Lawsuits against surgical stapler manufacturers are surging, according to recent news. In 2019, surgical staplers made headlines due to recalls and adverse events reports that came to light after years of being hidden in a “secret database.”
In June 2019, the U.S. Food and Drug Administration (FDA) released six million adverse events reports related to medical devices. The reports include devices like surgical staplers, pacemakers, dental implants and breast implants. These reports were essentially hidden in a database that allowed manufacturers to report complaints, but those complaints were never made public.
For millions of people who rely on medical devices, this hidden cache of medical device complaints has shaken their trust in the safety of the healthcare system and the agencies in charge of oversight. For numerous others, their own adverse experiences with medical devices and the release of the information in the hidden database have prompted legal action.
Surgical Stapler Lawsuit Information
Since the FDA published the millions of previously unknown complaints, numerous lawsuits have been filed. A significant number of lawsuits relate to surgical staplers. Evidence suggests there are more than 100,000 adverse events reports related to surgical staplers.
Between 2011 and 2018, 41,000 surgical stapler injuries were made public. Another estimated 56,000 were locked away in the FDA’s hidden database. Of the 41,000 injuries that are public, there were 9,000 serious injuries and at least 360 deaths. Combining the total public and hidden injuries, the total number of adverse event reports increases to more than 109,000. Of those incidents, there were more than 11,180 serious injuries, and at least 412 deaths.
Now, lawsuits are surging against surgical stapler manufacturers. The majority of surgical stapler lawsuits are against four companies – Johnson & Johnson and subsidiary Ethicon, and Medtronic and subsidiary Covidien. These four companies manufacture 80 percent of the surgical staplers used in American hospitals.
Lawsuits suggest a variety of problems with surgical staplers, including:
- Failure to fire
- Punching holes in the body without a staple
- Inserting malformed staples
As a result of these malfunctions, patients have experienced a wide range of injuries, such as:
- The staple line opening
- Chronic pain
- Organ damage
- Formation of fistulas (abnormal connections between tissue and organs)
These injuries often require additional hospitalization, treatment and sometimes additional surgeries. The most severe injuries result in death. Patients and their loved ones may be devastated by the consequences of these injuries, which are often life-changing.
Surgical Staplers Recalled due to Manufacturing Defects
What is alarming about these defects and resulting injuries is that there is quite a lengthy history of surgical stapler malfunctions. Since 2013, more than 3.4 million surgical staplers have been recalled due to manufacturing defects. Some of these recalls include:
What is more alarming is the fact that surgical stapler defects have been underreported for many years prior to 2013. That means there may be more defective staplers currently in use. Furthermore, there may be tens of thousands more injuries than what we currently know.
Patients Seek Compensation from Surgical Stapler Manufacturers
Patients who have suffered harm due to surgical staplers are filing lawsuits for two reasons. First, they want justice against negligent medical device manufacturers. Second, they want compensation for their losses. Serious injuries caused by surgical staplers cost patients a great deal of money, lost income and other expenses.
Injured patients and surviving family members of patients who have died can pursue compensation for:
- Medical expenses
- Funeral or burial expenses
- Pain and suffering
- Loss of enjoyment of life
- Lost wages
- Punitive damages
A secondary reason for filing lawsuits against surgical stapler manufacturers is that these lawsuits may prompt change in the industry. Surgical staplers are an important part of the healthcare system and they are beneficial when they function properly. Recalls and lawsuits are two ways to ensure proper oversight and demand change that will improve the safety of these medical devices.
Contact a Defective Medical Device Attorney
If you or someone you love is suffering due to a surgical stapler malfunction, contact a defective medical device attorney to learn more about your legal rights. At Drug and Device Watch, we handle claims for patients and their families who have been harmed by defective medical devices. Schedule a free consultation with one of our legal professionals to find out if you have an actionable legal claim.
If you have an actionable claim, our team can certainly help you pursue the compensation and justice that your family deserves. Schedule your free consultation by calling 1-888-458-6825, or complete our online contact form.