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Gadolinium Lawsuits

Patients who say they were harmed by gadolinium-based contrasting agents used as dye in MRIs and other medical imaging tests are filing lawsuits against the makers of the drugs. Lawsuits say the gadolinium is retained in the body and is causing serious, life-altering injuries.

Lawsuits say patients can experience gadolinium toxicity after having an MRI scan with a linear gadolinium-based contrast agent (GBCA). Gadolinium is a metal used in MRI contrast dyes to help produce better images for doctors.

Patients who experienced side effects from gadolinium toxicity after having an MRI — and who had no known kidney issues before the scan — have filed lawsuits seeking compensation for serious injuries they sustained.

In 2018, the U.S. Food and Drug Administration approved updated prescribing information to include warnings about gadolinium retention. Side effects from gadolinium retention are progressive and can be life-threatening.

Research and adverse events reports to the FDA link GBCAs to these conditions:
  • Gadolinium toxicity
  • Gadolinium deposition disease (GDD)
  • Nephrogenic systemic fibrosis (NSF)
Illustration of kidneys.
Gadolinium lawsuits claim GDD occurred in people who had no known prior kidney issues.

Chuck Norris Lawsuit

Perhaps the highest profile lawsuit involving gadolinium was filed by actor Chuck Norris and his wife, Gena, in 2017. The couple claimed Gena developed gadolinium deposition disease after undergoing three MRIs in which the substance was used to enhance images.

The Norrises said they spent almost $2 million for Gena’s treatment over five years. She had to be hospitalized repeatedly with debilitating pain.

She also says she is suffering other effects, including problems with thinking, kidney damage and loss of energy. She says her ribs were damaged, and she has trouble breathing. They are seeking $10 million in damages.

Part of the costs were because the couple says Gena Norris has had to seek treatment outside mainstream medicine.

“Unfortunately, litigation is the only course of action we can take to hold the drug companies accountable for threatening the lives of so many innocent people who undergo MRIs,”

“These companies continue to say that there is no link between gadolinium and adverse events, even though the evidence is overwhelming that this heavy metal stays in the body for years, rather than hours,” she added.

As of October 2018, the case was still pending in San Francisco.

Another California man, Jeffrey Steiner, filed a lawsuit in federal court in June 2018 claiming he was seriously injured after being injected with gadolinium during multiple MRI tests. He claimed he retained gadolinium in the neurons of his brain. His lawsuit was dismissed on July 30, 2018 by U.S. District Judge Edward J. Davila, who cited jurisdictional problems.

Experiencing symptoms of gadolinium toxicity? Review Your Legal Options

Federal Case Consolidation Request

After 21 federal lawsuits were filed in 12 courts on behalf of patients around the country who say they were injured by gadolinium contrasting dye, lawyers filed a motion in July 2018 with the Judicial Panel on Multidistrict Litigation. The lawyers asked the court to consolidate the cases to be managed by a single judge. Attorneys said in the motion that they expect that ultimately, hundreds of such cases will be filed.

Lawyers are asking that the cases be assigned to a judge in the Northern District of California, where there were five cases pending at the time of the motion. Two of the defendants named in lawsuits are also headquartered there. In the alternative, the lawyers suggested a court in Massachusetts.

The plaintiffs say they had normal or near-normal kidney function when they underwent MRI or MRA procedures in which a gadolinium-based contrasting agent was injected into them. They then developed symptoms consistent with the known toxic effects of gadolinium that is retained in the body.

Gadolinium-based contrasting agents are used in 33 to 50 percent of all MRIs, translating to 1.5 million procedures a year.

Consolidation of Federal Cases Denied

Two companies, Guerget and Liebel-Flarsheim, filed a response to the motion, arguing that consolidation of the cases in a multidistrict litigation (MDL) is not warranted. The companies said plaintiffs suffered different injuries, and “different combinations of unique symptoms.”

Moreover, they argued, “The overwhelming weight of scientific and regulatory findings demonstrate that there is no sound scientific or medical basis on which to conclude that GBCAs cause any adverse health effects in patients, such as plaintiffs, with normal kidney function.”

On Oct. 10, 2019, the panel denied the motion for an MDL. “We find movants have failed to demonstrate that any common questions of fact and law are sufficiently complex or numerous to justify centralization,” the panel wrote in its order. “In particular, the injuries alleged in each case appear to be highly plaintiff-specific, and the actions involve GBCAs manufactured by one or more of four different defendant groups, involving different formulations.”

In 2009, another group of gadolinium contrast dye products lawsuits was organized into an MDL that was centralized in Ohio. That MDL closed in 2015. Those lawsuits involved patients with abnormal kidney function who were given gadolinium contrasting agents and developed nephrogenic systemic fibrosis. The FDA later required a black box warning against using the dyes for patients with abnormal kidney function.

Injuries

People who filed lawsuits claim GBCAs caused them to develop gadolinium deposition disease (GDD). Plaintiffs had normal kidney function at the time they developed the disease.

Gadolinium deposition disease is progressive and has no known cure.

Symptoms include:
  • Persistent headaches
  • Weight loss
  • Kidney impairment
  • Body aches and stiffness
  • Bone and joint pain
  • Brain fog
  • Thickening of the skin that appear spongey or rubbery
  • Thick, painful ligaments and tendons
  • Cutting, burning pain in arms, legs and the torso

Brands

There are two basic types of GBCAs: linear and macrocyclic. These agents surround the gadolinium ions when injected into the body. This lowers toxicity levels.

Linear agents do not fully surround the gadolinium ions, and macrocyclic agents do, according to lawsuits.  So, linear agents are more likely to cause gadolinium toxicity.

Linear Gadolinium-Based Contrast Agent Brands & Manufacturers
Brand Name Manufacturer
Magnevist Bayer
Omniscan GE Healthcare
Optimark Geurbet
Multihance Bracco

Settlements & Verdicts

Because lawsuits involving patients with normal kidney function are so new, there are not yet any settlements or verdicts.

But, in 2013, a jury ordered GE Healthcare to pay $5 million in a lawsuit that claimed an Ohio man, Paul Decker, developed nephrogenic systemic fibrosis (NSF) after being injected with the gadolinium-containing product Omniscan. That trial was conducted after GE had settled several hundred gadolinium cases.

Decker was retired after working 30 years at a tire company. At the time of the verdict, he was being cared for by his wife.

A federal appeals court  later upheld the award and denied a defense motion to grant a new trial.

NSF is a rare condition that affects the skin and organs. The skin becomes thick and hard. As the condition progresses, multiple organs may fail. The condition may be fatal.

According to a report by ProPublica, Decker’s lawyer told jurors during the trial that Decker’s skin “feels like wood or granite.”

Decker, attorney Christopher Tisi added, “has a really hard time doing most anything.”

The case was the first to go to trial in a multidistrict litigation (MDL) in Cleveland, Ohio, involving gadolinium nephrogenic systemic fibrosis lawsuits. The patients in those cases had abnormal kidney function when they were injected with the contrasting dye.

Most of the other cases in the MDL were settled.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Elaine Silvestrini
Written By Elaine Silvestrini Writer

Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems. She joined Drugwatch in 2017. Her coverage for Drugwatch has been cited in the CDC’s Public Health Law News and the USA Today Network. Some of her qualifications include:

  • Centers for Disease Control and Prevention certificates in Health Literacy
  • Experience as an assistant investigator for the Federal Public Defender
  • Loyola Law School Journalist Law School Fellowship
Edited By
Kevin Connolly
Kevin Connolly Managing Editor

16 Cited Research Articles

  1. Munnuru v. Guerbet, LLC, et al. (2018, January 26). United States District Court Northern District of California. Complaint for Damages. Case No. 4:18-cv-00571-SBA. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-01-26-Munnuru-Complaint.pdf
  2. Gever, J. (2011, January 25). GE Settles Omniscan Lawsuit. Medpage Today. Retrieved from https://www.medpagetoday.com/radiology/diagnosticradiology/24521
  3. U.S. Food and Drug Administration. (2018, May 16). FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
  4. Dinerstein, C. (2017, November 3). Chuck Norris, FDA And Gadolinium – Untangling The Lawsuit. Retrieved from https://www.acsh.org/news/2017/11/03/chuck-norris-fda-and-gadolinium-untangling-lawsuit-12086
  5. Parton, J. (2017, November 2). Chuck Norris Says Big Pharma Poisoned His Wife. Retrieved from https://www.courthousenews.com/chuck-norris-says-big-pharma-poisoned-wife/
  6. United States District Court Northern District of California San Jose Division. (2018, July 30). Jeffrey Steinder v. Bracco Diagnostics, Inc. et al. Case 5:15-cv-03830. Order Dismissing case. Retrieved from http://www.pacer.gov
  7. United States District Court Northern District of California San Jose Division. (2018, July 30). Jeffrey Steiner v. Bracco Diagnostics, Inc. et al. Case 5:15-cv-03830. Retrieved from https://cand.uscourts.gov/home
  8. United States Judicial Panel on Multidistrict Litigation (10/27/07). Civil Docket for Case #: MDL No. 1909 In Re Gadolinium Contrast Dyes Products Liability Litigation. Retrieved from http://www.pacer.gov
  9. United States Judicial Panel on Multidistrict Litigation. (2018, July 31). In Re: Linear Gadolinium-Based Contrast Agents Products Liability Litigation. Retrieved from http://www.pacer.gov
  10. United States Judicial Panel on Multidistrict Litigation. (2018, August 23). In Re: Linear Gadolinium-Based Contrast Agents Products Liability Litigation. Defendants Guerbet LLC and Liebel-Flarsheim Company, LLC’s Response in Opposition to Plaintiffs’ Motion for Transfer and Centralization. Retrieved from http://www.pacer.gov
  11. Superior Court for the State of California County of San Francisco. (2017, November 1). Gena Norris and Chuck Norris, also known as Carlos Ray Norris vs. McKesson Corporation, et al. Complaint for Damages. Retrieved from https://webapps.sftc.org/ci/CaseInfo.dll?&SessionID=3B99F760B2CCC055DD2814A9978314044E371655
  12. Cleveland Clinic. (n.d.). Nephrogenic Systemic Fibrosis (NSF). Retrieved from https://my.clevelandclinic.org/health/diseases/17783-nephrogenic-systemic-fibrosis-nsf
  13. United States Court of Appeals, Sixth Circuit. (2014, October 20). Paul Decker, Karen Decker vs. GE Healthcare inc., et al. Opinion. Retrieved from https://caselaw.findlaw.com/us-6th-circuit/1681196.html
  14. Cision PR Newswire. (2013, March 22). Ashcraft & Gerel LLP: Jury Orders GE Healthcare to Pay Injured Ohio Man $5 Million. Retrieved from https://www.prnewswire.com/news-releases/ashcraft--gerel-llp-jury-orders-ge-healthcare-to-pay-injured-ohio-man-5-million-199551541.html
  15. Gerth, J. (2013, March 7). 'Burn the Data': Did a Company Try to Hide Risks of MRI Dye Omniscan? Retrieved from https://www.propublica.org/article/burn-the-data-did-a-company-try-to-hide-risks-of-ges-mri-dye
  16. BusinessWire. (2017, November 1). Actor Chuck Norris and Wife Gena Norris Announce Multi-Million Dollar Lawsuit against Pharmaceutical Companies for Dangerous MRI Drug. Retrieved from https://www.businesswire.com/news/home/20171101006063/en/Actor-Chuck-Norris-Wife-Gena-Norris-Announce
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