A jury awarded $5 million to a patient and his wife after it found GE Healthcare did not adequately warn patients and doctors about the risk of its imaging dye, Omniscan. It was the first case involving the dye to go to trial
In a setback for GE Healthcare, a jury on Friday found that the company failed to adequately warn patients and doctors about the dangers of its medical imaging dye. The jurors awarded $5 million to the plaintiff and his wife.
The verdict, after a two week trial in federal court in Cleveland, marks the first time a jury has examined whether the dye, injected into patients to sharpen MRI scans, can cause a rare but debilitating disease in which large areas of the skin become thick and hard. ProPublica investigated the dye in 2009 and 2010, revealing that GE ignored the advice of its own safety experts to "proactively" restrict its use.
GE has settled out of court a few hundred cases involving its dye, marketed as Omniscan. Other manufacturers of similar imaging agents have also resolved cases before trial. All the settlements are confidential.
Plaintiff Paul Decker, 61, was diagnosed with the disease, nephrogenic systemic fibrosis, in 2010, and he claimed it was caused by an injection of Omniscan he received during an MRI in 2005. GE acquired the drug in 2004.
A key question for the jury was whether the risks of the dye for patients such as Decker — who suffered from severe kidney disease, known to increase the risk of Omniscan side effects — had been adequately disclosed by the drug's manufacturer, not only GE but also the predecessor companies that had previously owned the dye.
At the opening of the trial, arguments were made — and disputed by GE — that data was ordered destroyed and that research was not shown to a key scientist who co-authored a study finding the dye was safe.
GE maintained it had properly and promptly disclosed the dye’s dangers and that it had been the first to warn about the disease. But the jury rejected the company’s defense and awarded $4.5 million to Decker and $500,000 to his wife, Karen Decker. The jury also denied GE’s claim that Decker filed his case too late.
GE, in a statement, said it “was disappointed in the jury’s decision” and plans to appeal the verdict on “several grounds.” The statement pointed out that the jury had rejected Decker’s claims that Omniscan’s design was defective and that the company’s representations about the dye’s quality and safety were not accurate.
Omniscan and similar dyes manufactured by other companies contain a toxic metal, gadolinium, which is bonded with a protective coating to keep it inert. In the vast majority of patients, the drug is filtered out through the kidneys without causing harm.
There have been no new cases of the disease in recent years.
Only a few Omniscan cases are still in litigation.
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Two months after Infosys, India’s most celebrated information technology company took over MCA21—the e-filing portal of the ministry of corporate affairs—it remains unstable. Anguished users want to know why a system that worked well under TCS is causing such pain to companies and users
Anguished Chartered Accountants (CAs) and Company Secretaries tell Moneylife how MCA21, the e-filing portal remains unstable over two months after Infosys Technologies took it over from TCS (on 17th January) after a two-month handover process.
A month ago, when Moneylife first highlighted the fact that MCA21 wasn’t working, we were assured that it would be up and running soon. Another month later, the ministry of corporate affairs (MCA) is still struggling to fix the problem. Fortunately, Naved Masood, Secretary MCA is not trying to gloss over the problem. In an email response to our query he calls it worrisome that there are “repeated glitches” in the working of the portal since mid-January when Infosys took over. He also says, “There have been disconcertingly large instances of user inconvenience”.
Mr Masood says that “the situation is steadily improving” and the number of filings and new company incorporation services “more or less conform to the past averages for the corresponding period”. He agrees that the system “has not yet fully regained its pristine efficiency” but would like to dispute our “epithets like scandalous”. He also says “we are acutely conscious of providing a level of service that leaves no room for disappointment” and expects that the “intermittent difficulties” that users still encounter will soon be over.
But this is only part of the story. Company Secretaries and Chartered Accountants whose professional services require a functioning MCA21 are desperately appealing for help—but they do not dare to confront the ministry openly. Since Mr Masood, in his email, asked Moneylife to keep in touch with Mohan Joseph, Additional Secretary, MCA (who is apparently working at specific complaints received by the ministry and trying to get the site working), here is a list of problems that we have put together based on user feedback.
1. Users say that the MCA21 has become very vulnerable; it works only in parts during a given working day. If some services work at one point of time, they don’t at others. These include features such as—View Master Data, View Signatory Details and View Charge index.
2. Public inspection of documents is a mess. So, while MCA21 collects fees for viewing documents, users find that many documents and forms are missing. Sometimes a balance sheet is available but not the profit & loss statement, even though they are filed together.
Forms that you click on show processing errors. Now remember the government charges people for this and there is a three-hour window to access what you need. Often you end up paying the fees again, because the faulty system does not allow you to access all the documents in the three-hour window. The irony is that people who are being charged for this faulty system have a right to complain and recover their money. It is only fair that the new vendor—Infosys— should not be allowed to collect any fees until the system is restored to its ‘pristine’ level. The ministry has made no move to do so as yet.
3. A successful login requires 10 or even 20 attempts. Failure to log in blocks access to major services like filing and inspecting documents, checking transactions, etc. Problems with MCA21 have increased the time taken to register a company to 25 days in Delhi. Quick and seamless registration of companies was one of the touted achievements of MCA21.
4. Filing forms is a big nightmare and often requires two days of trying to succeed. There are problems with registering digital signatures and back-end processing of forms.
5. It is difficult to verify PAN (permanent account numbers) with DIN forms.
The only concession made by the ministry so far is to extend the date for filing forms that were due after 16 January 2013, the day that Infosys took over MCA21.
Mr Masood’s proactive response is appreciated and one would also concede that the first task is to correct the system and then fix responsibility for the problem or investigate the level of competence or lack of it. But an investigation is clearly in order, along with a change in how large IT contracts handed out by the government are structured or auctioned. Failure to deliver must have consequences. Similarly, if the delays and problems are due to government apathy or the recalcitrance of sarkari officials, that too must have consequences, if it causes undue harassment to a person.
Our email to Mr Masood was also copied to the Infosys communications team, which has not bothered to respond.