Surgical Stapler Lawsuits
Medical negligence attorneys frequently review cases arising out of complications of surgery. Many of these situations do not support a medical malpractice lawsuit because the complication is a known and accepted risk of the procedure. Prior to undergoing surgery, virtually every patient is required to sign an informed consent form that provides, among other things, that the patient has been advised of the risks of the procedure and, despite this knowledge, consented to undergo the surgery. Common risks of surgery include bleeding, damage to nearby organs and infection. Though these are accepted as risks of the procedure, many of these complications can be avoided through proper and careful surgical technique. However, it is virtually impossible to prove that a surgeon botched an operation by using improper technique. Though surgeons are required to prepare an operative note, they never include language that suggests bad technique was used or an avoidable surgical error occurred.
Surgery, by definition, causes harm. An incision must be made or a puncture caused by a trocar in order to access the operative field. Likewise, stitches used to close the surgery site cause harm. This type of harm is clearly unavoidable. However, when damage occurs to surrounding structures, like a bowel perforation or laceration of an artery, that type of damage is not always unavoidable. The rule of the road is “don’t cut what you can’t see.” This means that the surgeon has a duty to identify structures in the operative field and avoid them while cutting and performing surgery. Many surgeons will argue that when has occurred before, scar tissue and adhesions in the operative field prevent easy identification of surrounding structures. However, in a “virgin” operative field, this excuse is not available.
Surgical staplers provide an efficient and cost-effective way to stitch the incision site after surgery. The surgery staples, sometimes called sutures, are applied just like a regular stapler. Problems arise with surgical staplers when they do not fire properly, leaving areas unstitched that are prone to bleeding and infection. One watchdog group identified the misuse and malfunction of surgical staplers as the number one technology hazard in the U.S. today. The FDA reported that it received reports of 56,000 surgical stapler malfunctions, leading it to reclassify surgical staplers from low risk to moderate risk devices in 2019.
Lawsuits arising out of defective surgical staplers pose several challenges. First, the device manufacturer will blame the surgeon for failing to use the equipment properly. The so-called “learned intermediary” defense can be difficult to overcome. Second, medical device manufacturers typically must be sued in federal court. Federal courts require a unanimous 12-person jury in order to hold a device manufacturer liable for selling a defective piece of equipment. By contrast, in state court, only 6 out of 8 jurors must be convinced in order to obtain a favorable verdict.
Medical negligence attorneys are frequently contacted by patients who have suffered injury as a result of a defective medical device or dangerous drug. Many medical malpractice attorneys do not handle these cases, but refer them to large, multistate law firms who tackle complex product liability lawsuits.