When a defective product or a defective medical device causes you harm, you can file a lawsuit against the manufacturer who produced that product. If a person is killed as a result of a defective medical product or device, his or her surviving family members can bring a wrongful death claim. Unfortunately, in some cases, it is very challenging to prove that the defective product was actually the cause of some type of compensable harm. For example, a drug may cause a bad side effect such as high blood pressure, but since lots of things cause high blood pressure it can be hard to link the use of the drug to the resulting medical problem.
In the case of GranuFlo, however, proving that the drug is dangerous may be a little bit easier. Our Boston dialysis malpractice attorneys explain why.
The FDA Recall of GranuFlo
In the United States, an estimated 400,000 people receive dialysis each year and approximately a third of those receiving dialysis use products from a company called Fresenius. One such product is called GranuFlo. GranuFlo is an alkaline intended to neutralize acids that build up in a patient’s body during dialysis. Unfortunately, GranuFlo contained a lot of a substance that converted to bicarbonate in the body. Clinicians weren’t aware of this and didn’t adjust their treatment accordingly, and many patients began to experience bicarbonate overdoses.
A bicarbonate overdose creates a risk of sudden cardiac arrest. Patients in Fresenius’ own dialysis clinics began experiencing serious complications and more than 900 suffered heart attacks by November of 2011 when Fresenius sent out an internal memo to care providers in their clinics warning them of the dangers. Despite the huge number of heart attacks, Fresenius did not warn the general public and many more patients at dialysis clinics throughout the U.S. continued to be given GranuFlo and continued to be at risk for cardiac problems.
The FDA, however, took action and a Class I recall was issued in March of 2012. Class I recalls are limited only to situations where there is a serious risk of injury or death.
What the Recall Means For Your Dialysis Malpractice Case
The FDA Class I recall is very important for patients who have already suffered a cardiac event as a result of a Fresenius product. It is also very important for family members who have lost loved ones due to the sudden development of cardiac arrest due to dialysis. The recall is important to these individuals not because it can stop a heart attack that has already happened, but because it provides evidence that the injured victims can use to get fair and just compensation from Fresenius.
The FDA warning helps patients to overcome the difficulties inherent in proving that a drug or device specifically caused harm. With the FDA’s class I recall, it is openly and clearly acknowledged that GranuFlo is dangerous and that it is linked to cardiac arrest. Patients, therefore, will be able to use this information in a personal injury action against the manufacturers for the defective dialysis drugs.
If you or a loved one has experienced dialysis complications in the Greater Boston area, contact the Boston dialysis malpractice attorneys at the Law Offices of Jeffrey S. Glassman, LLC for a free consultation to discuss your claim. Call 1-877-617-5333.
Another Massachusetts Pharmacy Under Fire: Ameridose Injections Contaminated, Nov. 13, 2012, Boston Personal Injury Lawyer