Claim that hospitals caused rare disease in woman
A woman suffering from a rare and fatal disease is considering taking legal action against the hospitals that administered the drug she claims caused her illness.
Silvia DeSilva, 70, went to King Edward VII Memorial Hospital and Brigham and Women's Hospital in Boston, Massachusetts to have a series of routine scans in 2007.
During the scans doctors administered gadolinium, a dye which enables a clear view inside veins and arteries. But as a dialysis patient, the drugs allegedly had severe implications for Mrs. DeSilva.
She and her husband Allan DeSilva, 75, allege that the doctors who treated her ignored FDA warnings published in 2006. Those warnings state that patients with moderate to chronic kidney problems could develop Nephrogenic Systemic Fibrosis (NSF) after being exposed to the drug.
Today Mrs. DeSilva has been formally diagnosed with NSF and lives with the consequences.
She is largely bedridden and finds it painful to move her joints. The tissue beneath her arms and legs is taut and has hardened. The disease has begun to attack her eyes and could destroy the soft tissue in other vital organs such as her brain.
Mrs. DeSilva relies on her husband to make her meals and manage the household. Once normal activities such as going to the bathroom or getting a drink from the fridge, are painful and exhausting.
"It is so hard to know what to do now because I can't do anything," she said. "I can, thank God, still eat my own meals, but I can't do too much. Just lay here is really all I can do."
According to doctors, the rate of survival for NSF patients plummets to 50 percent after two years for Mrs. DeSilva that time is almost up.
Now she and her husband are desperately searching for answers as to why FDA warnings were apparently overlooked, and trying to get Mrs. DeSilva the help she needs.
"The point that we need to make is it is not that Silvia has a disease, but is the way she got it," said Mr. DeSilva.
"It is not the disease itself, but it is the effect of knowing that the persons who gave this injection should have known that two years previous, in 2006 and 2007, warnings were sent out not to give it."
The couple say they have been fighting for close to 18 months to get the hospitals to admit the mistake and pay for the best treatments possible. But so far their requests have fallen on deaf ears.
Six weeks ago the DeSilvas contacted a New York law firm Parker Waichman Alonso LLP. For them it was a last resort. They are now waiting to see what action their lawyer decides to take.
Legal action may be pursued against Brigham and Women's Hospital, but there are no plans yet to file a lawsuit against KEMH.
Brigham would not discuss the issue and said only: "Due to federal patient privacy laws, we will not be able to comment on your inquiry."
The DeSilvas lawyer, Matthew McCauley, represents numerous clients with NSF claims in the United States.
He told The Royal Gazette yesterday: "Mrs. DeSilva was administered a gadolinium-based contrast when it was well known throughout the world that it should not be used in a patient with the underlying medical conditions she presented with and were known to the medical staff."
He continued: "There was no rational reason for using this product in Mrs. DeSilva's procedure when safer alternative products were available and readily being used by the medical community throughout the world. Her injury was preventable."
According to Mr. DeSilva, he has approached the Bermuda Government and his insurance company and also sat down with the Bermuda Hospitals Board (BHB) last September.
He said he is now done talking.
"I haven't done this to be malicious. I have done this in good faith. But I have exposed all avenues of care for my wife and now it is time to get action from whoever reads this story to get back to me and say they will help," he said.
Last night a BHB spokesperson said: "BHB has sympathy for Mrs. DeSilva and the health challenges she is facing. Certainly, we recognise it is a distressing time for Mrs. DeSilva and her family.
"While BHB is unable to discuss individual patient matters with the media, we can confirm that we are still working with the family in trying to help them through this situation. We met with family representatives recently, and will continue to do so.
"We would like to stress, however, that treatments and scans at the hospital follow best practice, evidence-based medicine. Patient safety is the number one priority for us. Any concerns raised by patients and their families are thoroughly investigated and results shared with them."