What Causes Surgical Staples Injury?
According to the Food and Drug Administration (FDA), an increasing number of surgical staples injuries occur because the stapler failed to properly fire. As a result of this exposed incision, patients may suffer from organ failure, internal bleeding, and pain.
If you suffered a surgical staples injury, you may be able to sue the liable party for your medical bills, lost income, and pain and suffering. You might have the option to file an individual lawsuit or start a mass tort. A product liability lawyer can represent you throughout all legal proceedings. Reach out to us today for more information.
Surgical Stapler Injuries
From January 1, 2011, to March 31, 2018, the FDA received more than 41,000 medical reports regarding surgical staplers—over 32,000 cited malfunctions, including:
- Difficulty firing
- Failure to fire
- Malformation of staples or opening the staple line
- Misapplied staples
Over 9,000 reports of the 41,000 claimed victims suffered serious injuries, such as:
- Sepsis: the body’s serious, life-threatening response to an infection, typically occurring in the gastrointestinal tract or urinary tract, per the Centers for Disease Control and Prevention (CDC)
- Fistula formation: an abnormal connection between two or more structures in the body (e.g., organs, tissues, etc.) and usually occurs because of surgery or injury, per Medline Plus
- Internal bleeding: often a result of serious trauma
- Increased risk of cancer
- Tearing of internal organs
- Leaking intestinal contents: toxic bacteria and undigested food leak out of the intestines and into the bloodstream
Sadly, there were 366 reports of death related to the faulty surgical staplers and staples within this time frame.
Seeking Medical Attention
After any surgery, there are side effects you may have to deal with—not to mention the increased risk of developing an infection. However, if you feel like what you’re experiencing is abnormal or you’re starting to feel ill, go to the doctor right away, especially if:
- The incision reopened
- You have a high fever
- The area around the incision is red, swollen, and/or painful
- The incision area is bleeding
Don’t put off seeking medical care and trying to fix it yourself. The injury could worsen and lead to other complications. A doctor can identify the problem and treat you right away.
Also, if you decide to bring a lawsuit against the liable party, documentation of your doctor’s visit will help establish a connection between the surgery, the defective stapler or staples, and your injury. That way, the representative may have a hard time claiming that something else caused your ailment.
Who Manufactures Surgical Staplers?
Ethicon, a subdivision of Johnson & Johnson, and Medtronic manufacture two of the most popular surgical staplers—about 80%. Other manufacturers are:
- 3M Company
- Welfare Medical
- B. Braun
- Meril Life Science
- Reach Surgica
Ethicon has issued three recalls on their surgical staplers and staples within the last 10 years.
- More than 57,500 ECHELON 60mm Endoscopic Linear Cutter Reloads Black were recalled in 2013 because the manufacturer found a potential issue with reloading that could keep the device from firing staples in a straight line.
- Over 6,700 Endopath Echelon Flex Powered Vascular Staplers were recalled in 2015 because the staples would fire in a straight line.
- Two models of their surgical stapler, Endo-Surgery Curved Intraluminal Stapler and Endo-Surgery Endoscopic Curved Intraluminal Stapler amounted to more than 92,000 in 2019 because they didn’t fire correctly. These devices were primarily used in gastrointestinal surgery. The FDA classified this recall as a Class I recall, which is the most serious kind.
In terms of the latest recalls, it suggested reclassifying the devices from low-risk to moderate-risk. That way, they would undergo stricter testing. The FDA followed through with this reclassification and instructed the manufacturers to tighten their safety procedures. After looking at the reports of surgical staple malfunction, injury, and death, the organization warned doctors and hospitals about the high risk associated with this medical device.
Ethicon Surgical Stapler Lawsuit
Surgical stapler lawsuits against Ethicon allege that the device malfunctioned and led to serious injuries, including organ damage and bleeding.
Ethicon Settled a Surgical Stapler Lawsuit for $80 Million
Ethicon has already settled a case for almost $80 million in a California court. The award comprises $70 million in punitive damages (later down to $19.6 million due to state limits) and $9.8 million in compensatory damages for the plaintiff. The latter category accounts for pain and suffering, humiliation, medical bills, and disfigurement, as well as loss of consortium for her husband.
The plaintiff of the case, Florence Kulmann, had her anal canal sealed shut after the stapler misfired during surgery in 2012. As a result of this malfunction, she developed an infection and went through two surgeries. She almost lost her life and continues to have complications from the initial surgery.
Ethicon Settled for $5 Million in a Wrongful Death Case
Even though the FDA issued the recall on some of the Ethicon surgical staplers starting in 2013, people were having complications long before then. In 2007, a Pennsylvania jury awarded a woman’s family $5 million for her wrongful death. The device was defective, so it didn’t close her incision properly during surgery.
Surgical Stapler Lawsuit Against the Manufacturer
You may have grounds to bring a product liability lawsuit against Ethicon for manufacturing a defective product. However, you must establish that they were negligent and careless in that:
- They manufactured a device that posed a threat to you and didn’t warn you.
- The device was used as it was intended.
- You suffered health complications as a result of this negligence.
- You have to deal with monetary losses.
Only individuals have brought surgical stapler lawsuits thus far—no multidistrict litigation or class action. However, as more people bring lawsuits against manufacturers, the courts may consider consolidating the cases and hearing them.
How Much Can You Expect from a Surgical Staples Lawsuit?
It is impossible to say how much you can expect to get from a surgical staples lawsuit without reviewing the facts of your case. Although, common factors that may influence your settlement include:
- The nature of your complications
- Your prognosis
- Your ability to work
- Any pain and discomfort that the complications brought on
- Your resulting financial status
From here, a product liability attorney can identify which damages you can seek. They may include:
Past and Future Medical Care Expenses
Your initial surgery that necessitated the surgical staples could have made a dent in your finances. However, you may require other medical care following the botched procedure and its resulting complications. You could recover the costs for:
- Additional surgery
- Pain medications
- Medical equipment
- Doctor’s visits
- Diagnostic and imaging tests
When you file your case, you can also account for the medical costs you anticipate spending.
Lost Income and Benefits
Dealing with pain and other issues resulting from the defective surgical stapler or staples can put you out of work for a while. You have the right to seek the earnings you would have acquired if the surgery and recovery went according to plan, some of them may be:
- Hourly pay or salary
- Commissions or tips
- Promotional and business opportunities
- Paid time off
- Employee benefits
Compensation for lost income can help you maintain your financial status until you can get back to work.
Loss of Future Earning Capacity
If you sustained long-term or permanent complications from the faulty surgical staples, you may not be able to return to work—or at least to the same job. Loss of future earning capacity can make up for the:
- Difference in pay between your old and new job
- Money you would have earned if you were healthy
Pain and Suffering and Other Non-Economic Damages
All of the injuries and illnesses that result from defective surgical equipment can inflict pain and suffering on your life, such as:
- Mental anguish
- Chronic pain
- Disfigurement and scarring
- Diminished quality of life
Even though these hardships don’t come with a price tag, that doesn’t mean you can’t quantify them and request financial help. Pain and suffering damages could help you adjust to your new lifestyle and access the care you need.
It’s rare for plaintiffs to recover punitive damages. However, if the jury deems that the defendant was grossly negligent or acted egregiously, they may award punitive damages, punishing them for their actions.
Wrongful Death Damages
Some people succumb to their complications from the surgical staples injury. If that is the case, you and your family could file a wrongful death case and request compensation for:
- Final medical bills, including for post-mortem
- Burial, funeral, or memorial expenses
- Loss of companionship
- Loss of inheritance or financial support
Other damages that aren’t listed in this article may also be available.
Hiring a Surgical Stapler Lawyer
Trying to recover from your surgery and dealing with your complications, while figuring out how to pursue the liable party may seem next to impossible. Luckily, you can retain a personal injury lawyer’s service.
Usually, firms that take cases like yours work on a contingency-fee basis. That means you won’t have to worry about paying upfront fees or out-of-pocket costs unless they recover a settlement for you. While operating under this payment structure, they’ll provide various services, like:
Collecting Evidence of Negligence
Your lawyer must obtain evidence to back up your product liability claim. Common types of evidence include:
- Medical testimony that connects the defective surgical staples to your health complications
- Medical diagnosis
- Medical documentation
- Recall announcement for the device your doctor used
The smallest piece of evidence can be key to recovering compensation. If you think you have any remotely valuable evidence, bring it up to your doctor.
Negotiating a Settlement with the Insurer
Facing giant companies armed with insurance companies and a team of attorneys can be intimidating, but you don’t have to talk to them. Your attorney can speak to them on your behalf. So, if one of the other party’s representatives contacts you, direct them to your lawyer.
Your attorney can also handle settlement negotiations for you. This aspect of your case can get tricky, because the insurer may try to pass the blame for their negligence to avoid paying you compensation. For example, they could claim that a defective design wasn’t the culprit of your surgical staples injury, as it could have been medical malpractice. Your physician might have failed to clean the area before stapling it, leading to serious injury.
Your lawyer should be familiar with these tactics and work to protect your right to secure fair damages. In the event they cannot settle your case out of court, they will litigate your case before a jury.
Meeting Important State Deadlines
Every state has a statute of limitations by which claimants must file their lawsuit. How long you have will depend on what state you’re in, when you discovered your health problem, as well as other factors. A lawyer can help you identify which deadline applies to you and be sure to comply with it.
Don’t wait to contact a lawyer, though. The states strictly enforce these deadlines, and there are few exceptions. If you’re too late, the court may refuse to hear your case—even if you meet all of the other requirements.
Offering You Responsive Legal Support
Your injury lawyer should always have your best interest in mind throughout the entire legal process. This means that they will inform you about any updates and make themselves available to you if you have any questions or concerns. We have a network of lawyers that can manage your case.
To find out more about how they can help, fill out our contact form today.