Where and When Was Contaminated Heparin Given in the US?

How Do I Know If My Reaction Was Linked To Heparin?

Every patient that has been hospitalized in the last year wants to know where and when contaminated heparin was administered in the United States. Sadly, no one knows. To date, the most concrete information issued by the FDA suggests that contaminated vials may have been introduced to the market as early as 2006. However, the FDA notes that the majority of injuries have been reported between January 2007 and the recall in early 2008.

Patients who have experienced weird reactions after heparin use can only wonder what, (if any) effect did the heparin have on their body. This is especially true in the case of high-risk pregnant mothers who were given heparin regiments to prevent clotting and dialysis patients who have died instantly during treatment. Families are scared, and at the very least, they want answers.

My Personal Investigation Into Heparin Contamination

Like many people who have had a loved one mysteriously die this year or experience strange reactions after heparin use, I too have become very suspicious of the drug and the allergic reaction my mother had following her abdominal hysterectomy in 2007.

My mother came through the surgery with flying colors, but became strangely ill during the recovery process. During that time, it is believed she was given heparin to prevent blood clots while she was on bed rest. Shortly thereafter, she started experiencing chest pains, irregular heartbeat and a swollen throat that affected her ability to breathe. Consequently, she was hospitalized, given every test in the book, but the doctors could not figure out what was causing these serious reactions.

For months, she swore something happened during that surgery. She insisted to every doctor on her case that the surgeon must have left behind a sponge or a tool in her body that was making her sick. Needless to say, now our family is in the same boat as many of you in trying to figure out if contaminated heparin could have caused this problem.

What Do I Do If I Was Given Bad Heparin?

Based on my own personal experience with the heparin problem, I can tell you that people are calling product liability lawyers such as those in our firm. They want answers, they want explanations-but they just are not getting them from the FDA. As a result, these people turn to lawyers to help them investigate. Again, based on my own experience, I understand the desire to hold the drug companies accountable for the pain and suffering of a loved one. In my opinion, purposely including a deadly contaminant in heparin to save a buck is unacceptable and the Chinese and American manufacturers should have to pay for the harm it has caused our families.

As I have said before, if you or a loved one is a dialysis patient, a heart patient, or was placed on heparin during a high-risk pregnancy or during a period of bed rest, contaminated heparin may be to blame for serious reactions including swollen throat, shortness of breath, blood pressure problems, shock or death. Our firm is aggressively looking for answers and we encourage you to contact us if you have any questions regarding tainted heparin and the reactions it has caused in you or a loved one. Our nurse will evaluate your medical history to determine whether a link exists between your symptoms and contaminated heparin.

If you wish to speak to someone about this issue, call toll-free (856) 833-0600 in New Jersey, (215) 567-2380 in Pennsylvania. You can also fill out the case evaluation form on the right side of the page and our nurse will contact you as soon as possible.

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.

Medical Malpractice and Serious Injury Page

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