Contact Us
Blog
Subscribe to this list via RSS Blog posts tagged in product recall

tort reforms, Chicago product recall attorneysThere was a time when corporations cared about their products and the effect they had on the general population. It was a time when companies worked hard to prevent the distribution of defective products; when the system failed and a defect did make its way to the public, the issue was quickly rectified. In some ways, it is an indication of just how much values have changed over the years, but it is an even stronger indication of how the decisions made by lawmakers, legislators, and courts have diminished the sense of accountability for large corporations.

Punitive Damages and Corporate Accountability

Punitive damages and corporate accountability go hand-in-hand because, when a corporation has the fear of being hit with damages above and beyond just the typical damages, they are less likely to gamble with the lives of their consumers. But punitive damages have become nearly non-existent, with some states placing caps on the amounts and others doing away with them altogether. As a result, corporations have begun to weigh the cost of continuing to produce defective products against the cost of correcting the problem or pulling the product altogether.

...

OtisMed recall, knee replacement liability, Chicago injury attorneyThe OtisKnee device, made by OtisMed Corporation, was not approved by the Food and Drug Administration (FDA) to be used in knee replacement surgeries. The OtisKnee devices were not proven to be safe or effective. OtisMed Corporation distributed and marketed the OtisKnee and is responsible for product liability and the injuries patients have been caused due to the defective product.

“The OtisKnee device was used by surgeons performing total knee arthroplasty, known as knee replacement surgery. OtisMed advertised the cutting guide as a tool to assist surgeons in making accurate bone cuts specific to individual patients’ anatomy based on magnetic resonance imaging (MRI) performed prior to surgery,” according to the FDA’s statement about the OtisKnee, following a lengthy investigation.

The OtisKnee device was marketed to surgeons as a means to match the size and placement of the implant to an individual’s normal knee alignment. It was supposed to allow surgeons to be able to keep more of the patient’s bone and ligaments, which meant a quicker recovery and greater range of motion. Patients claimed their recovery was longer and many have had to undergo a second knee replacement surgery to remove the defective product, more bone, and have a new implant placed in their knee, costing them more recovery time and more medical expenses.

...

FDA product recalls, Chicago product liability lawyerThe FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a factor critical when determining potential health risks and dangers to consumers.

Many in the medical device industry were concerned about additional paperwork rather than focusing on the importance of detailed documentation for the benefits of safety. Certain devices have been approved for market that have represented an upgrade, innovation, or correction to a previous device and have resulted in recalls.

It is a manufacturer’s responsibility to find the original source of the problem and not look at a defect as an isolated incident. One of the main intentions of the new guidance is to clarify when a change to a device constitutes a product recall. One example states, “a change to a marketed device to address false or misleading labeling or other labeling violations would generally constitute a medical device recall.”

...
To Top