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Articles Posted in Medical Devices

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Medical devices are some of the greatest inventions of modern medicine and have helped countless sick individuals overcome painful conditions. Despite this, however, there are far too many instances in which a medical device manufacturer fails to ensure that its device is safe for its intended use. When this happens, the injured patients can bring a product liability claim against the device manufacturer to recover damages for their injuries. In some instances, plaintiffs can even successfully obtain punitive damages against the manufacturer, which are intended to punish a manufacturer whose conduct is found to be willful, reckless, and malicious and to serve as a deterrent for other manufacturers.

To prevail in a product liability claim, the plaintiffs must prove that the device was designed in an unreasonably dangerous manner or that the specific devices that the plaintiffs received suffered from a manufacturing defect that caused them to be unreasonably dangerous.

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Medical devices are among the most commonly litigated items in product liability lawsuits. To recover damages in a defective medical device lawsuit, the plaintiff must show that the device in question is unreasonably dangerous or that the device the plaintiff received suffers from a manufacturing defect that renders it unreasonably dangerous.

In one of its first actions for the new year, the U.S. Food and Drug Administration (FDA) has issued two orders increasing the regulation of transvaginal surgical mesh products used to treat pelvic organ prolapse (POP). The first order reclassifies transvaginal mesh used in POP procedures as a Class III device. Class II devices are those that generally involve moderate risks, while Class III devices are high-risk devices.

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Earlier this month, a California jury awarded nearly $10 million in compensatory damages and a staggering $70 million in punitive damages against Johnson & Johnson’s subsidiary company Ethicon, stemming from alleged defects in the subsidiary’s hemorrhoid stapler device. The plaintiff was a former police officer who suffered injuries when medical professionals accidentally stapled the officer’s anus shut during a hemorrhoid operation. As a result of these complications, the plaintiff suffers from internal and external scars and a deformed bowel, and she has required the use of a colostomy bag for four years.

In her complaint, the plaintiff alleged that the surgeon who performed the operation was unable to fire the stapling gun properly because the device contained a defect. The plaintiff also alleged that this same defect could be found in roughly one-third of all Ethicon hemorrhoid stapler devices. The surgeon fired the stapler gun once and was unable to remove it without firing it a second time, resulting in the closure of the plaintiff’s anal canal.

The jury concluded that the force required to fire the stapler was more than what was provided in its specifications, and it was the result of a defective manufacturing process that minimized the amount of lubrication provided in the device. Instead of modifying the design and processes used to manufacture the device, the jury concluded that Ethicon pointed the blame at the surgeons who reported experiencing problems when using the stapler devices, despite the fact that Ethicon knew about the devices’ issues.

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There have been thousands of lawsuits brought in recent years against the manufacturers of transvaginal mesh (TVM) products, which have been identified as causing severe, painful, and often permanent injuries. Multiple medical device manufacturers have developed and marketed these devices, which are designed to treat pelvic organ prolapse and stress urinary incontinence. What the patients soon realized, however, is that the device caused severe internal damage, intense pain, and other related injuries.

To recover damages against a medical device manufacturer, the plaintiff must show that the defendant’s device bears an unreasonably dangerous design or that the device possesses a defect that occurred during the manufacturing process that renders the device unreasonably dangerous. The overwhelming majority of plaintiffs bringing claims against TVM manufacturers claim that the devices are unreasonably dangerous.

Once the U.S. Food and Drug Administration started receiving complaints about the health effects of these devices, it launched an investigation into multiple brands of TVM products, issuing warning letters to some and ordering others to perform post-market studies on the TVM products’ safety.

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One of the first bellweather trials in the Wright Medical metallic hip implant litigation went to trial earlier this month, and the jury returned a verdict of $1 million in compensatory damages and $10 million in punitive damages. A bellweather trial is part of a multi-district litigation (MDL). Like a lead plaintiff in a class action lawsuit, the bellweather plaintiff’s claim is used to test the legitimacy of the plaintiffs’ claims and to help the parties get some picture of what common issues of law, fact, and damages might look like for the other claimants in the MDL.

In a product liability action, the plaintiff needs to prove that the defendant’s product was defective. This can be done in two ways: by showing that the product bears an unreasonably dangerous design, or by showing that the particular device that the plaintiff received suffered a manufacturing defect that rendered the product unreasonably dangerous.

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Earlier this month, medical device manufacturer Boston Scientific announced that it has initiated a voluntary recall of its Chariot Guiding Sheath devices (CGS). The CGS devices were designed and manufactured to be used in peripheral vascular procedures. The U.S. Food and Drug Administration, which is responsible for overseeing the approval and safety of medical devices, among other things, has labeled the recall a Class I, the highest and most serious level of recall that the agency issues. The agency’s website defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

According to the recall, Boston Scientific has received reports that at least 14 of the CGS devices experienced shaft separation issues and other related issues that created complications in patients who were implanted with the CGS device. According to its statement announcing the recall, separation of the shaft can lead to life-threatening injuries like embolisms, blood flow obstruction, and emergency surgery to remove the device or its fragments.

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In Arnoult v. CL Med. Sarl, a product liability case, the plaintiff filed suit against the manufacturer of a mid-urethral sling intended to treat stress urinary incontinence. The device, called an I-STOP, was manufactured by a company based in France called CLMS, which sold the device in the United States. The device was distributed by another company called Uroplasty, which the plaintiff also sued in her product liability action.

In her complaint, the plaintiff alleged claims of design and warning defects pursuant to Mississippi’s Products Liability Act, in addition to actions based on negligence, breach of express and implied warranties, fraud by concealment, fraud, negligent infliction of emotional distress, negligent misrepresentation, and loss of consortium.

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When a lawsuit involving a defective product or pharmaceutical involves punitive damages allegations, many defendants will attempt to offer evidence to mitigate any potential award of punitive damages against them. In litigation against Wright Medical Technology and Wright Medical Group involving its allegedly defective hip implant devices, the defendants have offered evidence designed to persuade the jury members that punitive damages awards are not necessary.

According to a recent decision from a federal district court in Atlanta, however, the court granted the plaintiff’s motion in limine seeking to exclude the defendants’ evidence. The excluded evidence consisted of testimony regarding the availability of implant devices and the financial cost of these devices, in addition to evidence about the impact that a large punitive damages award would have on the defendants’ likelihood of successfully competing in the market. It also indicated that layoffs may result if a large punitive damages award was levied against them.

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Although every injury involving a medical device is stressful and devastating, many women have experienced deeply personal emotional and physical pain as the result of defective transvaginal mesh products. Injuries arising from these products can lead to severe and long-lasting complications, often requiring a series of surgeries or procedures to address the internal damage.

In a September 2014 West Virginia case involving Johnson & Johnson’s Ethicon vaginal mesh product, the jury awarded $3.27 million to the plaintiff. In the lawsuit, the plaintiff alleged that the company failed to adequately warn her about the dangers and permanent injuries that can arise from use of the mesh. One year earlier, the company faced an $11 million jury verdict in a New Jersey-based trial over Ethicon.

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On October 14, 2015, the United States Food and Drug Administration released a document providing draft guidance for animal studies used in medical device development and testing. In many lawsuits regarding defective medical devices, studies and guidance documents of this nature are used by the parties’ experts to testify about certain aspects of a party’s legal theory or to rebut testimony from another expert.

These studies will frequently provide evidence regarding the purported safety of a drug or device based on how the drug or device affected animals used in studies. As a result of this precarious situation, there are strict regulatory and industry standards associated with how these studies can be performed.

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