Our law firm has tried eight trials in a row to successful plaintiffs’ verdicts; involving what has become known as the “Engle Progeny Cases”. These cases arise from the “Engle” case tried two decades ago in which juries heard 12 months of evidence and made a series of findings about cigarettes. Subsequently, the Florida Supreme Court found the following facts about the conduct of tobacco companies including:

• Cigarettes are addictive.
• Tobacco companies concealed important information about the dangerous health effects and the addictive nature of cigarettes from the public.
• Smoking cigarettes cause over 20 different diseases.
• Cigarettes are a defective product placed in the market by tobacco companies.
• Cigarettes are unreasonably dangerous as manufactured by tobacco companies.
• Tobacco companies conspired to conceal from the public important information about cigarettes and the dangers of smoking.
• Tobacco companies were negligent.

Those of us in this law firm who have worked on cases against the tobacco companies have read the documents used in the Engle case and other cases, including the Minnesota Attorney General’s case. Once you read and review those documents it could not be clearer that all of the findings by the Florida Supreme Court set forth above are absolutely, crystal clear. In fact, because so much evidence and so many documents exist, most of it is never exhibited at the trials of cases against tobacco companies by tobacco company victims – most jurors never see but a small fraction of all of the evidence available .

We have seen the evidence of an industry that has made a science out of hiding, lying and manipulating. We have seen the documents summarizing plans by the tobacco companies to manipulate the nicotine in cigarettes; to create marketing plans that target teenagers; and to create “scientific” data in order to support the message that smoking cigarettes is actually good for you. Tobacco’s marketing plans for doctors to tell the public that smoking is good for you; athletes talking about smoking cigarettes improving their “wind”; and movie stars glamorizing the entire smoking genre – all are diabolically brilliant.

So, quite frankly, members of our firm were not at all surprised that we received two verdicts in favor of our clients and against the tobacco companies; in two different trials; tried in two different parts of Florida. The fact is that when anyone involved in the trial of tobacco cases hears about a verdict in favor of the tobacco companies, we are, well, shocked.

It is inspiring that two juries; in two different geographic locations; with two different sets of lawyers, can reach the same conclusion: the tobacco industry addicted people to a drug they knew was one of the single most addictive drugs in existence and then further manipulated that drug to increase its desperate hold on smokers. Then this industry literally invented the art of propaganda marketing and threw billions of dollars to make it successful.

We are pleased that our clients received their opportunity for justice in receiving verdicts of $3.5 million in one case and $2.7 million in another case. We would also like to recognize the talented attorneys who tried these cases: James Gustafson, Matthew Schultz (Levin, Papantomio law firm), Brian Denney, and Hardee Bass.

These were truly victories for “the good guys”.

When faced with a possible danger, how much of a warning do you need? As far as the Food and Drug Administration is concerned, your tolerance for risk is pretty high. And what about its responsibility for sounding the alarm? Eh, that can wait a while.

When picking up a prescription drug from your pharmacist, you usually receive a few sheets of paper detailing how to use the medication and its possible side effects. Some warnings don’t sound so bad—nausea, loss of appetite, drowsiness. But then there are more extreme warnings…suicidal tendencies, liver failure, heart attack or even death. The text of these stronger warnings is outlined with a black square. Hopefully your doctor or pharmacist will point it out.

Called “black box warnings,” this wording is printing on drug packaging inserts after a drug has shown, through medical studies, to be quite harmful—even deadly—and the FDA deems it worthy of its strictest caution (yet seemingly not serious enough to remove it from pharmacy shelves).

For instance, Seattle Genetics Inc. announced last week that its Hodgkin lymphoma drug, Adcetris (brentuximab), will carry a box warning due to brain infection risk called progressive multifocal leukoencephalopathy (PML). This is a fatal condition that starts with memory loss, clumsiness and aphasia, an inability to communicate using language. There’s no known cure.

The box will also warn that taking Adcetris with cancer drug bleomycin may cause lung toxicity. Since it was approved in August 2011, three people have developed PML and about 2,000 people continue to take the drug.

So why doesn’t the FDA pull Adcetris off the market? According to Bloomberg estimates, Adcetris sales may surpass $275 million in 2014. Even if prescriptions wane between now and then, there’s still plenty for the drug to bring in. Will the FDA stand in the way? Not yet, it appears.

This is just one of many drugs that carries a box warning. In 2007, the FDA issued a black box warning for all antidepressants for users 18 to 24 years old who risk committing suicide when taking drugs like Paxil and Prozac and the other 37 antidepressants on the market. However, millions continue to take antidepressants, even though they’ve also been proven to cause pulmonary hypertension in babies of mothers who took them during pregnancy and triple the risk of potentially fatal falls for people with dementia living in nursing homes.

And there are many other popular drugs with black box warnings … Pfizer has a few you’ve heard of: the anti-inflammatory Celebrex, contraceptive Depo-Provera and smoking cessation drug Chantix. And although they’ve been shown to cause cardiovascular problems, bone loss and suicidal actions (respectively), they remain on the market.

A classic case of prolonging a drug’s availability through a black box warning is Avandia (rosiglitazone), used to increase the body’s sensitivity to insulin in type 2 (adult-onset) diabetes. Its risk? A 43 percent increase chance of having a heart attack. Manufacturer GlaxoSmithKline provided less-than-transparent clinical data that focused on efficacy rather than safety, which the FDA used to fast-track its approval in 1999.

Eight years later, Avandia was making more than $2 billion a year for GSK before it got a black box warning. Some experts estimate that 100,000 heart attacks can be attributed to Avandia. In November 2011, the FDA severely restricted access to the drug, making it no longer available at retail pharmacies (but not pulled from the market completely). But there was still time for GSK to rake in more than $655 million in 2009 and $355 million in 2010 in U.S. sales alone, according to the firm’s annual report. In December 2011, GSK settled an illegal marketing suit related to Avandia and other drugs for $3 billion. The drug maker still came out ahead. Way ahead.

But the bigger point is: Why isn’t the FDA acting faster? You have to wonder who the FDA is truly looking out for. The drug manufacturers? They get to continue business as usual. Americans whose hearts, livers and lives are on the line? Well, at least we get a warning.

You wouldn’t let your toddler play in a busy street. That’s just good common sense that you already know. However, if you’re in a more precarious position—perhaps you’re pregnant and depressed—you need expert guidance you can trust to keep you healthy and your baby out of danger. You should be able to turn to the medical profession to steer you in a safe direction, right?

In your highly vulnerable state, the pharmaceutical and medical industries have assured you that there’s almost no risk in taking medications like antidepressants during pregnancy. But are they using common sense?

The British Medical Journal released a study last week that examined 1.6 million births from 1996 to 2007 and found that women who take selective serotonin reuptake inhibitors (SSRI) antidepressants late in their pregnancy are twice as likely to give birth to a baby with pulmonary hypertension.

This condition occurs when a newborn has high blood pressure in its lung and the lungs do not adequately adapt to breathing on their own after birth. It’s a dangerous disorder that can lead to organ failure, brain damage or even death. About one in every 1,000 babies is born with the condition.

Yet some experts are discounting the severity of the study’s findings. “You’re doubling the risk of extremely low risk to again, an extremely low risk,” Dr. Marjorie Greenfield, division director of obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland, told ABC News.*

Yes, and maybe there’s an extremely low risk that a driver won’t swerve his car in time to avoid hitting your kid.

But there’s a lot at stake in maintaining the “good name” of antidepressants. SSRIs hit the market in the 1980s and ’90s and gave hope to many people battling depression, eating disorders, post-traumatic stress disorder and obsessive-compulsive disorder. Medications like Prozac (fluoxetine), Zoloft (sertraline) and Lexapro (escitalopram) offered a safer, more effective answer to their side effect-plagued predecessors.

Today, antidepressants are the third most widely prescribed drugs in America, with 1 in 10 Americans taking some form of the drug, according to the Centers for Disease Control and Prevention. This translates into $20 billion in annual profits for pharmaceutical giants like Eli Lilly, Pfizer and Forest Pharmaceutical.

SSRIs work by targeting serotonin, a neurotransmitter that sends messages in the brain. The theory is that a serotonin imbalance will lead to mood variations and depression—or, conversely—that depression will cause a serotonin imbalance. It’s not known which comes first or even exactly how SSRIs work in the brain, other than that they seem to wash away the blues.

People who take SSRIs are subject to side effects that range from restlessness to committing suicide. And while depression during pregnancy can also be dangerous, is the risk worth the benefit? This isn’t the first time that question has been asked. To wit:

• In 2009, a Dutch study of 39,000 children found that those who had mothers who took antidepressants were more likely to have respiratory and digestive problems.
• A Denmark study released in 2010 followed 82,000 babies and discovered that those whose mothers took antidepressants had slight delays in reaching developmental milestones like sitting up and walking.
• A small Kaiser Permanente study in 2011 suggested a link between a pregnant woman’s SSRI intake and her baby’s chance of developing autism.

In addition, it is well known that newborns of mothers who take antidepressants like SSRIs are often jittery and cry excessively during their first month of life, likely due to the fact that stopping SSRIs abruptly causes irritability and is highly discouraged due to these withdrawal symptoms. But when you leave the womb laced with SSRIs, you don’t have much of a choice.

Yet antidepressants are still widely prescribed to pregnant women who are battling mood swings, highs and lows and emotion turmoil during their babies’ development. Are the manufacturers of these medications and physicians who dole them out trying to lead you through a healthy pregnancy and offering a variety of feasible treatment options…or are they sending your unborn baby out into oncoming traffic? Where’s the common sense there?

Let’s say you want to form a committee to evaluate the safety of a drug; say for example the drugs Yaz, Ocella and Yasmin.

You begin by looking for people who are “experts” about the drug, the ingredients in the drug and the use of the drug.

You find 26 or so people who fit your criteria.

Do you want to eliminate those people who may, might, could, have a conflict of interest; a “dog in the fight”; a prejudice one way or the other about the drug or its ingredients or its use?

If you are forming this committee as a public safety body, wouldn’t you also want to eliminate those individuals who even have “an appearance of conflict” in being independent about their evaluation of the drug?

I think any objective person would answer “yes” to both these questions. The Food & Drug Administration – well, they apparently do not subscribe to the same tenets for evaluating potential conflicts of interest as most of the rest of us.

On December 8, 2010, the FDA convened a committee to evaluate the safety and continued sale of Bayer’s drug Yaz. Yaz, Yasmin and Ocella and drospirenone as an ingredient. These drugs have been linked to an increased level of stroke, heart attack, pulmonary embolus and a number of other life threatening conditions in women who used them and otherwise had no risk factors for these conditions. It has been fairly established that these birth control drugs caused the life threatening and, in some cases, life ending conditions for thousands of women.

It also seems pretty clear that Bayer was less than forthcoming about the dangers associated with Yaz, Ocella, and Yasmin. In fact, there have been allegations that Bayer actually knew and consciously withheld important data from the Food & Drug Administration.

So, given all this “gray matter” surrounding the drug, you would want your conduct, as a regulator, to be beyond reproach, right? Testimony from a former FDA regulator, David Kessler, about some of the committee members raises concerns; perhaps not actual conflicts, but certainly potential conflicts suggesting that Bayer may have felt “owed” something by these committee members:

• One of the committee members was considered a “Bayer trained speaker” and was involved in promotional programs for Bayer. This same physician was in the Bayer speaker program and helped Bayer by reviewing research materials related to Yaz. This member also participated in video promotions on behalf of Bayer.
• A second committee member was listed as a “Bayer Contraception Expert” and apparently conducted research for a company that Bayer eventually purchased. The research the physician was involved in related to the use of drospirenone, which, of course, is the key ingredient in Yaz, Yasmin and Ocella.
• A third is listed by Bayer as a “key opinion leader” and an “external expert”.
• The fourth committee member apparently performed at least four research projects for Bayer; including one involving, yes, you guessed it, drospirenone. All four research projects seem to relate directly to contraceptive drugs.

In a paper filed with the court, Bayer now seeks to exclude the testimony of Dr. David Kessler; who believes these potential conflicts are important. In their court paper, Bayer does not argue that what Dr. Kessler states is untrue; rather Bayer argues that, for legal reasons, he should not be permitted to testify about his findings.

Does this all mean that the members, and possibly others, in the committee voted in favor of Bayer being allowed to keep its billion dollar money maker drug on the market? Not necessarily. That is not the point.

The point is that we will never know for certain.

No one should sit in judgment of whether a drug is or is not too dangerous to remain on the market if they have even the “appearance of” a conflict of interest. Why risk it? Why risk the potential of exposing the public to unnecessary risk if, in fact, a drug is too dangerous, but remains on the market because someone did have a “dog in the fight”?

The point is that these circumstances fairly raise the question of exactly who is really running the FDA and who does the Food & Drug Administration really work for in safety vs. marketing situations.

Big Tobacco has recently agreed to pay over $6 million to settle claims with the US Department of Justice.

A summary of the conduct causing the $6 million payment?

US district Court Judge Gladys Kessler, after hearing mountains of evidence, says this about the tobacco corporations:

• They lied.
• They misrepresented the truth.
• They deceived.
• They concealed.
• They destroyed documents.
• They distorted the truth.
• They abused the legal system.

They conspired to keep away from the public scrutiny documents that demonstrate “smoking’s negative health effects, nicotine addiction, and altered cigarette design to increase addiction, light- and low-tar cigarettes and marketing to young consumers”.

Judge Kessler went on to say:

“In short, defendants have marketed and sold their lethal product with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted”.

But, Big Tobacco did not act alone. Judge Kessler also had comments about Tobacco’s lawyers: they “played an absolutely central role in the creation and perpetuation of the enterprise and the implementation of its fraudulent schemes”.

These findings and Big Tobacco’s willingness to pay millions in order to avoid an airing of the evidence in a court of law come as no surprise to attorneys who have had to litigate against them. Simply reviewing the tobacco documents that have not been destroyed or hidden by Big Tobacco leads to only one conclusion. The tobacco industry has spent a hundred years perfecting a talent for hiding the truth and spinning facts to a point that fact becomes fiction.

Big Tobacco wrote the playbook for all other corporations who have held “shredding parties” and data dumping get-togethers in order to hide their wrongdoing.

Corporate America needs protection from trial lawyers!?

So goes the tort reform mantra. Trial lawyers are victimizing corporations; which is causing job loss; which is ruining the economy; which is leading to higher prices; which is causing Wall Street uncertainty; which is leading to all around chaos.

I have worked for Corporate America and I have worked for lawyers. All the lawyer jokes aside, I am happy to no longer be working in the moral ambiguity of Corporate America.

Let’s take today’s Corporate citizenship example. Pfizer, Inc.

Recently, Pfizer agreed to pay fines of a record amount, $2.3 billion, for hiding off-label drug marketing practices. That would be the practice of selling drugs for uses that the FDA has not approved them for or, in some cases, uses that the FDA has specifically prohibited. Now, Pfizer investors are suing Pfizer saying that the Corporate Pharma “promised” it would stop its off-label marketing practices, but $2.3 billion later proves otherwise.

Also, just unsealed yesterday, is a complaint filed against Pfizer for the marketing of its drug, “Vfend” (voriconazole); an antifungal medication approved for the treatment of invasive aspergillosis and candidemia. Pfizer requested FDA approval to market the drug as “empiric therapy” as well. Empiric therapy is the medical practice of initiating treatment before an actual diagnosis can be made based upon laboratory or other objective studies. Antibiotics and some antifungals are often prescribed, quite correctly, by physicians based only upon their judgment of a patient’s symptoms. Pfizer wanted the ability to market Vfend on this broad basis so that physicians would prescribe it more often and, thus, increase Pfizer’s profits proportionally.

The FDA refused to allow Pfizer to market Vfend as an empiric therapy. So, what did Pfizer do? You guessed it, they marketed Vfend for broad use anyway. Why would a corporation specifically violate FDA regulation?

Vfend was approved for the limited use of treating diagnosed fungal infections in 2002. Certainly, the fact that Pfizer made $825 million in 2010; $798 million in 2009; and $743 million in 2008 off the drug may have played into their decision. Also, Vfend was designed to replace an antifungal, Diflucan, for which Pfizer was losing its US patent. Diflucan had been generating annual sales for Pfizer averaging $1.1 billion per year – an amount they stood to lose if they could not replace Diflucan with a substitute.

The current lawsuit brought by the US government was the result of company “whistleblowers”; former employees of Pfizer who have provided information to the US government suggesting that Pfizer’s off-label marketing resulted in much higher sales and this resulted in a fraud upon Medicare and Medicaid.

Sour grapes from some disgruntled employees? Let’s take a look at those employees; both of whom reportedly resigned from Pfizer:

Catherine Brown was Senior Marketing Manager at Pfizer and had been employed by them from 1996 to 2005. She holds multiple degrees in science and business and she was, in fact, “Representative of the Year” in 1998. She resigned from Pfizer in 2005

Bernard Vezeau was a Senior Product Manager on the “Vfend Marketing Team”. Mr. Vezeau went to West Point, was a Captain in the US Army and held a Master’s degree in Business Administration. He worked for Pfizer between 1989 and 1992; and was rehired by them in 2003.

The complaint brought by the US government gives insight into what allegedly occurred. Apparently, Pfizer was using a study, “the 608 Study” to substantiate its claims that Vfend was effective in treating broad categories of fungal infections. Notably, Pfizer claimed that Vfend was effective in treating a very aggressive and potentially lethal fungal pathogen, C. glabrata. The problem explained in the complaint in detail is that the 608 study results were, first, of a small patient population and, second, the results were substantially manipulated by Pfizer in an effort to cause the study to demonstrate an effectiveness in treating broad categories of fungal infection when it, in fact, was not effective.

While Pfizer marketed Vfend as having an “extended spectrum” and recommending physicians use Vfend “at the earliest clinical suspicion of a fungal infection”, respected medical journals condemned these assertions. The New England Journal reviewers stated that the 608 study “significantly obfuscate the presentation of results” and found the study “a bit deceptive”. The Lancet published comments by a noted and respected expert in fungal infections as finding the results of the 608 study to be “most perplexing” and seeming “seriously flawed”. In English, they did not believe Pfizer’s study and, if the allegations prove to be true, these experts had good reason.

What did Brown and Vezeau do wrong? Well, from Pfizer’s perspective, they insisted on clarification of the study results and asked for substantiation for claims that Vfend was effective in treating broad categories of fungal infections, most notable a life threatening fungal like, C. glabrata. Pfizer’s medical director, Dr. Dr. Schlamm, allegedly complained that Mr. Vezeau, was asking too many questions about the 608 study.

Now, Pfizer stands accused, yet again, of marketing drugs for uses NOT approved by the FDA. In addition, they are accused of manipulating scientific studies and opinion – for what? To maximize profits.

So, ask yourself: who needs protection from whom?

Increase your possibility for blood clots – take Yaz birth control.

That would be bare truth in advertising were Bayer AG willing to be honest about its block buster contraceptive medication that generated over $1.5 billion in sales last year.

Another truth in advertising for the Yaz drug maker? We were just kidding when we claimed that Yaz was good for clearing up acne and treating all forms of PMS symptoms. We said it, but we did not mean it and, oh yeah, Yaz was never approved for those uses.

In an email discovered during the litigation that has been filed against Bayer, a company official encouraged sales representatives to propose that doctors prescribe Yaz for unapproved, off-label use:

“…what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder, and to seek information on “what they think the impact of Yaz will be.”

Yasmin and Yaz were never approved for treatment of common PMS symptoms.

In another email, a sales representative suggests that a noted gynecologist: “…definitely will mention the off-label benefits of our products.”

We have been writing since early 2009 about Bayer’s less than responsible commercials that used attractive, successful appearing women to promote its drugs Yaz, Yasmin and Ocella while using glitzy advertising to obfuscate the lack of FDA approval for some of its uses and to hide its sometimes lethal side effects.

An upcoming meeting at the FDA, on December 8, 2011, is designed to discuss the fate of oral contraceptives and the studies that have been conducted about them. At least one of the leading studies, conducted by Juergen Dinger then director of the Center for Epidemiology and Health Research, has come under scrutiny. Dr. Dinger is a former employee of the company initially marketing the Yasmin line of oral contraceptives and there have been emails discovered that cast some questionable light on the independence of the study. For example an executive at the company sent a 2005 email talking about the risk of “VTE” and “ATE” (referring to clots in users):

“One major reason for providing only tables and a synopsis is that we do not want to imply that we have a VTE problem but emphasize the fact that the study results indicate that Yasmin’s VTE/ATE is comparable to other” contraceptives.

Like buying “ghost writers”, some companies have sponsored “studies” of their products with the sole goal of supporting the safety of the product, rather than discovering independent, objective findings about their products.

Sadly, $1.5 billion buys a great deal of favorable opinions and provides more than enough motivation for companies to discover supportive findings in any study they conduct.

Just how much are consumers of eye care products supposed to take before they have had enough? On the heels of two major disasters in the eye care industry yet another has emerged. Cooper Vision a major manufacturer of eye care products including soft contact lenses has announced the recall of five million contact lenses due to sight threatening defects.

Initially Cooper announced in August it was recalling six hundred thousand Avaira Toric lenses after wearers reported severe pain, red eyes and hazy vision. More serious injuries including torn corneas were reported as well. Now the company has recently expanded that recall to five million lenses.

As is usual, the company blamed the problem on something simple and innocuous. This time it was a silicone oil residue on the lenses that they blame for the issues customers have experienced. Also par for the course, the original “recall” included only notice to eye care professionals and not consumers. Since many contact lens wearers buy several months’ worth of lenses at a time, this type of “soft” recall leaves thousands of defective devices in consumers’ medicine cabinets. Only after pressure from the FDA did Cooper take the extra step to alert consumers directly.

The expanded recall includes not only the Avaira Toric lenses but the Avaira Sphere as well. These lenses are sold at Wal-Mart, Costco and LensCrafters.

This recall comes on the heels of two major recalls of contact lens solutions manufactured by Bausch and Lomb and Advanced Medical Optics. In 2006 and 2007 these companies were forced to recall their newest flagship lens solutions when it was determined that they were causing sight threatening infections. Users of these solutions suffered unnecessary Fusarium and Acanthamoeba infections many of which led to the need for corneal transplant surgery and permanent loss of vision. Major litigation followed. To the best of my knowledge, neither Bausch and Lomb nor AMO has tried a single case. All have been resolved through settlement.

To find out if your Cooper Vision lenses are part of the recall, click on this link and see if the lot number on your lenses matches any listed on Cooper Vision’s recall list. http://www.coopervision.com/recall

It has now been more than a year since the DePuy ASR implant was recalled due to an alarmingly high rate of failure of the device, which was first documented in Australia and Europe years ago, at a time when the hip implants enjoyed continued strong sales in the United States.

For tens of thousands of patients, the past 15 months or so have been ones filled with extreme anxiety, pain, and frustration because of the following:

• Receiving countless empty promises, significant delays, and the proverbial “run around” from the Broadspire “claims program,” which has been far more kind to surgeons and healthcare providers with unpaid bills than to injured patients.
• Experiencing significant fear and apprehension over blood tests showing elevated levels of cobalt and chromium in their bloodstream, without any clear answers as to what harm this might cause them over time and what can be done about it.
• Enduring yet another painful hip implant revision surgery.  In some cases, within mere months of their original surgery (at which time, they were promised by DePuy that they would not have to undergo this ordeal for 15 years or more due to the alleged proven performance and superiority of the DePuy ASR and other metal-on-metal hip implant products over traditional ceramic and plastic liners).

Thousands of patients have suffered significant complications and have had less than favorable outcomes due to the trauma of extra procedures, complications stemming from metallosis and inflammatory reactions to the metal-on-metal surfaces, pseudotumor formation, infections, and other serious side effects.

Thankfully, scientists are working to answer questions that DePuy should have answered long before their first DePuy metal-on-metal device was implanted in patients.  Several studies have been recently published that help to expand the understanding of the systemic reaction that is triggered by metal-on-metal implants in patients as well as why these devices are failing at alarmingly high rates.  The recent most findings by scientists are:

• Cobalt and Chromium Ions Reduce Human Osteoblast-Like Cell Activity In Vitro, Reduce the OPG to RANKL Ratio, and Induce Oxidative Stress, published in the Journal of Orthopaedic Research, on October 24, 2011 – This study focused on how elevated levels of cobalt and chromium in the blood reduce the number of osteoblast-like cells and essentially impair the body’s ability to normally regenerate and maintain healthy bone.  Ultimately, the authors concluded that patients with elevated levels of chromium and cobalt in the blood are at risk for impaired bone health and that consideration should be given to removal of their metal-on-metal hip implants, even when x-rays and other evidence indicate that the DePuy ASR or other metal-on-metal implants are properly positioned without solid evidence of loosening.

• Corrosion Fatigue of Biomedical Metallic Alloys:  Mechanisms and Mitigation, published in the Acta Biomaterialia, in 2011 – This highly complex medical article from Brazil includes a review of the professional literature that has been published around the world on the scientific explanation for the widespread premature mechanical failure of metal-on-metal hip devices due to corrosion.  The study focuses on a number of different metals and alloys including titanium, surgical-grade stainless steel, cobalt, chromium, and magnesium.  The study also focuses on wear patterns, development of fatigue cracks, pitting corrosion, and formation of crevices at the taper junction, which allow infiltration and pooling of bodily fluids that induce corrosion and cause the release of metallic ions.  The processes of corrosion and metal fatigue combine to lead to premature failure of the devices, which necessitated the recall of the DePuy ASR implants, but, so far, has not resulted in the recall of a number of other metal-on-metal devices manufactured by DePuy (including some models in the popular Pinnacle family) as well as similar MOM products manufactured by Zimmer, Stryker, Biomet, Smith & Nephew, and other medical device companies.

• Pseudotumor from a Metal-on-Metal Hip, published in The Journal of Rheumatology, in 2011 – This publication from physicians in Tokyo includes a graphic, intra-operative photograph of a revision surgery where the synovial tissue has been stained due to the metallosis process.  This same staining as well as the presence of abnormal appearing inflammatory fluid and even metal shavings have been noted in other patients, including some of my clients, who have undergone revision surgeries following the DePuy ASR recall.  In the Japanese patient featured in this medical report, the surgeons noted the presence of pseudotumors in the patient’s pelvis, thigh, and gluteal region, which were triggered by a breakdown in the chemical properties of the metallic surfaces of the patient’s hip implant. This patient’s pseudotumors and obvious inflammatory reaction occurred about three years after being implanted with an Encore Medical metal-on-metal hip implant, a product that is now sold by DJO Surgical of Austin, Texas.

While the steady stream of new scientific reports are helpful to patients pursuing lawsuits against DePuy and other manufacturers, it is little comfort to those duped into implanting themselves with a toxic, defective product and are now faced with scary prospects with regard to their medical and surgical future.  While the Food & Drug Administration (“FDA”) has noted that it has been looking into safety issues for the past 15 months, the FDA’s slow pace in issuing stronger safety alerts and/or recalling defective metal-on-metal implants has resulted in tens of thousands of patients not being properly monitored for toxicity due to a lack of awareness by surgeons, patients, and the public.  I hope that the flood of new information will be disturbing enough for the FDA to act more definitively.

“Quid pro quo” happens in business all the time. You scratch my back, I’ll scratch yours.

Usually, the exchange is relatively even and the result doesn’t really cause any harm to anyone… or at least any harm of real consequence.

But, give me a million dollars for my “quo” and your “quid” must be huge!

That is what is happening between doctors and medical device manufacturers. Both drug companies and medical device manufacturers have been playing this game for decades. Whether it is a case in which the doctor gets paid for putting their name on an article they did not write and supporting the latest, greatest drug or they are paid for “consulting fees” that result in the doctor’s support of a particular new medical device. The result is the same – a respected name gets attached to the latest, greatest widget and sales rise.

The Chicago Tribune reports that “orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers…” Yes. You read that correctly – hundreds with six 0’s following them.

In 2007, device manufacturers were told they were going to be required to disclose payments made like this; so, since then the total amounts in tribute paid has dropped, while the amount of individual payments has gone up. So, manufacturers are simply being more selective in choosing “which” doctor and agreeable to paying a 40 % higher amount of “tribute” to each. The average payments per doctor have risen from $212,740 to $233,108; with some individual payments being as high as $1 million according to an analysis of statistics by Dr. Robert Steinbrook from Yale University School of Medicine.

Dr. Steinbrook notes that conflicts of interest continue as recently reported in The Spine Journal, in connection with a Medtronic clinical trial for recombinant bone morphogenetic protein:

“Financial information was available for 12 of the 13 original studies: “the median-known financial associations between the authors and Medtronic Inc were found to be approximately $12,000,000 to $16,000,000 per study (range, $560 000-$23 500 000). An editorial noted ‘a rising, if not malignant, doubt about the spine field’s ability to honestly assess and report on clinical practice and new technologies.”

Only 4% of physicians ever are treated with these bonuses by medical device manufacturers; so is it really a problem?

Yes.

The way your physician makes decisions about recommending drugs and medical devices is by reading about them in journals, going to conferences, and hearing about them from manufacturer sales representatives. The sales reps are a given that the information is slanted in favor of the manufacturer.

So, that leaves articles and conferences.

If the respected men and women in a given field are willing to receive payment for supporting a particular medical device or drug by making speeches at conferences or by talking to fellow physicians at them, then we are down to journal articles. We have already read the reports about articles being ghost written by marketing professionals and “experts” being paid to add their names as authors.

Who can your physician trust? Your physician who is simply trying to provide the best care he or she can – how do they make the best judgments of which device is the best and which new drug is the most effective? They read. They listen. The problem is…who are they listening to?