SURGICAL STAPLERS


Medical Device Lawyer investigates surgical stapler injury cases for injured plaintiffs nationwide
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Defective Surgical Staplers

Investigating medical device injury & medical malpractice lawsuits

The U.S. Food and Drug Administration (FDA) has said that between January 2011, and March 2018, it received over 41,000 medical device reports involving surgical staplers and staples for internal use. The surgical staple injury reports included 366 deaths, around 9,000 severe injuries, and 32,000 stapler malfunctions.

Common safety concerns include malformed, defective staples and staple misfiring. Surgical staple injury related to operator error are also frequent, spurring on new product liability and medical malpractice cases.

Surgical staplers are critical instruments for many operating doctors. The devices cut and seal blood vessels and tissue in a variety of invasive surgeries. But if the staplers are used incorrectly or they fail to fire, patients can bleed profusely and risk injury and death. The FDA says surgical stapler malfunctions and surgeon malpractice can cause one or more of the following surgical staple injury:

  • Bleeding
  • Sepsis
  • Internal tissue damage
  • Organ perforation
  • Increased risk of cancer recurrence
  • Wrongful death

Joe Lyon is an experienced Cincinnati, Ohio product liability and medical malpractice attorney reviewing surgical staple injury cases for injured plaintiffs nationwide.

The Lyon Firm is investigating surgical stapler injury cases against Medtronic and Johnson & Johnson. 


Surgical Staple Injury Lawsuits


Surgical staplers are used for both external and internal operations. They can be used externally to close wounds on the scalp or the torso. Surgical staples are helpful in many medical situations because of quick placement, little tissue reaction, a low risk of infection, and a high-tension would closure.

For internal use, surgical staplers are commonly used in gastrointestinal, gynecologic, thoracic, and other surgeries. Uses are varied and can include organ removal, organ and tissue incisions, connection structures, and closing wounds.

However, the FDA has its safety concerns, noted in a letter to healthcare providers, issued in March 2019. The warning aims to assist stapler manufacturers in the labeling process regarding information about specific health risks, device limitations, and directions for stapler use. Currently, surgical staplers for internal use do not require a pre-market submission to the FDA for approval.

The FDA alert follows an alarming number of medical device reports associated with surgical stapler injury and death. Retained instrument lawsuits can be valuable for plaintiffs, and patients can seek compensation.


Surgical Stapler Defects & Lawsuits


Lawsuits have been filed against surgical stapler manufacturers, including Ethicon and Medtronic, due to design defects, manufacturing defects, failures to warn and failures to properly test the device prior to distribution.

Surgical staples are commonly used for gastric bypass surgery, lung surgery, neck surgery, heart surgery, colonostomies, and appendectomies. These are everyday procedures, which is concerning for both doctors and patient safety advocates.

In their recent review, the FDA found 90 percent of surgical staple injury cases are due to staple misfiring, and stapler malfunction. Other noted complications include a separation of suture lines, staplers adhering to patient tissue, and staples not forming correctly. Stapler malfunction and improper use of the devices can lead to severe health risks, including death.


Surgical Staplers Injury


Most patients don’t think modern medical devices and equipment can malfunction or cause injury. But surgical injury and medical device defects are a reality, much to the dismay of safety advocates and injured plaintiffs across the country.

When medical devices fail and injury and death occurs, legal action may be necessary to ensure the removal of defective products and to compensate those who have suffered at the hands of medical device companies and negligent medical staff.

Surgical instruments can cause injury when poorly designed, poorly manufactured, or used incorrectly. Some instruments may even be retained in a patient’s body in rare cases. The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices, though with an easy path for some device companies, many defective medical devices slip through the cracks.

Surgical stapler lawsuits typically follow incidents where patients suffer an injury during surgery, which may include severe bleeding, sepsis, infection, chronic pain, tissue and organ damage or death. Surgical stapler malfunction typically involves staple misfiring, stapler misuse, defective staplers and staple misapplication due to medical staff negligence.

Ethicon Stapler Recall

Patients undergoing surgery assume the medical instruments that surgeons use during operations are effective and have been properly tested. But that is not always the case, as medical device companies often recall defective medical tools, as seen in the most recent surgical stapler recall initiated by Ethicon, a subsidiary of Johnson & Johnson.

Ethicon recalled the ECHELON FLEX™ ENDOPATH® staplers after they were found to fail to completely form staples. The FDA has been concerned with Ethicon surgical staplers for quite some time.

In May, the FDA decided to require a pre-market review of surgical staplers used in internal procedures, due to a poor safety record of surgical staplers. From 2011 to 2018, the FDA received 412 reports of surgical deaths and around 110,000 malfunctions linked to surgical staplers. About a third of the reported device failures were related to malformed staples, the same safety issue that led to the Ethicon surgical stapler recall.

Earlier in 2019, the FDA recalled 92,000 circular staplers in a Class I event, meaning the agency believed the devices had the potential for serious harm or death. Ethicon warned of an “out-of-specification component” that may misform staples. The malformed staples could lead to a range of severe complications, from prolonging operations to death.

Ethicon has asked doctor and surgeons to check their stocks of affected Echelon Flex Endopath staplers. The 60mm staplers are meant to be quarantined and returned to the manufacturer. The poor safety history of surgical staplers makes them one of the top health technology hazards.

The Echelon Flex Endopath staplers are single-use devices that cut and staple internal tissue. The stapler is designed to simultaneously cut and staple tissue back together during surgery. But the misformed staples fail to properly close incisions.

The stapler recall involves an alleged defective component within the jaw of the device, leading to malformed staples. The company has said the stapler design could lead to prolonged surgery, post-op connection leak, hemorrhage, or death. At least seven serious injuries and one death have allegedly been reported to Ethicon.

Last year, the FDA sent a letter to health care providers and hospitals after discovering more than 41,000 medical device reports that describe adverse events and deaths linked to the use of surgical staplers.

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

photo of attorney Joe Lyon reviewing surgical stapler defects
A Voice for Those who have suffered

Why are these cases important?

Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.

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Questions about Defective Surgical Staplers

Can I File a Defective Medical Device Lawsuit?

When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.

what are surgical staples?

Surgical staples are used for closing surgical incisions, internally and externally. These closures may be used for large or complex wounds which can’t be closed effectively with normal sutures.

But surgical staples do not dissolve and they must be removed by a doctor after a wound has healed. Staples may stay in the body for up to 21 days before they must be removed.

are surgical staples safe?

Not always. The FDA has reported that patients have experienced sepsis and fistula infections, blood clots, and damage to internal organs and tissue from improperly inserted or defective surgical staples.

What are symptoms of a surgical complication?
  • Infections
  • Poor wound healing
  • Wound re-opening
  • Allergic reaction
  • Severe pain

The FDA warns that defective surgical staplers could be associated with serious risks and complications, including:

  • Internal bleeding
  • Sepsis
  • Bowel leakage
  • Fistulas
  • Revision surgery
what are surgical staples made from?

Medical staples are usually made from stainless steel or titanium. 

How is a Surgical Instrument Defined as Defective?
Ohio Definition of Defective

A medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials.

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

(2) Defective design and/or formulation:

Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. 

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. 

How are surgical staples removed?

Surgical staples should be removed by a medical professional. The procedure depends on the location of the staples, if the staples are located inside or outside the body, and the type of surgery. 

Have surgical staplers been recalled?

In 2019, the U.S. Food and Drug Administration (FDA) initiated a Class 1 recall for Ethicon surgical staplers.

According to the FDA, the device fails to properly form staples which can increase the risk of surgical complications.

There have reportedly been injuries caused by Ethicon stapler complications and one death.

If you or a loved one suffered from surgery complications caused by internal staples, you may qualify in filing a surgical stapler lawsuit.

Should I hire The Lyon Firm?

The Lyon Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

Experience:  Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world.

FAULTY MEDICAL DEVICES

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Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law. 

IN RE: DEPUY ASR

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.

IN RE: BIOMET MSA MAGNUM

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.


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