Drugs/Medical Archive

Week Adjourned: 11.4.11

November 4th, 2011. By LucyC

Top Class Actions

Could this mean resolution for thalidomide victims?…New research suggests that thalidomide—a drug that caused thousands of horrific cases of deformities in children—caused far more deformities in the U.S. than were reported during the height of the pharmaceutical crisis of the early 1960s.

Invented by German drug company Grunenthal, thalidomide was widely used throughout Europe during the late 1950s and early 1960s, resulting in thousands of deaths and extreme, disfiguring birth defects when used by women during pregnancy. The drug was never approved in the United States, but the new lawsuit filed late October 2011 alleges that as many as 2.5 million doses of the drug were distributed by more than 1,200 doctors to more than 20,000 people, including pregnant women.

Newly discovered and translated documents reveal that Smith, Kline and French (SKF), now owned by GlaxoSmithKline (GSK)conducted a trial of the drug in 1956 and 1957, but buried the evidence, allegedly resulting in a missed opportunity to save thousands of lives.

Instead, according to the filed lawsuit, brought on behalf of 13 men and women with severe birth defects, SKF concealed the results of its trial from the public, allowing another company, Richardson-Merrell, now owned by Sanofi-Aventis to move ahead with large-scale “clinical trials” that involved more than 20,000 people, including pregnant women.

The lawsuit also claims that conclusions made in the early 1960s about the types of birth defects caused by the thalidomide were incorrect.

According to legal counsel, researchers concluded that thalidomide causes bilateral birth defects, such as two missing or shortened arms or hearing loss in both ears. As a result, babies born with unilateral defects, such as one deformed limb, or hearing loss in only one ear were not deemed thalidomide victims, even when their mothers were given the drug while pregnant.

However, new research involving thalidomide as part of a treatment regimen in cancer patients show that many of the assumptions used in the 1960s are incorrect. The thalidomide lawsuit alleges that this new understanding of the drug means that many individuals who experienced unilateral defects may have been misdiagnosed when their doctors told them thalidomide could not have been the cause.

“Among other things we intend to show in court that thalidomide does not work through a neural mechanism as previously thought, but affects the vascular system,” a lawyer for the plaintiffs said.

The complaint claims that the defendants are either guilty of or liable for a civil conspiracy, failing to report and covering up evidence that thalidomide was harmful, especially when taken during the early stages of pregnancy. The lawsuit also says that the defendants were negligent in continuing to manufacture, test and distribute the drug.

Top Settlements

Motrin SJS Verdict. This is one for the books. Let’s hope it makes a difference. On October 3, 2011, a Los Angeles jury returned a record-setting verdict against Johnson & Johnson and their fully owned subsidiary McNeil Consumer Healthcare for $48.2 million—with pre-interest and cost of judgment it’s expected to reach $60 million. The lawsuit alleged that Motrin caused SJS/TENS or Stevens Johnson Syndrome (SJS), also known as Erythema Multiforme, Leyll’s Syndrome, and in its later stages, Toxic Epidermal Necrolysis (TEN). SJS/TEN is a serious and potentially life-threatening disease that causes large areas of the skin to become detached and lesions to develop in the mucous membranes.

The verdict was based on findings of malice towards the consumers of the over-the-counter drug Motrin, specifically for not putting a warning label on the product that could have spared Trejo’s and others’ health. This is believed to be the first verdict of its kind involving punitive damages associated with this over-the-counter temporary pain reliever.

At age 16, Christopher Trejo, who is now 22 years old, took some Motrin as directed on the label for less than one week, but contracted TEN. It caused a severe inside-out exfoliating reaction affecting all of his mucosal membranes, which is equivalent to second- and third-degree burns over 100% of his body. The TEN reaction also caused severe pulmonary damage, near-blindness, infertility, whole-body scarring and a hypoxic brain injury. Trejo’s abilities to see, hear, smell, taste and touch have been severely diminished.

After hearing the evidence, the jury found that the labeling on Motrin was inadequate and should have been changed years earlier to properly educate and alert consumers to the developing signs of severe reactions, which include skin reddening, rash and blisters. Early detection and treatment of these symptoms can prevent TEN or SJS.

Apple Playing the Same Old tune? Apple, Inc., has agreed to settle a consumer fraud class action lawsuit that could amount to over $50 million dollars in payouts—but before you get all excited know this “Apple has agreed to provide an iTunes® Store credit in the amount of $3.25 to all settlement class members who qualify and submit a valid claim form. ” That’s the skinny.

The lawsuit claimed that Apple advertised and sold gift cards which stated that if one purchased and used the gift card, all songs purchased at Apple’s online iTunes® Store would cost 99¢ per song. The lawsuit further claimed that in April, 2009, Apple raised the price of certain songs at the iTunes® store, yet refused to honor the promised 99¢ price when the gift cards were redeemed. In addition, the company continued to sell iTunes® gift cards with the phrase, “Songs are 99¢” printed on them.

Consumers who were overcharged for iTunes songs while using iTunes® 99¢ gift cards are now eligible to receive an iTunes® Store credit in the amount of $3.25 after completing the simple iTunes® class action lawsuit online claim form. Millions of e-mails are currently being sent to persons who may have used affected gift cards to purchase songs from the iTunes® Store.

You can find out how to make an Apple iTunes lawsuit claim here.

Ok—That’s enough for this week. See you at the bar—don’t forget your iPod.

Tags: Apple, birth defects, Class Action Lawsuit, Glaxo Smith Kline, iPod, iTunes, iTunes Gift Card Lawsuit, Johnson & Johnson, Motrin, Motrin Verdict, Settlement, SJS, Smith Kline French, Stevens Johnson Syndrome, Thalidomide, Thalidomide Lawsuit
Posted in Class Action, Drugs/Medical, lawsuits, Settlement, Week Adjourned | 9009No Comments »Week+Adjourned%3A+11.4.112011-11-04+23%3A01%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

When Cancer Research is Faulty, is it Fraud?

August 30th, 2011. By Hunter West

Cancer is so widespread that it touches us all in some way. Either you have lost a loved one or friend to cancer, you know someone who is afflicted—or you, yourself might be in the throes of battling some kind of cancer. It’s everywhere. Without getting into the debate as to why cancer rates appear to be rising, at least we can take solace in the research that we hope will one day result in a cure.

But perhaps that day may never happen. And recent events involving cancer research and fundraising have raised some doubts as to the effectiveness—and worth—of the cancer machine.

The New York Times recently chronicled the rise and fall of Dr. Anil Potti, a cancer researcher at Duke University Medical Center. Dr. Potti and colleagues had undertaken promising studies on genomic testing for molecular traits of cancerous tumors, and determining which chemotherapy treatment would be most appropriate.

Lung cancer patient Juliet Jacobs had a lot to gain and everything to lose, to that promise. Jacobs was part of the Duke University study, hoping for a breakthrough that would prolong her life.

Instead, the promising research was discredited due to the discovery of errors. Four gene signature papers were retracted, three trials at Duke were shuttered and the lead researcher resigned.

Juliet Jacobs died a few months following treatment that promised much but proved ineffective. Her family has launched a lawsuit, as have the relatives of other similarly doomed patients who had high hopes from the Duke research, since dashed.

Then, there’s the controversy in Canada over the allocation of fundraised dollars to research, compared with other needs of an apparently ravenous cancer machine.

A consumer advocacy arm of the Canadian Broadcasting Corporation last month looked at the financial records of the Canadian Cancer Society, following a complaint from a cancer researcher that research dollars appear to be harder to get—even though more people are Read the rest of this entry »

Tags: Cancer Drug Clinical Trials, Cancer Drugs, Cancer Research, Cancer Society, Duke University Medical Center
Posted in Drugs/Medical | 8383No Comments »2011-08-30+13%3A38%3A34Hunter+West

Prescription Hell: When Curing Your Ill Causes More Ills

August 4th, 2011. By AbiK

True Story: I saw a comment from a reader here at LawyersandSettlements.com who had gone to the doctor to get some help for his acne. While there, the doctor noticed that this guy’s hair was starting to thin. Long story short, the guy walked out of the doctor’s office with a prescription for Propecia. He now claims he suffers sexual side effects (like erectile dysfunction and impotence). Oh, and btw, he still had his acne.

It got me thinking…

I’m not a glass-half-empty type, but it’s easy to see how, with prescription drugs, one can envision a worst-case-scenario downward spiral of things—especially given the potential side effects with some drugs that are on the market.

So then I started thinking, what if…

What if a guy goes to the doctor for acne. What could happen based on which drugs he’s been prescribed and what the side effects of those drugs could be? The graphic above depicts “The Snake Pit” (classic movie if you haven’t seen it) version of taking prescription upon prescription. A modern day Dante’s “Inferno”. Only in this little vignette, no one emerges from hell in their attempt to mitigate (via new prescriptions) the snowball effect of increasingly negative side effects.

Here’s how this plays out.

(Note, yes, it’s hypothetical, assumes various doctors/specialists involved, and yes, assumes worst case and/or rare scenarios…but still, it could happen. And before you get on me for Accutane being off the market, the drug isotretinoin is still alive and kicking…)

A guy goes to the doctor for acne. He’s given Accutane (isotretinoin). A possible side effect of Accutane is Inflammatory Bowel Disease (IBD). To treat the IBD, he’s given Cipro (antibiotic) and Prednisone (corticosteroid). Cipro has been linked to tendon rupture. Reported, though rare, side effects of Prednisone can include high blood pressure and osteoporosis. Assuming his luck is nil, he experiences these side effects and is given Lisinopril (ACE inhibitor) to combat the high blood pressure, and Fosamax to help combat the osteoporosis.

As we know, Lisinopril has been linked to liver damage (or worse, liver failure). And Fosamax has been under fire for femur fractures. Which, outside of pain meds—which have their own set of side effects—requires another form of medical intervention (surgery). So we come to a “STOP” on that path.

But between the Accutane and the Lisinopril, he begins to experience some hair loss as well—a rare side effect of both drugs, and he’s Mr. Unlucky. So next up, Propecia. Propecia side effects include sexual dyfunction. And he finds himself having some “issues” on the love-making front. Well, there’s a drug for that—Viagra! But let’s face it, between hair loss, sexual dysfunction, a broken thigh bone, a ruptured tendon, high blood pressure and some bowel problems, is it any wonder this guy’s now depressed? So, it’s time for some SSRI’s—like Prozac. And Prozac’s been linked to suicidal behavior.

And, with that, I guess it’s another “STOP”.

Tags: Accutane, Cipro, Depression, femur fracture, Fosamax, Hair Loss, IBD, Inflammatory Bowel Disease, Isotretinoin, Lisinopril, Osteoporosis, Prednisone, Propecia, Prozac, Sexual Dysfunction, SSRI, Tendon Rupture, Viagra
Posted in Drugs/Medical | 82721 Comment »2011-08-04+16%3A19%3A39AbiK

Poll Results: Should States Legalize Marijuana?

August 2nd, 2011. By AbiK

We’ve just closed our poll asking whether states should legalize marijuana for medical use. And the results are interesting, as they seem to indicate that public opinion may be shifting a bit in favor of legalization.

Now, admittedly, you could argue that LawyersandSettlements.com readers might somehow inherently represent a group that’s more open to the idea of legal pot. But as of the close of our poll, the results based on 301 respondents are as follows:

Yes, Legalize Medical Marijuana: 75% (N=226)

No, Do Not Legalize Medical Marijuana 25% (N=75)

The reason for saying that public opinion might be shifting a bit is that when we took a look at the same question asked over at Urtak.com a while back, the results were not as clear cut as they appear to be here. At the time, only 55% of respondents at Urtak.com felt that medical marijuana should be legalized.

For those who are keeping track, there are currently 16 states (and Washington DC) in which medical marijuana is legal: Alaska, Arizona, California, Colorado, Washington DC, Delaware, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington.

Additionally, according to MedicalMarijuana.ProCon.org, there are 10 states that have pending medical marijuana legislation: Alabama, Connecticut, Idaho, Illinois, Massachusetts, New Hampshire, New York, North Carolina, Ohio and Pennsylvania.

Tags: Legal Marijuana, Legalize Medical Marijuana, Legalize Pot, Medical Marijuana, Poll
Posted in Drugs/Medical, Emerging Issues | 8217No Comments »2011-08-02+14%3A14%3A55AbiK