Drugs/Medical Archive
Topamax and Cleft Palate: Now the Insurance Battle
March 21st, 2011. By AbiK
Hooding Eyelids? Cosmetic elective surgery. Frown lines and laugh lines? Cosmetic elective surgery. Cleft Palate? Cosmetic elective surgery.
Wait—what was that last one?
That’s the incredulous moment a number of parents experience after submitting insurance claims for their child’s cleft palate surgery. They find themselves hearing that their insurance company deems the surgery as either “cosmetic” or “dental”. Translation: You’re on your own. And it doesn’t help to see those ads all over of children with cleft palates in foreign lands for whom there are constant requests for charitable relief. Not that those children don’t deserve assistance—they do—but it leaves folks closer to home questioning whatever happened to that phrase, “charity begins at home”?
Well, insurance companies aren’t in the charity business.
For parents of a child who’s been born with a cleft palate or cleft lip due to Topamax side effects—ie, a birth defect directly related to the mother having taken Topamax during the first trimester, navigating the world of insurance claims and denials is an unexpected battle. But there are some things you can do. Here, some tips from Cleftline.org, the website of the Cleft Palate Foundation:
1. If your insurance company denies your child’s cleft palate surgery claim, make sure you review your insurance plan—some policies have a clause for genetic birth defects that requires coverage for any medical treatment that is necessary because of a birth defect.
2. Try to talk with a case manager—not the customer service person who’s just following the insurance company script. The case manager typically has a medical background and may be better informed and versed in understanding your situation.
3. If your insurance provider deems cleft palate surgery as cosmetic, you can submit an appeal but you should have your doctor write a letter on your behalf to state the medical reasons why the surgery is necessary. A reviewer with the insurance company may not understand that their are benefits to having cleft palate surgery beyond boosting self-esteem. The Cleft Palate Foundation also suggests submitting pictures as well.
4. If your insurance provider says the cleft palate surgery is dental, not medical, try to have a plastic surgeon review your claim. Additionally, have your surgeon and primary physician write letters of support to be submitted to the insurance company. In the letters, ensure that the medical reason for the cleft palate surgery is stated, and that it is necessary, not some elective procedure.
5. If your child also has speech difficulties associated with the cleft palate, ensure that you document with the insurance company—and your doctor can state this in his letter also—knows that the condition is a direct result of the initial birth defect—not the result of an interim surgery or other condition. Otherwise the insurer may consider the speech problem as a secondary condition.
6. If your insurance company considers the cleft palate as a pre-existing condition, understand that many times—and particularly in this economy when many are still going without health insurance to get by—that insurance companies often receive claims from individuals who only sign up for benefits right before they know they will need to file a claim. The Cleft Palate Foundation suggests that you do not let your benefits lapse because you then may become at risk for this type of claim denial.
For more information and for further cleft palate resources, visit the Cleft Palate Foundation at cleftline.org, or call at 800-24-CLEFT. For more information regarding Topamax birth defect legal help and news see our Topamax news page.
Latest Import Propecia Lawsuits?
March 4th, 2011. By AbiK
The drug may be from the good ol’ U.S. of A., but it would seem that Propecia lawsuits—and a recent Propecia class action in Canada (or, actually a Proscar class action, as it’s known up north)—may be forging a groundswell here for Propecia litigation. Not surprising, given that the issues with Propecia center around something a red-blooded American male may not want to be publicly “first to market” with, so to speak—i.e., Propecia sexual side effects—better to let the folks across the pond start that trend.
The Propecia side effects being referred to here are lack of sexual drive…impotence. And, from the sound of it in the BBC radio clip above, they may be less rare than you’d expect. Unfortunately too, both “James” (profiled above) and the lead plaintiff in the Canadian Proscar class action are young men—men who should be in their prime sexually. Needless to say, finding themselves unable to perform on the heels of seeking out a remedy for male pattern baldness has been quite emotionally devastating.
Now, to be fair, that Propecia does work to combat male pattern baldness is not in question here—and many men have used the drug successfully. Even those who speak out against it state that it does work for the majority of patients taking it. But at what potential price? What’s at issue here is the number of men who appear to be suffering some rather serious side effects in direct correlation to taking Propecia.
And now, the big question that’s being asked not only here in the US but also on the international media scene, is to what extent are these Propecia side effects permanent? Historically, the ‘official line’ has been that if you either a) continue to just use Propecia, any such side effects will subside; or b) that if you stop taking Propecia, the side effects will go away. Hmm. Try telling that to James and Michael Miller, the young gentleman who’s filed the Canadian Proscar class action against Merck Frosst Canada…
Drug Advertising: “Side Effects May Include” MIA – Why?
March 3rd, 2011. By Hunter West
You know all those drug ads on TV, where new drugs for everything from erectile dysfunction to depression, to cholesterol are touted complete with a shopping list of side effects against a backdrop of shiny, happy people dancing in slow motion in the green grass of a city park, or cavorting across an idyllic beachfront? Case in point, Cialis ad at left.
All that damning voiceover information on side effects and adverse reactions can get lost in the visuals (which is probably the plan), but at least the requisite information is there.
Why did that not happen with Tylenol, and the potential for acetaminophen toxicity?
Why did that not happen with denture adhesive, and the potential for zinc poisoning?
Most realize that most drugs have side effects. Fewer realize that all drugs have side effects at all. And the more intense the drug, the longer the list of adverse reactions. When a new drug designed to treat, say, the propensity to have to get up to pee several times in the night for aging Americans comes on the market, manufacturers know that in order to advertise the drug where their constituents are—parked on their sofas, watching television—they have to abide by advertising regulations and include the side effects.
You may not recall every adverse reaction rattled off in such TV commercials. You may not remember even one. But you are left with the sense that this is serious stuff, and if you’re at Read the rest of this entry »
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.
Research Links Tetracycline to IBD – and to Lawsuits, too?
February 24th, 2011. By Hunter West
A recent study on UK patients conducted by the researchers at the University of Pennsylvania* could have an impact on Accutane lawsuits. As most know, class actions as well as individual lawsuits have attempted to hold the manufacturer of Accutane, Hoffman-LaRoche, accountable. The Vitamin-A drug has been linked to inflammatory bowel disease, or IBD.
But wait a minute—so too are tetracycline drugs, say the U of P researchers.
So how does that impact an Accutane lawsuit?
Accutane (isotretinoin) has always been considered a last resort for problematic acne, which is the scourge of adolescents and, if left untreated, could scar the face for life.
Dermatologists will almost always start with more natural ways in which to control acne, such as diet and hygiene—or perhaps an OTC benzoyl peroxide or salicyclic acid solution.
If that doesn’t work, then they turn to tetracycline, which is an antibiotic and thought to carry minimal risk. How can you go wrong with an antibiotic, a microbial? Are they not the magic bullets of our society?
Antibiotic resistance notwithstanding, there’s now a fly in the ointment, if you will. That’s because Read the rest of this entry »
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