Proposed Legislation Would Require Reporting of Medical Device Injuries To The FDA


The Medical Device Injuries Reporting Bill Was Inspired By Complaints Over Power Morcellators Allegedly Spreading Cancer During Surgery.

morcellator-cancer-lawsuit-southern-med-lawSouthern Med Law is monitoring the progress of a medical device bill after representing women in morcellator cancer lawsuits alleging the medical device spread undetected uterine cancer. The bill, called the “Medical Device Guardian Act” could soon require doctors and doctor’s offices to report all medical device injuries. The medical device reports would be filed with the U.S. Food and Drug Administration (FDA). Currently, only hospitals and manufacturers are mandated to report surgical tools that seriously injure to the FDA.

“Medical Device Guardian Act”

The bill was introduced by U.S. Reps. Louis Slaughter (D-NY) and Mike Fitzpatrick (R-Pa). Fitzpatrick is seen an advocate for women who developed cancer after a laparoscopic power morcellator was used during surgery. Rep. Fitzpatrick is one of 12 bipartisan Congressional members who asked the U.S. Government Accountability Office to investigate reports of power morcellators spreading cancer. Including a rare and aggressive form of cancer called, leiomyosarcoma, during a hysterectomy and myomectomy. In addition, the FBI also opened an investigation on power morcellators and the medical devices’ link to spreading cancer.

“Southern Med Law supports this proposed legislation as doctors are among the first to know when a medical device may cause patient injury,” says Dr. Blaudeau, who is also a practicing obstetrician/gynecologist. Southern Med Law filed the first federal morcellator cancer lawsuit in the country in 2014. The case was settled last year for an undisclosed amount.

Essure Birth Control Lawsuits

In addition to power morcellators, Southern Med Law is representing families in litigation involving other medical devices. For instance, the firm’s attorneys are representing clients in Bayer AG’s Essure birth control system. The Essure birth control lawsuits contend Essure can perforates the uterus or fallopian tubes. This in turn can cause chronic pain, and ectopic pregnancy, which occurs outside of the uterus. In 2015, an Essure petition was submitted to the FDA calling for a ban on the birth control device.
[, FDA, February 29, 2016]

Mirena Pregnancy Lawsuits

Bayer is also a defendant in more than 1,300 Mirena IUD lawsuits. The firm represents women who have become pregnant while using the Mirena IUD and have experienced the loss of their infant. Women who have filed Mirena pregnancy lawsuits have experienced miscarriages or premature births when the IUD could not be removed. In addition, Mirena IUD birth injury lawsuits contend babies are born with underdeveloped vital organs, brain-related injuries, pulmonary hypertension, and other birth injuries. (In Re: Mirena IUD Products Liability Litigation, MDL No. 2434)

IVC Filter Lawsuits

After reports of Inferior Vena Cava (IVC) breaking and causing injury over 1,150 IVC filter lawsuits continue in litigation. The complaints were filed by patients who suffered serious injury or died after the filter failed to prevent blood clots. Cook Medical and C.R. Bard are accused of making IVC filters that tilt, migrate, and break. The broken components of the filters may puncture internal organs or embed themselves in the heart or lungs.

DaVinci Robot Lawsuits

Another medical device manufacture facing litigation is Intuitive Surgical Inc., Intuitive is known for its da Vinci robotic system, and is facing lawsuits over its computer-assisted surgical device Dr. Francois Blaudeau of Southern Med Law recently settled a DaVinci robot lawsuit filed on bahalf of a California women for an undisclosed amount. The Da Vinci lawsuits still pending contend patients experienced surgical burns to tissue and blood vessels, puncture vital organs, and cause other excessive injuries.

Southern Med Law is currently investigating reports of medical device injuries. If you or a loved one have been seriously injured by these and other defective medical devices, please contact Southern Med Law for a free legal evaluation of your claim. To speak with one of our lawyers, please call 205-547-5525 or visit and fill out the form on our website.

About Southern Med Law And Filing A Defective Medical Device Lawsuit

Southern Med Law is an experienced law firm who advocates for people that have been injured by defective medical devices. The firm is not afraid to take on the nation’s largest corporations in their pursuit of justice. Therefore, they are committed to ensuring all victims have access to the type of aggressive legal advocacy that assures success. To obtain a free, no-obligation medical device lawsuit review, please visit, or call the office directly at 205-547-5525.

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