Drug Injury Lawyers Blog
Is Negligent Medical Device Testing to Blame for Thousands of Injuries and Deaths?
Seemingly countless injuries involving defective or dangerous medical devices have occurred in recent years, prompting the question—are medical devices being adequately tested for safety? Earlier this month, the Medical Imaging and Technology Alliance (MITA) held a congressional briefing “to discuss how medical device providers are regulated and how standards can be better aligned to ensure patient safety.”
The need for such a briefing may confirm what lawyers, physicians, and the general public have been saying all along—manufacturers’ desire to get medical devices to market supersedes their desire to ensure public safety through proper testing. A Boston personal injury lawyer can help you determine how to proceed if you’ve been injured due to the negligence of a medical device manufacturer.
Medical Device Servicing and Safety Accountability Act
The MITA has proposed new legislation that would make it a requirement for any medical device servicer to “maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices.” The Medical Device Servicing and Safety Accountability Act would reduce or eliminate the risk of improper servicing and reporting. According to the MITA, “the current regulatory structure for medical device providers could lead to instances of improper servicing.” The quality of servicers varies widely, and improper handling can lead to avoidable injuries, and even death.
In addition to proper servicing, the new bill would prompt any entity performing service on a device to alert the FDA to any issues or “adverse events should they occur.” Further, most medical device servicers agree that “consistent standards for device servicing” would be of benefit to everyone involved. A MA personal injury attorney can help you recover damages if you’ve been injured due to the negligence of a medical device servicer or manufacturer.
Medical Device Testing Facts
The facts below further illustrate the severity of the problem involving improper medical device testing.
- The vast majority of medical devices receive no testing before going to market.
- Metal hip implants, surgical mesh, and lap-bands are among the most prominent recalls of medical devices in recent years.
- According to the Institute of Medicine, medical devices should be tested “at least as rigorously as drugs.”
- Currently, no national registry for patient medical devices exists that would allow patients to know if they have a dangerous or defective device.
- In 2017, Endo, a major manufacturer of transvaginal mesh agreed to pay $775 million to settle 22,000 lawsuits.
- Earlier this year, Mary McGinnis received $68 million after she suffered severe injuries as a result of Bard’s pelvic mesh. The award consisted of $33 million in compensatory damage/$35 million in punitive damages.
- All-metal hip implants have been involved in countless lawsuits. In 2014, Stryker settled thousands of lawsuits involving its Rejuvenate and ABG II hip implants for $1.43 billion.
- Power morcellators, commonly used during hysterectomies, may spread uterine cancer cells. So far, Johnson & Johnson has settled nearly two-thirds of the morcellator lawsuits it is facing. Individual settlements ranged from $100,000 to $1 million based on various factors.
Most recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.
