Is More Government Regulation Needed to Prevent Recalls?

05/16/2011 07:55 pm ET | Updated Jul 16, 2011
  • Debbie Hines Trial Attorney, Former Prosecutor and Founder,

We are used to recalls of automobile parts, children's toys, electronic devices and grocery items, but few expect recalls of defective body implants already implanted in patients. DePuy ASR hip implants, a subsidiary of Johnson and Johnson Services, are joining the long list of defective manufacturer recall products. In April, the Senate Special Committee on Aging heard testimony for persons who had subsequent surgery due to the DePuy hip implant. One patient, Katie Korgaokar, reportedly told the committee that "In my mind, recalls were for dishwashers and cars, not body parts."

The DePuy hip implants are said to release high levels of cobalt and chromium, at sometimes 1,000 percent higher than they should. This is the same type of chromium poisoning levels that were found in the water, based on the real life movie, "Erin Brockovich." The DePuy hip implants were recalled, by the manufacturer in late August, 2010, due to a high failure rate requiring subsequent surgery over what was expected. Many say the recall should have been much earlier. It is also reported that decay of bone and tissue has also been caused by the implants. DePuy denies these claims.

The real failure for these hip implants may be due, in part to corporate greed and a lack of government oversight on medical devices. Although, DePuy recalled the product in August, 2010, lawsuits claim that the company was aware of the device's failure in 2008. One patient, Larry Barnett, who is represented by Texas attorney, Ed Blizzard, put off the surgery for two years and finally had the implant inserted in 2008, due to its claim to last 15 years or longer.

Ed Blizzard, a tort attorney, is no stranger to large pharmaceutical cases, having represented 200,000 women injured by silicone breast implants, patients inured by diet drugs Ephedra and Fen-Phen and heart attack victims due to Merck's Vioxx. Blizzard knows the drug companies "didn't just uniformly decide to clean up their ways for the betterment of the public."

In an age when there is a cry by Republicans and the Tea Party movement for less government regulation, there is really a need for more government regulation in the medical device and pharmaceutical arena to address issues before patients are injured or killed. Patient Larry Barnett, didn't sign up for an oil spill inside his body when he agreed to hip implant surgery to relieve his pain. But, that's exactly what he got, according to Blizzard, referring to the dark slime now found inside many patients.

While the debate over government regulation rages on, the need for more government scrutiny of medical devices is needed to protect and save lives. Today, there are over 93,000 persons who have these types of hip implants worldwide. Many have endured years of pain before making the decision to undergo hip implant surgery. Now, they may have to ironically undergo even more years of pain due to the very thing that was supposed to relieve their hip pain. Some may even die as a result. Saving one life is truly worth increasing government regulations for medical devices.