Posts Tagged ‘ FDA ’

Yaz Scandal? Doc’s Accusations v. Bayer Unsealed, Revealed

December 7th, 2011. By AbiK

Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.

Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.

What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).

According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”

Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.

That was the draft version.

The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”

Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.

According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.

The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.

Is a new warning label in the offing? Stay tuned.

Tags: Adverse Events, Bayer, Dr David Kessler, Drospirenone, DVT, FDA, VTE, Warning Label, Yasmin, Yaz, Yaz lawsuit, Yaz side effects
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | 9166No Comments »2011-12-07+15%3A13%3A50AbiK

Week Adjourned: 11.26.11

November 28th, 2011. By LucyC

Top Class Actions

Do you know who’s got your personal information? An unfair business practices class action lawsuit has been filed in the Southern District Court of Florida against Best Buy Corporation for violating the Drivers’ Privacy Protection Act or “DPPA”, a federal statute that protects the privacy of personal information assembled by State Department of Motor Vehicles (DMVs).

The lawsuit alleges Best Buy has established a business practice of taking, storing, using and/or sharing customers’ personal or highly restricted personal information, without consent, when customers make a normal return of Best Buy merchandise. Their receipt indicates that Best Buy “tracks exchanges and returns … and some of the information from your ID may be stored in a secure, encrypted database of customer activity that Best Buy and its affiliates use to track exchanges and returns.”

The DPPA specifically prohibits Best Buy’s conduct and was instituted to protect consumers from abuses such as identify theft and stalking, which often result when information is unsecured and improperly stored. The class action alleges that Best Buy’s retention of data accessed on a driver’s license is not “use in the normal course of business” as described by the DPPA.

Top Settlements

What’s that old adage—if it sounds too good to be true… Power Balance LLC, the company that made Power Balance bracelets, has reportedly settled a consumer fraud class action lawsuit this week for $57.4 million and filed for federal bankruptcy protection. The details and amount of the Power Balance settlement remain to be confirmed, although it’s all over the Internet.

The company was sued over allegations of misleading advertising, advertising that allegedly claimed the hologram-embedded rubber bracelets enabled the wearers to “achieve their best,” a statement that begs the question—best what? Best outlandish claim? Possibly. Although the company claims there’s science to back up the statement. I have one word—and it’s “placebo.”

About time: Merck Vioxx settlement. There’s not much that’s funny about this. Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced. The FDA approved Vioxx for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.

Merck is also entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the United States, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx, which was withdrawn from the marketplace in September 2004.

The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck. The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug. Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.

Ok—That’s the week that was. Hope everyone had a wonderful Thanksgiving!

Tags: Best Buy, Best Buy Privacy Lawsuit, DPPA, Drivers Privacy Protection Act, Drug Marketing, FDA, Merck, Off Label Marketing, Power Balance Lawsuit, Power Balance Settlement, Vioxx Settlement
Posted in Class Action, lawsuits, Settlement, Week Adjourned | 9117No Comments »Week+Adjourned%3A+11.26.112011-11-28+15%3A42%3A16LucyC

Big Pharma’s Big Credo: Money is King

September 8th, 2011. By Hunter West

A long time ago, in a different life, the instructor in a business course I was taking asked the class the Number One Reason why people go into businesses. The answers varied from creating jobs, to bringing new products to market, to the prestige that can come with being a business owner, to ultimately helping mankind and make the world a better place.

As I sat there, listening to all of this, it suddenly struck me what the basic foundation for any business enterprise was, is and always will be.

“Making money,” I blurted out.

And apparently, I was right.

The successful former businessman in his own right, the founder of his share of multi-million dollar corporations, maintained that different businesses would have different credos, goals and objectives.

But all of that takes a back seat to profits. You don’t have any of the other stuff—prestige, job creation, R&D, charitable good works—without the money.

It’s all about the money, stupid. Show Me The Money.

Think about that the next time you take that pill for the umpteenth time, or undergo that hip replacement, or accept that pacemaker.

The drugs, the devices available to prolong our lives in the modern age are, in many ways, nothing short of remarkable. They really are. And I like to think that the doctor, who prescribes all this stuff to me, truly has my best health and welfare uppermost in his mind.

But you have to wonder at a regulator like the US Food and Drug Administration (FDA) that is partially funded by the industry over which it is charged to police on our behalf.

You have to wonder about the various loopholes and shortcuts that allow manufacturers to bring ‘promising’ new product to market faster—with minimal testing—only to have a lot of these drugs and medical devices turn out to be hugely problematic, if not outright dangerous.

You have to wonder at an FDA that acknowledges side effects as a necessary evil to the ingestion of chemicals whose benefits outweigh the risks for the largest segment of the population (there is no such thing, therefore, as a completely safe drug…).

You also have to wonder, the next time your grandmother breaks out her pill organizer and proceeds to ingest an insane number of different-colored pills…

How many of those pills are actually prescribed to treat an actual condition, v. the number that are needed to counteract the side effects from other pills?

And I wonder just how important that is to the drug companies, and their respective bottom lines? (And, I’m not the only one who’s wondered–I’m recalling the documentary “Big Bucks Big Pharma” from a few years ago.)

Their profits…

Pharmaceutical companies, and medical device manufacturers appear to be licenses to print money—especially with the large Baby Boomer sector approaching retirement. There’s so much money, in fact, that the cost of defending lawsuits is simply a cost of doing business.

There’s that word again. Business. Profits, and revenue, and dividends for shareholders. How important is it for drug companies to know their products are helping us to live longer, v. the money they are making off of us to their ultimate benefit and that of their investors?

I know what my business instructor, all those years ago, would say…

There’s nothing wrong with running a business—with making profits. That’s what business does.

What bothers me about the pharmaceutical and medical device industries, is that the consumer doesn’t have a choice…

Need a car? You can buy GM, or Toyota, or Honda, or Chrysler Fiat, or Mitsubishi…

If you need a TV, there’s Samsung, or LG, or Sony, or…

Or maybe you don’t want to buy one at all…

The difference with prescription drugs and medical devices is that more often than not, we don’t have a choice. We are mandated to take it, conscripted to do it. We rarely have the capacity to choose. And, if we’re lucky, the one choice we might get is to go for the generic version.

I’m at the age now where I’m on a low-dose aspirin a day, to keep my blood from getting as thick as my own head. I’ll probably be doing that for the rest of my life. But I’m also on a statin for high cholesterol, and I hate it. The sooner I can get my bad cholesterol in check by my own hand—diet and exercise—the happier I will be, and I can kiss the statin goodbye.

Ultimately, I don’t want to take something that I don’t need. But beyond that, I loathe being made to take something against my free will—something with which Big Pharma is laughing all the way to the bank.

I’ve always maintained that health—products, devices, drugs, health care of any kind—should be not-for-profit, free from greed and the blind pursuit of revenue.

But then, it wouldn’t be America, would it?

Tags: Big Pharma, Drugs, FDA, medical devices, pharmaceuticals
Posted in Drugs/Medical | 85093 Comments »2011-09-08+14%3A50%3A17Hunter+West

Government Audit of FDA Food Oversight Not Pretty

July 26th, 2011. By Hunter West

The Obama Administration has tried to beef up the FDA (US Food and Drug Administration). Give it more authority, and more autonomy.

But it’s too little, too late. And the law that the President signed in January, giving the FDA the power to mandate food recalls (it didn’t in the past???) has yet to be implemented and can’t be enforced until they figure out how.

Sorry, but I always thought the FDA was the prescription drug police, the overseer of our food chain and the watchdog over medical devices. Cross that watchdog and look out. Pushing the envelope and dissing the regulator might get you a warning if you’re lucky. Chances are, if you’re a pharmaceutical company, or a food supplier and you screw up—you WILL find yourself in the FDA slammer.

In our dreams…

It comes as no surprise that a recent government review of serious food recalls reveals that the FDA is dropping the ball on its responsibility for protecting the nation’s food supply.

And in so doing, protecting us.

According to a CNN report last week, the Department of Health and Human Safety Services (HHS) reviewed 17 Read the rest of this entry »

Tags: FDA, FDA Authority, FDA Recall, food safety, Government FDA Audit
Posted in Drugs/Medical, Food Illness | 8262No Comments »2011-07-26+13%3A08%3A33Hunter+West

Midway Point for Heart Drug Plavix Statute of Limitations

May 20th, 2011. By AbiK

Plavix has started to appear in the news again. Word about Plavix lawsuits—as happens with many pharma tort cases—had died downed within a few weeks of the FDA’s announcement that it would place a black box warning on Plavix (clopidogrel bisulfate). That black box label change happened back in March, 2010—so for many, the statute of limitations for filing a Plavix lawsuit will be up as we approach April 2012—and that’s not as far away as it might seem.

Plavix, which is prescribed for patients at higher risk for heart attack or stroke, is an anti-platelet drug that works by helping to prevent blood from forming clots.

The issue with Plavix—and the reason for the black box warning—is that some patients are not able to metabolize the drug effectively once it’s in their system. The result is that the drug’s effectiveness is reduced. Which, for a person who may be prone to heart attack or stroke, could perhaps be life-threatening.

The patients identified as those at risk for lower metabolization of Plavix are those with an abnormal CYP2C19 genotype—those known as “poor metabolizers”; CYP2C19 is the drug-metabolizing enzyme that serves as the body’s catalyst to convert Plavix to its active (and effective) form.

Reports have indicated that potentially 2 to 14 percent of the population are “poor metabolizers”. Read the rest of this entry »

Tags: antiplatelet, black box warning, blood clots, blood thinner, clopidogrel bisulfate, CYP2C19, FDA, heart attack, Plavix, plavix_heart_attack_stroke, stroke
Posted in Drugs/Medical, Emerging Issues | 78581 Comment »2011-05-20+19%3A07%3A16AbiK