Suits mounting against makers of MRI-enhancing dye
A growing list of suits are being filed against makers of gadolinium contrast dyes used to enhance MRI results, which are thought to be causing some cases of a progressive, untreatable and possibly fatal disease known as Nephrogenic Systemic Fibrosis or Nephorgenic Fibrosing Dermopathy. NSF/NFD, which occurs in patients with kidney disease, creates thickening and hardening of the skin, joint problems, muscle weakness and eye discoloration.
About 68 cases have been filed against makers of gadolinium contrast dye makers, according to attorneys filing suit against one such maker, Novation. The most recent case, filed for Philadelphia resident and Zbignew Marcinczyk, contends that he developed NSF after receiving two injections of the dye, in this case the Omniscan brand created by Novation. Marcinczyk had pre-existing kidney disease when he was given the dye. He has since become permanently disabled, disfigured and severely impaired, his attorneys say. This case contends that the defendants, which also include parent company GE, failed to let patients and providers know that Omniscan is defective, failed to test it adequately and failed to let the public know that Omniscan could cause NSF.
Since the wave of problem reports on gadolinium contrast dye use surfaced, the FDA has asked manufacturers to add a black-box warning on all such labels. A too bit late for those who've already got NSF, isn't it?
To learn more about this issue:
- read the FDA advisories on the subject
- read the release issued by Marcinczyk's attorneys
Comments
You need to check your facts about stories like this
If there's anything out of order with the story we're always happy to hear it -- can you be more specific?
NSF only affects a miniscule portion of the millions who receive the contrast agent. These people are very sick people with malfunctioning kidneys who happen to get an MRI with gadolinium. It is not known what specific set of circumstances cause what is safe in 99.8% of the population to be detrimental to the few who develop NSF. This could be a strange interaction with another drug, some other conditition or contamination that causes the body to break down the chemical in the contrast agent. What if the syringes the drug comes in were contaminated and the allergic reaction to the contaminant caused the already sick people to retain or break down the medicine differently? This is not an easy disease to decipher as it affects so very few of recipients.
Post new comment
Paid Research Reports
- Stakeholder Opinions: Percutaneous Coronary Intervention - Adverse events with drug-eluting stents demand a new safety standard
- Impact of Pharmacogenomics on Public Healthcare Policy
- The Cardiovascular Disorders Market Outlook to 2012
- 2008 Trends to Watch: Pharmaceutical Technology
- Pharmaceutical Pricing and Reimbursement: Strategies for market access across the US, Europe, Japan and other key geographies




