dose Heparin vials in January. The FDA began receiving reports of allergy-type reactions linked to Baxter Heparin, most of which occurred in dialysis patients. The side effects experienced in some patients who received this contaminated Heparin included:

• Abdominal pain
• Burning sensation
• Chest pain
• Decreased blood pressure
• Diarrhea
• Difficulty swallowing
• Dizziness
• Dyspnea (shortness of breath)
• Erythema (redness of the skin)
• Headache
• Loss of consciousness
• Nausea

A Chinese factory owned by Scientific Protein Laboratories LLC that supplied the active ingredient for Heparin to Baxter International had never been inspected by the FDA. Later investigations by the FDA found that the factory had substituted raw Heparin for a cheaper alternative- oversulfated chondroitin sulphate. Baxter International and Scientific Protein Laboratories LLC are liable for the injuries and deaths caused by their failure to adequately regulate their suppliers and their sacrifice of safety for economic gain, respectively. In addition, the long-term damage to those who survived the contaminated Heparin is not yet known but may include permanent brain damage caused by the deprivation of oxygen to the brain. Heparin has been cited for other problems including faulty packaging which allows hospitals to easily mistake low dose vials with high dose vials, resulting in the overdoses of at least 6 newborns and 2 other patients on this drug since 2001. At the Law Offices of Hensley|Chalfant, we have experience handling wrongful death, personal injury and medical malpractice cases involving improper, wrong or over-medication. If you or a loved one has sustained injuries or died while taking the drug Baxter Heparin, you may be eligible to receive compensation. Please call us for a free initial consultation at (727)781-3433 or submit a simple case form.