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Defective Surgical Staplers

Surgical staplers, also known as sutures for minimally invasive surgeries, are used to save time during surgery and supposedly reduce the risk of anesthesia complications. Their purpose is to both cut tissue and vessels and then quickly seal them. But serious complications can occur by firing defective staples into organs or other tissue. Surgical stapler injury can also occur by not firing all the staples necessary to seal an incision, which can cause bleeding and other complications. Defective surgical stapler reports include staplers that have created holes in the tissues without leaving staples behind, or staplers that have failed to close the implanted staples.

If the surgical stapler is defective, the repair it is supposed to secure could break loose and cause the contents of an organ that is undergoing repair to be released into the surrounding body.

The ECRI Institute, an independent non-profit health safety group, identified misuse of surgical staplers as a top health technology concern. In its “Top 10 Technology Hazards Report” surgical stapler misuse and malfunction ranks Number 1.

“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”

Surgical Stapler Risks and Complications

Patients have been seriously injured when staplers have failed to fire or seal tissue, causing internal bleeding, organ damage and/ or infections or death when used during surgeries.  Reported complications include severe infections, cardiac problems, and the need for corrective surgeries. One patient required several additional surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his bowel. Another patient reported that her intestines were punctured when a Medtronic EEA surgical stapler allegedly misfired during her surgery.

Surgical Staplers and FDA “Secret” Database

It took a Kaiser Health News report in 2019 for the FDA to release its hidden database and tighten regulations around surgical staplers. The agency admitted in a letter to doctors (March 2019) that it received more than 56,000 surgical stapler malfunction reports from 2011 through 2018 but chose not to inform doctors, hospitals or the public.

In April 2019 the FDA toughened regulations and proposed reclassifying surgical staplers from low-risk to moderate-risk devices, which meant a stricter approval process. (Surgical staplers were in the same category as simple devices like tongue depressors and bandages.) At the same time, labeling changes included proper use and safety hazards. The agency then asked for expert input on its analysis of all reported injuries and less than two months after toughening regulations, it warned to doctors and hospitals of the high number of deaths and injuries related to staplers.

Of the 41,000 malfunctions reported to the MAUDE public database, at least 366 deaths and more than 9,000 serious injuries were related to surgical staplers over eight years—from 2011 until early 2019.  But the FDA posted less than 100 stapler-related injury reports to the public MAUDE database in 2016.

The FDA in May 2019 published an analysis of 109,997 stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. According to MAUDE, deaths were associated with Ethicon and Covidien (a division of Medtronic) products.

Medtronic and Johnson & Johnson’s Ethicon are the two biggest surgical stapler makers. Medtronic said the FDA granted it exemptions for stapler-related malfunctions, but J&J said it had not.

Surgical Stapler Lawsuits

In lawsuits filed against Medtronic and Covidien, plaintiffs blame the manufacturers for serious health complications, claiming that the staplers were defectively designed and manufactured. Medtronic has been blamed for failure to warn doctors and patients of the potential dangers.

At least three lawsuits filed in late 2017 against Medtronic involve patients who underwent gastrointestinal surgeries that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned by creating holes without leaving behind staples or not properly closing implanted staples.

One of those lawsuits filed against Medtronic states that “A reasonable and prudent manufacturer is or should be aware of the risk that if its product is defective, the [surgical] repair it is intended to secure could break loose, causing the contents of an organ undergoing repair to be released into the surrounding area of the body.”

Another patient sued Medtronic after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to several infections, more surgical treatments a serious complication called an anastomotic leak.

The FDA and Medtronic ASR Reports

The FDA hid from the public 10,000 reports as so-called “alternative summary” reports according to Kaiser Health News.
The above plaintiffs all say Medtronic intentionally used a secret loophole in federal adverse-event reporting laws that allowed it to conceal the true risks from the device by burying injury reports in nonpublic files known as alternative summary reports (ASRs). “By doing so, [Medtronic) intentionally concealed from public view the many injuries caused by the use of its Endo GIA staplers,” one lawsuit says.

Federal law requires med-tech companies like Medtronic and Covidien, the staplers’ maker before Medtronic acquired the company in 2015 — to file a public report with the FDA anytime anyone at the company learns that “any of their devices may have caused or contributed to a death or serious injury,” says the FDA. “Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

However, until 2019 the FDA’s ASR program allowed manufacturers to secretly file spreadsheets summarizing large numbers of adverse events with little to no supporting detail, in cases in which the FDA agreed with the manufacturer that the adverse events were “well-known and well-established risks associated with a particular device,” reported the Star Tribune.  Back in 2016, the Tribune reported that Medtronic was a prolific user of the virtually unknown ASR system, but the following year—once this information was made public– the number of ASR reports filed with the FDA declined steeply, FDA filings show. Following critical reports in other media outlets, the agency eliminated the program in 2019.

Surgical Stapler Recalls

In May 2019, Medtronic recalled a number of its Ethicon Endo-Surgery Staplers, identifying it as a Class 1 recall, the most serious type. The recall said a missing pin in devices distributed since 2014 could lead to problems, including anastomotic leak. In October 2019, Ethicon recalled the Echelon Flex Powered Plus Endopath 60mm Stapler, due to the potential for malfunction.

An attorney for one of the plaintiffs said in late 2019 that these lawsuits might spur the beginning of litigation against Medtronic regarding the way it sells and reports safety information on its now-recalled staplers.

Ongoing Surgical Stapler Litigation

The largest surgical stapler lawsuit verdict was $80 million for a woman who suffered injuries during surgery that nearly killed her. Due to recalls, reclassification and increased public awareness of these defective devices being hidden from the public, attorneys predict an increase in  surgical stapler lawsuits.
 

Surgical Stapler Injury Legal Help

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Published on Sep-21-20

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There are nearly 5,000 different types of PFAS, according to the FDA. Many PFAS are resistant to grease, oil, water, and heat, and this is why PFAS have been used in a variety of applications since the 1940s. They were used in stain- and water-resistant fabrics and carpeting, cleaning products, paints, and fire-fighting foams. The FDA authorized certain PFAS for limited use in cookware, food packaging, and food processing equipment.

PFAS Studies and Regulations

The International Agency for Research on Cancer (IARC) and the Environmental Protection Agency (EPA) have both conducted studies and concluded that these chemicals are highly toxic and hazardous to the environment and human health. According to the CDC , PFAS increases the likelihood that communities around PFAS manufacturing, or facilities using PFAS containing chemicals, are likely to be adversely impacted.  A 2007 study  by the CDC estimated that PFAS chemicals could be detected in the blood of 98 percent of the US population.

The CDC, The National Center for Environmental and the Agency for Toxic Substances and Disease Registry have all labeled human exposure to PFAS as a public health concern.

The Environmental Working Group reports that more than 1,500 drinking water systems serving nearly 110 million Americans may be contaminated with the chemicals. According to CNN, the Department of Defense has identified at least 400 active or closed military installations or bases with potential PFOS or PFOA and the Pentagon has identified at least 36 military installations where drinking water levels of PFOS and PFOA exceeded the EPA’s health advisory.

PFAS Serious Health Conditions

Some of these PFAS have been more widely used and studied than others. According to the FDA, science surrounding potential health effects of PFAS is “developing” but evidence suggests it may cause serious health conditions.

Studies in humans exposed to PFAS have shown that these chemicals can:

• Increase cancer risks, especially testicular and kidney cancers
• Increase cholesterol
• Affect immune system functions
• Disrupt the body’s natural hormonal levels
• Decrease fertility
• Cause liver damage
• Cause thyroid disease
• Affect infants and children’s growth, learning abilities, and behavior

PFAS Lawsuits

A recent class action lawsuit is potentially open to any U.S. individuals who claim to have injuries from PFAS exposure and if the chemical has been detected in their blood. One proposed class action filed in Ohio federal court could include every person in the U.S. because PFAS is believed to be present in most everyone.  And a federal court in South Carolina is overseeing federal multidistrict litigation involving hundreds of plaintiffs who also claim they have been exposed to PFAS.

PFAS Firefighters Class Action Lawsuit

Three firefighters from New York State in May 2020 filed a class action lawsuit
on behalf of all firefighters in the U.S. against 28 companies involved in varying degrees with the manufacture and sale of aqueous film-forming foam (AFFF). Thomas J. Gentile, Tommy McGarry, and Charles O’Keefe filed suit in US District Court for the Eastern District of New York. Gentile developed testicular cancer; McGarry suffers from chronic fatigue, heart disease, and high cholesterol.

In addition to individual lawsuits, many states and municipal governments have filed environmental lawsuits against the chemical manufacturers, accusing them of polluting water and soil, fish and animals, and causing serious health issues in human beings. As well, the chemical manufacturers are accused of concealing and misleading the public by promoting slightly altered chemical varieties as safe alternatives, and 3M “knowingly and willfully” disposed of those chemicals that allowed them to enter the water supply.
 

PFAS Health Risks Legal Help

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Published on Sep-15-20

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Plaintiff’s Complaint:
At approximately 8:00 pm on October 22, 2019 Plaintiff Mariela Madariaga was traveling in a vehicle operated by Emmanuel Franco Quintero. Mr. Quintero lost control of the vehicle causing it to crash into a tree on SW 23 Ave and South Dixie Highway in Miami Dade County, Florida. Ms. Madariaga suffered catastrophic injuries including a compound comminuted fracture of her lower leg requiring emergency surgery and subsequent permanent disability.

Injury, Damage, or Loss:
Madariaga was traveling in a vehicle operated by Emmanuel Franco Quintero. Mr. Quintero lost control of the vehicle causing it to crash into a tree on SW 23 Ave and South Dixie Highway in Miami Dade County, Florida. Ms. Madariaga suffered catastrophic injuries including a compound comminuted fracture of her lower leg requiring emergency surgery and subsequent permanent disability.

Defendant’s Wrongdoing:
Madariaga was traveling in a vehicle operated by Emmanuel Franco Quintero. Mr. Quintero lost control of the vehicle causing it to crash into a tree on SW 23 Ave and South Dixie Highway in Miami Dade County, Florida. Ms. Madariaga suffered catastrophic injuries including a compound comminuted fracture of her lower leg requiring emergency surgery and subsequent permanent disability.

Plaintiff’s Attorneys:
Raymond R. Dieppa FLORIDA LEGAL, LLC 12550 Biscayne Blvd. Suite 209 North Miami, FL 33181-2536 (t) (305) 901-2209 (f) (786) 870-4030 rd@floridalegal.law

Defendant’s Attorneys:
N/A

Judge/Arbitrator/Mediator:
Hon. Barbara Areces 73 W. Flagler St Miami-Dade County, FL
 

Free Legal Help

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Published on Sep-3-20

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