Posts Tagged ‘ Roche ’

Thousands may have Claim for Pharmaceutical Sales Rep Overtime

March 2nd, 2011. By LucyC

Well, it looks like the little guys could have it. Yesterday, February 28, 2011, the US Supreme Court announced that it would not reconsider appellate court decisions against Novartis and Merck Schering regarding unpaid overtime class actions.

Essentially, this means that Novartis may have to pony up $100 million or more in back overtime as settlement for some 2,500 plaintiffs. 

In so doing, the Supreme Court leaves intact two separate decisions against Novartis and Schering Corp. In July 2010, the 2nd Circuit issued a pair of rulings that found the pharmaceutical sales reps were covered by federal wage-and-hour law.   

But—it ain’t over as the expression goes—until the fat lady sings. At least half a dozen pharmaceutical companies are tied up in overtime suits, according to various media sources, and yesterday’s US Supreme Court decision presents a major conundrum. According to the attorneys that represented the Novartis employees, the various rulings against the pharmaceutical companies have ‘opened the floodgates for liability.’ This same law firm is currently representing plaintiffs in four identical wage-and-hour lawsuits against Pfizer, Roche, Merck and Abbott Laboratories. So the bigger question is—does this decision translate into overtime requirements for all pharmaceutical sales reps? (Now we’re talking tens of thousands of workers.)

That remains to be seen, in part because the courts themselves are guilty of issuing conflicting information—other appellate court decisions have decided in favor of the employers. The reason? It’s all down to interpretation. A report in the Star-Ledger indicates that this Supreme Court ruling was partly based on a brief from the Department of Labor that supports the sales’ reps stance on qualifying for overtime pay. As far as Novartis is concerned, they intend to evaluate ‘all legal options.’ Part of an email published in the Star-Ledger, from Novartis, states, “For decades, companies in the pharmaceutical industry have classified their sales representatives as exempt employees and have compensated them on a pay-for-performance basis, the same way they compensate executives, managers and other professionals.”

And, in a brief submitted by Merck, the pharmaceutical company reportedly wrote that another appellate court concluded that “no deference was owed to DOL’s new interpretation expressed in its brief.”(Star-Ledger). Of course Merck isn’t too happy about the Supreme Court ruling either. The company inherited an overtime lawsuit against Schering-Plough, when it acquired SP in 2009. 

It doesn’t help that the Supreme Court offered no comment whatsoever on its decision: an explanation making clear their reasons for their decision could have helped in reducing the likelihood of further legal wrangling—which will almost certainly occur because the stakes here are high indeed.   

The Pharmaceutical Research and Manufacturers Association (PhRMA), which is the leading trade group representing the US pharmaceutical industry, had argued in its petition to the Supreme Court that the lower court’s decision had “potentially far-reaching ramifications’’ for the industry, and called the decision against Novartis an error. “The decision unexpectedly exposes PhRMA members to potentially staggering retroactive liability from lawsuits by current and former employees,’’ the brief stated. “Serious consequences loom because of nothing more than an unexplained change in the Department of Labor’s interpretation of its regulations.’’ (Star-Ledger)

Of course, none of this changes the fact that the reps who filed the suit against Novartis—more than four years ago now—did put in the time—as much as 70 hours per week, according to their lawyers. 

Frankly, I can’t help thinking that the whole debate around unpaid overtime is just a little too Dickensian for 2011, and that a little more clarity would go a long way to improving the situation for both sides.

Tags: Abbott, Exempt, Merck, Non-Exempt, Novartis, Overtime Pay, Pharma Sales Overtime, Pharmaceutical Sales Reps, Roche, Schering-Plough
Posted in Drugs/Medical, Employment, lawsuits | No Comments »

Will Generic Accutane Spawn more Lawsuits?

March 30th, 2010. By janem

Accutane may be buried but the generic form, isotretinoin, is alive and may be hurting. Roche Holding pulled Accutane off the market in June 2009, about 15 years too late for countless victims of Accutane injury. Since its approval in 1984, the drug had been linked to psychological changes, suicidal behavior, auto-immune disease, central nervous system problems, birth defects and most notably,  inflammatory bowel disease (IBD).

But Roche didn’t discontinue manufacturing its blockbuster drug for safety reasons. Instead it had to do with legal and economic issues: generic competitors reduced the drug’s market share to less than 3 percent — Accutane’s departure leaves Claravis (Teva/Barr) with 54.8 percent of the isotretinoin market, followed by Amnesteem (Mylan/GenPharm) and Sotret (Ranbaxy), each with 22.8 percent. And Roche has paid out plenty in personal injury lawsuits. (To date, juries have awarded more than $33 million to patients who blame Accutane for their IBD.)

So the pharmaceutical industry spawns other generic forms of Accutane, called isotretinoin, priced from 10 percent to 65 percent (Sotret) less than Accutane. That may be good news for some lawyers–one attorney has filed more than 100 similar cases against makers of generic isotretinoin–but bad news for teens and young adults who (might) weigh the odds and decide they would rather develop IBD than suffer with acne and hey, the medication is now so much more affordable. Granted, acne can be debilitating emotionally. It can cause high levels of anxiety or depression during teen years, reason enough to disregard more dangerous side effects such as IBD.

The dermatology jury isn’t out on isotretinoin, yet. One dermatologist says that pharmacists mistakenly believe all isotretinoin products are therapeutically equivalent and they prescribe the generic brand because their patients wanted a cheaper product. “Dermatologists were essentially forced by patients to abandon [Accutane],” says Dr. Taub, who believes that “bioavailability from patient to patient differs so much more with generic isotretinoin than with Accutane.” Dermatologist Ty Owen Hanson says Claravis didn’t seem to work for his patients. “It was almost like patients were taking a placebo.”

Another dermatologist, Dr Webester, says Accutane and its generics possess identical pharmacokinetic curves. Dr. Feldman says he sees no difference between Accutane and its generics and doesn’t know which generics his patients get. Generally dermatologists stopped prescribing Accutane when the Roche reps stopped coming by with free samples, about the same time the generic isotretinoin debuted. More than two decades after Accutane’s introduction, it still cost up to $1,200 monthly, versus $600 to $900 for generics.

So the end of  Roche’s blockbuster drug paves the way for other drug companies to cash  in.  But will generic manufacturers remain in the marketplace if they begin to get slapped with personal injury lawsuits? After all, there’s only one way to spell isotretinoin…

Tags: Accutane, Add new tag, defective drugs, Isotretinoin, Roche
Posted in Drugs/Medical | 3 Comments »