By: George Mikhail
The number of medical device products affected by recalls has increased the past eight quarters reaching over 123 million units recalled in the second quarter of 2012, up from 82 million last quarter and 16 million in the second quarter of 2011. One-hundred and forty-two companies were subject to at least one device recalled from the market in the quarter.
While manufacturers have flooded the market with devices such hip implants, knee replacements, ultrasound gels, dental implants and various products used in heart surgery, the FDA’s responsibility to have administrative abilities to keep up is questionable considering these staggering statistics. The total number of Class I recalls, which are considered the most dangerous devices that have potential to cause serious injuries or even death has nearly doubled from the previous quarter, increasing from 4% to 7% of the total numbers recalls.
Drug and device manufacturers have become quite clever with recalls in ducking public scrutiny by using “silent” and “claw back” recalls. In fact, they may choose to just stop marketing a product by stating the market share has dropped, but once a company voluntarily stops selling a product they have no further responsibility in sending the FDA adverse event reports. Another scheme is to recall the product “instructions” and blame the doctors using it while hiding the actual product defects. This may be happening with the Stryker Rejuvenate hip, which our firm is pursuing. Our firm is actively pursuing all metal-on-metal hips at this time, filing suits on behalf of DePuy ASR and Pinnacle hips, as well as Biomet M2a hip implant. Currently, only the DePuy has been recalled, but the FDA is highly suspect of all metal-on-metal hip implants.
