A watchdog agency’s failure to ask questions may be the main reason many of these devices have high levels of cobalt and other dangerous metals.
In the only extensive study of this problem to date, researchers found that 100 percent of hip implant patients whose devices failed had symptoms of depression, and in about a third of these cases, the symptoms were severe. Moreover, 70 percent of these victims suffered from severe cognitive impairments, such as the loss of short-term memory. Lead researcher Ben Green, of the University of Chester, called his team’s findings a potential public health crisis.
One patient, whose artificial hip failed only four years after implantation and whose bloodstream had very high cobalt and chromium levels, said she felt constant fear, guilt, and anxiety. “I used to be very active and now I feel a mess,” she lamented.
Components of Metal on Metal Hip Implants
Device manufacturers touted their Metal on Metal hip implants as long-lasting and safe alternatives to the ones then on the market, and hundreds of thousands of people had these devices surgically implanted to replaced their ailing hips over the next several years. But many of these individuals now suffer from metallosis (metal poisoning) due to the design and manufacturing defects in these devices.
To understand the design defect, one must first look at the way the human hip works. The hip is a ball-and-socket joint that provides almost unlimited mobility. MoM devices have all metal parts. When the patient uses the artificial hip, microscopic metal fragments flake off and enter the bloodstream. Over time, the fragments build up, inflame the surrounding tissues, and cause the device to break.
This failure is a classic design defect, so thousands of victims have filed damage claims. This doctrine applies if the product contained a design flaw that made it unreasonably dangerous, the manufacturer failed to address the flaw, and the defect caused injury. In November 2017, a Dallas federal jury ordered DePuy Orthopaedics, a Johnson & Johnson subsidiary, to pay $247 million in damages to six New York victims. The award included almost $170 million in punitive damages.
Premature failure is not the only issue. To cut costs, many manufacturers used cobalt, chromium, and other dangerous metals instead of more expensive and safer components. Such shortcuts are especially common among foreign companies who sold cheap copies in the United States and elsewhere. These metals have been linked with a number of serious health problems, including:
- Lung disease,
- Tinnitus (excessively loud ringing in the ears),
- Total hearing loss, and
The Food and Drug Administration is supposed to screen new devices and make sure that they are safe before they are sold in the United States. But under the 510(k) shortcut, the FDA does not examine new drugs and devices if there is a “substantial equivalent” already on the market. The manufacturer, and not the agency, usually determines what devices meet this test and therefore what devices the FDA will actually review before it issues approval.
Dangerous metals in hip implants are not design defects, because the devices were clearly not designed to give people brain injuries. However, the use of cheap ingredients is a manufacturing defect. The manufacturer is strictly liable for issues that occur between the time a manufacturing process begins and the time a product reaches retail shelves. In addition to compensatory damages, juries often award significant punitive damages in these cases, as mentioned above.
Manufacturers that sell unsafe products must answer for their misdeeds. For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. We handle mass tort cases on a nationwide basis.