Articles Posted in Medical Devices

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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Last month, Zimmer Biomet, a company that manufactures medical devices, won a lawsuit against a plaintiff who alleged that he suffered serious injuries as a result of being implanted with Zimmer Biomet’s NexGen Flex knee replacement device. The federal judge presiding over the Illinois lawsuit declared that the plaintiff had failed to establish that the product suffered from a design defect.

In 2007, the U.S. Food and Drug Administration, which is responsible for regulating medical devices, among other things, approved the NexGen Flex device. It is designed to offer greater flexibility than other devices designed for knee replacement.

Since then, thousands of lawsuits have been filed against the manufacturer, alleging that the device is unreasonably dangerous because it cannot withstand the force of extra flexion. The company, which is based in Warsaw, Indiana, denied that the device is unable to withstand this extra flexion in marketing materials associated with the device. Other plaintiffs have alleged that the device is susceptible to premature weakening because of a design flaw, leading to multiple revision surgeries to correct the errors.

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This month, a court in Georgia reduced a $4 million verdict awarded to the plaintiff in a Johnson & Johnson transvaginal mesh lawsuit in half, stating that a statutory cap on damages limited the plaintiff’s recovery to $2 million. The plaintiff requested that the judge refrain from applying the cap, but the judge declined. In addition to the $2 million award, the judge approved a $400,000 compensatory damages claim, making the total award to the plaintiff $2.4 million.

The plaintiff in the lawsuit was a Florida woman who filed a lawsuit after discovering that she suffered injuries and complications after being implanted with an ObTape Sling manufactured by Mentor Worldwide LLC and Johnson & Johnson. According to some estimates, nearly 35,000 women were implanted with the device between 2003 and 2006. The plaintiff received the device in 2004 to treat her stress urinary incontinence condition. Shortly after being implanted with the device, the plaintiff experienced the erosion of bodily tissues, including her vaginal wall, requiring substantial reparative surgeries. Among the many painful injuries she sustained, the plaintiff also dealt with ongoing and excruciating infections.

In her lawsuit, the plaintiff alleged that the defendant failed to provide sufficient warnings regarding the dangers associated with the ObTape sling device, including the erosion of bodily tissue, and that the company failed to provide sufficient testing to determine whether the product was safe for its intended use.

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Boston Scientific, a company that developed a pelvic mesh product called Obtryx, failed in its effort to appeal a $18.5 million verdict against the company in a product liability lawsuit. In November 2014, a West Virginia jury concluded that the company owed compensation to four different women who received the Obtryx device. At the close of the 10-day trial, the presiding judge ordered that Boston Scientific must pay each plaintiff between $3.25 and $4.25 million.

Following the verdict, the Massachusetts-based medical device manufacturer appealed the award, asking the judge to reduce it on the basis that the plaintiffs did not demonstrate that the product is unreasonably unsafe. According to Boston Scientific, this product’s design and warnings were within the standard of care that applies for stress urinary incontinence products. The company also argued that the plaintiffs did not draw a causal connection between the alleged defects of the product and the injuries that they sustained. Boston Scientific also claimed that the warnings it included with the Obtryx product were sufficient and that the jury’s award of punitive damages was excessive.

On review, the appellate judge rejected Boston Scientific’s claims. According to the court, the record contained ample evidence that could support the jury’s conclusion that the plaintiffs had satisfied each element of the claims they advanced. For example, the defendant was misguided in referring to the standard of care for stress urinary incontinence. In a product liability action, the standard of care is the level of care that the manufacturer owed when creating the product, rather than the level of care a doctor owed in prescribing it.

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Thousands of women have filed lawsuits against Bayer, alleging that they have suffered injuries as a result of receiving the company’s birth control implant device, called Mirena. The T-shaped device is made of polymer and implanted in the uterus. It releases synthetic progestin hormones that alter the uterine wall and decrease the rate at which sperm can survive in the uterus. It also prevents ovulation.

In March 2014, one of these lawsuits went to trial in the Northern District of Georgia. The plaintiff in this case stated that the contraception device resulted in the development of a pseudotumor cerebri. The symptoms associated with this condition led to vision and hearing issues, neck and head pain, vertigo, and severe migraine headaches. The plaintiff’s complaint included claims for concealment, failure to warn, breach of express and implied warranties, negligence, fraud, and strict liability. The defendant moved for summary judgment, and the district court granted the motion. The plaintiff appealed, stating that the lower court abused its discretion when it denied her motions to extend the time to conduct factual discovery and expert witness disclosures.

On review, the Eleventh Circuit Court of Appeals upheld the lower court’s motion for summary judgment. The appellate court concluded that it was proper to deny the plaintiff’s motion to extend the discovery deadlines, particularly since the lower court had already granted the plaintiff one prior extension to conduct discovery. Additionally, the appellate court ruled that the lower court was not acting beyond its discretion when it denied the plaintiff’s request to amend the complaint to name two additional defendants that were foreign companies.

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In the first pelvic mesh trial to go forward against Boston Scientific, the plaintiff obtained a victory from a Massachusetts court, which overturned a prior verdict rendered in 2014 that had dismissed the case. The plaintiff will now be able to proceed with a new trial. Boston Scientific’s pelvic mesh product has been the subject of thousands of lawsuits, resulting in the compilation of a Multi-District Litigation proceeding in West Virginia.

The plaintiff in the case, Diane Albright, contended that the company’s Pinnacle mesh product was designed in a defective manner and resulted in her experiencing serious injuries. The woman received the device to treat her pelvic organ prolapse condition. In July 2014, the jury hearing her case concluded that Boston Scientific designed the device properly and that it provided sufficient warnings about the risks associated with the product. The plaintiff appealed this verdict, stating that the lower court judge erred when it precluded the jury from hearing evidence regarding a material safety data sheet for the polypropylene that the company included in the mesh. The plaintiff argued that this MSDS document showed that the chemical was not appropriate for implantation in the human body.

The plaintiff also contended on appeal that the judge committed reversible error in preventing two letters from the FDA that were sent to Boston Scientific from being included in the evidence. The letters included directions from the federal agency ordering Boston Scientific to perform post-market surveillance studies for its mesh product. The letter also showed that the FDA agreed to suspend this order to perform studies after Boston Scientific said that it was no longer intending to sell the mesh product.

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A number of states’ attorney generals are taking action against Johnson & Johnson and its subsidiary Ethicon regarding the companies’ vaginal mesh products. In May 2016, California and Washington sued Ethicon, claiming that the company engaged in deceptive marketing practices when it came to failing to disclose the potential dangers and health consequences associated with using transvaginal mesh products. Now, Kentucky has joined the fray, suing Ethicon on behalf of all residents in the state.

According to the complaint filed by the Kentucky attorney general, over 15,000 female patients were implanted with an Ethicon transvaginal mesh product without sufficient disclosures from J&J about the potential side effects that could result. This prevented the women from making informed decisions about whether to proceed with the implantation.

In a statement regarding the lawsuit, Kentucky Attorney General Andy Beshear said, “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”

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