Medical Device Lawsuits Look To FDA’s Citing of Hospitals Failing To Report Injuries And Deaths From Medical Devices


Medical Device Lawsuits Allege Patients Contract Infections From Contaminated Duodenoscopes And Spreding Of Cancer By Power Morcellators.

fda-logo-food-and-drug-administration-reportAttorneys representing plaintiffs in morcellator lawsuits and dueodenoscope lawsuits are concerned with a recent news report citing hospitals not reporting injuries and deaths from medical devices. Recent Boston Globe report states the U.S. Food and Drug Administration (FDA) has cited 15 out of 17 hospitals nationwide for failing to report patient injuries or death linked to contaminated duodenoscopes, power morcellators and other medical devices. Medical device lawsuits are being filed nationwide on behalf of patients who allege manufacturers and hospitals failed to disclose the risks associated with medical devices that allegedly cause serious harm, life-threatening illnesses, and death.

FDA Finds 15 Hospitals Negligent In Reporting Injuries By Certain Medical Devices

The FDA inspected the hospitals in December 2015 and revealed its report in October, according to the Boston Globe. The FDA found 15 hospitals were either late or did not report cases where patients were injured by certain medical devices. One of the hospitals inspected was Massachusetts General which had patient infections linked to contaminated duodenoscopes. The medical scopes are used for gastrointestinal procedures. The FDA also faulted Brigham and Women’s Hospital for submitting four patient injury reports late and failing to report the death of one patient who 18 months earlier, had undergone surgery that used a power morcellator, the Boston Globe reported.

“The FDA has been aggressively addressing regulatory violations because of the controversy that is still swirling around duodenoscopes and power morcellators,” says Dr. François Blaudeau, founder of Southern Med Law.

Practicing Doctor and attorney fighting for injured patients

Led by Dr. Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the attorneys at Southern Med Law have a unique understanding of the complex medical and legal questions surrounding medical devices. Southern Med Law was the first law firm to file federal lawsuits on behalf of women who developed cancer allegedly after a laparoscopic power morcellator was used during gynecological surgery. The firm was also among the first to represent patients injured after robotic surgeries. Currently, the firm’s attorney are representing patients in lawsuits involving inferior vena cava filters, birth control systems, and other medical devices.

If you believe that you or a loved one have suffered injuries or contracted a serious infection due to a medical device, call Southern Med Law to speak with one of the firm’s attorneys regarding your legal rights at (205) 547-5525 or visit to fill out a contact form.

fda-logo-food-and-drug-administrationThe FDA inspections were conducted amid reports of contaminated duodenoscopes transmitting life-threatening bacteria to patients and laparoscopic power morcellators spreading cancer when used during a hysterectomy or removing uterine fibroids. Under current FDA rules, hospitals are required to report within 10 days information involving medical devices that may have caused or contributed to a patient’s death. Medical device manufacturers are also mandated to submit injury reports to the FDA. A bipartisan House bill proposed in June, the “Medical Device Guardian Act,” would require doctors and doctor’s offices to also submit such reports.

Court documents indicate medical device manufacturers continue to defend themselves in lawsuits alleging their devices seriously or fatally injured patients. For instance, in a duodenoscopes lawsuit against Olympus which makes duodenoscopes, a California woman alleges that she contracted the Carbapenem-resistant enterobacteriaceae (CRE) superbug when a contaminated Q180V scope was used during a procedure in October 2014 at UCLA’s Ronald Reagan Medical Center. (Duodenoscopes Lawsuit Case No. BC586295, Superior Court of California, County of Los Angeles) The Chicago Tribune reported a CRE outbreak occurred at UCLA’s Medical Center where two patients died and 39 patients fell ill between October 2014 and January 2015.
[, January 14, 2016]

About Southern Med Law And Filing Medical Device Lawsuits

Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a loved one were injured by medical devices, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation medical device injury lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526

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