Category: Dangerous Drugs

Profit Before Health: Bayer Hid Information From FDA About Deadly Drug Trasylol

“Good medicine demands that you protect the patient. That”s the issue here, and not the drug, and not the profit margin,” stated Dr. Dennis Mangano, the San Fransico doctor who conducted the largest study to date concerning the dangers of the anti-bleeding drug Trasylol. Dr. Mangano offered these comments during a scathing report featured on 60 Minutes which revealed that Trasylol”s manufacturer, Bayer, hid studies from the FDA which showed a clear link between the drug and heart and kidney failure. Other doctors interviewed by CBS suggest that Bayer was aware of dangerous side effects from Trasylol as early as the 1980″s.

Trasylol is an anti-bleeding drug that is given to approximately 1/3 of patients undergoing heart surgery. Trasylol was heavily marketed by Bayer and was projected to be the next billion-dollar drug in 2008. Fortunately, Dr. Mangano”s efforts set into motion a chain of events that would eventually put a stop to Bayer”s ability to profit (and profit a lot) from other”s misfortunes.

After following 5,065 patients in 17 countries, Dr. Mangano found that patients given Trasylol were more likely to experience death and kidney failure after heart surgery. This study was then published in the New England Journal of Medicine, which prompted other doctors to speak out regarding the deadly drug. According to Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, Bayer was not interested in his results from studies conducted in the 1980″s that showed severe kidney damage in animals given Trasylol. Dr. Nicholas Kouchoukos also received the cold shoulder from the pharmaceutical company for his human study in 1992 that showed that patients given Trasylol were more likely to experience kidney failure after surgery.

Kouchoukos called this study a “red flag”, but explained that safety studies are generally not taken seriously until they involve thousands of participants. Since Bayer did not conduct a large-scale investigation of the drug following these complaints, the proof was not available to pull the drug from the market. Consequently the FDA approved Trasylol in 1993–noting kidney problems as a potential side effect from the drug.

Thankfully, Dr. Mangano”s 5,065 patient study in 2005 was sufficient to finally catch the FDA”s attention. The FDA scheduled a meeting with Bayer executives to discuss the issue eight months after the report was issued. As a result, Bayer went on the defense and set out to conduct a study of it”s own to dispute Dr. Mangano”s study. Their plan backfired. Bayer”s study confirmed Dr. Mangano”s findings that Trasylol may have been responsible for thousands of deaths and serious injuries in the United States.

What Bayer decided to do with this information next, in my opinion, proves the company”s clear disregard for patient safety. Bayer hid their study from the FDA. They acted as though it never took place. It wasn”t until a whistleblower from Bayer contacted the FDA regarding the proven dangers of Trasylol that the true findings from the report were made public. Following this disclosure, Canadian researchers attempted to perform their own Trasylol study, but had to stop because too many people were dying.

So what are the consequences of Bayer”s lack of scientific testing and honesty regarding Trasylol? According to Dr. Mangano, “Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It”s about a 1,000 lives saved per month delay in taking that drug off the market.”

Sad. And while the story reads like a bad novel, real people”s lives have been ruined by this drug. Loved ones have died or were forced to go on dialysis after otherwise routine procedures. Livelihoods were stolen as injured patients struggle just to pay the bills with their meager disability check. Ironically, Bayer walks away with millions of dollars and no consequences from the FDA. And I can almost guarantee that the politicians in Washington will turn a blind eye as well. After all, they need a paycheck too and who do you think funds the campaign that allows them to stay in office? The pharmaceutical companies of course. What politician in his right mind would bite the hand that feeds him?

Clearly, the only remedy for patients that have experienced side effects from Trasylol is to file a lawsuit against Bayer. It”s more than just money-it”s the only way to change the system. Complaints to the FDA do not work. Letters to Washington do not work. Pharmaceutical sales are big business driven by the desire for profit at any cost. To change the system, the American people have to take what matters the most from these companies-their profit. When they finally realize that they will have to pay for hurting people, maybe they will invest some of their billions into better scientific testing and personnel to handle investigations before drugs like Trasylol, Vioxx and now Heparin take the lives of trusting people who depend on this medicine to make them better, not worse.

Alternatively, if you or a loved one may have suffered a serious reaction to Trasylol, a lawyer in our New Jersey or Philadelphia office can help answer any questions you may have. For further information on Trasylol or Trasylol side effects, click on the links below:

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FDA Finds "Clear Link" Between 81 Deaths and Contaminated Heparin

As reported in the New York Times, federal officials have now identified a “clear link” between contaminated heparin from China and 81 US deaths from severe reactions to the drug. Up until this point, Chinese heparin manufacturers (including Baxter) have openly doubted that a link could be proven connecting these deaths to the contaminant. Baxter even issued a public statement claiming that they did not expect any “material litigation” as a result of the dangerous drug.

Similarly, Chinese officials have now joined the drug manufacturers in disputing the validity of this FDA report showing a “clear link” between reported illness and contaminated heparin. They openly dispute the possibility that the fake chemical additive found in Heparin was responsible for the 81 deaths and countless severe reactions reported in the US. Chinese officials are also suggesting that because reactions to heparin have only occurred in the United States, the problem must stem from the American processing plants that also handled the drug.

Unfortunately, international reports have proven otherwise. German officials have recently come forward reporting strange reactions in dialysis patients after heparin use. The contaminant itself (which has been linked directly to the Chinese manufacturers) has also been found in heparin supplies in 11 other countries to date. And, although Chinese manufacturers and officials dispute a link between the contaminant and the resulting illnesses, FDA director Dr. Janet Woodcock makes an excellent point: “Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events.” She also adds that, “we [the FDA] are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

And while China attempts to pass the buck onto American processing plants, China”s recent track record is a major factor contributing to the public”s distrust. Contaminated Heparin is just another addition to the other toxic imports from China, including contaminated toothpaste, dog food, lead paint toys and tainted fish products. After the discovery of these products, China was equally defensive and unwilling to accept responsibility until July of 2007 when the government executed its top food and drug regulator for taking bribes and promised product safety reforms.

Obviously, those reforms were not carried out. Furthermore, Chinese officials have made clear that plant inspections and better testing methods will only be implemented if the United States agrees to reciprocity. This means that the inspection of Chinese plants will only be allowed if the Chinese can set up shop in the US and inspect our facilities as well (something they know that the US is less than willing to concede). Budget issues are another factor stopping better regulation of dangerous foreign imports. The Government Accountability Office has found that the FDA will need an additional $56 Million next year alone to conduct more thorough drug inspections abroad. Additionally, the Bush Administration has failed to provide funding for additional FDA personnel in it”s current budget proposal. Without the necessary personnel in place, it is clear better inspections will be difficult, if not impossible to follow through with.

The whole situation is very disturbing and has left a bad taste in the mouths” of American consumers. Locally, people have no way of knowing if heparin has been distributed in New Jersey or Pennsylvania hospitals. They want to know if there is any link between contaminated heparin and the illnesses they have experienced. Even more disturbing is that these people aren”t sure where to go for answers. Most reports about contaminated heparin have been vague at best, and there is really no way of knowing at this point where and when contaminated vials of heparin were administered. The most concrete information released by the FDA is that the contaminant was found in vials manufactured as early as 2006, with the majority of reactions and deaths occurring between November and February of this year.

It”s clear that these reports have been considered unacceptable by injured patients and the lawsuit process has begun for many consumers of the drug. This is true even in the local New Jersey and Pennsylvania area. While it is sad that it has to come to this point, sometimes the litigation process and the monetary judgments against such companies are the only language that these manufacturers seem to understand. Their number one concern seems to be profit, and as long as that remains untouched, they will continue to produce unsafe products for the unsuspecting American public. Until then, people want answers-and if they FDA or heparin manufacturers will not give it to them, they will take matters into their own hands and file suit.

Alternatively, if you suspect that you or a loved one has experienced a bad reaction after taking contaminated heparin, our licensed RN is available to help you and your family determine if there may be a link between your illness and the drug. It”s OK to ask questions and we encourage you to do so–even if you are not sure if Heparin is to blame for your injuries. Our firm has received numerous inquiries from people that just want answers and quite frankly, that”s what we are here for.

Should you have a Heparin related question, we encourage you to call (856) 333-0600 in NJ or (215) 567-2380 in PA or follow the link below to fill out an online case evaluation form:

Medical Malpractice

Baxter Not Expecting ‘Material Litigation’ After Contaminated Heparin Recall

Pharmaceutical giant Baxter announced today that it does not expect any “material” litigation with regards to the contaminated heparin recalls. Although the FDA has received a ton of complaints about death and serious reactions to the drug, Baxter claims that they only know of four possible injuries to date. They also believe it will be difficult to prove a link between the drug and some of the side effects reported by the general public.

I think the report on CNN.com gives a little more insight as to why Baxter is not overly concerned with this issue. CNN reports that:

Despite the high-profile nature of the heparin troubles, the drug is not a major or high profit-margin product for Baxter, which expects a muted financial impact from the recall. On Thursday, when the company reported first-quarter results, it noted $11 million in after-tax charges associated with the heparin recall in the U.S.

All this uproar is just a drop in the bucket to Baxter. No wonder why they are so indifferent to the fact that a drug, which people rely on to prevent clotting, is contaminated with a foreign substance that makes people sick. With this mentality, why in the world would drug companies want to change up the regulation standards when they only experience a “muted financial impact” from a national recall? It”s so much easier to just sell the bad drug, make money and apologize later. And I guess that”s the course of action that they are gonna take on this one too. Very scary.

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Dennis Quaid Takes on Medical Errors & Baxter Heparin

In addition to facing lawsuits for contaminated heparin, pharmaceutical giant Baxter, is now facing a lawsuit from actor Dennis Quaid after his newborn babies almost died from a fatal heparin overdose. Apparently, a labeling mistake was to blame for a nurse injecting his twins with full-on heparin instead of Baxter’s Hep-Lock (which is a weaker form of the blood-thinning drug). And although Baxter changed the confusing labels after they were linked to other mix-ups and the death of three infants, the company did not recall the existing vials that were still being used in maternity wards across the US.

Baxter, however, continues to blame the staff at Cedars-Sinai Medical Center for the error. Debra Bello, a senior director at Baxter, told reporters for CBS that the hospital bears full responsibility for the incident “because the product was safe and effective, and the errors, as the hospital has acknowledged, were preventable and due to failures in their system.”

I probably would buy that excuse if it weren’t for the fact that Baxter redesigned the label prior to this incident for the very reason that mix-ups were occurring. Obviously, they knew that the similarities in the labels were causing major problems, yet they failed to issue a recall to take the drug off the shelves. Not too smart in my opinion- and now they have to deal with a lawsuit from Dennis Quaid and all the negative publicity that comes with it.

In other Dennis Quaid news, the actor has also decided to tackle the medical malpractice crisis by setting up a foundation to fund efforts to reduce medical errors. “We all have this inherent thing that we trust doctors and nurses, that they know what they”re doing. This mistake occurred right under our noses…the nurse didn”t bother to look at the dosage on the bottle,” Quaid told CBS. “It was avoidable, completely avoidable.”

It’s really sad when Dennis Quaid can see there is a problem in the medical community, yet our trusted lawmakers and officials do not. If they did, they would silence the cries for tort reform legislation and tell the doctors to deal with the problems by cleaning up their act. Maybe once a politician falls victim to medical malpractice, Washington will be singing a different song.

For further information on the recent heparin deaths or medical malpractice, click on the following link:

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Hungry? Coffee, Bagel and Salmonella poisoning for breakfast anyone?

The Center for Disease and FDA announced a defective product the recall of two breakfast cereals manufactured by Malt-O-Meal. The cereals “Puffed Rice’ and “Puffed Wheat’ were found to be contaminated by salmonella.

Salmonella is bacteria that can cause diarrheal illness in humans. These microscopic living creatures pass from the feces of people or animals, to other people or other animals. Salmonella has been known to cause illness for over 100 years. People with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness and other personal injury.

A hard working and serious, American scientist named Salmon, for whom the nasty little microbe is named, discovered the bacterium. Why such a learned man of science would want to give his name to this illness which comes from feces is another story. For more tid bits regarding salmonella click on the CDC website.

The defective products were distributed nationally under the Malt-O-Meal brand name, as well as private labels including Acme, America’s Choice, Food Club, Giant, Pathmark, Shaw’s, ShopRite, Tops and Weis Quality. The cereal bags have “best if used by” dates from April 8, 2008 (coded as APR0808), through March 18, 2009 (coded as MAR1809). If you have purchased such a box, you are advised to throw them out, and retailers have been told to remove the cereals from their shelves.

If you or someone you loved have become ill from salmonella and believe it may have been caused by this cereal, click here for further information. We will continue to post information on the illness , so check back regularly for any new developments.

Who Is Really To Blame For Contaminated Heparin?

I read an interesting post by a fellow blogger regarding the dangerous Chinese import saga. While I don”t entirely agree with his argument, I think his thoughts are worth re-printing in their entirety:

“Ask yourself this question, How important is the health, safety, and well being of my family?”

First it is toys from China being recalled because of various safety issues, but more specifically from lead in the paint. Now there is a recall on blood thinner [Heparin] manufactured in China, which is causing deaths in patients.

It is obvious in the Chinese quest for money it is willing to put our health and the health of our children at risk. When will the world community say acquiring cheap goods is not enough and demand quality in those goods? Do you support inhumane and unethical treatment of human beings just so you can by more “stuff”? The Chinese should be scrutinized and held to our safety and health standards.

ABC News reports, FDA Links More Deaths to Blood Thinner:

Heparin is derived from a mucous obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China.

FDA determined last month that Baxter”s drug was contaminated with an unnatural chemical during production at a plant in China.

This in part is our own fault. Demanding a bargain, the willingness to look the other way, and greed. The Wal-Mart economic plan (cheap second rate goods), which many of Americans support is jeopardizing our safety and economy. When will your family”s well being become more important than getting a good deal? It is your greed which is driving the Chinese economy?”

Ouch. That”s a bit hard to swallow, yet there is a lot of truth to it. Obviously there is something that is hindering the American public from speaking out against dangerous imports. Could it very well be our desire for cheap “stuff”?

While I believe that may be true with regard to the recent influx of toxic toothpaste, dog food and lead paint toys from China, I think the Heparin recalls fall outside of that box. My personal opinion is that most Americans feel helpless against the pharmaceutical giants (such as Baxter) who practically play puppet master with our politicians. They have an endless amount of resources, a tremendous amount of clout and because of this people just give up and accept whatever they dish out.

I just read an article about the rise in Heparin deaths by journalist Stanley Bing. Sadly, he decided to name his article “More Good News For Lawyers”.. Apparently, what he doesn”t realize is that people depend on trial lawyers for help when things like this happen. It is our job to take on these giants when they unleash their garbage (ex Heparin, Vioxx) on the public. Without the ability to file a lawsuit and affect the only thing that matters to these companies (i.e. their money), nothing will change and the despair will continue.

There needs to be some fear instilled in these drug companies. They need to realize that if they fail to keep the American public safe, there will be consequences. There will be lawsuits filed and they will loose a ton of money. It”s just that simple–and it”s our only hope.

For further information, click on the following links below:

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The Latest Heparin News: Hillary Speaks Out On Dangerous Chinese Imports

After learning that Heparin from China has been contaiminated with a cheap man made chemical substitute (which has now been linked to 62 deaths and a whole host of other illnesses) Presidential Candidate Hillary Clinton has issued the following press release on her website:

“When it comes to the threat of unsafe drugs from China, the Bush administration is sitting on its hands and rolling the dice with our safety. Heparin is the latest example. Americans have a right to know that their government is taking their health and safety seriously.

With news accounts of a potentially tainted Chinese supply of the blood-thinning drug, heparin, and a new FDA report that the drug has caused hundreds of adverse reactions and 62 deaths, there is an urgent need for the administration to take decisive steps to protect patients from unsafe imported drugs. If George Bush won”t start that process now, I will when I am president.

As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance – and giving them a chance to clean up their act — as we do now. And I will stiffen civil and criminal penalties for violators.

It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick.”

Its about time someone in Washinton spoke up about the influx of dangerous chinese imports that are hurting American consumers. And while most of us can choose not to buy Chinese toys or Chinese dog food, hospitalized Americans do not have that same freedom. Patients with heart conditions and those on dialysis depend on Heparin to prevent life threatening blood clots. How patheitc is it that these poor people have to worry about getting sick from Heparin because drug manufacturers wanted to save a few bucks. That my friends is greed at its worst.

John R.Mininno, Esq. is a New Jersey and Pennsylvania trial lawyer representing clients in medical malpractice, defective products and other serious injury claims. He also writes about issues concerning patient safety. His offices are in Collingswood, NJ and Philadelphia, PA.
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Heparin Deaths Jump From 19 to 62 According to FDA

The FDA announced this week that 62 deaths have now been linked to the blood-thinning drug, Heparin. This new estimate is almost triple the 19 fatalities reported last month. The drug, which is generally used in patients with heart problems and those undergoing surgery, is believed to be contaminated with man-made oversulfated chondroitin.

This contaminant is said to mimic chondroitin sulfate, which is a naturally occurring substance derived from animal cartilage and used to treat arthritis. While the FDA is still investigating the matter, it appears that the tainted animal cartilage containing oversulfated chondroitin has come from unregulated mom and pop pig farms in China.

I hope people are finally starting to notice a trend here. Chinese manufacturers have been the common denominator in the recent influx of dangerous imports, including contaminated toothpaste, dog food, and lead paint toys. Even more frightening, however, is the fact that the FDA will not completely recall the batches of contaminated Heparin out of fear the hospitals will experience a shortage. Based on that fact, I don’t see this issue going away anytime soon- especially if the FDA continues to allow Chinese manufacturers to operate below the regulation standards imposed in the U.S.

We will continue to post information on the Heparin recalls as they occur, so check back regularly for any new developments.

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Health Alert– Botox Injections for Neurological Injuries Causing Death and Serious Illness in Patients

On February 8, 2008, the US Food and Drug Administration issued a safety alert regarding the use of Botox injections for neurological injuries. Prior to this date, the FDA had received reports for patients who have had severe respiratory side effects following the use of botulinum toxins type A and B. These reactions are believed to occur when the botulinum toxins spread in the body beyond the site where it is injected. The most serious cases associated with these injections resulted in hospitalization and even death in children treated for cerebral palsy associated limb difficulties. It is also worthwhile to note that this injection treatment has not been approved by the US Food and Drug Administration for children or adults.

Although not approved, doctors have recently experimented with using botox injections in patients with neurological injuries. In this treatment, doctors inject small amounts of Botox into areas of the neck which purportedly relieves pain for up to 120 days before it wears off. Unfortunately, because the technique and treatment is poorly understood, some patients have had muscle paralysis to the esophagus. As a result, these patients are unable to swallow, nor function properly as fluid and food is aspirated into the lungs. Tragically, as of February, 16 deaths have occurred and 658 reports of injuries have been associated with Botox injections.

And while Botox is receiving a lot of negative attention in the United States, Europe continues to permit Botox to be used for this treatment. However, the Europeans require a specific warning before use that the treatment can result in long-standing muscle weakness or paralysis–especially among children.

Fortunately, The FDA continues to monitor and study this issue. However, for those who have suffered an adverse event related to Botox, I highly recommend that they complete the form online posted on the FDA”s website.

For further information filing a dangerous drug or medical malpractice lawsuit, click on the following lins:

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What Makes Fish Swim Weirdly And Not Eat? PROZAC IN THE WATER! A NJ & PA Study of Pharmaceutical Drugs in the Drinking Water.

Philadelphia and New Jersey made national headlines last month as scientists questioned whether the vast amount of pharmaceutical drugs found in our water supply could have long term effects on health and wellness. Now, new studies show “abnormal behavior” in human cells and wildlife after exposure to the same prescription drugs that we are consuming on a daily basis.

Locally, Philadelphia was found to have 56 different pharmaceutical contaminants (including medicine for pain, epilepsy, heart problems and mental illness), while water supplies in North Jersey were found to have significant amounts of metabolized angina medicine and psychiatric drugs.

Researchers believe the drugs entered the water supply through human waste. Apparently, when people take prescription drugs, whatever is not absorbed by the body is naturally eliminated and flushed down the toilet. And, although water is treated before public use, most treatments fail to completely remove pharmaceutical drug residue.

While health officials continue to insist that the amount of prescription drugs found in public water supplies are too small to have a therapeutic effect; they do not, however, dismiss the fact that frequent consumption of contaminated water can have long term health effects. EPA administrator, Benjamin Grumbles says that the situation is a “growing concern” and that they are taking these findings “very seriously.”

Furthermore, while it is too early to track the long-term effects of pharmaceutical contaminants in drinking water, scientists have

John R. Mininno, Esq. is a New Jersey and Pennsylvania trial lawyer representing clients in medical malpractice, defective products and other serious injury claims. He also writes about issues concerning patient safety. His offices are in Collingswood, NJ and Philadelphia, PA. For further information visit our our medical malpractice and injury website.