Should Tainted Heparin and Trasylol Victims Be Concerned With The Upcoming Drug Case Before The Supreme Court?

There is no doubt that tainted Heparin victims, Trasylol victims and lawyers alike are concerned with the upcoming decision on Wyeth v. Levine, which is scheduled for a ruling by the Supreme Court this fall.

The issue in this case is whether drug companies should be immune from product liability suits concerning dangerous or defective products if they had prior approval from the FDA. Specifically, the appeal filed in Wyeth v. Levine seeks to overturn a $6.8 million judgment awarded to a Vermont woman that lost part of her arm after doctors injected her with a nausea drug. The lawyers for the drug manufacturer claim that the company is not liable for her injuries because the drug met all necessary FDA requirements and ultimately received FDA approval.

One can only hope that the Supreme Court will see this argument for what it is-just another attempt by a billion dollar drug company to avoid responsibility for a defective product. I heard someone recently put it this way, “So because I passed my driver’s test and the State gave me a license, you can’t sue me if I carelessly wreck your car.” I think that analogy shows just how ridiculous this argument is. Even if you break it down to the issue of “fairness”– no person in their right mind can justify how a woman who is permanently disabled because the FDA and a multi-billion dollar pharmaceutical company released a dangerous product on the market should be faced with economic hardship because her disability check barely pays the bills. Where is the justice in that?

Furthermore, lets consider the people who’s loved ones were killed after receiving a lethal injection of contaminated Heparin. Consider the anxious mothers who became seriously ill after they were placed on a Heparin regiment during pregnancy and are now scared to death of the effects it may have had on their unborn child. How about the patients that sailed through heart surgery, only to die in the recovery room after a lethal dose of Trasylol?

Clearly, a Supreme Court ruling in favor of the drug companies will be nothing more than a license to push questionable drugs through the understaffed FDA and make billions of dollars at the expense of the American people. This is not justice and we can only hope that the Court rules in favor of the little guy in this situation.

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Heparin Update: FDA Says Contamination May Be Intentional

While I am not surprised by this news, it still saddens me to report that the FDA and CEO of Baxter announced this week that the contamination of Heparin (which has been linked to 81 deaths and over 700 allergic reactions), may have been intentional. (The full story can be found on USA Today”s website.).

Ironically, that same report states that the Chinese plant accused of intentionally contaminating the Heparin supplies passed an audit by Baxter International just months before the recalls. The FDA then conducted an audit of its own after Baxter broke the news, only to find the facility lacked the appropriate equipment to remove impurities from the drug. And what was Baxter’s pathetic response? Apparently, Baxter CEO, Robert Parkinson, testified before a Congressional hearing that “the Baxter audit was ‘routine,’ while the FDA”s was an ‘inspection for cause.'”

So what exactly was the purpose of Baxter’s “routine” audit? An executive vacation to China? A networking event? Obviously it has nothing to do with patient safety or the contaminant would have been found before it made its way into 11 countries and killed 81 people so far. This is especially true when you look at the details surrounding the contamination. According to USA Today, an investigator for the House subcommittee found that:

…the chemical mimics the effect of manufactured heparin but costs one-hundredth as much. The heparin case has similarities to last year”s recalls of Chinese-made flour used in pet food. The ingredient was contaminated with the industrial chemical melamine, which makes the flour appear more protein-rich than it was. As with melamine, standard industry tests for heparin were not designed to find the contaminant.

Clearly, the goal in China is to use the cheapest materials possible and make the highest profit possible at the expense of consumers. And since the FDA essentially allows drug companies to police themselves until complaints begin to surface, this continues to be a successful plan for Chinese manufacturers and US pharmaceutical companies. Maybe when Baxter’s CEO is faced with the death of a loved one because of a dangerous drug product, then consumers might be afforded better protection than what they are receiving now.

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Your Opinions on the Recent Trasylol and Heparin Recalls

I wanted to highlight a comment posted by one of our readers over at My Fox Philly regarding our recent post, “Lessons Learned From Vioxx: Why Trasylol and Heparin Victims Must File Suit To Ensure Honest Marketing and Safer Drug Products. I believe this comment reflects most of the feedback that we have gotten concerning the recent drug recalls and the questionable inspection standards of the FDA. The comment is as follows:

“I”m not a fan of trial lawyers, but when it comes to the FDA and drug companies, you go for it! Clindamycin is another dangerous antibiotic drug in which the FDA and drug companies know there are serious and potential side effects, yet they will do nothing about it. And those who have suffered are often no longer in any condition to be able to sue or to afford to sue. It”s pretty odd that nurses would all know as common knowledge the risks of prescribing this drug and see the potential results first-hand. But the FDA, doctors, drug companies and pharmacies are in denial. And the side affects are most often not reversible. Same with Lipitor. Many have no problem. But those that do find that once they experience side effects, they are irreversible, even if they stop taking the drug, which again doctors, drug companies, pharmacies and the FDA will deny! It”s a racket. I know they do lots of good, but they”ve created an over-drugged and unnecessarily drugged society in which many times the cure is worse than the disease itself they are trying to treat.” – Stever2258

I find this comment to be such an honest and genuine assessment of the drug crisis happening in our nation. This is more than a “get rich quick scheme” by “sue happy people and lawyers“. The real “get rich quick scheme” is an invention of the multi-billion dollar drug companies who produce a questionable product, offer incentives to doctors to market the drug and issue a recall as soon as people start dying. So remember, the next time drug companies post record high profits from drug sales, real people are suffering irreversible and permanent injuries at their expense.

So thank you to our readers for sharing your comments. Hopefully trial lawyers and consumers can work together to put an end to this problem in the near future.

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When Should I Call a Lawyer About My Heparin Side Effects?

What Do We Really Know About Bad Heparin?

For the past month, popular search engines such as Google have been inundated with anxious people typing in questions such as, “Was contaminated Heparin given in NJ or PA hospitals?” or “What are the side-effects of contaminated Heparin?” Unfortunately, the FDA and Heparin manufacturer, Baxter, have been reluctant to release such information to the public. All we really know for sure is that the contaminant came from China and has been linked to 81 deaths and over 700 severe allergic reactions. With such vague answers, it”s easy to see why anyone who has been hospitalized in the past few months would have concerns.

Even more disturbing is the latest hypothesis from the FDA that the contamination of Heparin may have been intentional. Baxter president, Robert. L. Parkinson Jr., told members of a Congressional subcommittee this week that he is “greatly concerned that our Heparin product appears to be the target of a deliberate adulteration scheme.” And while no further information was given to elaborate on this theory, Heparin victims are speaking out. In fact, dozens of families participated in Congressional hearings this week to share stories about their Heparin side effects and to plead with lawmakers regarding stricter inspection standards.

Should I Call A Lawyer?

Here at Mininno Law Office, we have received numerous phone calls from NJ & PA residents whose loved ones were given Heparin and died shortly thereafter or became violently ill after using the drug. And while they are not 100% positive that the events are connected, they would still like answers for their own peace of mind. We understand the anxiety associated with this issue, so we have tried to compile a list to help you decide when to call a lawyer. And while we can not cover every circumstance or side effect, as a general rule of thumb you should call a lawyer if:

  • You or a loved one is a dialysis patient and has suffered unusual side effects after treatment. Some of these side effects include severe abdominal pain, diarrhea and swollen throat that affects the ability to breathe.
  • Your loved one is an otherwise healthy dialysis patient and died shortly after a recent treatment.
  • You or a loved one is a heart patient and has suffered the same side effects listed above.
  • You were given Heparin for a high risk pregnancy and suffered chest pains, shortness of breath and required hospitalization after using the drug.
  • You or a loved one has undergone routine a surgical procedure and experienced the same potentially deadly side effects listed above.

If you can identify with any of these scenarios, there is a good chance that you may have been given contaminated Heparin. I highly suggest that you contact a lawyer immediately to begin an investigation with trained medical professionals. Furthermore, if you would like to speak with our licensed RN and staff doctors regarding your symptoms, fill out the form on the left side of the page or call (856) 833-0600 in New Jersey or (215) 567-2380 in PA.
Our lawyers and medical malpractice professionals are available to answer any questions you may have regarding Heparin and the Heparin recalls.

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 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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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.

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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.

Mininno Law Office