Articles Posted in Medical Devices

A federal judge in California recently entered an order approving a $12.3 million settlement involving Caldera Medical’s transvaginal mesh product and associated insurance claims. According to the terms of the settlement, Caldera’s insurance company will provide $10.6 million in payments to nearly 3,000 members of the class, in addition to over $600,000 in payment for attorney’s fees and costs associated with the lawsuit.

The judge issued the order despite 36 objectors who wanted the court to order an independent audit. The objectors argued that there was not enough evidence regarding whether the payment would be larger if the company, based in Agoura Hills, CA, went through a liquidation.

Regarding the mesh product, Caldera’s Vertessa Lite mesh was made of polypropylene mesh and used repair pelvic organ prolapse. Some reports estimate that as many as 40 percent of women experience some type of prolapse and that as many as 250,000 surgical procedures are performed to address this condition each year. When marketing the product, Caldera claimed that it was 31 percent stronger than other comparable mesh products on the market, lighter, and that it featured stronger suture pull-out strength.

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The U.S. Food and Drug Administration (FDA) recently announced a Class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System, Model 115340 (“CRS”). A Class I recall is the highest level of recall according to the FDA’s regulations. This class of recall is used in situations in which there is a reasonable probability that using the subject product or exposure to the subject product will cause adverse health consequences or even death. Zimmer Biomet initiated the recall after reports indicated that the CRS device fractures at a higher rate than indicated on the label.

The CRS device is a shoulder replacement mechanism that is implanted into eligible patients, and it is designed with the intention of restoring arm movement. Some of the most common patients who have received the CRS device in a surgical procedure are patients who experience a tear in their rotator cuff and who experience severe arthritis in their shoulder as a result. This level of arthritis is commonly referred to as arthropathy. The patients have also typically experienced a failed shoulder joint replacement procedure prior to receiving the CRS implant.

According to the recall announcement, physicians who have used the CRS device in shoulder replacement procedures are affected. The announcement encourages them to review the safety notice and other associated information regarding the CRS device, identify any remaining devices that have not yet been used in surgical procedures, and contact any patients who received the CRS device in a surgical procedure. Patients who received or believe they have received the CRS device should consult their physician immediately. Devices subject to the recall were manufactured between August 25, 2008 and September 27, 2011.

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Intuitive Surgical, the company who developed and markets the da Vinci surgical robot, is facing another lawsuit challenging the sufficiency of the warnings that the manufacturer provided with the device. Recently, the Washington Supreme Court ruled that a plaintiff could proceed with a product liability lawsuit on behalf of her deceased husband against Intuitive Surgical. In his complaint, the plaintiff alleged that he suffered serious physical injuries during a prostatectomy using the da Vinci surgical device. According to the plaintiff’s allegations, the physician who performed the surgery noticed during the procedure that the plaintiff’s rectal wall had suffered lacerations. As a result of this complication, the physician had to perform immediate open surgery to repair the lacerations.

Following the surgery, the husband reported experiencing a serious reduction in his quality of life. During ventilation, the husband experienced respiratory failure requiring ventilation, renal failure, and an infection. The husband’s complaint also alleged that he was required to wear a colostomy bag and that he also experienced incontinence. The complaint also alleged neuromuscular damage and that the husband was unable to work correctly without assistance. Roughly four years after the procedure, the husband died. According to a physician who testified on behalf of the plaintiff, the da Vinci robot’s malfunction was a contributing factor in the husband’s death.

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Johnson & Johnson was named as a defendant in a recently filed product liability lawsuit involving its silicone breast implant product. The action, which was filed in state court in California, alleges that the plaintiff suffered severe injuries as a result of receiving the company’s silicone breast implants. The plaintiff’s alleged injuries include severe muscle pain, nausea, and more.

In 1992, the U.S. Food and Drug Administration banned the use of silicone in breast implants. The agency prohibited their use based on research suggesting that they cause health problems like rheumatoid arthritis. The primary manufacturer of silicone implants faced so many lawsuits at the time that it eventually filed for Chapter 11 bankruptcy. The FDA ultimately required the company to pay a total of $3.2 billion in damages to implant recipients. In 2006, the agency lifted this ban, and Johnson & Johnson became the first company to offer a silicone-based implant product in the years that followed.

The lawsuit is seeking damages based on Johnson & Johnson’s alleged failure to provide sufficient warnings to the plaintiff about the potential side effects and safety of the implants. The plaintiff contended that the silicone implants are prone to leaking, which can cause a host of physical injuries and ailments.

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Johnson & Johnson, the manufacturer of the DePuy Pinnacle hip implant device, has asked a federal judge to issue an order granting new trials after juries returned a total of $1 billion in judgments to six total plaintiffs. Each of these plaintiffs sued the medical device maker, alleging that the Pinnacle hip implant device failed to include proper warnings about its potential side effects and that it was designed in an unreasonably defective manner. These plaintiffs alleged specifically that the metal-on-metal aspect of the device resulted in dangerous side effects, including metallosis, a condition in which metal particles escape into the bloodstream.

In December 2016, a jury in Dallas concluded that the metal-on-metal hip implant devices were designed in a defective manner and failed to include warnings about their dangers. The Dallas jury awarded the six plaintiffs $32 million in compensatory damages and over $1 billion in punitive damages. Compensatory damages are a type of damages designed to compensate a plaintiff for expenses associated with his or her injuries that stem from the accident. Common examples include medical expenses and lost wages.

Punitive damages, on the other hand, are a separate category of damages that are designed to punish a defendant for engaging in particularly egregious, wanton, and willful conduct while also serving to deter other similarly situated individuals from engaging in similarly reprehensible behavior.

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In the final days of 2016, a federal appellate court revived a lawsuit brought by a group of shareholders accusing Medtronic, a major medical device and technology company, of concealing information about the negative impacts of its bone growth protein product, Infuse, for over 10 years.

According to the United States Court of Appeals for the Eighth Circuit, a lower court judge incorrectly concluded that the plaintiffs filed their action outside the statute of limitations. According to the lower court record, the plaintiffs did not file their complaint until two years after they learned about Medtronic’s alleged fraudulent activity. The lawsuit also states that executives at the company were not truthful with investors regarding the commercial viability and safety aspects of the Infuse bone growth protein. They also allege that company analysts were not truthful about the prospects of a possible follow-on product, Amplify.

The complaint states that the shareholders purchased shares of Medtronic stock in reliance on these misrepresentations and suffered serious financial harm when the stock price crashed after numerous reports questioning the safety of Medtronic’s Infuse product surfaced. These reports and numerous lawsuits filed against Medtronic allege that the Infuse bone growth paste was used in countless off-label procedures.

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A federal judge in Texas recently entered an order reducing a jury verdict against Johnson & Johnson regarding its DePuy metal-on-metal hip implant device. Marketed under the brand name Pinnacle, thousands of plaintiffs have sued DePuy, alleging that the metal-on-metal hip implant was defective, was unreasonably dangerous, and failed to include proper warnings about the risks associated with the device.

One of the most common injuries associated with metal-on-metal hip implants is metallosis, which is a type of metal poisoning. When the metal components of the hip implant device rub together, microscopic fragments of metal are released into the blood and surrounding tissues. Metallosis causes serious complications, including damage to the bone, tissue, and nervous systems. In some cases, the symptoms associated with the condition do not manifest for several months. These symptoms include skin rashes, infection, nerve pain, cognitive impairment, heart problems, depression, anxiety, and visual impairment that can lead to blindness. Other complications associated with the Pinnacle device include chronic pain, popping and clicking, and complications requiring a revision or removal surgery.

In December 2015, a jury in Dallas returned a verdict concluding that DePuy designed the Pinnacle device in an unreasonably dangerous manner and failed to warn patients. It awarded the plaintiffs in the lawsuit $32 million in compensatory damages and over $1 billion in punitive damages. Punitive damages are a separate category of compensation that is designed to punish a defendant for reckless, malicious, and wanton conduct. It is also intended to deter similarly situated individuals from engaging in comparable behavior.

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Open-heart surgery is a very serious procedure that poses substantial risks on its own. Recently, a number of hospitals in Illinois and around the nation have warned patients who underwent open-heart surgery that they could be at risk for contracting a dangerous infection due to contaminated medical equipment. Patients who may have been exposed to the infected equipment are being sent letters to warn them and to urge them to undergo tests immediately.

The contaminated device in question is a heater-cooler unit that surgeons use to keep a patient stable while undergoing open-heart surgery. According to recent estimates, roughly 60 percent of open-heart bypass surgeries in the United States use the device in question.

According to the CDC, the contamination could have occurred at the time the device was manufactured. Regarding the potential outbreak, a spokesperson for the FDA said that the infections are highly invasive and could be life-threatening for many patients, posing a risk of serious illness and even death in some cases.

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Medical device manufacturers make products that are sold all around the world. Although most of the lawsuits we read about regarding medical devices involve American plaintiffs, there are some instances in which foreign individuals sue U.S. manufacturers abroad for damages they sustained as a result of the defendant’s products. Recently, two French women filed a lawsuit against Bayer, alleging that they sustained damages as a result of using the company’s Essure contraceptive implant device.

The Essure device is comprised of a small metal coil that a doctor inserts in the fallopian tubes by using a catheter. According to the U.S. Food and Drug Administration (FDA), during the 13 years since the Essure device was approved, the FDA has received over 5,000 complaints regarding the device. These complaints describe a wide variety of side effects, including breakages of the device, severe pain, and menstrual irregularities. Other complications include intra-abdominal or pelvic migration of the device, irregular bleeding, and complications requiring the women to undergo surgical procedures to have the device removed. There were also some reports indicating that the patient experienced an unintended pregnancy, depression, uterine perforation, and dizziness. Sources indicate that some 120,000 women in France obtained the device during the last 14 years.

In their complaint, the plaintiffs are requesting an expert to determine the relationship between the damages that they are experiencing and the device. In response to the women’s lawsuit, the French Health ministry stated that the problems that the women experienced may have been a result of the methods that the physicians used to insert the device rather than an issue with the device itself. Still, this could result from the manufacturer’s failure to provide appropriate instructions on how to implant the device, or it could be the result of malpractice on the physicians’ part.

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• Earlier this month, a federal jury in Dallas returned a verdict against DePuy Orthopedics, the manufacturer of the Pinnacle hip replacement device, awarding the six plaintiffs in the lawsuit more than $1 billion in damages. The Pinnacle hip implant device is a metal-on-metal device that has been linked to serious injuries in patients who received the implant. Among the many injuries reported following implantation, metallosis or metal fragments in the blood stream are among the most common. Other injuries reported include severe pain, instability, and complications requiring revision surgeries.

According to the jury in the Dallas case, DePuy’s metal-on-metal device was designed in a defective manner, and the company failed to provide appropriate warnings to patients regarding the risks that the device poses. One of the lawyers for the plaintiffs informed news sources that the verdict was decided with $32 million for compensatory damages and the remainder reflecting punitive damages. Compensatory damages are damages reflecting direct costs and monetary expenses that the plaintiffs incurred as a result of the defendant’s conduct, including medical bills. Punitive damages are an entirely separate category of damages that are purely intended to punish a defendant’s willful, reckless, and wanton conduct while discouraging similarly situated parties from acting in a similar manner.

The plaintiffs were comprised of six individuals from California who were implanted with the Pinnacle device. They reported a number of serious injuries associated with their devices, including bone erosion and tissue death. According to their complaint. the plaintiffs were informed that the metal-on-metal device was a longer-lasting solution than traditional ceramic hip implants or plastic devices. Sources have also revealed that prior to the trial, DePuy rejected a $1.8 million settlement offer by the plaintiffs.

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