The medical industry is still absorbing the shock from the Food and Drug Administration’s 2019 announcement that more than 56,000 reports of surgical stapler defects from 2011 through 2018 had been kept from public disclosure in a hidden FDA database. Many of those reports included references to excess bleeding and other surgical complications that resulted from stapler defects or defective surgical stapler operation.
Showard Law Firm is accepting surgical patients throughout the United States who experienced complications as a result of surgical staplers that were used in their procedures. Surgery patients who experienced stapler complications may be entitled to receive significant damages to compensate them for excess medical expenses and other costs associated with those complications.
What Do Surgical Staplers Do?
Every minute counts during a surgical procedure. Surgeons move as efficiently as is possible to minimize the amount of time during which a surgical patient is under anesthesia. Surgical staplers were invented to allow doctors to cut tissue and then to seal the cuts as quickly as possible to reduce bleeding.
What Are the Risks of a Surgical Stapler Defect?
Surgical staplers that fail to work or that do not create complete seals can cause a number of problems:
- Excess bleeding if a blood vessel is not closed;
- Tissue and organ damage;
- Internal infections when surgical staples fail to steal stomach or intestine linings;
- Increased risk of cancer due to uncontrolled dispersion of cancerous cells.
Why Did the FDA Create a Non-public Database for Stapler Defect Reports?
More than 20 years ago, the FDA created a non-public mechanism for medical device manufacturers to report product defects and other problems apart from reporting that information into the public database. The FDA’s rationale for the non-public database was to better enable the agency to review adverse events, to reduce paperwork, and respond more rapidly.
The FDA granted special exemptions to about 100 different medical devices that allowed the manufacturers of those devices to report adverse events into the non-public database. The exemptions for certain surgical stapler manufacturers expired in 2017 and 2018, and the public reports of stapler defects soared after those exemptions ended. Surgical stapler malfunctions are now under review as the potential cause of thousands of surgical complications and several hundred deaths.
How Can an Injured Surgical Patient Recover Damages?
Patients who experienced surgical complications may be entitled to receive compensation for their injuries and additional medical expenses if a stapler defect was the direct and proximate cause of the complications and injuries. The statute of limitations in your state sets a hard deadline for how long you have to file a lawsuit. An experienced defective device lawyer can determine whether a lawsuit is viable, and how much money you and your family may be entitled to.
Call Showard Law Firm for Information on Filing a Surgical Stapler Lawsuit
Showard Law Firm has the knowledge and experience to help injured surgical patients to recover the largest possible damages to compensate them for complications they experienced from a defective surgical stapler.
Do you have questions about your eligibility to file a surgical stapler lawsuit? Please call us as soon as you can after sustaining injuries that you believe may be due to faulty surgical staplers. We will review your case for free and provide a frank and fair assessment of your opportunity to recover compensation for your losses and injuries.
- khn.org: Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices. https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
- cnn.com: FDA to Review Surgical Staplers After Thousands of Reports of Malfunctions. https://www.cnn.com/2019/03/11/health/fda-surgical-staplers-partner/index.html
- khn.org: More Than Half of Surgical Stapler Malfunctions Went to Hidden FDA Database. https://khn.org/news/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/