Drugs/Medical Archive
Actos Heart Attack Victims Back in the Ring for Round #2?
April 26th, 2012. By AbiK
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.
Tribeca Film Festival Must-See: “Off Label” Looks at Big Pharma’s Human Guinea Pigs
April 15th, 2012. By AbiK
If you’re lucky enough to be in New York City later this month, try to make it over to the Tribeca Film Festival for a showing of “Off Label”. The movie, by Michael Palmieri and Donal Mosher, takes a look at America’s drug culture—how drugs are tested, marketed, sold and consumed. And it reveals an oft times less-than-pretty picture of big pharma’s ‘twilight zone’, where drugs are tested by human guinea pigs and the results can be shady at best, devastating at worst.
Just as LawyersandSettlements.com brings you the stories of victims who’ve had their lives irrevocably changed by harmful drug side effects, “Off Label” brings you up close and personal with its subjects’ narratives–and it’s definitely worth seeing. Here are the times & venues where you can catch the film:
4/19 – Thursday, 7:00pm, at AMC Village 7, located at 3rd Ave and 11th St.
4/20 – Friday, 7:30pm, at ClearCinemas Chelsea, located at W 23rd @ 7th and 8th Ave
4/23 – Monday, 10:00pm, at AMC Village 7, located at 3rd Ave and 11th St
4/24 – Tuesday, 3:30pm, at ClearCinemas Chelsea, located W 23rd @ 7th and 8th Ave
How Generic Drugs Discriminate Against the Poorest Patients
April 10th, 2012. By AbiK
No one wants to come right out and say it, but that’s basically what’s going on with generic drugs. Poor patients are effectively discriminated against simply by having no choice other than to buy the cheapest version of whatever pill they’ve been prescribed. Cheaper meds are fine—until you factor in that the more expensive brand name equivalents come with a bit of an extra ‘insurance policy’—no, not the type of insurance you’re thinking of—it’s insurance in the sense of legal recourse should something go wrong as a result of taking the drug.
Let’s face it, outside of those who claim to buy the cheaper equivalent on ‘principle’, for the most part the folks who are buying generics are those who either simply cannot afford the brand-name drug or those who’ll lose prescription coverage benefits unless they opt for the generic shown on the approved formulary from their insurance company. We’re not talking the 1% here, folks.
Sure, it’s great that cheaper generic versions of big-name blockbuster drugs are available—we’d all be broke otherwise. But generics have a hidden cost, too…
Legally speaking, that cost can be tremendous. How so? Well, what if something goes wrong—horribly wrong—upon taking the drug? What if there’s a serious reaction to the drug, like a ruptured tendon from a fluoroquinolone? Or tardive dyskinesia from a ‘good as Reglan’ generic? Sure, the generic drug should in most instances perform like its pricier twin—but there’s a catch: unlike with brand name drugs, if something goes wrong, there’s not much legally at present that can be done (from a strict product liability standpoint—not talking malpractice here).
The issue with generic drugs has to do with liability—being liable when harmful side effects occur. And simply put, generic manufacturers are not held liable.
Currently, it’s the brand name drug manufacturers who are responsible for ensuring their drug has gone through a rigorous FDA-approval process and they’re also responsible for making any label changes should new warnings be applied to a drug they’ve produced.
Generic manufacturers, however, don’t have quite the same responsibility. The Hatch-Waxman Act—officially, the Drug Price Competition and Patent Term Restoration Act of 1984—made it easier for generics to find their way to market. Generic drugs do not have to go through a lengthy FDA approval process if they’re able to prove that the generic drug is equivalent to the brand name version. And, as such, the generic drug simply picks up the labelling information and package insert information from the brand name drug. When any changes are necessary (e.g., adding a black box warning), the generic is required to duplicate what’s happened with the brand name drug.
The most significant benefit of the Hatch-Waxman Act for blockbuster brand name drug manufacturers is that it allows the big pharma companies a period of exclusivity in the marketplace before the generic drug enters the market.
Now, the difference between a drug liability lawsuit for a generic vs a brand name is most glaring when you look at lawsuit outcomes. One of the most publicized examples showing the difference between a brand name drug lawsuit and a lawsuit with the same, but generic, drug involves phenergan.
In both cases the plaintiffs—both women who were administered the anti-nausea drug in a hospital and then subsequently lost an arm due to gangrene—sued the drug manufacturers. In the brand-name case, it was v. Wyeth; in the other, the generic, it was v. Baxter Healthcare. The upshot was that the plaintiff who had the ‘good fortune’ to have been given the brand name version received a multi-million dollar settlement. The generic patient? Her lawsuit against Baxter was dismissed. She had also filed a malpractice lawsuit, the final terms of which were undisclosed.
Both women had life-altering injuries; only one received settlement money from the drug manufacturer.
While the phenergan lawsuits began in a hospital setting where the choice of brand name or generic may not have been the patients’ to make, the outcomes of their lawsuits show the stark difference in terms of liability claims. And, for patients who simply cannot afford to choose a brand-name drug, choosing the generic becomes a more or less de facto decision to give up the right to sue the drug company. And in that sense, generic drugs do discriminate against the poorest patients.
Week Adjourned: 2.24.12
February 24th, 2012. By LucyC
Top Class Actions
Hotels.com—too good to be true? Kaylen Silverberg thinks so. She filed a consumer fraud class action lawsuit this week against the online booking agency, alleging it does not back up its promise to refund money if hotel guests can find a better rate elsewhere online.
Instead, Silverberg’s lawsuit claims, Hotels.com sets an “arbitrary and undisclosed limit” on refunds.
Silverberg’s lawsuit states Hotels.com will not back up its promise: “‘after you book with Hotels.com, if you find a lower publicly available rate on line for the same dates, hotel, and room category, we will match the price and refund you the difference.’” Instead, the lawsuit states, “Hotels.com has an arbitrary and undisclosed policy to refund only a portion of the difference between its rate and other, lower rates. For example, in Silverberg’s case, Hotels.com stated that ‘we can only refund you $142,’ even though the price difference was substantially greater.”
Silverberg’s story, short version, is allegedly that she booked a room through Hotels.com for two nights in Rancho Palos Verdes, CA., for $355 per night, then found a $223 rate at HotelClub.com. A third website advertised an even lower rate, $213. Silverberg then asked Hotels.com to back up its guarantee but she was told by the company that they would refund her only $71 a night, which she calls “an arbitrary and undisclosed limit.”
The lawsuit seeks restitution and class damages for breach of contract and unjust enrichment—otherwise known as “business as usual.”
Top Settlements
Every so often a class action settlement comes along that results directly from very unfortunate circumstances. This is one such settlement. This week, Teva Pharmaceuticals, the maker of Propofol, announced it will settle 120 personal injury lawsuits arising from a hepatitis C outbreak in Southern Nevada. The amount of the Nevada Propofol settlement is a reported $285 million.
The Israeli-based generic drug maker was facing lawsuits brought by some 150 former patients of The Endoscopy Center of Southern Nevada and its sister clinics, who contracted the disease after receiving propofol at the clinics. LAS reported on this in some detail at the time.
According to a report in the Las Vegas Review Journal, nine hepatitis C cases were found to be linked to the clinics which were run by Dr. Dipak Desai. Seven of the nine cases were genetically linked to the center. Health officials called another 106 cases “possibly linked.” According to health officials, more than 60,000 former clinic patients were potentially exposed to hepatitis C because of unsafe injection practices by nurse anesthetists at the clinics.
Teva lost the first three trials and was facing payments of nearly $800 million dollars in compensatory and punitive damages. The fourth trial was under way when settlement talks began in earnest. The settlement leaves 15 lawsuits unresolved.
Antennagate may be drawing to a close…if a preliminary settlement reached in a defective products class-action lawsuit against Apple is approved. The lawsuit alleges underperformance of its iPhone 4 resulting from antenna problems. And oh brother did we ever hear about it! While the iPhone 4 settlement per class member is certainly not large, by anyone’s measure—the size of the class certainly is—25 million US residents no less, each of whom could receive $15 in cash or a bumper case provided by Apple under the terms of the settlement. So, don’t be quitting your day job just yet.
The class action combined 18 separate lawsuits, all of which allege Apple was “misrepresenting and concealing material information in the marketing, advertising, sale, and servicing of its iPhone 4—particularly as it relates to the quality of the mobile phone antenna and reception and related software.”
As part of the iPhone 4 settlement original purchasers will be sent emails before April 30, 2012 alerting them to the settlement. The claims period is then open for 120 days.
OK—And it’s off to the bar we go. See you there!
You’ve Heard of Thalidomide Babies, what about DES Babies?
February 21st, 2012. By AbiK
It’s a startling reality that DES Mothers, DES Daughters and DES Sons live with—that not many people know about or have heard about the pregnancy drug DES—diethylstilbestrol—or the harmful effects its had on both mothers who took the drug, and children who were exposed to the drug in utero.
DES was prescribed during the 1940′s to the 1970′s to expectant mothers who were at risk for miscarriage or pre-term delivery. The drug, however, was found to potentially cause clear cell adenocarcinoma (CCA), a rare form of vaginal and cervical cancer; reproductive tract structural changes such as a T-shaped uterus; complications in pregnancy such as ectopic (tubal) pregnancy and pre-term delivery; and infertility.
DES finally had its FDA approval revoked in 2000 (it had been recommended that doctors not prescibe it in 1971)—but not until potentially millions of mothers and children had been negatively affected by it. And those children are now between forty and seventy years of age or so—some of whom have lived through infertility or miscarriages of their own with out knowing that the reason could be connected to exposure to DES.
And that begs the question: why do so few people know about DES and the damage its caused? DES seems to be in the shadows of thalidomide—so much so that it’s been referred to as the ’silent thalidomide’ in the press.
There are some possible reasons why, of course.
First, thalidomide was never approved for use in the US. DES was approved which perhaps made it appear less pernicious—after all, ‘my doctor prescribed it’.
Second, thalidomide babies could not help but evoke the collective sympathy and outrage of all who had seen a picture of an innocent newborn with severe birth defects such as missing or shortened arms or other severe disfigurement. There are no alarming pictures of DES victims—only faces; and those faces look just like you or me.
And finally, thalidomide, by its horrific nature, wove its way into popular culture—probably the most familiar evidence of this for many is the Billy Joel lyric from “We Didn’t Start the Fire”.
Diethylstilbestrol (DES), however, has potentially affected many more women in the US—and their children and perhaps their children’s children (aptly called ‘DES Third Generation’)—than thalidomide and is in some ways a much more heinous drug in that DES is the one that slipped through the proverbial cracks—the one that the FDA didn’t put the brakes on—soon enough.
Perhaps you now know about DES. But more importantly, do you know if you were on DES or exposed to it?
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