When there are defects in the manufacturing process, automobiles may be recalled. Determining the need for a recall is a lengthy process, which is why many recalls take months or even years to begin.
When motorists believe there is a safety issue with the a vehicle, they often report their concerns to the National Highway Traffic Safety Commission. After a certain number of complaints have been filed, the agency may alert automakers there is a possibility a vehicle has a defect. From there, an investigation takes place to determine whether further action needs to be taken.
Many times, car manufacturers initiate a recall on their own; however, the National Highway Traffic Safety Commission may also force automakers to recall vehicles if they pose a serious safety risk. Consumers may also petition this agency to conduct their own investigation into defective vehicle components if they believe a manufacturer isn’t responding appropriately.
If an investigation shows that a potential problem exists, an engineering analysis is then performed to confirm this fact. During this stage of the process, a potential solution to the problem may also be sought. Once automakers are confident they understand the problem and have an appropriate remedy for it, a recall is then initiated.
Consumers can find out about recent recalls by visiting the official website of the National Highway Traffic Safety Commission,http://www.nhtsa.gov/. Those who have suffered an injury due to a defective vehicle may have a remedy available to them under the law and should immediately contact a lawyer.
Tanning beds are intended to put out a certain amount of heat; however, when they are not calibrated properly, they could reach extreme temperatures. This could cause burns to the skin, even when they are only used for a short period of time. A customer’s eyes could also sustain burns or retina damage if the protective goggles worn during a tanning session are defective.
Stand-up booths are sometimes equipped with an exhaust fan which can also malfunction and cause injury. Individuals could get their fingers or hair caught in the exhaust fan if it is not properly located or maintained. When exhaust fans do not cycle on and off properly, this could also result in users suffering from a heat stroke.
Tanning beds should be cleaned thoroughly after each use, as they can harbor bacteria from sweat. When they’re not cleaned properly, guests can become ill or may develop disease as a result of unsanitary practices.
The first step to take after a tanning bed injury is to seek medical attention. After doing so, it could become necessary to talk with a personal injury lawyer about the possibility of recovering for your injuries.
The Dangers of Mirena IUDs – Could you be at Risk?
The Mirena IUD is a device that has been implanted in thousands of women as a form of birth control. This device is manufactured by Bayer Pharmaceuticals, and works by emitting a hormone that helps prevent pregnancy. The IUD was designed to last for up to five years without needing to be replaced. It has recently come under attack for causing a number of complications that could sometimes result in permanent injuries.
The problem with the Mirena IUD is that it sometimes migrates through the uterine wall and then enters other parts of a woman’s body. When this occurs, there could be severe complications that may include:
- Perforation of the Uterus or Cervix
- Device migration resulting in Laparoscopic surgery
- Ectopic or intrauterine pregnancies
- Pelvic inflammatory disease
In addition to these complications, IUD devices that migrate could cause the perforation of other organs such as the spleen, liver or pancreas. Surgery is required to remove this device if it becomes dislodged. In some cases, the device could cause serious trauma to the uterus, thereby making it difficult for a woman to conceive even after it is removed.
There is some evidence that shows Bayer received warnings from the FDA about the possible complications involved with Mirena IUDs. This agency claimed that Bayer misstated the product’s effectiveness and failed to provide patients with information about the possible risks. Although there have been more than 45,000 reports of complications from users and numerous lawsuits have been filed, Bayer has yet to formally recall this birth control device.
There is an increased risk of Mirena injuries among women who have an unusual-shaped anatomy or previous trauma to the uterus. When the device is placed shortly after childbirth, the odds are also greater than it will migrate or tear the uterus.
Women who have been implanted with the Mirena IUD may want to speak to their doctor about having it removed. Those who have suffered an injury after the insertion of this device may want to contact us to protect their rights.
It appears the makers of GranuFlo®, Fresenius Medical Care North America is heading to court again. Bettye Alexander filed suit in Boston Federal Court due to the death of her late husband after using this product. GranuFlo® had been used at dialysis clinics all over the country, even after an internal memo demonstrated the maker of the drug knew there was an increased risk for cardiac arrest or stroke. The maker failed to warn patients of this risk and an alarming 947 people were injured during the year which this internal memo covered.
The deaths from GranuFlo® were commonly sudden and would occur within the dialysis clinics or within a few days after receiving treatment at such a center. Mrs. Alexander is seeking both compensatory and punitive damages for the sudden and unnecessary death of her husband Gary.
On March 29, 2012 the FDA issued a Class 1 recall to revise prescribing procedures of this product.
If you or a loved one suffered a heart attack or stroke after receiving treatment at a dialysis center, we would encourage you to check to see the treatment involved the drug GranuFlo or a similar product NaturaLyte®.
Some of the reasons people are now filing lawsuits in regards to GranuFlo® or NaturaLyte®:
- Frenenius Medical failed to warn health care providers of risks when they knew the risks existed.
- Intentionally withheld information and did not report these known risks to the FDA or public.
- Failed to warn the most vulnerable, or “acute” patients of the known risks
- Even after knowing the risks, continued to actively market GranuFlo® or NaturaLyte®
The truly unfortunate part of this case is that it appears Fresenius warned their own internal clinics of the substantial risk to patients, yet but did not warn independent dialysis centers who they were supplying the product to of the cardiopulmonary risks.
If you or a loved one were one of the victims affected by the use of the products, GranuFlo® or NaturaLyte®, call Ed to see if you may have a case!
In 2010, Teva Pharmaceutical Industries ceased production on the popular anesthetic Propofol. After nearly three years, this drug manufacturer has begun making this drug again, and distribution should begin sometime in February 2013.
The lapse in production was due to lawsuits that resulted from several endoscopy centers in Las Vegas improperly using syringes filled with this anesthetic. The improper use by these clinics resulted in an extensive outbreak of hepatitis C, largely due to the fact that syringes used to administer this medication was reused at the clinics.
Edward M. Bernstein and Associates was instrumental in Teva’s decision after obtaining $104 Million verdict (one of the 10 highest verdicts in the United States in 2012).
The ensuing lawsuits ended with Teva Pharmaceuticals paying out extensive damages to settle them. In all, more than $250 million in damages was awarded in more than 80 different suits. Many of these lawsuits alleged that the pharmaceutical giant actually encouraged physicians to reuse syringes l because they had discontinued production on 10ml vials. Litigants alleged that profit was a primary motivator in the company doing so, and this action directly resulted in physicians being persuaded to reuse the larger vials on multiple patients.
For information about this verdict or any other potential bad drug feel free to browse this site.
In the news recently was the tragedy that affected a local family. A child was riding in her father’s vehicle at the intersection of Eastern Ave and Pebble Rd. Her father was critically injured in the accident. We are not yet certain of all the details of this particular accident, but we do know the child was in a booster seat and not in a car seat with a built in harness.
One of the unfortunate problems in accidents like this, is there are people who are using safety equipment they falsely believe will help them in the time of greatest need. The consequences of using the wrong equipment can be life or death. Authorities acknowledge in this particular case, it may not have changed the outcome, but for many families it would, so knowledge is the key.
In the midst of tragedy, what can we do?
Obviously, keeping this family in your thoughts and prayers is a good place to start. However, if you have children, it may be an opportunity to evaluate your own car seat situation and see if improvements can be made for the safety of your child.
Experts on car seat safety say a child who is under 40 pounds should never be placed in a booster seat as the safest option. For small children, a better option is using a car seat with built in harnesses. Most consumers are not taught the difference between what is legal and what is safe; so they make an invalid assumption that if a seat is legal it must be a safe option for a child. There is little room for error when it comes to a collision, so having the best safety option is paramount to secure your child’s well being.
If you need an in-depth set of guidelines to help keep your family safe in an accident, the American Society of Pediatrics has web page giving their recommendations.
As always, if you have been in an accident or injured, please call the office of Ed Bernstein to discuss the details of your case.
Monster Energy Drinks cited in Death of Maryland Teen
The Food and Drug Administration is investigating allegations that Monster energy drinks have caused the death of at least five people over the past few years. This investigation comes after the mother of a 14 year-old girl filed a lawsuit in Maryland court claiming that the popular beverage caused her daughter’s death.
In the lawsuit, Wendy Crossland alleges that Monster failed to properly warn consumers about the dangers of consuming this drink. A spokesperson for the beverage company claims that one is not needed because Monster drinks are safe to consume and therefore not the cause of the young girl’s death.
A spokesperson for the Food and Drug Administration claims that in all, they have received five reports of deaths that are attributed to the highly-caffeinated beverage along with one report of a heart attack occurring. Although this agency is looking into these allegations, they have not yet established whether or not there is a link between the reported deaths and use of the beverage. That spokesperson also claims it is the responsibility of the beverage maker to fully investigate the alleged deaths.
According to current FDA guidelines, companies that produce energy drinks such as Monster do not need to disclose how much caffeine these beverages contain. Certain products such as Monster Rehab, Assault, and Heavy Metal do contain warnings stating that they are not suitable for children or people who have sensitivity to high levels of caffeine; however, these labels do not disclose the exact amount of caffeine the beverage contains.
Caffeine can be especially troublesome for people who have heart conditions. A 24-ounce Monster energy drink can contain around 240 milligrams of caffeine, which is a significant amount when compared to the amount of caffeine contained in a cup of coffee or soda.
At least one Senator is asking the FDA to consider regulating the caffeine levels in energy drinks. The FDA had earlier stated there was not enough evidence for them to do so. Whether or not the information presented in this Maryland lawsuit will have a bearing on new regulations is yet to be seen.
If you have a loved one with a bad reaction to energy drinks like Monster, give the office of Ed Bernstein a call to see if you have a case!
Dangerous drug related to severe bleeding issues and in some cases even death…
It is rare that we get excited to take on a case here at the Edward M Bernstein and Associates law firm. Generally it is simply a matter of evaluating the facts and aggressively helping our injured clients. We love helping injury and accident victims in Las Vegas, but most of the injuries we deal with are not life and death, but more related to pain, suffering and work loss.
When we began hearing rumors about Pradaxa a little over a year ago, our fears were raised. Here was a drug which had serious side effects that were un-reverseable and the maker seemed more intent on marketing the drug, rather than warn the doctors of the serious side effects patients were experiencing.
In one six month sampling we looked at, there were over 270,000 prescriptions written with 237 deaths and over 1,000 serious major medical complications. This is about .45% of patients taking this dangerous drug either died or had a serious medical issue. That’s about 1 for every 200 people.
Why were we excited to get the first Ptadaxa case in Nevada? Because we know how dangerous this drug has been to some people (even if great number of people were totally fine). With all medications come risk, but the risk in the Pradaxa cases is excessive and compounded by Boehringer Ingelheim’s silence to inform patients of these substantial risks.
If you have a loved one who died or had a major bleeding issue while on Pradaxa, please give us a call today to see if you have a case!
Pradaxa Interview Transcript
Ed Bernstein: Now we’re going to talk about some of those drugs you just saw the commercials for at the break with the attorney Michael Lynch, who is a nationally renowned attorney – handled a lot of these – we’ll call them drug cases for lack of a better term. It seems like there are more and more products that come out. We see more and more commercials of – for products and for suing the companies which manufacture these products. And then you hear, at the same time, less products and less drugs are being manufactured because of patent issues and lawsuits and things like that. What’s really going on?
Michael B. Lynch, Esq.: Well, first of all, I want to thank you very much for inviting me to come on the show. It’s always a pleasure and it’s always great seeing you. Back to your question, you’re exactly right as to two things. We’re seeing lots of drugs that folks are suing over and we’re seeing less come out. There are two reasons. One – about five years ago, I thought the pharmaceutical companies couldn’t do any worse meaning we have seen kind of the end of the flow of this constant stream of dangerous products that were coming out and sure enough, a few years later, once again, we see three or four major drugs that are the subjects of recalls or serious health concerns.
At the same time, then you see companies that are protecting their kind of golden lambs – Lipitor or other drugs that have a strong safety profile and they’re kind of inhibiting the progress of other drugs through patents and the putting drugs on generics. The pharmaceutical companies are always looking for the next best thing and unfortunately, the consumer is always looking for the next best thing. Some of the best drugs out there are drugs that have been around for a long, long time that have long safety profiles – that we know what they’re going to do, and when they’re going to it to whom.
I always want to say with folks that you always got to be aware of the next greatest thing with a pharmaceutical product or the next greatest thing in terms of a hip implant or some other medical device because those are the ones in all likelihood that haven’t been tested adequately. What I mean by tested adequately is the clinical trial process only allows for so much testing. The real test of any product is what happens when it gets out into the population. And that’s also a test of what a drug company will do because we can’t expect the drug company to know everything about a drug until it gets in the market. But it’s what they do after they begin to see problematic concerns over a drug – if they begin to see safety profile concerns or they begin to see deaths and hospitalizations. How that company acts in the face of that data.
Bernstein: Because they hide it.
Lynch: They hide it. They ignore it. They brush it under with a lot of other data because we have the watchdog of the United States – the FDA, which is overburdened, understaffed and sadly, in many circumstances, in the back pocket of industry.
Bernstein: Because aren’t a lot of FDA employees then going on to work for drug companies?
Lynch: They do. Some of them go right from FDA work to work in the pharmaceutical companies themselves. The very ones that they’ve been reviewing, they go right to work for. But then, also, there is something known as – are advisory boards within the FDA – outside experts that constitute boards that make opinions as to whether or not drugs should be approved or stay on the market. The problem is that 80-90 percent of those individuals have some type of conflict of interest because they’re paid in some way either as spokesmen or they do clinical trials for the very companies they’re exposing an opinion on.
Now, there are some disclosures that they have to tell you about, but even if they tell you – if I say I make a lot of money from Merck, does that do away with that conflict? It discloses it, but in my mind, it doesn’t do away with the real conflict of the same people that try and look after our health and safety and welfare are the ones being paid by the individuals that made these drugs.
Bernstein: You said earlier, and oftentimes, there’s a drug that suffices, but then the drug company will come out with a newer or better kind of drug – Pradaxa.
Lynch: Pradaxa is a great example.
Bernstein: I did a commercial at the break about Pradaxa replacing what, Coumadin?
Lynch: Coumadin. What we have with Coumadin – Coumadin has been around for over 50 years. Is being on Coumadin the funnest thing in the world? No, it’s not. I mean, Coumadin’s a tough drug to be on.
Bernstein: And why is that?
Lynch: Well, just because Coumadin has a lot of problems. A lot of people feel very weak on it – headaches and there are some more serious problems where you can get some bleeds from Coumadin.
Bernstein: You have to be tested.
Lynch: You have to be tested and about every week or two you have to get pricked. You have to measure what’s known as your INR. Now, that’s not exactly fun and that’s not exactly also convenient for some people. If you don’t have a ride to your doctor’s office every two weeks and you can’t get tested, Coumadin might not be appropriate for you.
Bernstein: Right, and you get tested because they moderate – they up or down the dose based upon your testing.
Lynch: Yes, and without that, you could be getting too much Coumadin or too little. Coumadin treats what’s known as – a condition or clotting coming from what’s known as irregular heartbeat known as atrial fibrillation. If you have that, your heart flutters abnormally and you throw out some clots. Now that clot can go to your brain and you can get a stroke.
Bernstein: It can be very dangerous and typically it’s very common among the elderly population.
Lynch: Right, so you see a lot of people on Coumadin. Now, what happened with Pradaxa was that a German company known as Boehringer Ingelheimm developed what they said was essentially the best-case anticoagulant. You can take it, but don’t have to get monitored – don’t have to get pricked. And also, they said it had a better safety profile. What they did is they kind of rigged a clinical trial. When you do a clinical trial with a drug, what you should have essentially, is what’s known as a double-blind placebo control study, meaning some people get sugar pills and some people get the drug. No one knows who’s on what. You have an investigator who doesn’t know who got what and he just makes a determination. Did this happen or did this happen?
Now in this case what they did is they didn’t do one of those. What they did is what’s known as an open-label study. So everyone knew someone was getting Coumadin or someone was getting Pradaxa. Now what does that do, however? Most of these clinical trial individuals have conflicts of interest. They’re getting paid by Boehringer Ingelheimm to be the clinical investigator and lo and behold, not expectedly, we began to see a better safety profile at least in the reported results for Pradaxa. What happens after Pradaxa comes out in October or 2010? We began to see an absolute epidemic of uncontrollable – that’s an important word – uncontrollable gastrointestinal bleeds.
Individuals get on Pradaxa and usually, within a few months – sometimes even a few days, you get an uncontrollable internal bleed that cannot be stopped and the biggest difference between Coumadin and Pradaxa is that Coumadin actually has kind of a safety mechanism and it sounds weird, but it’s Vitamin K, meaning you can go and take some Vitamin K from your medicine cabinet or go to the hospital and get a shot and your bleeding will stop almost in its tracks. With Pradaxa, you can’t. There’s no way to stop this, so people go into hospitals. They hang blood after blood on them and essentially, they pray that they hopefully will get better.
And I have well over 100 clients that – and many of them did not survive and I’m not speaking to the client, I’m speaking to the son or daughter or husband or wife that went into a hospital with his gastrointestinal bleed from Pradaxa, stayed for several days and never made it out and the drug is still on the market. It still doesn’t have a black box, but I will predict that you’re going to see the black box on Pradaxa and very soon – hopefully by the end of the year, you’re going to see a huge downturn in the use of Pradaxa on patients because I almost think it’s approaching a national health crisis – is the use of Pradaxa in a patient population that was pretty safe on Coumadin. So you never should’ve been on it in the first place.
Bernstein: Explain what a black box is.
Lynch: Okay. When anyone gets a product, it’s going to come with a big list of warnings – page after page and to be honest, almost no one reads it. However, what the FDA can require on certain drugs is a black box warning. Literally, it’s a black box – big bold letters surrounded that will give you the most important warning. “Don’t take this with alcohol”. “This can cause uncontrollable bleeding”. It gives you the condensed and most important information that you can have as to a product. That usually is – it could be, in some circumstances, the death toll for a product because once you really let someone know how bad something is, a lot of times, the patient will say “I’m not taking it”.
Bernstein: It scares them.
Lynch: It scares them and usually, rightfully so. And there have been numerous examples of drugs that have been on the market doing very, very well and there are two birth control devices. One’s a pill and one’s kind of a device that I can talk about that you began to see they were very, very popular and once the black box comes out or the little warning comes out, you begin to see the usage almost go down to nothing.
Bernstein: But sometimes the opposite is true as well that a black box warning will come out and people somewhat tend to ignore it.
Lynch: Well, what it can do also, is that it also can really improve the safety profile since because if you just adequately warn – maybe this population shouldn’t use it or this, what you’re doing is making the drug safer. Maybe – “If you’re over 75, don’t take it”. As long as people over 75 really know not to take it, what that’s going to do is make that drug much, much safer for everybody because the right people are then taking it. The problem with drugs like Pradaxa is that there’s only so much you can warn. You can’t warn someone that this is going to kill you. If it really is going to kill you, there’s no amount of warning that’s going to make that drug safe in my mind.
The only thing that you could do – what I think would be the proper thing is to ask for it to be withdrawn from the market. Now, that could be a voluntary act by the company, which hardly ever happens, or it could be spurned on by the FDA.
Bernstein: I’m going to ask you a very naïve question. Why wouldn’t the drug company want to put specific warnings to avoid lawsuits – the kind that you’re handling now – just by putting a warning and being truthful and honest about the side effects of the drug? Like Pradaxa, for instance, you said there’s not a black box warning. There have been a lot of lawsuits for several years now with Pradaxa and the company still has not put a black box warning. Why?
Lynch: It comes down to money – a very simple answer. They’re worried that if they put that black box warning on Pradaxa, that all of the physicians that used to have their patients on Coumadin will just revert right back to Coumadin and they’re probably right. What does that mean? They’re putting money – profits over patient safety and that’s really what the key is. Many times companies will wait as long as they can to put that black box because every day that they don’t have a black box is probably going to be another day where they’re going to have that drug on the market and make money.
Now in Pradaxa’s case, I think if a black box comes out, it’s going to be great for the consumer and it’s going to be very bad for the company. It’s in the interest of public health to do it, not in the interest of their bottom line.
Bernstein: And the doctors are kind of in the middle.
Bernstein: Because I assume that they’re lying on the information that they got from the drug company before they prescribe something to the patients.
Lynch: I almost never sue doctors. In my 16-year career of only suing pharmaceutical companies, I don’t think I’ve ever sued a doctor. The reason being is that the doctors essentially get that same information that that patient has. They get what’s on the label and if the label doesn’t say x, y or z and if the company even knew it, which is even worse, the doctor’s in a terrible position and many times doctors really, really feel upset when they see one of their patients have a problem from a drug. They take it very personally and professionally. And sometimes they’re quite angry because doctors are – 99.9 % of them are really good folks and they feel badly and they feel betrayed when pharmaceutical companies don’t give them adequate information to treat their patients.
Bernstein: And of course, what they’re typically – who they’re typically communicating with are the sales people or the sales force of the drug company that is making a commission to go sell to the doctors, this drug for use.
Lynch: Sure, and if you’ve ever seen a pharmaceutical sales rep, usually, it’s an attractive person bearing gifts – bagels or lunch – speaks well and has a great personality and essentially is there as a sales person. And they don’t know – once again, anything more than the drug company tells them. And usually, it’s a couple of billboards and a couple of studies and to play nice with the doctor and be friendly and be the type of person like any salesman, which is to try to get your product sold and they just don’t know. It all comes back to what the drug company tells them.
Bernstein: How does the FDA allow these drugs to be approved without the double-blind studies?
Lynch: Well, they can, but the –
Bernstein: And they learn that in chemistry.
Lynch: Yeah – which is right. You can’t really do a real test unless something is placebo controlled or at the very least, double-blind. You can have two different things, you don’t have a control, but you can’t know which is which. How they let them do it, is first, the FDA is trying to see more drugs on the market. One of the things that you hear a lot of people complain about the FDA in this country is, well there’s a great drug in Canada and there’s a great drug in France or something and we do want to see more good drugs out there. However, in the manner in which we get those drugs to approval has to be under a lot of scrutiny.
And nowadays, we begin to see a couple of things that have really come under scrutiny. One – Pradaxa, I think, is going to change the way in which pharmaceutical products are approved and also, the hip implant that DePuy – ASR Hip Implant, which was a metal on metal hip implant that came out in 2005 was approved under the auspices of kind of a very infrequently used protocol in the FDA where you didn’t even actually have to test that hip implant on live people because they said that it was substantially the same as other products that were on the market. It was a 501K approval process, which now, you really can’t do anymore.
So what happens usually, is there’s an approval process that turns out not to be right and the ASR [Cut in Audio] shown. You have to have human testing. And then, I think with Pradaxa, I think you’re not going to see too many of these open-label studies that are going to lead to approvals of products. Now, who really brings that about? I really hate to say it. It many times is lawyers, who advance claims for injured people because the only way that the system is really going to change in terms of how drugs get approved and more importantly, I think, how companies act is by lawsuits. And people say there’s too much lawsuits and lawsuit abuse. In the pharmaceutical setting, I can say that that’s 100 percent not accurate.
Bernstein: Because these cases are so expensive to proceed, right?
Lynch: Cases are so expensive. Of all the drugs out there, I’m the first one to tell you that no drug is completely safe. However – and there are thousands of thousands that lawyers can sue if they so choose. And I get approached every day – sometimes a dozen to 20 times a day by individuals that want to sue product x, y or z and I tell them they don’t have a case simply because not every drug – no drug is completely safe and many times, you get results that are – you get an adverse effect that has been warned about. There’s no lawsuit there at all. You were told this would happen and it’s probably doing what’s known as the risk/benefit – always on the benefit.
However, with drugs like Pradaxa – or you see examples of Vioxx or Actos with bladder cancer. When you come to risk/benefit, what you see that the risk – and many times, it’s the undisclosed risk far outweighs any benefit from the drug, especially if it’s what’s known as a drug that has other options, meaning if it’s in a class of drugs where the patient can take another drug within the same class that doesn’t carry the same risk. Coumadin and Pradaxa are kind of the same thing.
Bernstein: And Vioxx.
Lynch: And Vioxx was what’s known as a cox-2 inhibitor. It came to the market in 1999 and took off in 2004. At the end, you found out that there was screwing that was going on with the data that Vioxx approved. And what you saw is Vioxx caused tens of thousands of heart attacks – upwards possibly that they’ve estimated of 160,000 Americans died from heart attacks attributed directly to Vioxx and there was no reason for that drug to really be on the market. What they did is they pushed also, some new indications for it. Give it to an Alzheimer’s patient. Give it for pain, give it for this and give it for that – anything that would expand the profile of that drug.
As it turns out, you see a lot of Americans that are unfortunately in the grave because of Vioxx. One of the largest lawsuits in a long time was that Vioxx case. It took four long years of hard-fought battles by myself and a number of other attorneys to try to get that drug – first of all, taken off the market and also to get adequate compensation for the victims of that drug.
Bernstein: And oftentimes – I mean sometimes the drug companies will change the warnings. Tylenol was an example of that. There is a certain dosage requirement – a maximum dosage on Tylenol and they changed that based upon some lawsuits.
Lynch: Based on lawsuits – Tylenol, believe it or not has always kind of had a good profile. If you remember this many, many years ago and this is kind of showing my age, there were some scares about poisons being – Tylenol – they removed them immediately off the shelves. They have always kind of been a pretty good landmark. If there is a problem, they do something. They don’t always do it right when they should, but in the end they usually put patient safety ahead. But then there are other companies that I see – and I hate to pick on one, but there’s one that I’ve been involved with many times, which is the Bayer Corporation that is consistently involved with shenanigans with their products. Starting in Baycol way back in 2001, we see the birth control pill Yaz and Yasmine.
Bernstein: Let’s talk about Yaz and Yasmine. We did a commercial at the beginning of the show regarding Yaz as well. It’s a birth control device. What’s wrong with it?
Lynch: Well, what I say is the birth control pill – “The pill” has been around for decades. It’s one of the most studied medical therapies in the world. It has a pretty good safety profile. If you take a pill “The pill”, which meaning birth control, you do have a risk of getting what’s known as a thrombotic event – a deep vein thrombosis, a heart attack, a pulmonary embolism, but the risk is very, very small and it is disclosed on the label. They say you could get this and they encourage you to not be too overweight, not to smoke, definitely don’t smoke if you’re over 35 if you’re on the pill. But everyone’s looking for the next best thing. First, we saw the Ortho Evra Patch. They put a patch on. Don’t take a pill, put on the patch. It turns out that that was like a death patch – killing girls left and right and giving you too much birth control medication, which caused those thrombotic events to happen.
Then you saw Yaz come out. Yaz came out in March, 2006. Almost immediately, the FDA was flooded with very, very high numbers of these thrombotic events, pulmonary embolisms and DVTs in particular. And Bayer was taken to task. They actually ran ads and downplay these risks – purposely downplay those risks and when they would talk about the risks, they’d have distracting things on the commercial. They’d turn up the music when they would talk about the risks or they would have a dog barking or something that would distract the user. And the FDA actually forced them to run new ads correcting that. Now that rarely happens. And we saw a flood of lawsuits that are still going on with that.
Bernstein: Don’t we see that often with commercials currently from the pharmaceutical companies. They have these commercials. Most commercials in today’s market are 15 seconds or 30 seconds. Oftentimes, the drug companies are running one minute or more – sometimes two minute commercials. Sometimes, when it comes time to talk about the side effects and the disclosures of the drug, there’s this lulling going on.
Lynch: Oh yes.
Bernstein: You have these scenes in the background that you’re really paying attention to instead of listening to the voice of the narrator, who is really talking about the side effects of the drugs.
Lynch: Absolutely, and that’s exactly what Bayer was taken to task on.
Bernstein: But they’re still doing it.
Lynch: They’re still doing it, but if you saw those Yaz ads – they really were atrocious and it was clear that that’s exactly what they were doing. Like I said, the FDA actually made Bayer, with Yaz, run new ads and say essentially, we’re sorry we didn’t tell you this. And that doesn’t do much for the girls that had a pulmonary embolism or had a DVT or are still suffering from a heart attack or from a stroke from these. And I always think that with birth control pills, they’re always looking for the better mouse trap. The regular pill is pretty safe, but you saw the Ortho Evra Patch and you saw Yaz. Now you see NuvaRing.
Bernstein: Are they still selling Yaz?
Lynch: They’re still selling Yaz. There’s been some increasing to the warnings. It’s not nearly the same as it used to be. It was a blockbuster drug for Bayer. They tottered it as essentially a more natural product, which people seem to really enjoy now – the idea that they’re taking a greener pharmaceutical, but it’s just not a pill that anyone should be on and we now see, which is another case – another pharmaceutical product that’s for birth control, the NuvaRing. NuvaRing is manufactured by Merck. It’s essentially a insert-able – it looks like a little ring. It’s insert-able once a month. You keep it in for three weeks and it does its work. However, it once again – with NuvaRing, it’s just that everyone’s looking for that next big thing that they don’t have to take a pill every day.
And once again, we see this incredible increase in DVTs and pulmonary embolisms and those are serious medical conditions. The pulmonary embolism is a life-threatening condition. A DVT, even though it’s in your leg usually –
Bernstein: Deep vein thrombosis.
Lynch: Deep vein thrombosis can easily break off and go to your chest and go into your lungs and you get pulmonary embolism – go to the brain and get yourself a stroke or go to the heart and get a heart attack. And the folks that have these can be on lifetime Coumadin, for example to prevent those from happening, which will prevent them in many cases from being able to have children. It’s just kind of a nightmarish scenario you think just to try and take a better birth control pill when there are a lot of better options out there. But the Yaz and NuvaRing cases are ones that I represent a lot of – young ladies who have taken those two are just absolutely horrific.
Bernstein: But doctors are still prescribing the NuvaRing?
Lynch: Doctors are prescribing them, but not as much as other things and I think based upon some of the adverse event data that’s coming out, I think you’re going to see a decrease in the prescriptions of NuvaRing. In terms of Yaz, you don’t see hardly any Yaz anymore just because of all the problems. I mean, there are thousands and thousands of lawsuits and many of them are getting resolved now just because I think Bayer is well aware that those cases are essentially unwinnable at trial.
Bernstein: Is there a difference between the actual devices that the drug companies come out with compared to the drugs or the pills or serums as far as how they get approved and the safety measures that are taken in these?
Lynch: Yes, kind of when I say the DePuy ASR Hip. That’s a medical device approved under a different process and they approve that under that 501K – that speedy approval process. Medical devices are treated differently. They’re treated differently under the law and they’re also treated differently under the approval process. Under the law, there are some certain protections that the drug company has for medical devices simply because to develop a medical device is a major, major deal and if you didn’t give some more speedy approval processes, you almost never would have a medical device. You wouldn’t have a pace maker and you wouldn’t have other things.
As long as they have some background in what’s known as some substantially similar product that’s out there somewhere, you can get a medical device approved a lot more quickly. However, the problem with that is the whole epidemic of metal on metal hips. Way back 2005/2004, what you began to see is all the rage was taking a hip implant and instead of making it from the poorest material like ceramic or something, they said let’s make it metal and we’ll make the cup metal and we’ll make the ball metal. It will last forever. You can have it in for 20 years. A hip implant is really supposed to last 15 years.
The problem was that no one thought of this – that when you have two pieces of metal rubbing against each other, even if they just look like they’re being happy, little microscopic pieces of metal are coming off and in the DePuy ASR case, we began to see the chromium and the cobalt began to essentially rub against each other and everyone was getting poisoned by this and it was a condition known as metallosis and you have individuals then that had a failure of that hip after one, two or three years. This was something that was supposed to last for 15 years.
Bernstein: And they’d have to have another surgery.
Lynch: You’d have to have it come out, which is a major surgery. Any surgery is bad, especially on me is major surgery. But a hip implant is a life-changing operation and to get one put in and then immediately put out, it’s a lot of trauma on the body. It’s a lot of pain and there are a lot of results and ancillary problems that can happen. You’re bed ridden, you get pneumonia and all of that stuff. But the metal on metal hips, which were the ASR model – the DePuy Pinnacle Hip, which is also the Striker Rejuvenate – all of these metal on metal types of components are really bad and you’re really not going to see them anymore – almost very, very few orthopedics use them.
Bernstein: Because of the lawsuits.
Lynch: Once again, because of the lawsuits. They wouldn’t have done it without the lawsuits.
Bernstein: Right. So how are the hip replacements doing today?
Lynch: You mean like what ones are doing –
Bernstein: Are they safer than the metal on metal?
Lynch: Well, they went back to the old standby – the one I would say that’s been used time and time again, the old ceramic cup and something like that, the porous material that the body likes or that the body is used to. It’s when you always try a new thing. If the doctor says “I’ve got something new for you”, I probably would say “I’ll pass”. I mean, you’re pretty much being the guinea pig.
Bernstein: Does it make a difference if these devices and/or drugs are available in Europe and have been there for a number of years before they’re brought here?
Lynch: Well, it can and it cannot. Sometimes, Europe acts more quickly than the United States and I’ll use an example of the drub Actos. Actos is a drug that’s used to treat diabetes. It’s been around since 1999. Well, in June of 2011, the FDA announces hey, by the way, we’ve got a serious problem with Actos causing bladder cancer and I have over a hundred folks that I represent that some of them – I would say about 30 percent of them – males are having their bladders removed, which is a major, major surgery – a life-changing operation and you have cancer. That was never a part of the bargain. Every drug has a risk – sure, but bladder cancer should never be part of that equation.
Bernstein: And we got about 30 seconds left.
Lynch: Oh, okay.
Bernstein: You want to finish the story?
Lynch: Yeah – with bladder cancer, but back to your thing. Europe sometimes, is ahead of our game on that one, but it took the US about five years behind Europe. So just because it’s in Europe, that doesn’t mean that you should be taking it here in the United States.
Bernstein: Well, thank you for the great job you do because you do change lives – a lot of people and make it safer for all of us. So if you have had a serious side effect from these drugs or any drugs, call me or call Mr. Lynch. Don’t sit back and do nothing. We’ll see you next week.
Lynch: Thanks Ed.
Precautions for Avoiding Negative Drug Reactions
Drug reactions can occur because of interaction with other drugs or substances. They can also occur because of an allergy. Symptoms of a reaction may be mild or serious. It’s important to understand the severity of reactions and the steps to take in dealing with them, especially if you use more than one prescription drug. This is also true with over the counter medicines as these also have the potential of causing reactions.
Reading labels is important. Whether you are dealing with over the counter substances or prescriptions, literature is provided to explain the types of substances that will interact adversely with the drug in question. It’s helpful to consult with your pharmacist or doctor if you aren’t sure about a given medicine, and online research can provide additional information. If you aren’t sure about how a new medicine will interact with a substance that you already take, it’s wise to contact your physician before taking the new drug.
It’s important to examine a new package or container of a medicine before taking it. Over the counter substances should be examined for tampering. Make sure that boxes are sealed and that packaging protection is intact. If this isn’t the case, don’t purchase the product. If you discover tampering after your purchase, return the product.
When your prescriptions are filled, you should take time to examine the contents of your bottle or package. A description of the product is usually included in the literature, explaining color, size and shape of the pill or medicine. Take time to verify that this is accurate. Bring discrepancies to the attention of a pharmacist right away. If a medicine is different from its usual appearance, check the packaging for possible explanations as many pharmacies strive to inform patients of manufacturer changes to medicines. It’s better to err on the side of caution than to experience serious consequences from taking the wrong drug.