CDC Report Confirms Heparin Injuries Caused by Synthetic Chemical Contamination

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.

 

Medtronic Faces Medical Injury Lawsuit Over Off-Label Use of Infuse

Medtronic Inc. is facing a lawsuit over the death of a California woman after a surgery during which the company's Infuse bone growth medical product was inserted into the neck. The lawsuit is the first for the company stemming from allegations that Medtronic indulges in promotion of off-label use of its bone growth product, a liquid protein sealed in a casing and inserted between the vertebrae.

The lawsuit is unusual in that it doesn't blame the doctor for the complications that resulted after 74-year-old Shirley Nesbit underwent the surgery to insert the bestselling bone growth protein in her neck. The FDA had recently warned doctors against use of the product in the neck, because of the possibility of respiratory difficulties. Nesbit underwent the surgery in August, a few weeks after the FDA's warning. She developed serious respiratory problems because of the pressure on her neck and throat.   Attempts to insert a breathing tube lost precious minutes for Nesbit, and she slipped into a coma, dying 9 days later.

Her family alleges in the lawsuit that Medtronic's representative who was present during the surgery, pressured the doctor to use Infuse in her neck, although the FDA approves it for use only in the lower back, and for certain dental applications. Doctors are not prohibited from using any medical product for applications that are not approved by the FDA, but companies are not allowed to push for off label use of the product, which is what Medtronic is accused of doing. Both Medtronic and the surgeon in question, deny any pressure to use Infuse. The company, no stranger to medical injury lawsuits because of its earlier problems with its defective Medtronic defibrillator devices, claims that representatives are sometimes present at procedures for support and advice to the surgeon. Making things worse for Medtronic are two whistleblower lawsuits by former employees that charge the company with paying doctors to use Infuse in ways not approved by the FDA.

Medtronic Encouraging Unapproved Use of Infuse

There have been several complaints about off-label use of Infuse, and patients have suffered obstruction of the airways leading to breathing problems after insertion. Lack of oxygen can cause brain damage in a patient. Patients often need tracheotomies to relieve pressure on their airways, and require respiratory and feeding support.

Infuse Medical Device Lawsuits

Medtronic is facing a Department of Justice probe into allegations of promotion of off-label use. However, for patients who have been injured because of such unapproved use, there is a way to obtain justice – through a defective medical device or product lawsuit against the company with the help of a medical injury lawyer. If you or a loved one has been injured by an off-label use of Infuse - meaning use of the product anywhere, except on the lower back or in oral treatments – then you may be entitled to compensation for your suffering. Contact the experienced medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.