Unsafe Medical Devices

Each year, hundreds of thousands of patients are treated for injuries directly linked to medical devices. In many years, over 50,000 of those injuries have resulted in hospitalization or death. While advances in technology have led to the development of beneficial medical devices, these technological advances often outpace meaningful safety studies. Unsafe medical devices have flourished in a regulatory environment that has encouraged a culture of placing profits over patient safety.


Medical devices are intended to improve or maintain a patient's health,
and they serve a critical role in modern health care. But when medical
devices are defective, they can cause serious injury or death. In the first
half of 2010 alone, 21 medical devices were recalled by the FDA because
they presented a risk of serious injury or death.


Medical devices can be defective in a number of ways. Generally, a med-
ical device's defect is caused by a design defect, a manufacturing defect,
or a warning defect. A manufacturer's design for a medical device must
be submitted to the FDA for approval, but FDA approval does not guaran-
tee product safety. Even when a medical device is safely designed, the
manufacturing process may deviate from the design or cause an other-
wise safe device to be unsafe. Some medical devices carry inherent risks
because of their nature even when designed and manufactured properly,
and an inadequate warning regarding the product can unnecessarily
subject patients to harm.


While medical devices require FDA approval, the FDA allows devices that cause harm to enter and remain on the market even when long-term studies into the safety of the devices have not yet been completed. Despite FDA approval, many commonly used medical devices have been found to be defective. These include drug coated stents, defibrillators, pacemakers, infusion pumps, hip and knee implants, and many others. As just a few examples, certain Medtronic defibrillators were recalled by the FDA in 2007. A specific Baxter infusion pump was recalled jointly by Baxter and the FDA in 2007. Numerous models of Guidant defibrillators and pacemakers were recalled in 2005. All of these recalls were of devices previously approved by the FDA.


Cases involving unsafe medical devices are very complex. It is important to hire an attorney who knows the methods for determining the device's design, manufacturing process, component parts, history of testing, and its performance on the market. At Riley & Jackson, we have years of experience pursuing litigation related to unsafe medical devices, and our physician attorney has unique insight into a device's intent and performance that is not available to most law firms.

Birmingham Unsafe Medical Device Attorneys

Alabama Unsafe Medical Device Attorney

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The attorneys of Riley & Jackson, P.C., serve clients in civil litigation throughout Alabama, including Birmingham, Hoover, Mountain Brook, Vestavia, Homewood, Pelham, Irondale, Cahaba Heights, Montgomery, Prattville, Mobile, Huntsville, Auburn, Tuscaloosa, Dothan, Troy, Gadsden, Cullman, Decatur, Athens, Selma, Fort Payne, Scottsboro, Talladega, Jefferson County, Shelby County, Montgomery County, Madison County, Walker County, Mobile County, Baldwin County, Tuscaloosa County, Lee County, Dallas County, St. Clair County, Talladega County, Clay County, Randolph County, Calhoun County, Winston County, Bibb County, Escambia County, Greene County, Pickens County, DeKalb County, Jackson County, Blount County, Cullman County, Chilton County, Morgan County, Limestone County and Butler County.




3530 Independence Dr.

Birmingham, AL 35209

Phone: 205-879-5000

Fax: 205-879-5901

Birmingham Law Office


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