AstraZeneca has agreed to pay fines totaling $520 million in settlement of charges made by the Food & Drug Administration (FDA) that AstraZeneca illegally marketed Seroquel; a prescription drug used for the treatment of schizophrenia.

Although Seroquel had not been approved by the FDA, AstraZeneca marketed and continued to market the drug for sometime after it was warned. The FDA says AstraZeneca wrongly made claims that Seroquel was appropriate for the treatment of:

• Alzheimer’s diseases
• Anxiety
• Dementia
• Depression
• Post-Traumatic Stress Disorder

To read some of the news surrounding the marketing of this drug, drug companies must use the same “play book” that Big Tobacco has used all these years.

The FDA says that not only did AstraZeneca violate promotional regulations of the drug; they also apparently are guilty of paying doctors to sign articles promoting the drug. The articles were actually written by employees or agents of AstraZeneca and the fees paid to physicians were largely to put their name on the article. That practice is called ghost writing and it is a practice that has been engaged in by pharmaceutical companies in the past as a way of artificially validating their drugs. In the world of “Joe Citizen” the practice of ghostwriting is also referred to as lying, cheating, an, well let’s just say it, fraud.

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Long term use of denture cream products such as Poligrip and Fixodent may be associated with paralysis, numbness, tingling, muscle weakness, and other neurological issues, according to recent reports by manufacturer GlaxoSmithKline. Thirty-four million Americans rely on dentures to replace their missing teeth and some wearers have had difficulty with balance and walking. Once thought a “medical mystery” to doctors, these symptoms are now linked to their denture creams.

The authors of a 2008 study published in the Journal of Neurology concluded that long-term denture cream overuse was the culprit in the cases of four patients who had unexplained limb weakness and poor balance. “The patients were using at least two tubes of denture cream a week,” commented Dr. Sharon Nations, lead researcher and associate professor in the department of neurology at the University of Texas Southwestern Medical Center. “It was long exposure to very high amounts of denture cream that led to their problems,” concluded Dr. Nations.

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It seems clear that it is not clear… or is it the things we know do not include the unknowns…or is it the things we don’t know are known unknowns?

In any event, based on comments I have seen in blogs, one thing is clear: the public does not understand the lawsuits that are occurring against Big Tobacco here in Florida.

The lawsuits in Florida, known as the Engle cases, largely involve people who became addicted to cigarettes and nicotine back in the 1920’s, 1930’s, 1940’s, and the 1950’s. The cases involve evidence of tobacco companies paying big bucks to:

• convince the public that cigarettes were good for you
• convince the public that nicotine was not addictive
• convince the public that smoking was a positive social choice
• convince the public that smoking did not cause cancer, emphysema, or other diseases

When Big Tobacco was required to place warning labels on cigarette packs, they spent huge sums of money backing articles and other efforts designed to convince the public about the safety of cigarettes; that stated no reliable link between smoking and cancer, much less other diseases, could be established; and that a grand conspiracy existed against cigarette smokers and the tobacco companies.

Bottom line? The Big Tobacco lawyers now want to reinvent history. They want to convince everyone that tobacco companies did not spend massive sums on advertising to convince the public that smoking was good for you, actually healthy for you.

They want to paint smokers who got hooked before the public was really aware of the dangers of smoking as making bad decisions. What they want the public to remember is only history that existed after warnings were given to the public and after all the smoke they could generate to hide the truth had dissipated.

Just check out this Camel ad from 1949:

Or this one from the 1950’s:

Multidistrict litigation proceedings against Matrixx Initiatives, Inc., the manufacturer of the over-the-counter cold product Zicam, are heating up.

This is a process known as multi-district litigation (or an MDL) and is often utilized in mass torts cases where a number of claimants have been injured in a similar fashion by a drug, medical device, other product, airline crash, etc. MDL cases often include class action claims, but are generally aimed at managing a large number of individual lawsuits filed by Plaintiffs who have all suffered harm due to the same general conduct of the Defendants.

Currently, there are more than 300 MDL cases pending in federal court jurisdictions all over the country involving a number of different products, corporate fraud and other wrongdoing, and accidents, such as:

• Chantix (MDL No. 2092 in Birmingham);
• Prempro (MDL No. 1507 in Little Rock);
• Air Crash in Madrid on August 20, 2008 (MDL No. 2135 pending in California);
• Chinese-Manufactured Drywall Products (MDL No. 2047 in New Orleans);
• Gadolinium-Based Contrast Agents (MDL No. 1909 in Cleveland);
• Terrorist Attacks of September 11, 2002 (MDL No. 1570 in New York City);
• Yasmin and Yaz (MDL No. 2100 in East St. Louis);
• General Motors Vehicle Plan (MDL No. 1392 in Illinois).

In November of 2009, the Judicial Panel for Multi-District Litigation assigned all of the Zicam cases to Judge Frederick Martone in Phoenix, who will oversee pre-trial proceedings, discovery and the bellwether trial process for all of the lawsuits pending in the federal court system.

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Parents and Caregivers take heed – another child “safety” device was recalled on Thursday, March 25, 2010.

The Consumer Product Safety Commission (CPSC) and Health Canada, in cooperation with the manufacturer, Evenflo, announced the recall of Evenflo’s Top-of-Stair wood gates after receiving 142 reports of the slats breaking or detaching from the gates.

Nearly 200,000 of these gates have been recalled, after reports of children gaining access to the stairs through the defective slats and children being injured by the slats themselves or from falls relating to the slats.

According to the CPSC, “The slats on the gate can break or detach, posing a fall hazard to children… Evenflo has received 142 reports of slats breaking and/or detaching from the gate.

Three children gained access to stairs. One of those children fell through the gate and down five steps; another fell down one step. Injuries included four children who sustained bumps and bruises to the head and seven children who sustained minor injuries including scratches, scrapes and bruises.”

The model numbers affected by the recall, produced between October 2007 and July 2009, include 10502 and 10512.  The model number is located on the bottom rail of the gate. The defective wooden gates were sold by Toys “R” Us, Burlington Baby Depot, Kmart and other juvenile product and wholesale retailers throughout the U.S. and Canada.

The CPSC urges parents and caretakers to cease use of the recalled gates and contact Evenflo toll-free at (800) 233-5921 Monday through Friday from 8 a.m. to 5 p.m. or online at safety.evenflo.com to receive a complimentary replacement Evenflo Top-of-Stair™ Plus Wood Gate.

Those Big Tobacco guys are at it again.

Do they not care for Florida juries, Florida judges, or the Florida Supreme Court? At the least, Big Tobacco does not like the Florida Supreme Court’s decision in the “Engle” cases. These cases stem from a class, which was decertified by the Florida Supreme Court.

Big Tobacco just suffered yet another loss in Fort Lauderdale, Florida; where a jury, after hearing evidence, was apparently so outraged by the past conduct of Big tobacco they rendered a $20 million verdict for punitive damages against the tobacco companies. This was a case involving a 50 year smoker who died of lung cancer. The jury awarded $10 million in compensatory damages and assessed one third responsibility for his death against Mr. Cohen himself.

The tobacco companies are on a losing streak with juries who are permitted to hear even a small capsule of their history of conduct in marketing, manipulating and chemically engineering cigarettes. After this verdict on behalf of Mr. Cohen, Phillip Morris issued statements, which now have become the “party line” mantra and could simply be tape recorded and played after every trial they lose:

“We will seek further review of this verdict because this jury was allowed to rely on findings by a prior jury that are totally unrelated to the individual smoker in this case in violation of Florida law and due process.”

Let’s take a look at these “findings by a prior jury” about which Big Tobacco is so worked up. The findings they do not like and apparently feel are unfair, were actually set forth by the Florida Supreme Court after review of trial transcripts and other records involved in the “Engle” trials that went on over two years:

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The U.S. Consumer Product Safety Commission (CPSC) and Health Canada (HC) announced today that a free replacement program has begun for the “SlingRider” and “Wendy Bellissimo” infant slings, manufactured by Infantino LLC, of San Diego, California.  One million slings are being recalled in the United States and 15,000 are being recalled in Canada, in a cooperative effort with the manufacturer.

The CPSC has called for consumers to immediately stop using these slings for infants younger than four months of age due to a risk of suffocation.  The recall is announced following reports of three infant deaths that occurred in these slings last year involving 7-week-old infant, a 6-day-old infant and a 3-month-old infant.

The two slings involved in the recall are both soft fabric baby carriers with a strap which allows the parent or caregiver to have the baby lying against their chest.  The “SlingRider” model has “Infantino” is printed on the plastic slider located on the strap.  The “Wendy Bellissimo” carriers were sold only at Babies “R” Us and have a sewn-in label on the inside of the sling strap that says in part “Wendy Bellissimo Media, Inc.”

Consumers can contact Infantino toll-free at (866) 860-1361 between 11 a.m. and 7 p.m. ET Monday through Friday, or visit the company’s Web site to receive a free replacement product.

Suppose that when a product malfunctions it was acceptable for the manufacturer to pay “experts”, recognized and notable professionals; to write articles, opinion letters, and studies, that spoke of the product’s safety. Articles that dispelled any notion that the product was really what was causing the problem.

Suppose that each of these “experts” was paid for their literary contributions, but did not disclose the payment.

Does not happen? Experienced, reputable “experts” would never agree to such a charade?

Unfortunately, it happens all the time.

I have been dealing with experts for many years and have often heard the trap of, “well, she teaches at ___________ School, she must know what she is talking about” or “he did clinical research at _______________ institution, he is certainly an expert”. These are constant traps people fall into. Where an expert teaches or was educated is a very small part of what does or does not make them an expert.

Experts are human. Experts can be influenced by money; by self interest, and by a really good “snow job” from a manufacturer.

This topic has once again raised its ugly head through discoveries made about the drug, Avandia. The Mayo Clinic did a retrospective study, in which they determined that many “experts” forgot to disclose financial ties they had with the manufacturer, GlaxoSmithKline.

Avandia is suspected of causing fluid retention, congestive heart failure, and heart attacks in diabetic patients.

It seems a good time for the pharmaceutical and medical device industry to adopt strict guidelines relating to disclosures of possibly prejudicing financial or other interests, which “experts” may have in connection with products or drugs.

If the industry will not do it voluntarily, perhaps it is overdue for the Food & Drug Administration to compel them.

As thousands of Post-Engle cases wind their way through the Florida court system, Philip Morris, R. J. Reynolds, Lorillard and Liggett & Myers are facing daily challenges.  After years of priding themselves on winning most of  the lawsuits filed against them through historic “scorched earth” tactics, it appears that those days are over (and perhaps it is time for Big Tobacco to rewrite that old playbook).

Here are just a few of the highlights for the past week:

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First, let me start with a disclaimer of sorts. I admire people who have professions I wish I had; writers, for example. I admire someone who can combine words on a page and make me think or help me escape.

I thought, though, that if you chose to write non-fiction it required you to know something about the subject.  If you were uninformed about the subject, I assumed you researched it. If the subject was something involving important social, political or medical issues, you certainly would research it.

Right?

Apparently, not all reporters feel that way. A Palm Beach Post reporter wrote in yesterday’s paper something about which he clearly knows little or nothing. The title was: “What part of ‘hazardous’ don’t smokers get?”

This is a story criticizing smokers and casting judgment on those smokers who have sued Big Tobacco; the “Engle” plaintiffs. It seems evident to me this reporter clearly spent no time researching and brought an entire collection of “baggage” into his article.

The only tangible piece of information the reporter provides is that his parents smoked and “…they were lifelong slaves to — and, ultimately, victims of — the habit.” This statement certainly demonstrates facts, but completely misses the mark on any shred of insight.

The reporter apologizes for knocking “a possibly dying woman as she struggles for her next breath”, but he clearly knows nothing about the case, trial, or facts of the lawsuit filed by Cindy Naugle. This reporter also must have no respect for the intelligence of jurors who after hearing weeks of evidence, must have been outraged by the conduct of Big Tobacco, causing them to render a $300 million verdict.

All of this demonstrates at least one central issue. Before “dashing off” this article, want of any facts, the reporter could not have done even a modicum of research. Before criticizing an entire class of people, perhaps he should try researching and reading, just a little.

I have read many, many documents produced by Big Tobacco and they are full of thoughts, plans, and schemes to hopelessly addict people; keep them addicted; lure young children to become smokers; and to deceive the public about the dangers of smoking.

For those who who want to know facts about Big Tobacco and not hyperbole, I recommend the following sites:

Tobacco Documents

Legacy Tobacco Documents Library

British American Tobacco Documents Archive

Tobacco Control Archives

Tobacco Archives

Philip Morris USA

The Legacy Tobacco Documents

The Honorable Judge Gladys Kessler’s Findings Against Big Tobacco

So, to the Palm Beach Post writer I can only recommend that perhaps you should read more than you write…at least for a while.