Depuy Hip Implant Recall

 

 Everything breaks down eventually. Anyone who owns a car or a bike or a refrigerator or a television or a home can personally testify to this universal truth. This also applies to the human body. There isn’t one person living on the planet that has never gotten sick or injured themselves.

Nowadays, we are much more fortunate than we were a few decades ago. Technological advancements have given us the chance to replace many body parts that are either broken or are in the process of breaking down. There are cochlear implants for the hearing impaired, there are prosthetic limbs for people who have lost theirs, and there are artificial valves and pacemakers that keep a heart beating. If you consider what the alternatives used to be, we have many reasons to be thankful that we are living in 2011 and not 1911.

While these advancements are certainly good things, none of us can pretend that these new parts are perfect. For one thing, a victim of an IED is probably glad that he is able to walk on his own again, but we suspect that he would rather have not lost his leg at all. And another aspect is that the principle that “everything breaks down eventually” still very much applies to these new replacement parts. But the problem we are having with a particular brand of hip replacements is not that they are breaking down due to the normal wear and tear, but because they were defective.

 

The hip replacement in question is made by a company called DuPuy, which is a subsidiary of Johnson and Johnson. A study determined that the ASH hip implant had a failure rate of 13% after five years. That means that about 1 in 8 of the patients who had a hip replacement can expect something to go wrong with their hip replacement at some point in the future.

For those of you who do not have an artificial hip, you should be aware that it is a long and often quite painful procedure. Anyone who has gone through the process probably doesn’t want to go through it again. But because this DuPuy ASH hip implant is defective, people who have the implant in them when it goes wrong will have no other choice but to go through the surgery again. Surgeons will have to go in, remove the defective hip implant and replace it with one that isn’t defective.

While all of this is bad enough, DuPuy’s handling of the situation (and by extension, Johnson and Johnson’s handling of it) left much to be desired. We would go so far as to make the claim that their delay towards taking action has made circumstances even worse.

According to an article in the New York Times, DuPuy kept marketing and selling the ASH hip implant, even after they were made aware that there was a higher than normal failure rate. Rather than call a halt to distribution until they could be sure about the safety of their products, it was business as usual.

One of the major consequences of this defective hip implant is that the defect causes the ball part to rub improperly against the cup if the two parts are not properly joined together. This causes metal debris (shrapnel, essentially) to separate from the implant. These metal shards are then free to travel around the body cavity of the person with the implant. When the muscles are exposed to this debris, the tissue can become inflamed and the muscles can be damaged. The only way around this is, as we said earlier, to re-do the surgery, which means re-opening the leg, taking out the implant, replacing the implant, and closing the leg.

It is our belief that anyone who has been forced to go through this process a second time should not have to pay for it. They shouldn’t have to open their wallets for one second in the hospital, or to the insurance company. They shouldn’t even have to pay the deductible. Anyone who has a defective hip implant is completely absolved from any financial expenditure whatsoever as far as we are concerned.

We also believe that anyone who has suffered from a defective hip implant should be compensated for their time, and most specifically, their pain and their suffering. Going through a hip replacement twice due to the negligence of someone else is not something that you should just forget about and let go.

Greenberg and Bederman is a personal injury law firm in Silver Spring, Maryland. We are currently offering legal assistance to those in the Washington, D.C. area who have been injured due to DuPuy’s ASH hip implant. If you or a loved one has been adversely affected by this defective hip replacement, contact Greenberg & Bederman for a free consultation today.

 

Canadian Yaz Study

 

The Food and Drug Administration recently released a study confirming what the British Medical Journal had already suggested in April. The FDA study found that birth control pills containing an ingredient called drospirenone put women at a greater risk of blood clotting than from other types of birth control pills.

The Canadian Medical Association Journal came to the same conclusion, stating that the risk for women taking pills with drospirenone is about 3 or 4 in 1,000. To put it in perspective, the risk from other pills is 1 in 1,000.

If there were only 1,000 women taking these pills, then 3 or 4 blood clotting episodes would be bad enough. But the pills that the BMJ, the CMAJ and the FDA are referring to are Yaz and Yasmin, which are birth control pills made by Bayer. Significantly more than 1,000 women are taking these pills. Hundreds of thousands of women all over the world are taking them, so the threat to the health of these women is much more wide spread.

It should also be mentioned that Bayer engaged in a particularly heavy advertising campaign which made quite a few misleading promises. The advertisements claimed that Yaz could prevent women from gaining weight, could cure acne and could prevent PMS. This wasn’t true. Some people who took the pill did not gain weight, but there isn’t much evidence that suggests that all women would experience the same thing. And some women did experience a clearing up of some pimples. But in the advertisements, they listed symptoms that are commonly associated with PMS, while what Yaz and Yasmin actually had an effect on were symptoms of Pre-Menstrual Dysphoric Disorder. PMDD is significantly different from PMS, and the ads implied that the two conditions were interchangeable.

 

These exaggerated claims caused Yaz and Yasmin to become one of the best selling birth control pills in the country, which led to more women unknowingly placing themselves in danger.

Normally when you think of blood clots (if you happen to think about them at all,) you would think of them as positive things. They are part of a naturally occurring mechanism that keeps us from bleeding to death. If you cut yourself, the blood in the area of the cut begins to thicken, making it easier for the flow of blood out of the body to stop. But the problem with drospirenone is that it is apparently creating blood clots where there is no reason for them. These clots generally form in the deep veins of the legs, which causes pain and swelling (deep vein thrombosis.) The real danger happens when these clots break into pieces, because then they are small enough to travel through the bloodstream. They can cause blockages in blood flow to the heart, which is what causes heart attacks, and they can cause blockages in blood flow to the brain, which is what causes strokes. They can also cause pulmonary embolisms, which are blockages in blood to the lungs.

Blood clotting has always been a concern with birth control pills, but the numbers weren’t that high. Our main concern is that Bayer put out a drug that elevates the risk of clotting, and engaged in misleading advertising in order to market it. The sheer number of women taking these pills makes Yaz and Yasmin a very real health risk.

Greenberg and Bederman are currently representing women in the Washington, D.C. area who were taking Yaz, Yasmin or Ocella, which is the generic version of the drug, and were injured or hospitalized as a result. Many of these health problems have effects that can last your whole life, and if the cause of the problems was a prescription drug that you took in good faith, then you shouldn’t have to bear the costs of your injury. If you live in Virginia, Maryland or Washington D.C. and you have been hurt due to Yaz, Yasmin or Ocella, contact Greenberg & Bederman for a free consultation today.

Toyota's Latest Recall

There are two ways to look at Toyota’s latest recall. The first option is to scratch your head and wonder if the people in Tokyo are capable of designing anything correctly, considering the amount of missteps and recalls that took place throughout most of 2010.

The second option is to believe that maybe the higher ups at Toyota have learned their lesson, which is that the correct action in the event of a defect is an immediate recall combined with complete repairs of the problem.

This current recall involves 1.53 million cars, most of which involve problems with the master cylinder, which could leak and cause the brakes to lose power. If you can say anything about Toyota, you can say that their recalls don’t seem to be over minor issues. They always seem to involve the steering, or the accelerator pedal, or the brakes, or anything that seriously puts the lives of drivers, passengers and passersby in danger.

This new immediate action is surprising, mainly because for quite a few years this was not how things were done at Toyota. Nobody there seemed to be interested in really fixing the defects in the cars at all. They danced around the issue, negotiated a lesser recall with the NHTSA that saved them money but didn’t really fix the problem, and hid behind a wall of silence, denials, and claims of trade secrecy privileges even as their cars started to get into accidents and people started to get injured or killed.

One man in Minnesota even spent almost four years in prison after his Toyota slammed into another car, killing all three of its occupants. Toyota’s policies of denial and not allowing any attorneys to access company information or the on-board computers that all Toyotas have, effectively helped keep this man in prison.

According to the New York Times, this quick response is part of Toyota’s new “global safety initiative,” and while we certainly have no problem with that (or any problem with the speed and efficiency of this recall,) we do have a problem with the behavior that made this new efficiency and commitment to safety necessary. A commitment to driver safety should be the first priority of any auto company. Safety recalls should not be plea bargained, and crucial information should not be kept from the public.

We also have a problem with Toyota swearing up and down that all of these instances can be chalked up to “driver error,” when there are simply too many examples of this not being the case.

The recalled models are as follows:

2005-2006 Toyota Avalon

2004-2006 Toyota Highlander

2004-2006 Lexus RX330

2006 Lexus GS300

2006 Lexus IS250

2006 Lexus IS350

If you own any of these vehicles, and yours has been affected, you should expect notification via e-mail or postcard from the Toyota Corporation. It is very important that you take your car in for the necessary repairs.

Greenberg and Bederman is apersonal injury law firm based in Silver Spring, Maryland. For twenty five years we have helped injury victims all over the Washington and Baltimore areas, and that includes Northern Virginia. We are currently offering legal assistance to anyone who has been injured due to a malfunctioning Toyota or other defective vehicle. Dealing with any injury case is not something that you should face alone, particularly if the injury was caused by the actions of a large corporation. Let Greenberg & Bederman handlle your personal injury negotiation. Contact Greenberg and Bederman for a free legal consultation today.

Car Recalls History and Legal Help

By now, everyone has heard about all of the crashes, injuries and recalls involved with Toyota over the past year. Practically every model that Toyota has out on the market in multiple model years has been subject to a recall. The recalls involve defective braking systems, bad steering, and stuck acceleration systems.

Far from being theoretical, these defects have caused very real harm to innocent people, most notably the Saylor family, who were killed in San Diego when their Lexus suddenly accelerated, and Kuoa Fong Lee, who spent years in prison for vehicular manslaughter after the accelerator on his Toyota Camry got stuck. That resulting accident killed three people.

As long as cars are designed and built by human beings, there will always be flaws. The most important element of car defects is how responsible the car company will be when the flaw is discovered. Will they own up and initiate the recall and make the repairs, or will they try to hide the fact that the flaws exist? In the case of Toyota, it appears that they did the latter.

 

We would like to say that defective cars are an anomaly, or that all car recalls occur due to minor, cosmetic malfunctions that don’t affect the safety of the car, but the truth is that history is loaded with examples of automotive recalls that occurred because people were put in serious danger. Here are just a few:

In 1971, General Motors recalled over 6.7 million cars due to malfunctioning auto mounts. One of the mounts in particular caused a serious hazard to drivers, mainly because when it broke the V8 engine would shift upwards, which, similar to Toyota’s almost 40 years later, would cause the car to suddenly accelerate. The total of accidents for such a widespread problem was miraculously low (only 18 reported injuries,) but GM still recalled the cars and made the necessary fixes.

Between 1971 and 1976, Ford released a car called the Pinto, which had no reinforcement between the gas tank and bolts attached to the rear differential. In the event of a rear collision, there was a serious danger of the gas tank getting punctured and leaking. Gasoline on the ground is never a positive thing in terms of safety. Even though the recall affected 2.2 million vehicles, six people died in Pinto fires after rear impact collisions.

Ford also had issues with a transmission defect in the 1970s that allowed cars to slip into reverse while the gear was in “park.” Although the NHTSA received thousands of complaints, only 98 accidents were attributed to the defect.

Ford Explorers made in the year 2000 were also subject to a massive recall, not necessarily due to the car but because of the Bridgestone/Firestone tires that were issued with them. They had a tendency to blow out. 250 people died as the result of these faulty tires.

Again, car recalls are nothing new, and sadly, deaths and injuries are the result of car defects. What is  not new is the fact that car companies rarely offer fair compensation for the people who were injured or killed.  Initial settlements offered are quite often incredibly low, and if the case is taken to arbitration or court, many car companies do everything they can to discredit the victims or pay the least amount they can. This is the reason that it is so important to have experienced legal counsel in the event that you have been injured by a defective car.

Greenberg and Bederman is an injury law firm based in Washington, D.C, and we are currently offering legal assistance to those who have been injured due to cars that are faulty and defective. We haveserve Maryland and Baltimore, and we can help anyone in the Washington, D.C. or Northern Virgnia area.

If you or a loved one has been injured in a car accident caused by a defective car, contact Greenberg and Bederman for a free legal consultation today.

Former Toyota Attorney Can Provide Evidence For Lawsuits

There has been an important development in the ongoing Toyota recall story. According to ABC News:

An arbitrator has ruled that a former top Toyota attorney turned whistleblower can submit internal Toyota documents in court in order to prove his claim that the company asked him to hide evidence of product defects from the public. Dimitrios Biller, former managing counsel for Toyota, handled product liability suits for the automaker, and claims it regularly hid evidence of safety defects from regulators and the public. As part of a "civil racketeering" suit against Toyota, Biller had sought to place into evidence what he claims are four boxes full of internal Toyota documents that will show he was asked to hide facts from plaintiffs during product liability lawsuits.

This is incredibly significant. As we have learned from reports of various plaintiffs’ attorneys who have been attempting to read the data off of the so-called “black boxes” that exist in Toyota vehicles, this corporation makes every effort to hide behind trade secrecy laws. In other words, they are often allowed to claim that providing crucial evidence would somehow allow others to view and co-opt their technology, which keeps attorneys for the injured from getting crucial evidence needed to prove their case. Toyota’s resistance to Mr. Biller’s requests to provide these documents to the court serves as a perfect example.

The arbitrator’s ruling means that Mr. Biller can offer proof to his claims that Toyota asked him to hide evidence regarding the many faults of Toyota vehicles, such as accelerator pedals that stuck, brakes that didn’t work, and steering that failed. The reason that this is important is because Mr. Biller’s contention shifts the premise from negligence to criminal negligence. It’s one thing if there were defects in Toyotas and the people at Toyota were unaware of them. But it is a different matter entirely if Toyota knew about these defects and actively tried to suppress other people finding out about them.

These defects weren’t minor in nature. It wasn’t a faulty radio knob or a glove compartment latch. Toyota’s defects put the lives of drivers, passengers and anyone in the vicinity of these malfunctions in serious danger. Thousands of Toyotas had defective floor mats that made the accelerator stick to the floor. Thousands more had accelerator pedals which stuck to the floor regardless of the floor mat. Thousands more had steering that momentarily gave out. These would all be bad enough if Toyota simply didn’t know. But Mr. Biller is claiming that they did know, and chose to cover these defects up rather than act to fix them, all while Toyota drivers were losing control of their cars. Again, this goes beyond negligence and into criminal behavior, and it is a positive development that Toyota will not be able to hide behind any corporate privilege or trade secrecy laws.

Greenberg and Bederman is a personal injury law firm based in the Washington, D.C. area. We are currently offering legal assistance to those who have been injured incar accidents caused by faulty and malfunctioning Toyota vehicles. If you or a loved one has been injured due to a Toyota crash, contact Greenberg and Bederman for a free legal consultation today.

 

Toyota Engineers On The Job?

 

Believe it or not, there used to be a time when Toyota had a reputation for manufacturing safe and reliable cars. That certainly seems like a long time ago, what with all of the crashes and deaths and injuries. But there was a time when people used to get into Toyota model cars without having to worry about dangerous floor mats, bad brakes, stuck accelerators and faulty steering.

To be sure, the crash ratings for these cars were mostly average. But in fairness, they were no better or no worse than many of the other cars that were out on the market. Toyotas in the 90s and in most of the first decade of the twentieth century were no better or worse than Hondas, Chevys, Chryslers or Nissans in terms of safety.

So while they weren’t exactly up to the high safety standards of say, Saab or Volvo, they were at least well within established safety requirements.

 

 

We aren’t sure what went wrong with Toyota. Every car manufacturer has safety recalls, some major and some minor, but we have never seen so many things go so drastically wrong on so many models from the same company at the same time. It wasn’t just that one model had problems with floor mats jamming the accelerator pedal in one model. Or it wasn’t that just one model had a few accelerator pedals stick in the down position. This was a systematic failure of multiple cars. It was as if the entire Toyota Corporation all took a vacation at the same time and missed some very important meetings.

It was a failure of the engineering developers to not notice that the accelerator pedal was sticking. It was a failure of the design team to not notice that the floor mats were causing the pedals in other models to stick. It was another failure of the engineering team to not notice that there was an inconsistency in braking and steering when the Prius shifted between the electric and gas motor.

It was a failure of the company to “negotiate” a lesser recall with the National Highway Traffic Safety Administration, which might have saved Toyota millions in costs, but cost hundreds of people pain, money, time, and in some cases, their lives.

It was only a matter of time before all of these failures caught up with Toyota. There were too many bizarre and high profile accidents involving Toyota for the government to ignore. One recall came after another, and the Capitol Hill testimony of both crash victims and the President of Toyota itself did practically irreparable damage to the Toyota brand.

So you would think that after all of this, the Toyota Corporation has learned its lesson, right?

Apr 15, 2010: Toyota now says it will investigate its entire SUV lineup for safety problems uncovered by Consumer Reports earlier this week. 

The automaker announced Tuesday it would stop selling the 2010 Lexus GX 460 temporarily as it looks into handling problems that could make it unsafe.

Consumer Reports said the Lexus GX 460 slides around too much when drivers lift their foot off the gas pedal while negotiating around a tight curve. The vehicle can actually slide sideways, Consumer Reports says, which could result in the SUV hitting a curb or leaving the road.

Right on the heels of the worst year in Toyota’s history, yet another completely unsafe vehicle is put out on the market. It is a bad sign when the staff at Consumer Reports catches a potential major safety hazard before the engineering department at a major automobile manufacturer does. It appears that whatever overhauls that were promised by Toyota during the recalls and hearings on Capitol Hill have yet to take place.

Greenberg and Bederman is a Washington, D.C. area injury law firm that helps those who have been hurt due to no fault, or negligence,  of their own. The recent Toyota malfunctions have injured thousands of people all over the country, including people in Washington, Virginia and Maryland. If you or a loved one has been injured due to a Toyota that did not work as it should have, contact Greenberg & Bederman for a free toyota injury legal consultation today.

To learn more about personal injury law, please read our personal injury lawyer page, or watch our personal injury lawyer videos.

 

NASA May Help Solve Toyota Accelerator Defect

If you need brainpower in the United States of America, you can’t do much better than the National Aeronautics and Space Administration. Since it’s beginning in 1958, NASA has been responsible for any and all space exploration undertaken by the United States. That includes the first manned multiple orbit of the earth, the first manned flight around the moon, the first landing on the moon, the first satellite to leave our solar system, the first re-usable manned spacecraft, and any manner of advancements in satellite technology.

Anything involving spaceflight takes a mastery of multiple scientific disciplines. There has to be a mastery of chemistry (rocket fuel and lubricants, to name only a few applications,) physics (launching the spacecraft and keeping on a correct trajectory,) biology and environmental sciences (keeping the astronauts alive during the mission,) To give you an idea as to how impressive the minds are over at NASA, consider what had to be done for each of the Apollo lunar missions.

 

The vehicle that the astronauts were travelling in had to essentially break in half, and then one of the two sections had to do a 180 degree turn, and then gently thrust back towards the other section, where they re-attached. Bear in mind that this had to be done while they were travelling through the vacuum of space at thousands of miles an hour. Another stunning feat was the reattachment of the lunar module, which essentially launched itself from the surface of the moon (with two astronauts inside) and attached itself to the orbit module which was zooming along at thousands of feet above the surface. If you want a real life equivalent of how difficult that is, try hitting a bird flying overhead with a rock. If you also consider that these amazing things were done in the late sixties, which was practically the Stone Age in terms of computer technology, that gives you an idea as to how smart the NASA people are.

Any endeavor into outer space has to involve all manner of computers. All of the systems on any spacecraft are run by them, including steering, thrust, life support and navigation. Without the advent of computers, it would be impossible for us to imagine getting into space at all. If you consider that your average space craft is run by electronic systems that are often controlled from thousands (sometimes hundreds of thousands) of miles away, you would have to assume that NASA knows what it is doing when it comes to computers.

This is why we consider it a good thing that Transportation Secretary Ray LaHood has brought in scientists from NASA to investigate the recent alleged unintended acceleration incidents that have occurred in so many Toyota vehicles. The NASA scientists are specialists in computer controlled electronic systems, electromagnetic interference, software integrity and hardware. In other words, they are the folks who you can expect to get to the bottom of what has been going wrong.

It might seem a little drastic, bringing in space shuttle mechanics to examine the inner workings of a Toyota Tercel, but one of the reasons that they have to be drastic is that Toyota itself isn’t talking. They are fiercely protective of their design and data, and are equally tight lipped when it comes to allowing crash data to be studied. Part of this might be because they are genuinely concerned about somebody making off with proprietary software or design, but we suspect it also has something to do with Toyota not wanting to directly provide any evidence of culpability on their parts. In other words, they want to make it as difficult as possible for any victims of random accelerations, brake failures or steering problems to be fairly compensated for their injuries and damaged property.

Toyota has shown a willingness to put profits over driver safety before. In what was probably one of the darkest moments in government consumer protection history, the National Highway Traffic Safety Administration allowed Toyota to “negotiate” a 2007 recall that was limited to defective floor mats rather than move forward with a more extensive recall that could have possibly saved quite a few lives. Internal documents from Toyota referred to this as a “win.”  

 

We aren’t sure what the outcome will be of this NASA investigation, but what we are sure of is that too many people have been injured or even killed due to defective Toyotas for this to be considered a random, freak occurrence. Based on the evidence that has been gathered and the incidents that have been reported, we believe that Toyota not only put out a defective product, but also were aware of these defects and the dangers that they posed to the general public.

Greenberg and Bederman is a Washington, D.C. based injury law firm that is currently offering legal assistance to those who have been hurt due to Toyota malfunctions. We can help anyone in Maryland, Virginia, or Washington, D.C.

If you or a loved one has been injured in a Toyota accident, contact Greenberg and Bederman for a free legal consultation today.

Does FDA Ensure Safety of Yaz or Yasmin?

The Food and Drug Administration’s  (FDA)primary responsibility is to see that any food products and pharmaceuticals are safe for consumption or use, or at the very least they make sure that the benefits outweigh the risks. For instance, if you were to come up with an effective pain reliever using ingredients in your kitchen, you couldn’t mass produce and sell it as a pain reliever unless you had your product go through the FDA approval process.

This process actually takes years. After initial testing, the pharmaceutical companies have to send their testing results to the FDA’s Center for Drug Evaluation Research (CDER.) These results are then reviewed extensively by a team of doctors, statisticians, pharmacologists and other scientists. Aside from going over the testing results, they also see if the labeling proposed by the pharmaceutical company is accurate. In other words, if the CDER perceives a risk in the drug that isn’t mentioned in the labeling, or feels that the supposed benefits of a drug are overstated, it is their duty to inform the pharmaceutical company of their findings.

It is important to mention that the CDER doesn’t actually test the drugs themselves. They only go over the data provided to them by the pharmaceutical companies. That’s not to say that they do a poor job in analyzing the data, but what is to prevent the pharmaceutical companies from turning in half truths or incomplete information? What if the pharmaceutical companies fail to mention a possible side-effect because they view it to be “statistically unlikely?”

 

Another aspect of the CDER’s testing and safety process is that the same scientists, statisticians, doctors and pharmacologists who approve a drug as safe for consumption are the same ones who are in charge of handling safety concerns after the drug has been on the market. This has led to real problems in the past.

In 1999, the FDA approved a drug called Vioxx, which was developed and initially tested by Merck. Vioxx was marketed as a nonsteroidal anti-inflammatory drug (NSAID,) which was meant to provide non-narcotic pain relief for sufferers of arthritis. This pill was basically known as a “super-aspirin,” mainly because Merck claimed it was able to not only provide better pain relief than traditional over the counter analgesics, but was able to do so without causing upset stomachs, which is a common side effect of aspirin and acetaminophen.

The drug was a huge success, with an estimated 80 million people taking the drug worldwide. But almost immediately, there began to be some real problems. Within months, there were reports of people suffering severe heart attacks. However, the very nature of Vioxx actually provided Merck with some protection from FDA fallout. After all, Vioxx was a drug for the treatment of arthritis, and arthritis sufferers are generally elderly. The elderly are statistically more likely to have heart attacks than any other demographic. The fact that Vioxx was a common link with these victims was discounted by the FDA:

“There were 14 cardiovascular deaths, (nine and five in rofecoxib and naproxen groups,

respectively). Most of the cardiovascular deaths were in patients with known

cardiovascular risks.”

Obviously, Merck was not going to admit that there was anything wrong, considering that they had spent millions on both developing and marketing the drug, and they were making money hand over fist. And the problems and delays with the FDA were due to the fact that the people in charge of reviewing Vioxx complaints were the same people who approved the drug in the first place.

There were two things very wrong with this scenario. In the first place, if the same FDA workers who approved Vioxx came out publically and said that they were wrong to do so, that would essentially be admitting that they didn’t do their jobs properly. Secondly, aside from regular FDA workers reviewing the drug, it was also reviewed by what was called an “independent advisory board,” which wasn’t really “independent” at all.

In 2005, when it became clear that there was a severe problem with Vioxx that could no longer be ignored by the FDA, the advisory board met to discuss not only Vioxx, but also the similar NSAID drugs that were either on the market or were close to being put into production by all the other pharmaceutical companies. The advisory board voted to keep these drugs on the market, despite the estimated 27,000 deaths that had occurred since their introduction. A group called the Center for Science in the Public Interest looked into who was serving on this board, and found that of the 32 experts serving on the panel, 23 of them were either receiving consulting fees from the drug companies themselves or owned a considerable amount of stock in drug companies that were either marketing NSAID’s or were about to introduce one of their own.

So between rank and file FDA members who were hesitant to publically correct their own mistakes and outside advisory boards that were staffed with people who were practically pharmaceutical company employees, the environment for fast action on a dangerous drug did not exist.

To its credit, the FDA did in fact alter the rules of its advisory panels, so that in order to serve on one you couldn’t have a financial stake higher than $50,000. But the rules regarding in-house review of dangers at the FDA have not changed:

Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

This was one of the two major factors in Vioxx being allowed to stay on the market for so long, and this worries us because right now a popular drug is posing a serious danger to the health of women who have been using it.

Bayer’s line of birth control pills, which are marketed under the names Yaz, Yasmin and Oscella, have been linked to thousands of hospitalizations all over the world, and more than a few deaths. The active ingredient in these pills is a synthetic variation of progestin called Drispirenone, which has been shown to raise the potassium levels of women who use it. Elevated potassium levels can raise the risk of deep vein thrombosis, which is the formation of blood clots in the legs. These clots can break apart and travel, which can and does cause strokes, heart attacks, and pulmonary embolisms.

Bayer has been arguing that these dangerous side effects are not out of the statistical norm, and that the victims are mostly women who smoke or were over the age of thirty. But we and other attorneys like us have read about enough cases of perfectly healthy women ending up hospitalized after taking these pills disagree with Bayer.

With FDA culture being what it is, it isn’t very surprising that the only real problems they have had with Bayer so far is over their advertising. The rest of it, the strokes, the heart attacks, the elevated levels of potassium, well…that’s still under review. Perhaps by the exact same people who approved this drug in the first place?

Greenberg and Bederman is a Washington, D.C. area law firm that is currently offering legal help for women who have been injured due to the use of Yaz, Yasmin or Oscella. If you or a loved one has been injured or hospitalized due to the use of these birth control pills, contact our yaz stroke lawyer, Andy Bederman, for a free yaz legal consultation.