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”.

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.

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.

As I have written many times before, I believe in the jury system, but it requires a well-informed jury, given all the facts and evidence, to arrive at a just decision. Based upon my own research and the below discussion, I must conclude that, more likely than not, the jurors in the case of Hunter v Phillip Morris resulted in a less than full disclosure of the evidence relating to the outrageous conduct of the tobacco industry.

I have read many, many of the documents that comprise those involving Big Tobacco’s evolution in the development and production of cigarettes; evolution and production because what most people think of as tobacco was abandoned by cigarette manufacturers decades ago. What they sold and continue to sell to Americans and the rest of the world is a chemically engineered plant that they have called “the best drug delivery system” ever created.

A federal judge, Judge Gladys Kessler, has also read the documents, heard the testimony and saw fit to condemn Big Tobacco for sins against the American public:

• These cases are about an industry that profits from selling a highly addictive product that causes a staggering number of deaths each year and Big Tobacco has known about the dangers for more than 50 years.
• “Defendants have marketed and sold their lethal products 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.”
• “Over the course of more than 50 years, Defendants lied, misrepresented and deceived the American public, including smokers and the young people they avidly sought as ‘replacement’ smokers about the devastating health effects of smoking and environmental tobacco smoke.”
• “The evidence in this case clearly establishes that Defendants have not ceased engaging in unlawful activity…. For example, most Defendants continue to fraudulently deny the adverse health effects of secondhand smoke which they recognized internally; all Defendants continue to market “low tar” cigarettes to consumers seeking to reduce their health risks or quit; all Defendants continue to fraudulently deny that they manipulate the nicotine delivery of their cigarettes in order to create and sustain addiction; some Defendants continue to deny that they market to youth in publications with significant youth readership and with imagery that targets youth; and some Defendants continue to  suppress and conceal information which might undermine their public or litigation position…. Their continuing conduct misleads consumers in order to maximize Defendants’ revenues by recruiting new smokers (the majority of whom are under the age of 18), preventing current smokers from quitting, and thereby sustaining the industry.”
• “Despite Their Internal Knowledge, Defendants Continued, From 1964 Onward, to Falsely Deny and Distort the Serious Health Effects of Smoking”
• “As of 2005, Defendants Still Do Not Admit the Serious Health Effects of Smoking Which They Recognized Internally Decades Ago”

Even a powerful industry like the tobacco companies does not hide, deceive or scheme on their own, though. Judge Kessler also has interesting things to say about lawyers that have counseled and defended the tobacco companies for all these decades:

• “At every stage, (Big Tobacco’s) lawyers played an absolutely central role in the creation and perpetuation of the Enterprise and the implementation of its fraudulent schemes. They devised and coordinated both national and international strategy; they directed scientists as to what research they should and should not undertake; they vetted scientific research papers and reports as well as public relations materials to ensure that the interests of the Enterprise would be protected; they identified “friendly” scientific witnesses, subsidized them with grants from the Center for Tobacco Research and the Center for Indoor Air Research, paid them enormous fees, and often hid the relationship between those witnesses and the industry; and they devised and carried out document destruction policies and took shelter behind baseless assertions of the attorney client privilege.”
• Through their recruiting and training of consultants around the world, Defendants created a cadre of seemingly independent consultants to support the industry’s position on secondhand smoke and to create the impression that a legitimate controversy existed among independent scientists. The global effort to create and manage this program required intense coordination among the companies and their counsel [outside lawyers].

When an objective eye is turned upon all the evidence relating to the conduct of the tobacco industry the conclusions are inescapable. So, how can jurors reach differing verdicts? The lawyers representing Big Tobacco are some of the best in the nation, possibly the world. They have had decades to refine arguments that may convince even the most experienced jurist  to exclude certain relevant evidence.

For example, in a tobacco case brought since the issuance of the Surgeon General’s report on smoking in the 1960’s and after warning labels were put on cigarettes, it might be argued that any evidence of conspiracy or fraud on the part of the tobacco companies that occurred prior to the 1960’s should be kept from the jury. Tobacco lawyers regularly challenge the experts employed by plaintiffs by arguing that those experts are simply reinterpreting prior studies from the past and have done no “independent” testing of their own. The fact is the tobacco industry spent millions of dollars “creating” research results and conducting studies that would bring forth the evidence they wanted revealed; so, actually conducting a study has questionable value.

Once all evidence of Big Tobacco’s conspiracies, fraudulent tactics and deceptive practices hits the “light of day” it Tobacco’s arguments go up in smoke.

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.

Your blood needs to clot, but it is a delicate balance. Insufficient clotting leads to excessive bleeding and too much clotting leads to obstructed blood flow, pulmonary embolism and strokes.

So, it is understandable that the Food & Drug Administration became worried about reports that birth control medications containing drospirenone were causing excessive clotting in women taking them. The FDA decided to conduct a review of literature and investigate the potential risks associated with birth control drugs such as, Yasmin, Zarah, Syeda, Safyral, Ocella, Yaz, Loryna, Gianvi, and Beyaz.

The Food & Drug Administration has now reached some preliminary conclusions that would be disturbing to me if I were a woman taking these medications. The FDA believe s that the increased risk for blood clots, pulmonary embolism and stroke are around 1.5 times more in women taking the drugs than in women taking other types of similar medications for birth control.

The manufacturer of Yaz and Yasmin agreed with the FDA in 2010 to amend its labeling to alert users of the potential for venous thromboembolism (VTE), but also indicated the risk was no greater than with other oral contraceptive preparations.

There are really two central issues.

The study and investigation being conducted by the Food & Drug Administration is exactly the same evaluation which should have been conducted by the manufacturers of these drugs BEFORE they were placed on the market. Where were the manufacturers when these drugs were being evaluated through clinical testing? Were risks of VTE suppressed during clinical trials? Were all the data of clinical trials provided to the FDA at the time the drug was submitted for final approval?

When Bayer began producing its commercials for Yaz depicting young, successful, attractive women talking about the miracles of Yaz, did they know? When Bayer began pushing the envelope by trying to promote Yaz as a treatment for acne in young women, did they know about the increased risks of stroke? When Yaz commercials with their fun loving, balloon flying commercials tried to lure young women to Yaz, did Bayer know that each person faced a potential one and one half times greater risk they would develop a stroke or risk death as a result of a pulmonary embolus?

So, it is great that the FDA is now evaluating these dangers of medications like Yaz, Yasmin and Beyaz; but where were these investigations and studies when manufacturers were making billions of dollars through the sale of them to young women?

The evidence condemning Metal on Metal (MOM) implants continues to grow. In a recent announcement by the National Joint Registry for England and Wales (NJR), it was revealed that 30% of MOM implants manufactured by DePuy Orthopaedics, Inc., a division of Johnson & Johnson require removal and revision within six years of implantation. The industry standard is 15 years or more.

In its report, the NJR revealed that MOM hip devices experience “by far” the highest rate of revision including removal and replacement. NJR data indicates that these devices are failing at double or triple the rate of others at five years. In addition, the report indicates that as time passes, the failure rate increases when compared to other hip implants. The data also tell us that women fared worse than men.

This report follows DePuy and Johnson & Johnson’s recall of both its ASR XL Acetabular and ASR Hip Resurfacing systems in August of 2011. It appears the recall was warranted. At the time of the recall, the reported failure rate for these two systems was 13%. This new data suggests the failure rate was even higher at 17%. At six years the NJR reported that 29% or almost one third of these devices required revision. Even a lay person with no medical training should recognize that failure rate as staggering. It also calls into question how the company and regulators would fail to identify this problem before doctors started pounding these rods and cups into the hips of thousands of patients!

The sad truth is they didn’t. Even if the company did, it’s unclear what they would have done with the information. A DePuy “spokesperson” said in response to the reported 1/3 failure rate that it, “shouldn’t necessarily be taken as gospel.”

Unlike other consumer recalls, dealing with the problem is not as simple as taking your car into the dealership for repairs. These patients have the defective devices implanted in their bodies. Fixing the problem requires undergoing painful revision surgery. Doctors are on record saying that revision surgery is much more complicated than the original surgery and carries far more risks. Many are unsuccessful leaving the patient with permanent disabilities.

In addition to regulatory action in Europe, the FDA has ordered 21 manufacturers of MOM implants to carefully study the issue of whether patients with these implants are being poisoned by the release of metal shavings or debris that is cast off when the device fails. Studies of patients with MOM implants have reported abnormally high blood levels of Cobalt and Chromium which are potentially dangerous. The FDA is studying the long term effects of heavy metal poisoning in these patients.

If you are a user of bisphosphonate drugs – be a very active participant in your therapy; do periodic research; ask questions; and demand reasonable answers.

An advisory panel to the Food & Drug Administration has recently taken action on the danger presented by drugs such as: Actonel, Fosamax and Boniva. These are drugs originally marketed by Merck (Fosamax) and prescribed for people suffering from osteoporosis. Sadly, the decisive action the committee panelists decided to take was to affirmatively do nothing. So, unless the FDA itself acts to strengthen warnings or information provided to patients at the time these drugs are prescribed, it will require vigilance on the part of patients to protect themselves.

Osteoporosis is a thinning of bone tissue and a loss of density in bone that usually develops over time. It is the single most common form of bone disease known. Ironically, bisphosphonates have been found by a number of researchers to cause atypical thigh and jaw fractures in patients taking them. This is particularly remarkable after patients have been taking the drugs for around five years or more.

One of the members of the advisory panel, Lewis Nelson, director of medical toxicology at New York University, said, “…be very clear that efficacy may fall off after a period of time, perhaps five years. Serious concerns have been raised about risk, and those need to be continually evaluated as well.”

Bisphosphonate sales has been a huge money maker for pharmaceutical companies:

• Fosamax’s, Merck, reached sales as high as $3.19 billion in 2005 before other maker’s products sharply reduced those yearly sales.
• Actonel’s maker, Warner Chilcott had 2010 sales of $579 million.
• All together bisphosphonate sales generated $4.2 billion in the U.S. and $7.6 billion in sales worldwide during 2010.

Merck ten year clinical studies demonstrate that Fosamax’s benefits outweigh its potential hazards to osteoporosis patients – there is a big surprise.

In a 17 to 6 vote, some panelists felt new, stronger warnings should be provided to patients. Other panelists felt there was insufficient data to warrant stronger warnings than already exist.

Dr. Jennifer P Schneider has a little different view. She was taking bisphosphonate drugs for osteoporosis, but was otherwise a completely healthy woman, when her femur fractured as she was simply standing and waiting for a New York subway train. She sets forth:

What should we advise our patients?  Bisphosphonates are stored in bone for up to 10 years after their consumption is stopped, although their metabolic effects are of shorter duration.  Studies have shown the efficacy of bisphosphonates in the first five years of therapy in improving bone density and diminishing the risk of fractures. After that, until additional studies are done that clarify the risks of non-traumatic fractures and delayed healing in patients on long-term bisphosphonates, and which risk factors, if any, can help predict which patients are at increased risk of these adverse events, it is reasonable to suggest to patients to stop the drug after several years, continue weight-bearing exercise and calcium, and wait to see what the next scheduled DEXA scan shows.

Since the 1980s, many have turned to medications such as Prozac to combat their depression.  However, those who are pregnant or attempting to get pregnant need to think again before taking these drugs.  In fact, Prozac, when taken during pregnancy, has resulted in many birth defects, some of which include limb defects, craniosynostosis, anal atresia, persistent pulmonary hypertension of the newborn (PPHN), omphalocele, heart defects, and neural tube birth defects.

On July 19, 2006, the FDA released a warning that SSRI antidepressants can cause serious or life-threatening lung problems in newborns whose mothers took the medication while pregnant. The warning came after a study was published in the New England Journal of Medicine that showed infants were six times more likely to suffer Persistent Pulmonary Hypertension in the Newborn (PPHN) after being exposed to SSRIs, the class of drugs that includes Prozac, Paxil, Celexa, Effexor, Lexapro, Pristiq, and Zoloft.   Babies whose mothers took Prozac and other antidepressant drugs in this class while pregnant may also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia.

Prozac (also known as fluoxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Prozac affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.  In the early 1970s, evidence of the role of serotonin in depression began to emerge, and the hypothesis that enhancing 5-HT neurotransmission would be a helpful way to combat depression was put forward.  On the basis of this hypothesis, efforts to develop agents that inhibit the uptake of 5-HT were initiated. These studies led to the discovery and development of Prozac, which was approved for the treatment of depression by the FDA in 1987.

Prozac has been manufactured and marketed by Eli Lilly & Company, which is based in Indianapolis, Indiana.  However, on August 2, 2011, Lily’s patent for this profitable drug expired.  This has resulted in an estimated loss of  $2.4 billion in annual sales for Lilly.   The patent was invalidated after a lengthy legal battle waged by a small, aggressive generic-drug company called Barr Laboratories.  The loss of this patent lawsuit by Lilly will allow other companies that want to sell the drug to be able to do so.  Now, a 20-milligram capsule that presently retails for $2.50 likely will fall to less than 25 cents per capsule.  This will significantly affect Lilly’s revenues, which were reported during the 2010 fiscal year to be $23 billion in total sales and $5 billion in net income.  Since it was launched in early 1988, Prozac has been one of the biggest-selling drugs in history; its $21 billion in sales represents about 30% of Lilly’s revenues in that period.  Lilly is also the manufacturer of other well-known psychiatric drugs, including  Cymbalta and Zyprexa.

It is unclear at this time how this change in the patent protection for Prozac will affect some of the pending and upcoming litigation being filed on behalf of children who have suffered devastating birth defects as a result of their mother’s ingestion of this drug during the first trimester of their pregnancies.  Nonetheless, the drug is still being prescribed and children are still being born with birth defects.

It is important that patients obtain the facts about antidepressants and use of the drugs during pregnancy.  It is also important that patients understand what remains unknown about the potential safety risks that Prozac and other drugs pose to a developing fetus, facts that would be shocking to most patients especially since the drugs have been marketed for more than 20 years!  Most importantly, speak with your doctor before doing anything, especially before getting off the medication, as it is very important that patients be properly weaned from antidepressants and that other supportive therapy be administered to manage the depression.