A California defective medical device claim against Johnson & Johnson regarding its Ethicon subsidiary’s Proximate surgical stapler has resulted in a jury award of $8.5 million in compensatory damages to the injured woman for her pain and suffering, disfigurement, humiliation, and medical expenses, $1.3 million to her husband for his loss of consortium claim,, and $70 million in punitive damages awarded earlier this month for the defendant’s gross negligence.
The plaintiff, a retired San Jose, California police officer, had surgery in January 2012 during which an Ethicon Proximate stapler was used by the surgeon. According to the plaintiffs’ lawsuit, the surgical stapler was defective because it fired with force beyond its specifications, thereby leading to the stapler misfiring and accidentally stapling the woman’s anal canal shut.
As a result, the woman had to be hospitalized and suffered an infection, requiring a full laparotomy and colostomy. The woman now has a deformed bowel and must use a colostomy bag.
On October 24, 2012, the FDA issued a Class I recall of the Ethicon Proximate stapler products, which are used in the surgical treatment of prolapse and hemorrhoids or in other applications where circular or semicircular stapling of anorectal tissue is needed, stating that users have difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation. The FDA recall notice stated that the failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal, and can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding.
Medical and surgical devices are designed and intended to make patients’ lives better and to assist medical professionals in performing medical procedures as effectively as possible. Most medical devices meet their design specifications and help rather than hurt patients on whom the devices are used. However, sometimes a medical or surgical device is defectively designed, or is used in such a manner as to harm patients. When a medical device or surgical device is defective in design, manufacture, or use, patients are unnecessarily harmed, sometimes fatally.
If you or a loved one were injured or otherwise harmed as a result of a medical or surgical device that did not perform as intended or specified, the manufacturer and/or provider of the device may be liable for the injuries and harms caused by the defective medical device. Other times, the medical device may be negligently used or employed by the medical provider, thereby causing unintended harm. Many times it is difficult for the patient harmed by a defective medical device or a defective surgical device to know what caused their unanticipated injuries, with the medical providers knowledgeable about the incident engaging in a conspiracy of silence and misdirection to keep the hurt patient from becoming aware that their injuries were avoidable.
If you or a loved one suffered injury or other serious harm that may be due to a defective medical device or a defective surgical device, you should promptly find a medical malpractice/defective medical device lawyer in your state who may investigate your possible defective medical device claim for you and represent you in a defective medical device lawsuit, if appropriate.
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