Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

If the prospect of contaminated Heparin and injuries from Avandia were not disturbing enough, an eminent cardiologist has now warned of the danger of a biological threat if the FDA does not get its act together, and fast.

Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist and medical researcher, was one of the first to bring the risk of Avandia injuries caused by Glaxo's anti-diabetes drug into the spotlight. This man has a reputation for being straight forward and honest and has never shied away from calling out pharmaceutical companies and the FDA for their negligence.  He has also been named a possible contender for FDA chief.  Big pharmaceutical companies have always been wary of his announcements and the FDA has frequently been the target of Dr. Nissen's criticism. 

So, when Dr. Nissen raises concerns that terrorist organizations, like Al-Qaeda, could use the FDA's scant oversight of foreign pharmaceutical plants to mount a biological attack on the U.S., we are inclined to pay attention. Dr. Nissen insists that he is not trying to stir up paranoia. Recent instances of the FDA’s somnambular conduct of its drug safety processes, especially at foreign plants, do raise concerns that the facilities could be used by those who seek to harm Americans. China, for instance, is growing to be a significant source of drugs manufactured for Americans. Last year's heparin scandal was traced to batches of contaminated Heparin injections manufactured in China. The Heparin contamination, it is believed, came from adding a synthetic, cheaper compound in place of the original ingredient in a possible effort to cut costs. Since then, we have found that the FDA has not conducted a single inspection of the Chinese plant since it received approval several years ago. The FDA now has an inspection office in China to handle inspections of food and drug plants supplying the U.S. It seems like a reassuring first step, until you realize that the total staff strength at the Chinese FDA office is 8.

The FDA admitted that it has been unable to adapt to growing changes brought about by globalization. In a scenario where a growing number of drugs are sourced from Chinese plants, there may be reason to worry about whether a lack of FDA inspections, combined with poor regulatory standards in China could lead to the first major biological terrorist attack on the U.S. Of course, the chances of terrorists infiltrating a Chinese pharmaceutical plant and contaminating drugs meant for American consumers may seem far fetched now, but we never imagined that a group of zealots would drive aircrafts into the heart of New York City either. 

Medical Injury Lawyers

The FDA's poor oversight of drug makers and poor regulatory practices, combined with pharmaceutical companies' negligence, have time and again placed American consumers at risk of tainted or defective pharmaceutical drugs. If you have been injured as a result of using a dangerous drug or defective medical device, you will need the help of a medical injury lawyer to recover the compensation you deserve.

To get the help you need contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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A report titled Outbreak of Adverse Reactions Associated with Contaminated Heparin issued by the Centers for Disease Control and Prevention has confirmed the worst fears of the public – that Heparin injuries and deaths were caused by a synthetic chemical that was added to the drug at a Chinese plant.

According to a followup article published in the Washington Post, the CDC has found strong evidence linking the chemical oversulfated chondroitin sulphate and the symptoms that patients who had been given Heparin, Baxter's blood thinner began to suffer in November last year. Allergic reactions to the product included nausea, breathing difficulties and a rapid drop in blood reassure. In the United States alone, 81 people are confirmed to have died from the contaminated Heparin, and there have been hundreds of reactions to the medical product.  There are fears that more side effects could lie potentially hidden in a patient's system, to erupt later in unrecognizable forms. 

Oversulfated chondroitin sulphate is a processed form of chondroitin sulphate, an animal sourced product that is used in arthritis medications. Chondroitin sulphate is much cheaper to produce, and it's believed that this is why the Chinese producers added it to the drug to replicate the blood thinning properties of the original ingredient.  The recalled contaminated heparin continued to sit on shelves in hospitals in many states even after a recall was announced in early 2008, and it's entirely possible that there may be more injuries resulting from the contamination that are still under the radar. It's not easy to connect a contaminated drug to symptoms, and for months the FDA was unaware that the allergic reactions that patients were suffering were due to any contaminant in the Heparin.

Baxter's failure to maintain quality control at its Chinese supply plant, combined with the FDA's inadequate inspection procedures ensured that hundreds of people suffered violent reactions to the drug before experts were able to point to the source. An increasing dependence on foreign drug suppliers whose facilities are rarely put through FDA inspections has meant that Americans can hardly use a medication without worrying if it's going to cause extreme reactions or in worst case scenarios, even death. The FDA has had a particularly worrisome couple of years with numerous tainted drugs entering the market, many of them manufactured at overseas plants. It doesn't help that the agency barely has enough resources to inspect facilities at home, let alone plants that are located thousands of miles away.

Heparin Injury Numbers Continue to Rise

Contaminated Heparin has caused serious injuries in patients that may have long term implications, including organ damage, low blood pressure, and even death. There may be other little known effects that manifest themselves weeks and months after the administration of the drug. Across the country, dozens of patients have filed medical injury lawsuits against Baxter to protect their rights and obtain compensation for their suffering.

Pursuing claims for damages against large pharmaceutical companies like Baxter can be a complex and expensive process. Victims benefit from the expertise of a specialized pharmaceutical liability lawyer who has both the experience and the resources to pursue the claim.

If you've suffered adverse reactions to Heparin or another dangerous pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case. Our lawyers handle most cases on a contingency basis so there is no fee unless we prevail on your behalf.

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New information is emerging in the ongoing saga of Heparin contamination. Baxter, the largest distributor of contaminated Heparin, represented on several occasions that the earliest date of distribution of its contaminated products is September of 2007.  Scientific Protein Laboratories (SPL), the manufacture of Heparin API that was contaminated with Over Sulfated Chondroitin Sulfate (OSCS), for the most part has not issued a statement concerning when Heparin which contained OSCS was introduced into the market.  Baxter had about 50% of the market, and AAP had most of the rest of the market.

New information has emerged that manufacturers other than Baxter received contaminated crude Heparin from SPL as far back as 2006, much earlier than when Baxter reports it received Heparin containing OSCS. Specifically B. Braun Medical and Tyco Healthcare (now Covidien) received contaminated Heparin from SPL as early as 2006.

Both companies have issued recalls of the contaminated product. Details of both recalls, including the products affected can be found in the Heparin Contamination article published on our Medical Injury Lawyer website.

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The FDA confirmed today in a media briefing on the recall of contaminated Heparin that a total of 81 deaths are now known to have occurred as a result of adverse reactions to the contaminated product. The new total is an increase over the previously reported number of 62 deaths.

The FDA has also announced that Heparin's active ingredient was contaminated at Chinese manufacturing facilities where it was made, with a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain.

Laws in most states provide for several personal injury claims for persons who have been seriously injured due to defective prescription drugs and treatments.  If you are a loved one have been seriously injured by a defective product like contaminated Heparin, you can learn more about options for claiming compensation from those responsible for your Heparin injury.

Contact a medical injury lawyer from the Arnold & Itkin LLP law firm in Houston, Texas. We can answer questions and help you understand your options.

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The FDA announced that Baxter International's popular blood thinning drug Heparin was contaminated with oversulfated chondroitin sulfate.  Hundreds of adverse reactions have been reported in connection with the contaminated Heparin products. At least 19 people have died as a result.

Adverse reactions include refractory hypotension leading to organ damage, organ failure, shock, and death. Baxter began recalling Heparin products in January 2008 and by February 2008 had expanded the recall to include most Heparin products.

More information on the Heparin recall, including options for persons injured by the contaminated drug can be found on our Medical Injury Lawyer website.

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