In the practice of medicine, numerous imaging techniques are used to provide physicians, nurses, and other medical professionals valuable information about a patient’s health. One of the most common methods of imaging used is magnetic resonance imaging, or MRI. With this test, a magnetic field, as well as radio frequency waves, are used to create an image of soft tissue, organs, bones, or other internal body parts. With this powerful imaging technology, abnormalities may quickly be identified
Before many MRI procedures, a doctor or nurse places an intravenous catheter into one of the patient’s veins. After the IV has been placed, a gadolinium-based contrast agent, or GBCA, is injected. With GBCAs, the MRI images are enhanced to provide a better look into the patient’s body.
Gadolinium is a rare type of heavy metal. The inner orbits of gadolinium become partially full of electrons and are temporarily magnetic while they are moved into a magnetic field. Chelates form when a metal atom bonds with a molecule called a ligand. With gadolinium, the chelates are implemented as MRI agents. When the GBCAs are injected into the body, the contrast of the MRI is improved, allowing physicians to see more detail in blood vessels, tumors, and inflammation.
What happens to the GBCAs that are injected before an MRI?
For the most part, they are filtered out of the body by the kidneys. For some patients, however, gadolinium builds up on the body and causes side effects. According to the United States Food and Drug Administration, “Trace amounts of gadolinium may stay in the body long-term.”
For patients who have full kidney function, most of the gadolinium should be eliminated from the body within a couple of hours. Any remaining gadolinium should be expelled after 96 hours. But for some, even those with healthy kidneys, the gadolinium remains in the body for many months.
Gadolinium may accumulate in the brain or in other areas throughout the body. For some patients, painful side effects have been experienced due to this build-up of gadolinium.
The FDA published a safety announcement that stated the agency was investigating the risks associated with a build-up of gadolinium in the brain. Many patients have reported they suffered the effects of gadolinium deposition disease after GBCAs were administered just one time.
Presently, the FDA does not mandate any changes to GBCA product labeling. The FDA did announce that medical professionals should only use GBCAs when necessary.
A buildup of gadolinium in the body has been associated with:
- Gadolinium storage condition
- Nephrogenic systemic fibrosis
- Gadolinium deposition disease
These conditions may cause serious side effects.
Gadolinium storage condition occurs in patients who have healthy kidneys with normal function, but still experience an accumulation of gadolinium in the bones, brain tissue, and other areas of the body. The patients at highest risk of experiencing gadolinium storage condition are pregnant women, those who have taken multiple doses of GBCAs, patients with inflammatory diseases, and children.
Nephrogenic systemic fibrosis is a rare illness associated with gadolinium. With this condition, the patient does have kidney problems. The kidneys cannot rid the body of gadolinium in a timely manner. The kidney complications can be deadly for the patient.
The symptoms of nephrogenic systemic fibrosis include:
- Blood clots
- Bone pain
- The skin feels “woody”
- The skin becomes thicker and darker
- Skin swelling and tightening
- Reduction in joint flexibility
- Yellowing of the eyes
A patient experiencing these symptoms should seek medical advice as soon as possible.
Gadolinium deposition disease occurs in patients who have healthy kidneys that function normally. However, at some point after being injected with a GBCA, they begin experiencing painful symptoms. These symptoms include:
- Pain in the joints or bones
- Vision problems
- Hearing problems
- A cutting or burning pain
- Vomiting and/or nausea
- A tight feeling in the feet or hands
Symptoms may present within a few hours after the procedure, or they may appear a few weeks later.
In addition to these three conditions, a number of other side effects may occur. These side effects may be mild, moderate, or severe.
Mild side effects include a skin rash, headaches, itching, nausea, and vomiting.
Moderate side effects include unusual heart rhythms, a change in blood pressure, wheezing, hives or rash, and shortness of breath.
The most serious side effects are low blood pressure, swelling in the throat (or other areas of the body), breathing problems, cardiac arrest, and convulsions.
What are my rights if I was harmed because of an MRI?
If you suffered serious health complications after an MRI, you may be entitled to compensation.
Drug device manufacturers, pharmaceutical companies, medical equipment manufacturers, and other related entities have a duty to ensure their products are safe for consumers. If the products of these manufacturers are defective and a consumer is injured, the consumer may be able to file a products liability case.
In a products liability lawsuit, the consumer must show:
- The product was being used as anticipated or directed by the manufacturer
- The product was defective
- The consumer suffered injuries
- These injuries were caused by the defective properties of the product
Each of these elements must be proven for a claimant to recover damages in a products liability case. If one of the factors cannot be proven, the claim fails and is dismissed from court. With a dismissal, the consumer is not entitled to any damages. Therefore, the consumer would bear the burden of paying medical bills and other expenses associated with his or her injuries.
The following are the categories of product defects:
- Design defects
- Manufacturing defects
- Marketing defects
Design defects are those that occur before a product is ever actually created—there is a problem with the planning and design of the product. For example, consider a medication that uses an ingredient that is unknowingly harmful to patients with high blood pressure. If a consumer with high blood pressure takes this medication and is injured, that consumer may be able to file a products liability lawsuit.
Manufacturing defects occur as the product is being created or distributed to retailers and consumers. Using the medication example, a manufacturing defect may occur if the wrong formula is used to create the substance. The resulting medication may cause serious injuries. Consumers harmed by the medication may seek relief in a products liability lawsuit.
Marketing defects stem from improper warnings, instructions, or labeling. Consider the injuries that could occur if a medication should not be taken by pregnant women because it could cause miscarriage—and the company fails to warn of this risk on its labeling. Pregnant women who take the medication and experience miscarriages may have a strong case against the manufacturer.
A single type of defect may be present in a product, or all three may be present. With an experienced Gadolinium Deposition Disease lawsuit attorney, proof of any and all defects will be submitted to maximize a consumer’s compensation.
Call Parker Waichman LLP Today to Schedule a Free Consultation
At Parker Waichman LLP, our Gadolinium Deposition Disease lawsuit lawyers are experienced in numerous products liability claims, including those involving medications and medical devices. To schedule a free consultation with our excellent firm, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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