Four years after her long medical nightmare began, a woman has been awarded $5 million in her lawsuit against New Jersey-based C.R. Bard Inc., the manufacturer of the vaginal mesh device that has caused her significant pain and injury. The personal injury attorneys representing the hundreds of other injured women that have filed product liability lawsuits believe that it signals success for their clients in the pending consolidated cases against Bard, Johnson & Johnson, Boston Scientific Corp. and others, which are scheduled to go to trial early next year.
Earlier this week, a unit of New Jersey-based Johnson & Johnson announced that it planned to discontinue sales of its vaginal mesh implants. The company denies that the decision was made in response to the product liability lawsuits that have been filed in connection with the mesh, but that the "negative overall publicity about vaginal mesh devices" motivated the discontinuation.
According to a 2011 report from the U.S. Food and Drug Administration (FDA), the number of "adverse event" reports for medical devices has increased by about 15 percent every year for the last 10 years. If you are a regular reader of our New Jersey personal injury blog, you are likely not surprised by this increase.
As we previously discussed, several members of Congress are working to close a loophole in the U.S. Food and Drug Administration's approval process. Currently, the 501(k) process requires the FDA to approve medical devices if a manufacturer can show that the device is similar to one that has already been approved for sale.
Earlier this week, we talked about the loophole in the U.S. Food and Drug Administration's 510(k) medical device approval process which reportedly allowed for the approval of a vaginal mesh product manufactured by New Jersey-based Johnson & Johnson. Recently, members of the U.S. House of Representatives proposed a bill which, if passed, would close that loophole, effectively preventing devices based on dangerous, previously-recalled medical products from being approved by the FDA.
Last month, we wrote about federal legislators' efforts to close the loophole in the U.S. Food and Drug Administration's medical device approval process. Now, it appears that a top official with the device division of the FDA agrees that such a change should be made. Hopefully, this will spur the legislation and prevent dangerous or defective products from making it to the marketplace in the future.
Last week, we wrote that the U.S. Food and Drug Administration had ordered additional research into the vaginal mesh products that have caused injury and even death to women throughout the country.
Two New Jersey-based companies are among the more than 30 businesses that must conduct studies and clinical trials on the safety and effectiveness of vaginal mesh implants, according to recent media reports. The U.S. Food and Drug Administration ordered the studies after receiving multiple reports of injuries and fatalities caused by the defective products, an agency spokesman said.