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

Under scrutiny for its failure to prevent unsafe pharmaceutical and medical devices from entering the American market, the U.S. Food and Drug Administration has been criticized by a government body in a report filed this week.

The U.S. Government Accountability Office (GAO) expressed doubts that Americans can expect adequate protection “from unsafe and ineffective medical products” from the FDA.  The GAO submitted its list of federal government agencies that are in need of improvement and the FDA made the list, which also includes the Treasury Department and Medicare. According to the report, FDA efforts to ensure the safety of the American consumer have been deterred not only by increasing globalization that has led to a large number of drugs and devices being made in overseas plants, but also because newer and more complex devices are being developed. Already bogged down by a lack of resources to handle such complex and technologically advanced products, the FDA also lacks access to databases that allow thorough and regular inspections of all plants, including the many overseas.  Other groups have also criticized the FDA's record in keeping dangerous drugs and devices out of the American market. The FDA acknowledges that there are holes in the system that need to be plugged if the agency is to be able to carry on its task of protecting American consumers.

Meanwhile, with a new administration in power there are signs that a beefing up of FDA may be in the works. According to another report, House Energy and Commerce Democrats are planning to introduce new laws that give the country's premier drug safety agency greater powers to oversee pharmaceutical drugs and medical devices. Disapproval for the FDA's conduct has spilled over into criticism for just about anything the beleaguered agency does. Earlier in January, a slideshow that attempted to boost morale by comparing the FDA chief Janet Woodcock to Gandhi had lawmakers furious about the $1.5 million contract awarded to the consultant responsible for the creation of the slide show. Another point of criticism was that the slideshow contract was handed to a firm known for its contact with pharmaceutical companies. The FDA has, in recent years, also come under fire for its links to the pharmaceutical industry.

The agency's failure to guarantee the quality of pharmaceutical drugs and medical devices introduced into the market has left dozens of people dead and hundreds injured in recent pharmaceutical scandals. Some of these include Avandia heart injuries, contaminated Heparin and Paxil side effects.  

Medical Injury Lawyer

If you have been injured by the use of a defective pharmaceutical drug or medical device, you will need the representation of an expert medical injury lawyer to recover compensation. 

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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