For a medical device or pharmaceutical drug to reach the market, it has undergone rigorous testing and must receive pre-market federal governmental approval from the FDA. However, defects and severe side effects that may have been latent during the testing and approval process can and do exist. Additionally, failures in the manufacturing process itself, which occurs after governmental approval is granted, can result in defective products and drugs reaching the market. Often, these post-approval manufacturing defects are caused by poor quality control or inadequate safe manufacturing practices.
Medical device and pharmaceutical drug manufacturers who fail to do what is necessary to identify such defects or problems with their product or drug before they reach the market, or who fail to disclose the defects, side effects, or other complications associated with the use of their product or drug, are legally responsible for the injuries and deaths that result.
By the same token, medical device and pharmaceutical companies who fail to notify the public and health care providers of the risks associated with the use of their devices or drugs face potential liability for failed implants and adverse reactions caused by their drugs or devices when inadequate warnings or instructions for safe use are not provided.
As Medical Device and Pharmaceutical Drug attorneys we can help
If you or someone you know has used or had a medical device implanted which failed due to a defect in its design or manufacture, or, you or someone you know suffered adverse effects using a pharmaceutical drug or product, please do not hesitate to contact us for a free evaluation. Click on the links below to find more detailed information about claims relating to the following:
- DePuy Hip Implant Claims
- Heparin Claims
- Kugel Mesh Patch Claims
- Medical Devices Claims
DePuy Hip Implant Claims
DePuy Orthopaedics, a division of Johnson & Johnson, has issued a recall of the DePuy ASR hip systems, citing a higher-than-normal failure rate of the devices. New data shows that five years after implantation, approximately 1 in 8 patients who had received either the ASR resurfacing device or the ASR total hip replacement needed to have a revision surgery.
Heparin (also known as heparin sodium) is a blood thinner administered in surgery and other critical care situations to prevent clots. It is crucial in dialysis and heart surgery and other serious procedures. In earlier 2008, Baxter International recalled nearly all its multiple-dose vials in the U.S. after some patients experienced extreme allergic reactions as a result being given heparin. This adverse reaction happens within a few seconds of the injection of the drug and can be fatal.
Kugel Mesh Patch Claims
The Kugel Mesh Patch is a surgical device used to repair hernias caused by thinning scar tissue that is formed after surgery. The patch is inserted behind the hernia and expands/collapses as needed to protect the wound from re-opening. In 2006, the FDA issued a Class 1 recall on the Kugel Mesh Patch due to reports of bowel perforation after the recoil ring within the product broke, causing abdominal pain, internal bleeding and chronic intestinal fistulae.
Medical Device Claims
Millions of people have used or had medical devices installed in their bodies under the mistaken belief that they must be safe and free of defects because they have been approved by the federal government. Unfortunately, pre-market government approval does not guarantee that unsafe or defective medical devices will not reach the marketplace. In many cases, defective devices are inserted into unsuspecting patients who desperately require them. Medical devices, like artificial shoulders, hips and knees, pacemakers and defibrillators, and a wide variety of valves, stents, catheters and medical hardware are no different than other products to the extent that defects in their design, manufacture and warnings can exist and can lead to severe injuries and deaths.