• No Recovery, No Fee
  • Free Consultations
  • Home & Hospital Visits Available
Call Now!
Toll Free: 866-586-8164
Local: 734-274-2876

Hire A Real Attorney, Not A TV Personality

We know our way around a courtroom and we get the results our clients need.
View Our Practice Areas

Consumer Reports on defective medical devices

According to the President of Consumer Reports, Jim Guest, the Food and Drug Administration needs to do more to protect the American people from defective medical devices.

"This isn't science fiction. Millions of medical devices, including artificial hips, contact lens solution, heart stents, and pacemakers, are being recalled - 700 different products a year," Guest wrote. And many of these devices, he pointed out, were never properly tested.

That is because the Food, Drug and Cosmetic Act allows a faster process for some low- and moderate-risk devices. Known as Pre-market Notification, or 510(k) approval, this process has led to the approval of a number of high-risk devices that caused death or life-threatening injuries, including synthetic mesh devices (surgical mesh) and Johnson & Johnson's DePuy hip implants.

Consumer Reports is now attempting to change the approval process, which another nonprofit organization, the Institute of Medicine, supports. That organization has called the 510(k) approval process "fatally flawed."

The FDA has said it will not scrap the process, but that it could be improved. Unfortunately, the FDA does not have the authority to improve the process. What the FDA can do is change device classifications so that certain devices are not eligible for the process. Today, low- to moderate-risk devices are eligible for the 510(k) process, and it may be possible to reclassify some of those devices.

Lawmakers, on the other hand, can change the process. At least one piece of legislation is currently before the U.S. Congress: the Safety of Untested and New Devices Act of 2012 (SOUND Devices Act). That act would give the FDA more authority to reject certain devices as long as those devices are similar to other, recalled devices.

Those injured by defective medical devices can bring lawsuits against the companies that manufactured the devices. If a physician's actions contributed to the injury, they may also be able to bring a medical malpractice lawsuit.

Source: Reuters, "Consumer Reports taps ire over bad medical devices," Debra Sherman, Mar. 12, 2012.

No Comments

Leave a comment
Comment Information
  • $4,391,000: Judgment entered on Oakland County jury verdict, 2008. A Michigan man suffered traumatic brain injuries in a motor vehicle accident, which caused a permanent seizure disorder. View More results
  • $2,536,454: Verdict for no-fault benefits for client severely injured in motor vehicle accident. 2012.
    View More results
  • $2,360,000: Jury verdict for serious electric shock injuries sustained by client in a construction accident in Ann Arbor, Michigan.
    View More results
  • $1,400,000: Verdict for no-fault benefits due to a traumatically brain injured client, in this Washtenaw County action against Allstate Insurance Company. View More results
Email Us For A Response

Contact Us For A FREE Consultation

Tell us about your case.

Bold labels are required.

Contact Information

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.


Privacy Policy

2 convenient office locations free initial consultations

Ypsilanti Office:
119 North Huron Street
Ypsilanti, MI 48197

Toll Free: 866-586-8164
Phone: 734-482-5000
Fax: 734-487-7000
Ypsilanti Law Office Map

Ypsilanti Office:

Jackson Office:
410 South Jackson Street
Jackson, MI 49201

Toll Free: 866-586-8164
Phone: 517-787-9000
Fax: 734-487-7000
Jackson Law Office Map

Handling legal
crises throughout
all of Michigan,
especially Ann
Arbor and
Ypsilanti areas.