So after a few Budweiser class action lawsuits were filed last week over allegations that the King of Beers was selling ‘watered down’ beer, Budweiser took the opportunity to strike back. But rather than just defend itself or call the watered-down beer allegations pure bunk, it tried to get clever. How so? Anheuser Busch ran a full-page ad featuring a picture of Budweiser Water—actual canned water—that the brewer produces for disaster relief efforts.
Here’s the full-page ad:
A recent report by the Federal Elections Commission has come out putting the cost of the recent election cycle at more than $7 billion. That’s a lot of money. Enough that the folks over at Newsy put together the little video clip (above) about it.
But $7 billion ironically pops up in another tally for 2012—the top 10 whistleblower settlements for the year add up to more than $7.5 billion. It’s a staggering amount—not only for an election, but also for whistleblower cases as, think about it, it only represents the tip of the iceberg.
If you’re wondering what those whistleblower settlements were, here’s the list:
1. GlaxoSmithKine – $3 billion
Reason: Illegally marketing some of its prescription drugs such as Paxil, Avandia, Advair, Wellbutrin, Zofran, Imitrex, Lamictal, Lotronex, Floven and Valtrex.
2. Abbott Laboratories – $1.5 billion
Reason: Abbott’s off-label marketing of Depakote.
3. Bank of America – $1 billion
Reason: Mortgage and bank fraud.
4. Merck – $950 million
Reason: Marketing Vioxx illegally
5. Pfizer – $491 million
Reason: Kickbacks and using off-label marketing for organ transplant rejection drug, Rapamune
6. Senior Care Action Network – $323 million
Reason: California Medicaid and HMO cost reporting fraud.
7. Actavis – $202 million
Reason: to settle numerous claims that the company reported inflated prices of its drugs, causing the US and four state governments to overpay.
8. Deutsche Bank – $202 million
Reason: False certification for HUD/FHA loans
9. Oracle – $199 million
Reason: Failure to provide discount pricing
10. McKesson – $190 million
Reason: Accusations that the company inflated prices of numerous prescription drugs, resulting in Medicaid overpaying for those drugs.
Not long ago the diabetes drug Avandia had all the media focus. Patients who were on the drug were hit with a barrage of information—sometimes confusing, sometimes scary—about Avandia’s link to heart attack. And thus began the mad dash to switch over to Actos. After all, while there were also some studies linking Actos to heart attack (along with the infamous TIDE trial), they were reported to be “inconclusive”. Not concrete enough to stop a flurry of prescriptions.
And the black box warning that Actos received (along with Avandia) back in 2007 was only regarding heart failure risk in the form of congestive heart failure—not heart attack or myocardial infarction.
But some Actos patients had already suffered heart attack. And many had submitted complaints in hopes of an Actos lawsuit v. Takeda, the drug’s manufacturer. But their complaints, for all intents and purposes, seemed to fall on deaf ears—at least where lawyers were concerned.
How could it be? As lawsuits about Actos bladder cancer were sprouting up, Actos heart attack complaints fell by the wayside. And yet, given they share a drug class, thiazolidinediones, there seemed to be such similarity between Avandia and Actos—why, it would be almost intuitive that they could perhaps have similar side effect or adverse event profiles, right? And what about some of those studies—was there anything to them?
Then, something unforeseen happened in the form of former Takeda consultant, Dr. Helen Ge—the Actos whistleblower.
And suddenly, everything—sadly—made sense for those Actos patients who had tried to file Actos heart attack complaints. Only now, was it too late? They had already tried to contact lawyers who had rejected them or not taken up their cause simply because there wasn’t much the lawyers could do with them.
Now, however, there might be.
The Actos whistleblower lawsuit (U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston)) has shone light on Dr. Ge’s assertion that Takeda knew about instances of Actos heart attack but downplayed them—for the sake of increasing their profits.
Dr. Ge claims she was let go from Takeda after she raised concerns over the company’s handling of the Actos safety data—and that officials at Takeda tried to direct medical reviewers, including Dr. Ge, to “change their professional opinion” regarding the potential dangers of Actos heart problems—specifically Actos myocardial infarction.
The whistleblower lawsuit is, in effect, a game-changer for Actos litigation. And former Actos victims might find that where there once was no direct path to an Actos lawsuit, there now might be.
Welcome to Round #2.
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).
Call me jaded. Call me skeptical. Call me “oh, ye of little faith”. But I’m guessing most of you out there will call me a realist when you take into consideration that House Oversight Chairman Darrell Issa (R-CA) is running a whistleblower website (see pic; wb-gop-oversight.house.gov/) whereby government insiders and the general public can blow the whistle on perceived (or real) fraud or misconduct—done by anyone regardless of party affiliation.
By the way, for those who don’t breathe, eat, and live this stuff on a daily basis, when we’re talking government fraud, we’re talking “Qui Tam” whistleblower cases. More on what the heck Qui Tam means can be found here on our blog.
I do commend the effort—Issa’s not only got the website going—it’s a form that you can fill out to report government fraud, and of course, while you are required to submit your email address or phone number, all details provided will be “kept in strict confidence”. But he’s out there socializing it as well in an effort to not only be accessible but seemingly more transparent. Go Rep Issa.
According to a post over at TheHill.com, Issa’s also got a twitter account (@DarrellIssa, and yes we (@OnlineLegalNews) follow him) where he responds to tweets shot over in his direction.
[Note to self: given recent requests (er, subpoenas) for info exchanged on Twitter re: WikiLeaks, maybe not ideal to post sensitive info, questions, allegations, or otherwise on Twitter…]
Interestingly too, the article at TheHill.com also has some comments—one’s from a Daniel Haszard who’s a steady commenter here at LawyersandSettlements.com on Zyprexa. Guess it is true we all run in the same circles… But another, from Back Firer, reads “He just opened the door for more crazy people to take their anger out on govenment. This man is on a witch hunt, but the hunt will back fire.” Well, perhaps, but I do agree there will be quite a number of “vent” submissions, and submissions from crackpots, and I pity the fool who’s going to have to moderate it all.
But—I suppose if it does stop even just one act of fraud, maybe it’s worth it.
Again, I do commend Issa’s efforts—but for my money, give me an attorney who specializes in whistleblower litigation. I so want to trust that the powers that be will do the right thing, with zero repercussions or retaliation, but like I said, call me jaded, I just can’t “go there” yet.
What do you think?