Articles Posted in Medical Devices

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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Many patients have brought claims against Medtronic, the maker of spinal fusion device InFuse, alleging that they suffered serious injuries as a direct result of the device and that Medtronic failed to warn them about the potential side effects. The lawsuits also state that Medtronic encouraged surgeons and other medical professionals to use the device in unapproved, off-label procedures.

The FDA approved InFuse in 2002 to be used in limited spinal procedures. The device consists of a so-called bone paste containing a synthetic protein known as recombinant human bone morphogenetic protein, or rhBMP-2. The paste is designed to promote bone growth and encourage spinal injuries to fuse together. In 2004, the device was approved for use in tibia repairs, and in 2007, it was approved for dental surgeries.

Now, the University of California is agreeing to pay $8.5 million in settlements for two lawsuits that claim a surgeon formerly employed by the University of California, Los Angeles used Medtronic’s InFuse without disclosing that he has financial ties to Medtronic. Reports also indicate that in one of the surgeries, the physician used InFuse in an off-label procedure. The FDA did not approve InFuse for use in cervical spinal operations. After the procedure, the patient alleged that he suffered from serious bone overgrowth, which resulted in chronic nerve damage and other devastating and debilitating injuries.

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A California state court recently denied Johnson & Johnson’s appeal of an $8 million verdict against the company regarding its DePuy ASR XL metal-on-metal hip implant device. The device is manufactured by DePuy Orthopedics, a subsidiary of Johnson & Johnson. The trial that yielded the multi-million dollar verdict was but one of thousands of lawsuits that have been filed against Johnson & Johnson and DePuy, alleging that the hip implant devices caused serious injuries and that the companies failed to provide sufficient warnings about the potentially life-altering side effects that could result. The plaintiff, Loren Kransky, alleged that his device failed only five years after he received the implant. During the March 2013 trial, which lasted for five weeks, the California jury concluded that the device was designed in a defective manner and that both Johnson & Johnson and DePuy were negligent in the design, manufacture, and marketing of the hip implant device.

The plaintiff in the present case, Loren Kransky, alleged that his device failed only five years after he received the implant. During the March 2013 trial, which lasted for five weeks, the California jury concluded that the device was designed in a defective manner and that both Johnson & Johnson and DePuy were negligent in the design, manufacture, and marketing of the hip implant device.

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Roughly 8.5 percent of women in the United States use long-term birth control devices like intrauterine devices or IUDs. This method offers up to five years of birth control by emitting low-dose hormones. The implant can be removed at any time if the woman decides that she no longer wants to use the device or decides that she would like to become pregnant.

Despite the purported benefits of many IUD devices, some of them cause serious injuries and painful consequences for patients. One example is Bayer, which manufactured an IUD device marketed and sold under the brand name Mirena. The Mirena IUD was approved in Europe in 1991 and was approved by the U.S. Food and Drug Administration in 2000. Since its approval, the FDA has received over 45,000 reports of adverse events associated with Mirena IUD devices, including expulsion, migration, dislocation, and hemorrhaging of the vagina.

In the ensuing litigation and multitude of lawsuits filed against Bayer, patients alleged that Bayer intentionally sold the product despite knowing of the dangerous, painful, and life-threatening complications that could arise. The lawsuits were eventually consolidated into an MDL proceeding, which stands for multi-district litigation. Like a class action, common legal issues and factual issues are decided at the global level. When it comes to individual damages, however, each plaintiff must still prove his or her case before being awarded any compensation.

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Earlier this month, a federal district court judge entered an order reducing a jury’s verdict awarding a plaintiff $500 million in damages in a product liability lawsuit involving DePuy Orthopedics, a subsidiary of Johnson & Johnson, to $151 million. The jury’s verdict was returned in March 2016 and reflected compensation for five different plaintiffs who claimed they suffered injuries as a result of receiving a Pinnacle metal-on-metal hip implant device.

The trial lasted for two months and concluded with the jury determining that the metal-on-metal devices were designed in an unreasonably dangerous manner and that the manufacturer failed to provide appropriate warnings about the risks of the products. The jury’s verdict included $130 million in compensatory damages for the plaintiffs and $360 million in punitive damages. Punitive damages are intended to punish defendants who engage in willful, reckless, or malicious conduct and to deter other companies from engaging in similar conduct. The judge who reduced the verdict stated that according to Texas state law, punitive damages must be calculated according to a specific formula.

In related news, the same judge denied DePuy’s motion asking the court to stay the third bellwether trial in the Pinnacle MDL proceeding from going forward until the company could appeal the $500 million verdict, stating that it would create potentially adverse results and result in a waste of judicial resources to allow the third trial to proceed while the company appealed the results of the second bellwether trial. In October 2014, DePuy won the first bellwether trial.

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Patients who suffer serious and potentially life-threatening conditions after undergoing surgical procedures involving a duodenoscope may be entitled to compensation. Roughly 85 percent of these devices are manufactured, marketed, and sold by Olympus. Recently over 100 patients suffered infections from an antibiotic-resistant “superbug,” commonly referred to as carbapenem-resistant Enterobacteriaceae (CRE). There have been three deaths linked to the defective devices. Olympus has finally initiated a recall of the surgical scopes, but this is too late for many affected patients.

Duodenoscopes are flexible tube-based cameras that surgeons can use during procedures to see inside the human body without having to make large openings in the body. They are equipped with a light and are commonly used to help surgeons diagnose conditions in the pancreas and bile ducts. After the outbreak of superbug infections, however, it was discovered that the scopes have a design defect that makes them virtually impossible to effectively sanitize between uses. This means that bacteria from one patient was easily transferred to subsequent patients, despite the surgical staff’s attempts to sanitize the scopes. According to some reports, Olympus was aware that the devices were incapable of being sanitized effectively in 2012, but it failed to inform the medical community about the potential dangers. More specifically, a Congressional report concluded that the medical device maker did not meet the FDA’s basic requirements of transparency and openness in dealing with the superbug outbreaks related to its devices.

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Wright Medical, a manufacturer of hip implants and other medical devices, has asked a federal appellate court to overrule a jury’s verdict in the first bellwether trial to take place in the Conserve metal-on-metal hip implant MDL, which is situated in the Northern District of Georgia. According to the company, a new trial is justified because it believes that the jury was allowed to take two bites at the apple.

An MDL, or multi-district litigation, is a judicial mechanism that is used to consolidate and expedite cases that involve similar claims. It is like a class action in that plaintiffs with common causes of action and common factual allegations against the same defendant are grouped together. It is different from a class action when it comes to damages, however, with each MDL plaintiff needing to prove his or her individual claim. To test legal theories, claims, and damages, the lead attorneys in an MDL conduct a bellwether trial. This involves selecting a plaintiff whose case is representative of the broader MDL plaintiffs’ claims and litigating it to see what a jury would conclude. Hundreds of lawsuits have been filed against Wright Medical, which are now pending in the MDL action.

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