In case this one slipped under your radar, Danish drug company Novo Nordisk agreed to a settlement to the tune of $25 million to put to bed whistleblower allegations that it wrongly marketed its drug, NovoSeven (aka recombinant human coagulation Factor VIIa, or simply, Factor VII) as a treatment for traumatic bleeding due to injury.
Of course, outside of hemophiliacs—the obvious and intended audience for such a drug—who else could such a drug be marketed to? Well, gee, who might bleed a lot…let’s see…uh…well, there’s been a war going on over in Iraq and Afghanistan…maybe NovoSeven could be used to stop a soldier’s bleeding…whatdya think?
Sure, I’m being facetious here as I’m wont to do—but could such a scenario have really been all that far off—even if Novo Nordisk claims otherwise?
And ordinarily, this might have a shred of altruism to it—who wouldn’t want to help our soldiers? But here’s the catch: it seems that, according to The Baltimore Sun, NovoSeven was “a largely experimental drug” and it lacked FDA approval for combat wounds. According to the article, Novo Nordisk began promoting NovoSeven to military doctors way back in 2000, and by 2006, “Army protocol in Baghdad called for injecting it into virtually every casualty with signs of serious bleeding. Some Special Forces units in Afghanistan supplied combat medics with the drug, to inject in the field.”
Sounds like fairly extensive and routine use to me.
Add to this that studies have shown that off-label use of NovoSeven—which not only includes using it to treat combat wounds but also using NovoSeven for intracranial hemorrhage, cardiac surgery and aortic aneurysm, liver transplants and prostatectomy—has not translated to a reduction in mortality rates, and the use of NovoSeven for heart surgery and intracranial hemorrhage actually increased the risk of thromboembolism.
And this is how we want to treat our soldiers’ combat wounds?
I use the term “treat” a bit loosely—The Baltimore Sun had profiled three soldiers who’d been “treated” with NovoSeven in a series of articles written back in 2006. Sadly, two of those three soldiers later died as a result of complications related to blood clots. (Post script, the FDA has since added a warning to NovoSeven.)
Regardless, Novo Nordisk claims no wrongdoing (of course) in the NovoSeven settlement and, as business must keep on movin’ on, it appears Novo Nordisk is now seeking a new Senior Brand Manager for NovoSeven (see job posting above).
It’s Veteran’s Day today. A day when the country stops (hopefully), to give pause to those brave men and women who fought the great fight, so that we may be free.
But there’s more to it than that. Our veterans served with honor, on behalf of their countrymen. Their country.
What would they think of how [much of] America conducts itself today?
Greedy banks granted mortgages, and loaned money to people who could ill afford to support the payments, all in the name of getting more business on the books than the next guy. That’s the simple answer for the sub-prime mortgage mess that resulted in the burst of the housing bubble and driving the US economy into a deep recession.
Thousands have lost their homes, their jobs, and their livelihoods due to greed on the part of others.
Is this what our veteran’s fought for?
Some drug manufacturers sell pharmaceuticals while knowing they could be harmful—even Read the rest of this entry »
With Veterans’ Day upon us, Pleading Ignorance takes a break from explaining legalese and takes the opportunity to thank veterans for all they have done—and all they have sacrificed. And we look at some of the battles veterans face when they return home, and ask why we can’t do more for the people who have sacrificed so much?
Each year on Veterans’ Day, we take the time to pay tribute to those who have sacrificed so much—in some cases, their lives—in the service of their country. We take a moment to remember those who died and give our respect to veterans who so bravely fought, and continue to fight, so that many of us don’t have to.
I’d like to think that Veterans’ Day still means something, but some of the thank you’s might seem a bit hollow, considering the treatment that veterans return home to. After facing horrors that many of us can’t even conceive of, they come home to long and often complex claims processes, face having their very real claims of post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI) declined or questioned, and receive sometimes questionable medical treatment at the hands of Veterans Affairs medical centers and hospitals. They face medical malpractice and unreasonably denied disability claims.
It’s unacceptable.
Back in 2007, veterans spoke before Congress about horrific conditions at Walter Reed Army Medical Center. Those conditions included one sergeant being released to outpatient treatment within a week of being shot in the head, despite having a TBI and having lost an eye. The same sergeant faced delayed treatment because of lost documents and ultimately had to take his medical care into his own hands because no one from continuing care would contact him.
At the time, acting secretary of the Army, Pete Geren, stated, “We have let some soldiers down,” (as quoted in The New York Times (3/6/2007).
It’s unacceptable.
These are people who have given up so much for their country—they deserve more than to be “let down”. They deserve the best possible medical care, not weeks and months of waiting for Read the rest of this entry »
On July 13, 2010, Veterans Affairs put in a new rule regarding Post Traumatic Stress Disorder (PTSD). This change to the rule could mean that you are now eligible to file a VA PTSD claim where before your claim was denied. Ben Stewart, attorney at Stewart Law P.L.L.C. explains the changes in this week’s Pleading Ignorance.
“The new rule is a relaxation of the evidentiary standard for establishing in-service stressors for claims involving PTSD,” Stewart says.
Basically, the new rules make it easier for veterans to prove they have a disability (specifically, PTSD) that was caused by stressors related to their service. So, veterans who were previously denied PTSD claims may now be eligible to file claims.
How does the new rule make the claim easier for veterans? Prior to the rule change, veterans had to prove that they experienced a stressor that was related to hostile military activity. Now, they only have to show that their PTSD is linked to a “fear of hostile military or terrorist activity and is consistent with the places, types and circumstances of the veteran’s service,” (from a VA news release; 07/12/10).
According to the American Forces Press Service, approximately 400,000 veterans currently receive compensation benefits linked to PTSD. Of those, approximately 70,000 were veterans of operations Iraqi Freedom and Enduring Freedom.
For right now, however, the claims are not being applied retroactively. This means that you won’t receive benefits from the time your first claim was filed and denied. Rather, you have to file a second claim and the benefits will be applied from the date of the second application. That said, Stewart says he anticipates an appeal will be filed to determine whether the VA should be responsible for retroactive benefits in the case of PTSD.
Stewart also alleges that the VA has used personality disorders to attempt to avoid paying claims of PTSD. They can do so because personality disorder isn’t considered service-related.
“Personality disorders have been used by the VA to show that service people were not injured Read the rest of this entry »
Anyone who has dealt with Veterans Affairs can tell you that the system can be complex and maddening, much like so many other government-operated systems. Dealing with Veterans Affairs medical malpractice can be an exercise in frustration, for many reasons. Today, Pleading Ignorance aims to shed some light on VA medical malpractice.
First, the lawyer stuff: not every attorney will take medical malpractice claims against the VA. Why? Because when you sue the VA you are suing the federal government, and such a lawsuit has its own special rules and regulations. So, if you feel you have a medical malpractice case against the VA, you have to choose an attorney carefully. (Note, when you fill out a claim form here at LawyersAndSettlements.com, the claim form goes to an attorney who specializes in that area of litigation.)
Now, you might think that only incidents that occur at VA medical centers are covered by VA medical malpractice, but that’s not necessarily true. If you were sent by a VA doctor to an off-base provider, you would still be filing a case against the VA because the medical care was provided off-base pursuant to a VA directive. So, if the VA played a role in your medical care—even if it was to send you to an off-base provider—you might still have a VA medical malpractice claim.
To be eligible, the victim—the person who suffered the medical malpractice—must have been registered with the VA system, received treatment from the VA (or had the VA direct them to off-base treatment) and suffered injury or death because of negligence in the system.
It is not only veterans who fall under the VA directive, however. Any of their dependants Read the rest of this entry »