Articles Posted in Medical Devices

Recently, a group of doctors filed a lawsuit against Intuitive Surgical, the maker of the da Vinci surgical robot. According to their complaint, which they filed in the Northern District Court of Georgia, the device caused metal debris to travel to patients’ brains during mitral valve surgical procedures. This condition is referred to as metallic microemboli. Additionally, the complaint states that Intuitive Surgical and a number of other companies and individuals manufactured and marketed the surgical robot even though they knew that it had certain defects that could result in metallic debris reaching surgical patients’ brains.

The plaintiffs include two patients who underwent surgical procedures for mitral valve-related conditions that involved the da Vinci surgical robot. After surgery, both plaintiffs discovered that metallic debris had traveled to their brains. The injuries that the plaintiffs have suffered as a result are severe, including neurological injuries, emotional suffering, and substantial medical costs associated with diagnosing, monitoring, and treating the microemboli. The plaintiffs are seeking to certify a class action lawsuit encompassing other patients who underwent mitral valve surgeries involving Intuitive Surgical’s da Vinci robot.

In May 2016, Intuitive Surgical released an Urgent Product Safety Notice informing the public that its da Vinci robotic device could create metal particulates that could travel to surgical patients’ brains. According to the company, it has not received any notices or reports indicating that patients have suffered injuries of the nature described in the safety notice.

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In June 2016, an appellate court in Pennsylvania ordered a lower court to reverse its order granting $28 million in damages to a plaintiff who sustained injuries associated with a Zimmer-Biomet brand knee implant device. According to the complaint, the plaintiff was injured when she filmed a promotional video for Zimmer. She had received a knee replacement in 2006, using one of its Gender Solutions devices. In the video, she was instructed to engage in a variety of physical activities, including riding a bike and running on a treadmill.

The complaint contained causes of action for negligence, alleging that as a result of the commercial the plaintiff required three revision surgeries. Her husband also filed a cause of action for loss of consortium. To prevail in a cause of action involving a medical device on a negligence theory, the plaintiff must demonstrate that the manufacturer owed the plaintiff a duty of care, that the manufacturer breached that duty, and that the plaintiff suffered injuries as a result of the breach. In general, product manufacturers owe a duty to consumers to use reasonable care when designing, manufacturing, and marketing their products. This includes providing appropriate warnings and instructions about the safe use of a product.

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Pennsylvania- and Germany-based company B. Braun Medical has agreed to pay nearly $8 million after being accused of selling saline syringes fraught with contamination. Braun purchased the syringes from Am2Pat, a manufacturing company, even though it had acquired information prior to the purchase indicating that the syringes suffered from manufacturing issues at the plant in North Carolina where they were produced. Two months after Braun purchased the syringes, it initiated a recall based on information indicating that the radiation sterilization process used caused the saline to develop particulates.

Following the recall, Am2Pat stated that it had not provided correct information to Braun before the sale of the syringes. According to this information, the manufacturing company had installed new equipment at its plant without first ensuring that the equipment was in good working order following the move. Despite this provision of information, Braun started purchasing saline syringes from Am2Pat again and did not conduct its own independent inspection of the manufacturing facility prior to doing so.

Roughly one month later, the syringes were found to contain a dangerous bacteria called Serratia marcescens. Patients in New York, Texas, California, and Nebraska reported experiencing illness and contamination as a result of using the syringes. A second recall of this batch of syringes was also initiated.

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This month, a federal judge in West Virginia dismissed 149 product liability actions brought against C.R. Bard involving its transvaginal mesh device products after the parties entered into a settlement. The exact terms of the settlement agreement have not been revealed.

The company’s pelvic products are intended to treat women who suffer from pelvic organ prolapse and stress urinary incontinence. Thousands of women reported experiencing severe complications after the device was implanted, however, including cramping, abdominal pain, bleeding, painful intercourse, and more. In many cases, women required additional surgeries to remove the devices, which often migrated out of their original locations, and to repair the resulting internal damage. Although some injuries were addressed through the follow-up procedures, many women are facing long-term or permanent injuries associated with the products.

Thousands of lawsuits have been brought against Bard alleging that the Avaulta product was defective, resulting in the formation of a Multi-District Litigation proceeding, known as MDL No. 2187. An MDL is similar to a class action in that a number of plaintiffs with common injuries and causes of action are grouped together. It differs from a class action, however, in that each plaintiff must still plead and prove his or her individual claim.

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Earlier this month, we reported about a lawsuit in which the plaintiff alleged that she suffered severe injuries after a Da Vinci surgical robot device malfunctioned during a procedure. Now, the developer and manufacturer of the Da Vinci robotic surgery device, Intuitive Surgical, has entered into a settlement with the plaintiff following the close of a two-week trial. The settlement came on the third day of the jury’s deliberations over whether to award the woman compensation for damages to her bowel region that occurred during a routine hysterectomy procedure. The exact terms of the compromise, including the amount of compensation, are unknown at this time.

The plaintiff alleged that she suffered injuries when the scissor component of the Da Vinci robot malfunctioned during surgery due to improper insulation, cutting her internal organs and bowel region. Multiple follow-up procedures were required to address the injuries. According to her treating physicians, the plaintiff experienced permanent injuries and damages. In response, Intuitive Surgical argued that the woman was contributorily negligent because she engaged in sexual activity too soon after the hysterectomy procedure, failing to heed the doctors’ warning to wait the recommended six-to-eight weeks.  It also alleged that part of her damages were the result of physical abuse she suffered by her husband. According to her complaint, the plaintiff sought $300 million in damages. During trial, however, the plaintiff sought $30 million.

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Johnson & Johnson and its subsidiary Ethicon may be slapped with higher than anticipated costs for the settlement of the nearly 50,000 product liability claims brought regarding the company’s transvaginal mesh device. Last year, Johnson & Johnson agreed to enter a $5 million settlement with a plaintiff who sued Johnson & Johnson for injuries she sustained after being implanted with an Ethicon transvaginal mesh device. The news about the settlement broke in November 2015 when the attorney representing the plaintiff filed a motion seeking approval of his attorney fees, reports Bloomberg news.

In January 2016, Johnson & Johnson agreed to a $120 million settlement to resolve the first two to three thousand transvaginal mesh lawsuits filed against it. With news of the $5 million settlement, however, the settlement of these claims could cost the health care company to shell out more dough to settle additional claims.

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Medical technology has led to some incredible breakthroughs and has allowed doctors to heal certain injuries and conditions that were previously next to impossible to address. For all their benefits, however, there are some instances in which medical devices do more harm than good. One current example involves surgical robots like the Da Vinci robotic surgical system.

In a recent case, Zarick v.1 Intuitive Surgical, Inc., a 44-year-old woman has alleged that the Da Vinci robot caused her to suffer serious injuries when it malfunctioned during her hysterectomy procedure in 2013. The woman underwent the hysterectomy procedure to address a number of cysts growing in her pelvic region.

The malfunction resulted in the plaintiff’s intestines prolapsing through her vagina. The plaintiff required a second surgery to address the physical damage, but the malfunction was so severe that the plaintiff was left with permanent injuries that prevented the plaintiff from engaging in sexual intercourse with her husband, among other injuries.

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An appellate court in New Jersey has issued an opinion upholding a jury’s award of $11.1 million against medical device manufacturer Johnson & Johnson in a pelvic mesh product liability lawsuit. The verdict came at the close of a two-month trial in which plaintiffs Linda and Jeffrey Gross alleged that Johnson & Johnson’s pelvic mesh product caused Linda to suffer severe, painful, and permanent injuries. Pelvic mesh products are designed to treat conditions like pelvic organ prolapse and stress urinary incontinence.

Shortly after implantation, however, a number of women reported experiencing serious complications like severe abdominal pain, cramping, pain during sex, and bleeding. The mesh products often migrate or shift after implantation and are susceptible to erosion. Many cases required the removal of the devices, which led to additional pain and suffering, recovery time, and permanent complications. There have been thousands of lawsuits filed against Johnson & Johnson regarding its transvaginal mesh products, alleging that the products are unreasonably dangerous and that the company failed to warn patients about these risks and complications.

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