In November 2018, the Food and Drug Administration upgraded an earlier Zimmer Biomet Bone Growth and Spinal Fusion Stimulator recall to a Class I Recall. The FDA only takes this action if “ there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” Issues with the Bone Growth/Spinal Fusion Stimulator mainly include a lack of validation which can cause serious, and possibly fatal, bacterial infections.
This latest recall is just the latest in a strong of difficulties for Zimmer Biomet and the entire medical device industry. In 2017, a study linked cheap foreign components in hip implants with brain injuries. As a result of these supply chain problems and other challenges, Zimmer Biomet’s CEO resigned.
FDA officials knew about the Bone Growth/Spinal Fusion Stimulator’s issues for almost a year before they issued a recall. When government bureaucrats refuse to protect consumers, the assertive attorneys at Napoli Law stand in the gap. We roll up our sleeves and collect evidence that supports your claim for damages. Then, we present a compelling case in court. Because of our expertise, most of our defective medical device cases settle out of court. The big medical device companies are afraid of our legal team, and we use that fact to your advantage.
What is the zimmer biomet Bone Growth/Spinal Fusion Stimulator?
This device uses small electrical impulses to stimulate bone growth. Doctors typically use the Bone Growth/Spinal Fusion Stimulator to facilitate faster recovery from spinal fusion surgery or a serious broken bone. This gadget may have some off-label uses as well, most notably in certain kinds of dental procedures.
In 2017, the FDA began receiving complaints from patients who had this device implanted and experienced severe bacterial infections. But rather than take action, the FDA did nothing. Instead, it allowed Zimmer/Biomet to issue a voluntary recall in February 2018.
Two months later, FDA officials re-inspected the company’s Bone Growth/Spinal Fusion Stimulator production facility, and they were aghast at what they found. The company had apparently done little or nothing to correct the flaws in the manufacturing process. Zimmer Biomet officials said the problems were a “misunderstanding” and promised further corrective action. Rather unsurprisingly, that action did not materialize.
Nevertheless, the FDA waited another six months to issue a recall. That notice was backdated to Bone Growth/Spinal Fusion Stimulator which hit the market beginning in 2015. So, anyone who received a Zimmer Biomet Bone Growth/Spinal Fusion Stimulator between 2015 and 2018 is at risk for serious injury.
Common Medical Bacterial Infections
There is little anyone can do about sporadic, one-off bacterial infections. Understandably, manufacturers may not be liable for damages in these situations. But a chronic lack of oversight is a different matter. If the device is defective, people get hurt, and the company does nothing, liability may attach as outlined below.
The bacterial infections which result from a lack of control can cause serious and fatal conditions. The most common types of device-related infections are:
- Central Line-Associated Bloodstream Infections: In these infections, germs enter the patient’s bloodstream through the device’s central line. CLABSIs are one of the most serious, most expensive, and most preventable kinds of device-related infections.
- Ventilator-Associated Pneumonia: As the name implies, VAP is most commonly associated with germs in ventilators. But VAP is common in many medical devices as well. If just one microscopic germ migrates to the lungs, serious injury can result.
- Foley Catheter-Associated Urinary Tract Infection: UTIs, or bladder infections, can cause a number of serious complications, including narrow urethras, sepsis infections, VLBW (Very Low Birth Weight), and permanent kidney damage.
SInce the 1980s, the number of new antimicrobial agents has declined rapidly and resistance to antibiotics has increased dramatically. Furthermore, bacteria in the production stage may be 10,000 times tougher than bacteria at the treatment stage. Generally, the more complex the surface, the greater the possibility of infection.
Dangerous Medical Devices and Your Claim for Damages
The law holds medical device manufacturers to a very high standard. The people who receive these devices, especially gadgets like the Zimmer Biomet Bone Growth/Spinal Fusion Stimulator, are generally already in poor health and prone to infection. But in their rush to sell as many devices as possible, many manufacturers cut corners. Generally, these shortcuts occur during one of the following production stages:
- Design: Some gadgets suffer from design flaws. Manufacturers should identify these flaws before the devices go into production and hurt people. So, they are usually strictly liable for any damages.
- Manufacturing: Other gadgets look fine on the drawing board. But a lapse in the manufacturing process makes the device dangerous. That lapse could be as simple as a screw out of place.
Some cases also involve negligence. Essentially, negligence is a lack of ordinary care which causes damages.
In both negligence and defective product cases, damages normally include compensation for both economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages are available as well in many dangerous medical device cases.
Defective medical devices often cause serious injuries. For a free consultation regarding your Zimmer Biomet situation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. We handle these claims on a nationwide basis.