After 100,000 Adverse Events, Litigation Against Surgical Staples Are Burgeoning

After being hidden in a secret database for decades, evidence of 100,000 adverse reports for surgical staples are driving a burgeoning number of lawsuits against the manufacturers.

Used to close wounds quickly, the staplers misfire, fail to fire, punch holes in the body without injecting a staple, and insert malformed staples. Staples are more popular with doctors than suturing or stitching incisions.

Injuries are severe, including:

  • Opening of the staple line
  • Infections
  • Organ damage
  • Sepsis
  • Fistula formation
  • Death

“Mishaps like these can be severe or even fatal, especially when a staple is injected into a patient where it should not have been. In many of these cases, a defective stapler or defective staples could have been the root cause of the problem,” says the Shouse Law Group of California.

Nearly 80 percent of surgical staplers and sutures used in American hospitals are manufactured by Johnson & Johnson with its subsidiary Ethicon, and by Medtronic with its subsidiary Covidien.

Other manufacturers include 3M; B. Braun; Cardica; Care Fusion; CONMED; Frankenman; Meril Life Science; Purple Surgical; Smith & Nephew; Stryker; U.S. Surgical; Welfare Medical; Reach Surgical; and Zimmer Biomet.

Secret FDA Database

Now is an opportune time for mass tort lawyers to open a practice involving surgical staple injuries. The litigation is in an early stage, and no multidistrict litigation docket (MDL) has been created by the federal courts.

The adverse news began to show up at the FDA in 2011, recalls began in 2013, and a California jury awarded $80 million in damages in 2015.

The FDA’s MAUDE database (Manufacturer and User Facility Device Experience) has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers.

These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that an additional 56,000 reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public.

The FDA had created an exception for stapler makers to report adverse events in its Alternative Summary Reports database, where it was top secret and not even available to doctors. The program was in effect from 1997 through June 2019, when it was closed.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing lawsuit.

Years of recalls

According to the Belluck & Fox law firm, recalls began in 2013:

Manufacturer Year Number Recalled Products Included Reason for Recall
Ethicon 2019 92,496 Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
Two patients were injured after devices misfired, cutting portions of their rectums.
Medtronic 2019 3,113,280 Endo GIA Articulating Reloads with TriStaple Technology Missing components could affect staple alignment.
Medtronic 2018 171,271 Endo GIA “Auto Suture” Universal Articulating Loading Unit Five people were injured related to missing components that could affect staple alignment.
Ethicon 2015 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads Inspections found certain staplers may not insert a full line of staples when fired.
Ethicon 2013 57,540 ECHELON 60mm Endoscopic Linear Cutter Reloads Black Manufacturer identified a potential for reload damage that would prevent a complete line of staples firing.

These recalls covered manufacturing defects, missing components, and failed staples that all had the ability to cause pain, bleeding, leaks, infection, and sepsis throughout the body. They could also cause the need for permanent ostomy bags, antibiotics, additional imaging studies, and even surgery, as well as life-long nutritional deficiencies and life-long digestive issues.

The FDA finally warned doctors about reported problems in a letter issued in March 2019.

Burgeoning litigation

The FDA’s lack of action and transparency has not held plaintiffs back.

A retired San Jose officer was awarded $80 million over a defective stapler in December 2015. A botched hemorrhoid surgery in 2011 nearly killed Florence Kuhlmann. Experiencing severe pain afterwards, she discovered her bowel had been stapled shut against her rectal wall, closing off her intestine.

“She was diagnosed with an occlusion,” Kuhlmann’s attorney, Nina Shapirshteyn, said. “Her bowel ruptured, causing a major infection and sepsis. She was really close to death.”

It was later determined that the stapler used in the procedure was defective, and the company that manufactured it, Johnson and Johnson subsidiary Ethicon Endo-Surgery, recalled certain models of the device — including the one used on Kuhlmann — later that year.

A $5 million settlement was reached on Sep 29, 2017, against surgical device-maker Covidien, Southern Illinois University School of Medicine and an SIU surgeon. The plaintiff was April Ryan, a 33-year-old Charleston woman who bled to death during an elective surgery in 2013.

Surgeon Dr. Sabha Ganai used a Covidien surgical stapler during the procedure that cut a blood vessel but failed to properly seal the vessel shut. This led to massive blood loss, cardiac arrest related to the blood loss, and death the same day.

Separately, three plaintiffs who say they were seriously injured by Medtronic surgical staplers are sued the company in 2019 for knowingly selling defective devices and intentionally hiding risks from doctors and patients.
The three patients had gastrointestinal surgeries in 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.

  • Harris County, Texas resident Cynthia Nicholson in her Dec. 20 complaint filed against Medtronic in Hennepin County District Court. Her complaint states, “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.”
  • Robert Snyder of Gilman, Iowa, 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.

“Had these incidents been accurately reported, it is highly likely that public notice, FDA scrutiny, and product recalls would have preceded [Janet Adams’] surgery,” her lawsuit says, “and … the devices would have been appropriately recalled before being used on [Adams] by her unsuspecting surgeons.”

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Drug Manufacturer Mallinckrodt to Pay $1.6 Billion to Settle Opioid Claims

 With executives bailing out and its stock price crashing, opioid maker Mallinckrodt has agreed to pay $1.6 billion in a “settlement framework” as it put the company’s generics unit into Chapter 11 bankruptcy.

The plaintiff’s executive committee negotiated the settlement in MDL 2804 before U.S. District Judge Dan A. Polster in Cleveland, where 2,725 lawsuits are pending in IN RE: National Prescription Opiate Litigation.

Every day, 128 people in the US die after overdosing on opioids. The misuse of prescription pain relievers, heroin, and synthetic opioids like fentanyl—is a national crisis. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

A total of 47 state and territory attorneys general approved the framework for the agreement.

“Nothing can undo the devastating loss and grief inflicted by the opioid epidemic upon victims and their families, but this settlement with Mallinckrodt is an important step in the process of healing our communities,” California Attorney General Xavier Becerra said in a statement. “While today’s settlement is a step in the right direction, we’ll continue to work to bring more much-needed relief to families throughout California whose lives have been upended by the opioid crisis.”

Under the terms of its proposed agreement, Mallinckrodt would pay the $1.6 billion over eight years:

  • $300 million after the specialty generics business wraps its restructuring.
  • $200 million in anniversary payments for years one and two.
  • $150 million in anniversary payments for years two through eight.
  • The post-restructuring trust would also receive warrant options to purchase up to 19.99% of the company’s stock at $3.15 per share, Mallinckrodt said.

Mallinckrodt plc, which is based in Ireland and has U.S. offices in St. Louis, said the agreement involves subsidiaries Mallinckrodt LLC, SpecGx LLC, and other affiliates. Neither Mallinckrodt plc nor its “specialty brands” subsidiaries would be part of the bankruptcy.

Facing financial doom

Two Ohio counties, Cuyahoga and Summit, reached a $260 million settlement with Mallinckrodt and three other opioid distributors in October, averting an imminent trial. The counties also reached a $20.4 million settlement with Johnson & Johnson.

Facing financial doom, Mallinckrodt changed its severance policy in September to allow for departing executives to receive lump-sum payouts rather than installments.

In June, the Department of Justice filed criminal kickback charges on Mallinckrodt, which acquired Acthar-maker Questcor Pharma in 2014 for $5.6 billion, accusing the company of funneling money through front funds to illegally subsidize Medicare copays and jack up the drug’s list price by 85,000%.

The charges filed in Pittsburgh federal court took place on the same day the drugmaker agreed in principle to a $15.4 million settlement on separate charges tied to two whistleblower kickback suits the DOJ joined in early May.

Mallinckrodt’s announcement came just after more than 20 attorneys general rejected an $18 billion settlement deal proposed by three of the nation’s biggest opioid distributors. Negotiations are ongoing, as are in talks to settle the claims in the Cleveland case.

“In negotiations, our goal — and the goal of the communities we represent — is to create resource streams into localities that long have, and still are, battling the crisis,” the three co-lead plaintiff lawyers in the Cleveland litigation said in a statement. “Our pursuit of corporate accountability against a host of other defendants across the entire drug supply chain will not stop.”

Next month, numerous drug companies are scheduled to go to trial in New York, and later this year, additional cases are scheduled in West Virginia and Cleveland.

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Corporations Gang Up to Make It Harder to Admit Plaintiff Experts

A rogue’s gallery of pharma giants, insurance companies, and carmakers has called on a federal court committee to restrict Federal Rule of Evidence 702 to make it harder for plaintiffs to get their experts admitted.

The blatant move to rig the admission of experts in favor of corporations came from notorious mass tort defendants like Bayer, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Novartis, Pfizer, Teva, and Walgreen.

The brazen attack on Rule 702, or the Daubert rule, was sent on March 2 to the Committee on Rules of Practice and Procedure, Administrative Office of the United States Courts.

“Too often, courts do not fully execute or enforce the “gatekeeping” obligation. Instead, we see courts allowing juries a role in deciding whether an expert’s opinions have the requisite scientific support without first ensuring that the testimony is the product of reliable principles and methods and is reliably applied,” the gang of corporate marauders wrote.

Furthermore, the group wanted the Committee to get rid of the “presumption of admissibility” for experts. The Committee had issued a rule amendment in 2000 stating that “the rejection of expert testimony is the exception rather than the rule.”

The exclusion of an expert witness can cause the dismissal of a mass tort case. For example, Pfizer knocked out more than 300 birth defect lawsuits over the medication Zoloft simply by having expert witnesses disqualified.

Plaintiffs reject changing Rule 702

The corporations, who banded under the misleading name, “Lawyers for Civil Justice,” are making bids to gain a structural advantage for its members.

AAJ Senior Director of Policy and Senior Counsel Sue Steinman said, “Taken together, they are all designed to make it harder and more time consuming for people who are injured to get justice in courts. And in some cases, it would also add more time and burden to the judges who work on these cases,”

Rule 702 grew out of the 1993 Supreme Court ruling Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), which overturned the Frye standard for admitting experts, saying “that the rule incorporated a flexible reliability standard instead.”

Rule 702 of the Federal Rules of Evidence provides in part: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise…

Bayer, which makes the cancer-causing Roundup weed killer, and Johnson & Johnson, which makes cancer-causing baby powder and talc products, constantly argue that plaintiff experts are offering “junk science.”

The giant corporations have failed to persuaded juries, so they are running an end-around with the Court Committee.

Bayer faces 3,000 federal lawsuits over Roundup in MDL 2741, overseen by U.S. District Judge Vince Chhabria in California, IN RE: Roundup Products Liability Litigation. It faces another 10,000 cases in state courts. Recently a state court jury in Oakland in May found that the plaintiff’s use of glyphosate-based herbicide for over 30 years caused them to contract non-Hodgkin’s lymphoma. The judge cut a $2 billion verdict to $86.7 million.

Johnson & Johnson faces 15,299 cases nationwide in federal court, but all of the action so far has been in state courts. The federal cases are consolidated before Chief US District Judge Freda L. Wolfson in MDL 2738 in New Jersey, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation.

Many state juries have awarded 7- and 8-figure verdicts against J&J after it was proven that the company knew for decades about the risk of cancer-causing asbestos contamination in its talc products. For example, a jury awarded $4.7 billion against J&J in December 2018 to 22 women with ovarian cancer.

Many of the corporations seeking to restrict Rule 702 are insurance companies, along with:

  • AT&T
  • Benjamin Moore
  • Comcast
  • Dow Inc.
  • Electrolux
  • Ford Motor
  • Google
  • Hyundai
  • Microsoft
  • Smith + Nephew
  • Toyota
  • Whirlpool

The next meeting of the Committee is May 8.

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Yet Another Zantac Recall as Litigation Mounts

American Health Packaging announced yet another recall of 150 milligram Zantac pills because the heartburn drug has high amounts of the cancer-causing impurity NDMA.

Several recalls were made earlier by Appco Pharma LLC, Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Glenmark Pharmaceutical Inc., Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma, and Lannett Company.

Walmart, Walgreens, CVS, and Rite Aid also pulled prescription and over-the-counter varieties of the drug from their shelves.

Zantac (Ranitidine) provides heartburn relief for acid in the stomach and has been sold in the US for more than 30 years. The recalled batches of the drug contained high levels of N-Nitrosodimethylamine (NDMA).

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys, and respiratory tract.

Plaintiffs have filed 140 federal lawsuits against Zantac drug makers, as of February 19, 2020. They are consolidated in MDL 2924 before US District Judge Robin L. Rosenberg in West Palm Beach, Florida, IN RE: Zantac (Ranitidine) Products Liability Litigation.

The defendants include:

  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • GlaxoSmithKline LLC
  • Pfizer Inc.
  • Sanofi-Aventis U.S. LLC
  • Sanofi US Services Inc.
  • Chattem, Inc.

Many lawsuits to come

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and charge that the manufacturers, sellers, and distributors of Zantac knew that it contained NDMA and that the defendants concealed the NDMA-associated dangers posed to consumers.

Plaintiffs argue that NDMA is inherent to the drug’s molecular structure. Also, in a January 2, 2020 letter to the FDA, the Emery Pharma lab said that prolonged heat exposure can increase NDMA to unsafe levels in ranitidine. “This was concerning since significantly elevated temperatures can occur within closed vehicles during transportation and during storage of the drug,” the company.

Plaintiff attorney Robert Hilliard of Hilliard Martinez Gonzales said that his firm has already been hired by 15,000 consumers.

“Zantac will ultimately be one of the biggest consumer frauds ever perpetrated by Big Pharma,” Hilliard said. He believes consumer claims are backed by strong scientific evidence.

Concerns over Zantac began in 2019 when Valisure, an online pharmacy, discovered NDMA in batches of ranitidine during routine independent testing.

Valisure reported in a Sept. 9, 2019, FDA citizens petition letter that it detected extremely high levels of the chemical in every lot it tested across multiple manufacturers. The company said one tablet of Zantac may contain amounts of NDMA several thousand times higher than acceptable FDA limits.

The FDA announced on Sept. 13, 2019, that trace amounts of NDMA were found in Zantac.


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Defendants’ Distortion of the Fosamax Ruling Fails to Impress the Court

The Supreme Court handed down its ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019 on May 20, 2019.

The day after the Supreme Court Ruled Mass Tort Nexus published our take on the ruling in an article entitled: Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs

It has been apparent that the defense bars takeaway from the Fosamax ruling differed from that of MTN in that almost every defendant in every current pharmaceutical MDL, has threatened to raise a defense sounding in the Supreme Courts ruling in Fosamax, despite the fact that they can not allege that they actually sought approval from the FDA to make a specific change to their warning label, and were the requested permission from the FDA. It appears that the defense bar has interpreted the Fosamax ruling as green lighting future implied impossibility or possibility of impossibility defenses, versus foreclosing on these defenses. It was MTN’s take on the ruling that the Court foreclosed on any theory sounding in implied impossibility or possibility of impossibility defense versus green lighting these defenses for application in other cases.

We are happy to report that at least one Circuit Court, faced with a motion sounding in the defense bars take on the Fosamax ruling, interpreted the SCOTUS jurisprudence in the same manner MTN interpreted the ruling the day after the Supreme Court ruled.

Crockett v. LUITPOLD PHARMACEUTICALS, INC., Dist. Court, ED Pennsylvania 2020
Hypertext the link below to the above
https://scholar.google.com/scholar_case?case=972595979562724211&q=avandia+adequacy+of+warning&hl=en&scisbd=2&as_sdt=40006

In deciding whether impossibility preemption requires the dismissal of a claim, the judge must evaluate the evidence presented and “simply ask … whether the relevant federal and state laws `irreconcilably conflict.'” Merck, 139 S. Ct. at 1679 (quoting Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982)). To put the Court in a position to conduct this evaluation, Defendants must identify the state law at issue (e.g. the requirement that drug manufacturers warn about particular risks of a drug) and the federal law with which it conflicts irreconcilably. To “show[] that federal law prohibited [a] drug manufacturer from adding a warning that would satisfy state law,” the drug manufacturer must demonstrate that (1) “the drug manufacturer fully informed the FDA of the justifications for the warning required by state law” by “submitt[ing] all material information to the FDA[,]” and (2) the FDA “informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1678. Such demonstration must be made with “clear evidence,” i.e., “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Id. at 1672.

In making a preemption argument, it is not sufficient for the proponent to contend that if it had submitted a new label—with additional warnings—to the FDA, the FDA would have rejected the warning. See PLIVA, 564 U.S. at 624 n.8 (noting that the “possibility of impossibility” is not enough for preemption). In other words, the conflict must be real—”[t]he existence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute.” See Merck, 139 S. Ct. at 1679 (quoting Rice, 458 U.S. at 659).


Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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