Posts Tagged ‘ Glaxo ’
Understand the Pharmaceutical Representative Overtime Lawsuits? Here’s Help
March 25th, 2011. By Kristine B
If not, you’re not alone. In fact, even the courts have reached contradictory rulings in the pharmaceutical representative overtime lawsuits they’ve seen. While the pharma reps won the Novartis lawsuit, they lost the Johnson & Johnson and GlaxoSmithKline lawsuits. Those losses, however, don’t mean that pharmaceutical sales reps should just give up. In each case, the judges relied on different legal issues and exemptions, which is how such different results were achieved. Pleading Ignorance takes a look at what’s been going on…
First, the Backstory: the Fair Labor Standards Act
Under the Fair Labor Standards Act, certain employees are considered exempt from overtime pay. Those exemptions include outside sales employees and people who are considered “administrative”. Outside sales employees are considered exempt because they are paid on commission and therefore have an unlimited earning potential. Furthermore, many outside sales people work independently of an office and therefore have a say in what hours they work and how they go about their job. To be considered exempt from overtime pay, however, outside sales people must spend at least 50 percent of the time in their job involved in sales.
Administrative people are those who exercise independent authority, judgement or discretion in their job. They have a great deal of discretion in their job activities and how they fulfill their employment requirements.
Lawsuits have been filed against various pharmaceutical companies alleging that pharmaceutical sales reps do not fit either the outside sales exemption or the administrative exemption.
Novartis Sales Rep Overtime Lawsuit
In the Novartis lawsuit, the court found that the pharmaceutical reps were misclassified as exempt from overtime pay—meaning they should receive pay for overtime hours worked. In reaching the decision, the court found that Novartis sales representatives were not directly involved in the sales transaction. Instead, the reps informed physicians of a product’s benefits and encouraged physicians to prescribe Novartis products. At no point during the visit did the sales rep actually engage in a sales transaction.
Furthermore, the court found that the Novartis reps didn’t fall under the administrative exemption because Novartis controlled the sales pitches and reps were not allowed to deviate from that pitch. Additionally, the reps did not have the authority to in any way direct or interpret Novartis policies or procedures. Because the courts found the Novartis reps were not exempt under the outside sales or administrative rules, the reps are therefore, according to the courts, eligible for overtime pay.
Johnson & Johnson Sales Rep Overtime Lawsuit
A lawsuit against Johnson & Johnson, however, resulted in a different decision. In that case, the pharmaceutical sales representative was found to be exempt from overtime pay under the administrative employee guidelines. In that case, the court found that the plaintiff was able to develop her own itinerary, could visit some doctors more frequently than others and was expected to develop a plan to obtain more sales. The court found that the plaintiff worked without direct oversight most of the time and therefore had discretion and independent judgment required for the administrative exemption.
GlaxoSmithKline Sales Rep Overtime Lawsuit
In GlaxoSmithKline’s lawsuit over pharmaceutical representative overtime pay, the courts backed GlaxoSmithKline’s decision not to pay the reps overtime. In this case, unlike Johnson & Johnson, the court determined that GSK sales reps fall under the guidelines of outside sales representatives because they are motivated by commissions and they have freedom to work outside the office.
So it currently appears that whether or not a pharmaceutical rep is eligible for overtime pay is somewhat determined by which court hears the lawsuit and by which company you work for and how much authority you have in your job.
The court’s decision in GSK actually contradicted a brief filed by the US Department of Labor that supported pharmaceutical reps being paid overtime. So, even though the Department of Labor supports overtime for pharmaceutical reps, there’s no guarantee that the courts will agree with it. More lawsuits are still to come and the Supreme Court might wind up determining the whole thing in the end. As of now, though, there’s no reason for pharmaceutical representatives to give up the fight.
Hey, Leave my Nurdle Alone! (Glaxo & Colgate go at it…)
August 5th, 2010. By AbiK
The beauty of blogging about all things legal is that you just never know what you’ll come across. Many times there are heart-wrenching personal injury stories. Sometimes there are lawsuits that need to be filed under “ridiculous“. And then, there’s the nurdle.
For those of you not-in-the-know, a “nurdle” would be the dollop or blob of toothpaste that sits so beautifully with nary a smudge or drip on top of a toothbrush in a toothpaste ad. You’ve seen it hundreds of times—it ranks up there in ad-land with the Philly Cream Cheese dollop spread on a bagel or the Cool-Whip dollop (below) on some strawberry dessert. It’s photo-styling perfection and you best not mess with it.
Especially if it may be trademarked.
And, it appears Glaxo is claiming that the nurdle is, indeed, a trademark of theirs—for their Aquafresh “Triple Protection” (oh, btw, “triple protection” is also part of this trademark infringement case) toothpaste. You know, the one made famous by blending three color stripes of toothpaste into one squirt of the tube.
But see, then came Colgate-Palmolive with its “Triple Action” toothpaste. Uh-oh. Now things are getting fired up. “Triple Protection” vs. “Triple Action”. And Glaxo was thinking that was sounding pretty darn close to their long-established triple-play (note, “triple play” is not trademarked) toothpaste.
So, upon seeing the new Colgate toothpaste, Glaxo had raised objections with Colgate over its branding. And apparently Colgate didn’t back down, which got Glaxo’s dander up.
According to Bloomberg.com, Glaxo filed new trademark applications for the nurdle. In a complaint filed by Colgate, this move—filing the trademark application—is a “shot across the bow” in which Glaxo is attempting to gain exclusive rights for the nurdle design. The complaint seeks to have a federal court rule that the Colgate toothpaste does not infringe Glaxo’s trademarks for Aquafresh.
Glaxo’s take on this? According to an emailed statement from Glaxo’s spokeswoman to bloomberg.com, “More than 20 years ago, GSK’s Aquafresh brand created the highly distinctive nurdle device to promote its range of Aquafresh oral care products. These extremely valuable trademarks are the exclusive property of GlaxoSmithKline’s world famous Aquafresh brand and GlaxoSmithKline will take all necessary steps to defend its rights.”
Avandia Study Conflicts – and Conflicts of Interest?
June 30th, 2010. By AbiK
So after the latest two Avandia studies came out earlier this week, we then see a third Avandia study—this one will also be debating fodder for the advisory panels at the FDA’s July meeting—the one that will determine Avandia‘s fate. The study was presented late Monday at the American Diabetes Association’s annual meeting by Dr. Richard Bach, associate professor of medicine at Washington University School of Medicine in St. Louis.
Here’s the thing though—the fist two studies basically added a few nails in Avandia’s ever-growing coffin. But this latest study to hit the airwaves actually digresses from the previous two in its findings—it states that there is no increased risk of heart attack, stroke or death associated with taking Avandia.
Hmm. Doesn’t that just make things a little…less definitive?
However, upon looking more deeply into this third study, some things about it just sort of pop out. For example, according to an article from healthfinder.gov, this third study if of a smaller sample size: 2,400 patients—compared to over 35,000 from the study done at the Cleveland Clinic.
There’s more..
- The third study was funded by the National Institutes of Health (NIH). Oh, and GlaxoSmithKline (GSK). Oh, and if you recall, GSK just happens to make Avandia. Conflict of interest? (just asking).
- While death, heart attack and stroke incidence rates were apparently 28 percent lower in the third study for those taking Avandia vs. those not taking a thiazolidinedione (TZD) medication, congestive heart failure was higher—just not at a rate “considered significant”. What was significant was a 45 percent increase in risk of fractures for those who took Avandia. (Ok—not heart-related, but 45 percent sounds more than significant to me).
- Apparently the ages of the participants in the third study were lower than that of the other studies. Translation: the other studies’ participants may have been more frail. Two things here: first, I don’t care what ages folks are who are affected by a drug–everyone’s well-being matters. So if an older population is more adversely affected, they’re still adversely affected. And second, so the tests are not comparing apples to apples–which should detract from the ability to make comparisons and draw conclusions.
Hard to say where the FDA advisory panel will net out in July. Will we still see Avandia on the market? Stay tuned.
How Does the Avandia Settlement & TIDE Trial Affect Me?
May 18th, 2010. By Kristine B
If you’ve read the news lately, you may have heard that GlaxoSmithKline agreed to settle approximately 700 Avandia lawsuits for a reported $60 million. You may also have heard the calls to end the Avandia safety trial known as the TIDE trial. This may have you concerned about how these developments affect you, and rightfully so.
This week, Pleading Ignorance takes a look at how the Avandia settlement and the controversy over the Avandia and Actos TIDE trial may affect you.
Avandia Settlement
GlaxoSmithKline has reportedly agreed to settle 700 lawsuits for approximately $60 million. How this settlement affects you depends on where you are in the lawsuit process, if you are involved at all.
Obviously, if you’re one of the 700 lawsuits that have been settled, then your lawsuit is now done; you’ll receive your share of the settlement and no longer have to worry about the litigation.
If you are one of the remaining lawsuits (reported to number in the thousands), how this settlement affects you is less clear. Details about the settlement have been kept quiet. Based on how big businesses operate, my guess (this is just speculation here) is that GlaxoSmithKline has not admitted to any wrongdoing (something most businesses attach to their settlements). The settlement, however, shows that the drug maker is willing to sit down with plaintiff’s lawyers to negotiate, which could be a good thing for the remaining lawsuits.
That said, there is no guarantee that a settlement in those 700 initial lawsuits will translate into a settlement for the remaining lawsuits. It’s a good sign, but it’s no guarantee.
If you are considering contacting a lawyer but haven’t done so yet, the statute of limitations might be running out for you. One of the things that plays into how much time you have to file is whether or not your state follows a discovery rule. What’s that? Basically, it’s the point in time in which an individual would have likely been aware that a claim could be made against a defendant—or that a claim existed. In the case of Avandia, that would mean the point at which a person most likely knew they Read the rest of this entry »
Avandia and Alzheimer’s…What If?
September 24th, 2009. By LucyC
So here’s an interesting twist. Avandia, also known as rosiglitazone, once GlaxoSmithKline’s (GSK) blockbuster diabetes drug that turned out to be not so good for you after all, has failed to prove benefit in clinical trials as a treatment for Alzheimer’s disease.
Why was GSK testing Avandia in Alzheimer’s, you ask? Well, sales of Avandia plummeted after the now infamous Nissen study was published in 2007 showing a link between the diabetes medication and heart attacks. In fact, one source puts 2008 sales down by 40 percent from 2007. So, GSK was looking for a new indication that would generate some cash—up to $300 million one estimate suggests.
So GSK must look for new ailments for Avandia. After all—product recycling applies to the pharmaceutical industry just as it does in other industries.
But what if Avandia had proven beneficial in treating Alzheimer’s—whatever ‘beneficial’ was defined as being? It is unlikely that the risk for heart attack would have disappeared or not been an issue in this population. So I find myself wondering about the ethics of testing a drug with an established link to potentially fatal adverse events, such as heart attack, in a population that may not be able to articulate their health problems. Not only that, had Avandia made the grade, would the FDA have approved the indication, despite the health risks?
Perhaps the most worrying element of all this is why Avandia is being tested at all for any additional indications, when there are very real concerns about it remaining on the market in the first place.
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