Articles Posted in Medical Devices

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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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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