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FDA Recalls Medical Device Inherited by One Company That Also Now Faces Litigation


 In August, the Food and Drug Administration (FDA) issued a recall of Abbott’s Ellipse Implantable defibrillators; allegedly due to potential failure of the aluminum wires associated with the product and their ability to provide defibrillation therapy. According to allegations, the devices have wires that are not fully insulated and, as a result, could short out the capacitor. The FDA officially issued a Class I recall, which is the most type serious recall and indicated that the products could cause serious injuries or death.

According to Abbott, of the 31 defective devices implanted in U.S. patients, the company has received no reports that any adverse events occurred due to the wires. However, Humana filed a lawsuit against St. Jude Medical, which Abbott acquired two years ago in connection with allegations that the company covered up defects associated with the number of its cardiac devices between 2011 and 2015. Specifically, Humana alleges that St. Jude Medical knew that the batteries in its devices could deplete early and therefore present a risk to patients, but covered up that information for years. Humana is now asking the court to force Abbott to cover any and all fees associated with faulty medical devices associated that St. Jude Medical produced, pay double the damages and any future costs connected to the devices, and cover any and all hospital fees connected to the devices.

Is It Fair to Impose Strict Liability for Medical Devices?

When it comes to medical devices and prescription drugs, because it is difficult-to-impossible to design these products with desired health benefits while providing zero risk of harm to consumers, the courts have held that manufacturers of these products cannot be held strictly liable for injuries. Specifically, there are a number of questions before state supreme courts at the moment which pose the question of whether implanted medical devices fall under the “unavoidably unsafe exception” when it comes to strict products liability claims. Strict liability is imposed by those who sell products in defective conditions that are unreasonably dangerous to the user, regardless of how much care was demonstrated during the sale and preparation of the product. However, there is also an exception for ‘unavoidably unsafe’ products that provide an “exceptionally important benefit” yet pose a substantial and unavoidable” risk to users. Life-saving cardiac devices arguably fall into this category.

Contact Our Texas Medical Device Defense Attorneys

Fighting claims like these are difficult, especially for companies that ethically acquired another company and all of the products that the company produced. With it comes any allegations consumers bring against the previous company, even if the current company produces perfect products.

If you are facing defective medical device allegations, contact our Brownsville defective medical device attorneys at Colvin, Saenz, Rodriguez & Kennamer, L.L.P. today to find out how we can help you fight these claims.





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Colvin, Saenz, Rodriguez & Kennamer L.L.P., represents clients throughout South Texas and the Rio Grande Valley, including people living in Brownsville, Harlingen, McAllen, Edinburg, Laredo, Corpus Christi, San Diego, Alice, Kingsville, Rio Grande City and other communities in Hidalgo County, Duval County, Jim Wells County, Kleberg County, Starr County, Cameron County, Webb County and Nueces County. -Site Map-

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