In recognition of American Heart Month, which kicks off tomorrow (Feb. 1st), and National Wear Red Day (Feb. 3rd), LawyersandSettlements.com takes a look at our most-viewed drug lawsuit topics for 2011 in which heart attack or heart side effects were the alleged primary injuries.
Unfortunately, while a lot of focus this month will be on the positive measures we all can take to improve heart health—and that’s certainly important—it can be easy to overlook the negative heart side effects some drugs can have—and attention should be given to those as well.
As the chart at left depicts, Actos, Paxil and Zoloft accounted for the majority of 2011 traffic related to heart side effects, with Actos receiving the most at 25 percent. The Type 2 diabetes drug was released as an alternative to Avandia, which as you’ll recall came off pharmacy shelves as a result of the new FDA REMS program that became effective in November, 2011. Still, Avandia came in as the fourth most popular heart lawsuit topic.
Paxil, the popular antidepressant, has been linked to heart birth defects in infants and the drug drove in 18 percent of traffic last year. Ditto Zoloft, which accounted for 10 percent of the pageviews among readers concerned over the potential for heart birth defects.
The ten prescription drugs on the list fall into four distinct classes: Actos and Avandia are prescribed for the treatment of Type 2 Diabetes; Vytorin helps to control cholesterol, which has a direct impact on heart health; Trasylol is used during surgery to mitigate blood loss; the remaining drugs address depression and anxiety.
Reader interest in Prozac, Lexapro, Effexor, Celexa, Zoloft and Paxil shows continued concern surrounding pregnant women using selective serotonin reuptake inhibitors (SSRI) drugs and potential heart birth defects.
Here’s the full list:
Top 10 Drug Lawsuit Topics for Heart Side Effects in 2011
*SNRI (serotonin-norephinephrine reuptake inhibitor) or SSRI (selective serotonin reuptake inhibitors) drugs associated with heart birth defects when taken during pregnancy
That’s the question someone posted over at Answers.com—aka, wikianswers. And there it sits with zero answers—which should pretty much state the obvious, that, no, there is not an Actos class action lawsuit*. There may well be Actos lawsuits, however.
And therein lies the crux of what many type-2 Diabetes patients who are currently taking Actos are finding themselves asking. After all, Actos became to go-to drug—starting back in 2007–when drug-of-the-same-class Avandia started to come under fire. Doctors began switching patients, many of whom probably asked for the switch themselves, over to Actos. Needless to say, as more and more information became available regarding Avandia adverse events, Actos became the favored child of the family, so to speak—the lesser of two evils.
Even with the halting of the TIDE study—which compared Avandia vs Actos—over ethical concerns about continuing a study that involved a drug, Avandia, with potentially very serious side effects—the default takeaway message appeared to be, “switch to Actos”. It was only after the dust began to settle and the FDA had chimed in on Avandia’s fate that attention began to drift back over to Actos.
Recently, an article in Cardiovascular Business showed just how great the switchover to Actos has been:
“Even after the class-wide FDA black box warning for congestive heart failure was added in 2007, pioglitazone [Actos] use was largely unchanged and it was prescribed Read the rest of this entry »
Let’s face it, lots of drug companies face a variety of lawsuits and fines from the government. But 2010 might be a year that GlaxoSmithKline would wipe from its memory if it could—a sort of annus horribilis, if you will. Between the reported Paxil settlements, massive fines for illegal activity at its Puerto Rico plant and huge restrictions on its diabetes drug, Avandia, GSK appeared to be facing a TKO as we moved into 4Q’2010. So officials at GlaxoSmithKline could be forgiven if they toast the New Year and hope it’s better than the last 12 months…
Earlier this year, various media outlets reported that GlaxoSmithKline agreed to settle certain lawsuits alleging Paxil caused birth defects. According to Bloomberg, the drug maker agreed to pay more than $1 billion to settle approximately 800 lawsuits.
Meanwhile, a separate lawsuit also alleging Paxil birth defects, saw the family of an infant who died less than two months after birth, settle with GlaxoSmithKline for an undisclosed amount. In yet a different lawsuit, the family of a boy born with heart defects was awarded $2.5 million by a jury, which found that GlaxoSmithKline officials “negligently failed to inform” the mother’s physician about the risk of birth defects.
In October of this year, GlaxoSmithKline agreed to pay $750 million to settle allegations of wrongdoing at the company’s Puerto Rico plant, which is now closed. An investigation into the plant found that improper manufacturing procedures resulted in medications that could split apart or had improper amounts of the active ingredient. Officials alleged that GlaxoSmithKline knowingly manufactured, distributed and sold medications that did not meet FDA standards.
As part of the settlement, a whistleblower in the case received a whopping $96 million. So for her, 2010 might just have been a fantastic year.
Also this year, GlaxoSmithKline learned that its diabetes drug, Avandia, would carry severe restrictions on who can take the medication. The decision came after an FDA advisory panel recommended that use of Avandia be restricted in light of serious side effects. Patients who are not currently on Avandia will have to try other diabetes medications before using Avandia and will have to show they have been made aware of Avandia side effects. Although some people consider it a victory that Avandia was not pulled entirely from the market, these restrictions will likely have an impact on Avandia profits.
Based on those three issues alone, 2010 might be a year that GlaxoSmithKline tries—ever so hard—to forget.
Anyone who is aghast at the recent $750 million GlaxoSmithKline (Glaxo) whistleblower judgment to settle manufacturing deficiencies at a former plant in Puerto Rico shouldn’t be surprised that such things are going on. Happens all the time, it seems. And not just to Glaxo, either.
In actual fact, that $750 million—of which the whistleblower earns a share of the penalty totaling a whopping $96 million—pales in comparison to the $3.1 billion that the US Department of Justice has recovered under the federal False Claims Act so far in just this fiscal year alone.
Last year the haul was almost twice that—$5.6 billion.
Some will say that the whistleblower is an opportunist hoping for a big payday in the end, and will take any amount of criticism and crap en route to the pot at the end of the rainbow. Hell, I’d put up with a lot of grief to collect $96 million.
I would even eat liver.
But to those who view whistleblowers as ambulance chasers, consider the amount of fraud and wrongdoing that serves as a persistent blight on the business landscape. Somebody has to expose such misdeeds—and if the government can’t route out the evil-doers (sorry ‘W’…) on their own, then they have to provide incentive for those who can.
We would all wish that whistleblowers were not necessary. In a perfect world every business and corporate entity would operate with integrity and play by the rules.
Sadly, that’s not the case.
According to Taxpayers Against Fraud, a not-for-profit that supports whistleblower lawsuits, Read the rest of this entry »
If finding the right medication feels a bit like a minefield lately, it’s no wonder.
It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure…
And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events.
Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.
And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.
Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product.
This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »