Missouri Defective Medical Devices Attorneys
Medical technology is advancing every day, helping people live longer, healthier lives. But in the competitive world of medical device manufacturing, companies sometimes introduce products to the market without fully understanding the risks those devices could create.
The United States Food & Drug Administration is responsible for oversight of medical devices, and in recent years, it has announced several recalls due to serious defects that could cause injury or death.
If you’ve suffered an illness or injury because of a defective medical device, you may be entitled to compensation for your medical costs, lost wages, and other expenses. Call the experienced personal injury attorneys at Bley & Evans to request your free consultation: 844-443-8385.
FDA Recalls
The FDA classifies recalls as Class I, II, or III. Class III recalls involve defects that are unlikely to cause harm. Class II recalls apply to products that may cause a temporary or reversible health problem, with only a slight chance the products could cause serious injury or death. Class I recalls are the most serious, covering products that are most likely to seriously injure or kill patients.
It’s not uncommon for a manufacturer to issue several major recalls for different products. Stryker, a medical device and equipment manufacturer that has subsidiaries worldwide, has issued a few Class I recalls in the past few years:
- In 2016, Stryker Howmedica Osteonoics Corp. recalled its synthetic femoral head – part of an artificial hip implant – due a defect that can cause parts of the joint to fail. The company had received several reports of patients being harmed by the defect. This wasn’t the first hip-related recall for Stryker, either.
- In November 2015, the Stryker Fuhrman Pleural & Pneumocardial Drainage Set was recalled, because at least two healthcare providers reported that the catheter in the set broke off in a patient’s chest cavity during surgery.
Years earlier, in 2009, the FDA indicted Stryker Biotech executives for misrepresenting products to healthcare providers and providing an untested mixture of implant putty that caused serious problems in some patients who underwent spinal surgery and long-bone surgery. Charges against the executives included wire fraud, conspiracy, and making false statements to the FDA.
Notable recalls from other major firms include two from Zimmer Biomet, and one from Medtronic:
- In May, Zimmer Biomet recalled spinal fusion devices, because they contain chemicals that could be toxic to vital organs. Zimmer urged doctors to monitor all patients who have the implanted devices for three to six months.
- In December 2016, Zimmer Biomet recalled an implant that’s used in restorative shoulder surgery because of a high fracture rate.
- In February, Medtronic recalled a device because it could potentially cause the problem it’s designed to prevent. StrataMR Adjustable Valves and Shunts are implanted to prevent fluid build-up on the brain. But due to a “design problem,” the devices may not properly drain fluid, which could leave fluid on the brain and cause headaches, nausea, vomiting, coma, and death.
Patients Living with Defective Devices
Undergoing a major surgery is traumatic enough. But even more traumatic is learning after surgery that something implanted in your body is defective and could make you sicker than you were before surgery.
People living with defective devices must often undergo regular medical tests, as doctors check to make sure the devices are working as they should. In the meantime, patients may be hearing horror stories about what’s happened to other people with the same faulty devices. In some cases, long after a person undergoes a major, invasive surgery, the failure of a medical device forces them to start their journey all over again, undergoing subsequent surgery and rehabilitation.
Most hip implants occur late in life. The recovery time for a hip replacement surgery is long, especially in older patients. If that new hip is defective, the patient may not be strong enough to undergo another surgery and rehabilitation period. It’s a frightening prospect for many elderly Americans.
No one should have to face the fear and uncertainty that comes with knowing they have a defective medical device in their body. Even if that device never fails, the psychological consequences can be profound and include anxiety, depression, and other disorders.
If your doctor has told you a medical device used in your surgery was defective, it’s important for you to talk to an experienced personal injury attorney, who can advise you of your rights and of any recourse you may have. The attorneys at Bley & Evans are here to help clients with product liability claims in Missouri. Ask for your free consultation today. Contact us online or at 844-443-8385.
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