Three people who say they were seriously injured by Medtronic surgical staplers are suing the company for knowingly selling defective devices and intentionally hiding risks from doctors and patients.
An attorney for one of the plaintiffs said the three cases, filed in Minnesota and Texas courts in the waning days of 2019, might signal the beginning of litigation against Medtronic over the way it sells and reports safety information on its now-recalled staplers.
"This is all pretty fresh," said Noah Lauricella, a partner with Minneapolis-based GoldenbergLaw, which filed one of the three stapler cases against Medtronic. "Things are just starting to come to light, and I think we may have only seen the tip of the iceberg here in terms of the litigation."
Medtronic, one of the top companies in the multibillion-dollar market for staples and staplers used in surgery, declined to comment on the pending litigation.
The company filed a 219-page report with the Food and Drug Administration last month arguing that real-world experience with the 23 different internal stapling systems it sells confirmed the "consistent and favorable safety profile of Medtronic staplers." Overall, deaths were associated with the staplers in 0.0005% of cases, and injuries were associated with the devices 0.017% of the time.
"In most cases, [the deaths and injuries] are related to the inherent risks of the surgical procedure, patient co-morbidities, or the manner in which the device was used," the company said in its Dec. 19 filing with the FDA.
The three lawsuits filed against Medtronic in December over its surgical staplers involve situations in which patients were having gastrointestinal surgeries in December 2017 that required staples to be precisely placed in organs after surgery. The Medtronic staplers allegedly malfunctioned, for example, by creating holes without leaving behind staples or not properly closing implanted staples. Adverse effects included severe infections, cardiac problems, corrective surgeries, and hundreds of thousands of dollars in additional medical expenses.
"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," said Harris County, Texas resident Cynthia Nicholson in her Dec. 20 complaint filed against Medtronic in Hennepin County District Court.
A Gilman, Iowa, man named Robert Snyder sued Medtronic in Hennepin County District Court on Dec. 24 after experiencing years of negative effects following treatment for stomach pain. Snyder contracted infections and required several surgical treatments after a Medtronic Endo GIA stapler malfunctioned during the removal of a section of his small bowel, leading to a serious complication called an anastomotic leak, the lawsuit says.
Meanwhile, Janet and Randy Adams of Collin County, Texas, filed suit in federal court in the Eastern District of Texas on Dec. 23 alleging that the Medtronic EEA surgical stapler used in a procedure to repair Janet Adams' surgically created stoma misfired and punctured her intestines without engaging the staples.
All three cases allege defects in the design and manufacturing of the staplers, plus negligence and failure to warn. All three cases 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 ASRs, or "alternative summary reports."
"By doing so, [Medtronic)]intentionally concealed from public view the many injuries caused by the use of its Endo GIA staplers," Snyder's 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," the FDA says. "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 last year 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."
Medtronic was a prolific user of the virtually unknown ASR system, the Star Tribune reported in 2016. The following year, the number of ASR reports filed with the FDA declined steeply, FDA filings show. The agency eliminated the program last year following critical reports in other media outlets.
Last year, a series by Kaiser Health News prompted the FDA to release information on 5.7 million device-related injuries or malfunctions summarized since 1999, including tens of thousands of reports on Medtronic and Covidien surgical staplers. The FDA quickly opened a review and found the total number of reported problems associated with all models of staples and staplers between 2011 and 2018 was 109,997. Only 53,720 had been reported publicly, FDA officials concluded.
The FDA recommends new clinical studies and wants to increase the devices' risk category. Medtronic voluntarily recalled a number of its Endo GIA single-use surgical staplers in May 2019, because a missing pin in devices distributed since 2014 could lead to problems, including anastomotic leak, the recall notice said.
"Had these incidents been accurately reported, it is highly likely that public notice, FDA scrutiny, and product recalls would have preceded [Janet Adams'] surgery," the Adams' lawsuit says, "and … the devices would have been appropriately recalled before being used on [Adams] by her unsuspecting surgeons."