ETHICON SURGICAL STAPLERS RECALLED AFTER REPORTS OF SERIOUS MEDICAL HARM

Somerville, NJIn mid-October 2019, the FDA recalled Ethicon Echelon Flex surgical staplers because of a dangerous manufacturing failure that could cause serious health damage or even death. This followed, by only a few months, a recall of Ethicon Endo-Surgery curved intraluminal staplers, a defective medical product that posed similar dangers to patients.

The FDA’s immediate warnings were directed toward surgeons who were likely to use the product. Surgeons, of course, can be seriously inconvenienced, and their practices may be vulnerable to reputation damage and perhaps lawsuits because of the defective medical device. But the harm that threatens surgical patients is far more dangerous. 

WHAT COULD POSSIBLY GO WRONG WITH A SIMPLE STAPLER?

The non-medical person’s experience of office staplers is probably pretty benign, and it does little to shed light on this question. Surgical staplers are used to cut and staple internal tissue during surgery. They are often used for large or complex surgical wounds where stitches or sutures would be ineffective. Surgical staples must be removed by a doctor after the wound has healed, often after a few weeks.

The central problem with the Ethicon Echelon Flex surgical stapler is that staples are malformed. They are somewhat like the bent staples that come out of (or more likely jam) an office stapler.  In any event, they do not work as intended. The Echelon Flex Staplers affected by the recall include the following:

• ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A);
• ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A);
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A); and
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A).

The central issue with the Ethicon Endo-Surgery curved intraluminal staplers, most commonly used in gastrointestinal surgery, appears to be that they do not fire reliably. As has already been reported in one lawsuit, a surgeon may be under the false impression that an incision is closed when it is not. The Ethicon curved staplers affected by this recall are:

• Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples; and
• Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples;
• Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A.

ETHICON’S DEFECTIVE MEDICAL DEVICE DOES SERIOUS HARM TO SURGICAL PATIENTS

Sadly, when either kind of stapler is used during surgery, patients are at risk for serious medical complications. They may have little way of knowing that something is seriously wrong, until grave symptoms appear. These symptoms can include:

• Uncontrolled bleeding from the incision;
• Other leaks at the closure of the surgical site;
• Need for repeated surgical repairs;
• Infection;
• Need for a permanent ostomy bag;
• Life-long nutritional and digestive issues;
• Torn or damaged internal organs or tissues;
• Formation of fistulas, , an abnormal connection between organs or other tissue in the body;
• Sepsis; and
• Death.

DID JOHNSON & JOHNSON HIDE THE DANGER?

As the defective medical product lawsuits begin to multiply, as they surely will, one issue is especially likely to loom large. Did Johnson & Johnson, the manufacturer of the Ethicon surgical staplers know or have reason to know that the product was dangerous?

As reported by Kaiser Health News, the FDA has acknowledged that before February 2019 many adverse events reports concerning Ethicon surgical staplers were reported on the FDA’s alternative summary reporting database, rather than the FDA’s public MAUDE database. They were not, therefore, readily searchable by physicians seeking information on the medical device’s safety.

As of early October 2019, just before the latest recall, Ethicon was already aware of 7 serious injuries and one death related to its staplers. Had the adverse incident reports been publicly available, the number might have been much higher.