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Articles Posted in Medical Devices

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Medical technology has led to some incredible breakthroughs and has allowed doctors to heal certain injuries and conditions that were previously next to impossible to address. For all their benefits, however, there are some instances in which medical devices do more harm than good. One current example involves surgical robots like the Da Vinci robotic surgical system.

In a recent case, Zarick v.1 Intuitive Surgical, Inc., a 44-year-old woman has alleged that the Da Vinci robot caused her to suffer serious injuries when it malfunctioned during her hysterectomy procedure in 2013. The woman underwent the hysterectomy procedure to address a number of cysts growing in her pelvic region.

The malfunction resulted in the plaintiff’s intestines prolapsing through her vagina. The plaintiff required a second surgery to address the physical damage, but the malfunction was so severe that the plaintiff was left with permanent injuries that prevented the plaintiff from engaging in sexual intercourse with her husband, among other injuries.

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An appellate court in New Jersey has issued an opinion upholding a jury’s award of $11.1 million against medical device manufacturer Johnson & Johnson in a pelvic mesh product liability lawsuit. The verdict came at the close of a two-month trial in which plaintiffs Linda and Jeffrey Gross alleged that Johnson & Johnson’s pelvic mesh product caused Linda to suffer severe, painful, and permanent injuries. Pelvic mesh products are designed to treat conditions like pelvic organ prolapse and stress urinary incontinence.

Shortly after implantation, however, a number of women reported experiencing serious complications like severe abdominal pain, cramping, pain during sex, and bleeding. The mesh products often migrate or shift after implantation and are susceptible to erosion. Many cases required the removal of the devices, which led to additional pain and suffering, recovery time, and permanent complications. There have been thousands of lawsuits filed against Johnson & Johnson regarding its transvaginal mesh products, alleging that the products are unreasonably dangerous and that the company failed to warn patients about these risks and complications.

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Bayer is one of the largest pharmaceutical and medical device manufacturers in the world today. Recently, a group of over 30 women filed a lawsuit against the company alleging that its Essure permanent birth control device resulted in serious and painful health problems. Common symptoms that the plaintiffs reported suffering from included menstrual bleeding, migraines, abdominal cramping, and abnormal bleeding. The complaint was filed on March 17 in St. Louis, Missouri.

The Essure birth control device consists of a metal coil inserted in the fallopian tubes using a catheter. Last year, the U.S. Food and Drug Administration reported that during the 13 years following approval of the device, it received thousands of complaints regarding physical complications that resulted after implantation. During the time between July 2015 and October 2015, the FDA received over 2,800 complaints alone.

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After a two-month trial and a one-week period of jury deliberations, the jury in a case against medical device and home consumer goods company Johnson & Johnson has returned a $500 million verdict in the plaintiffs’ favor. Johnson & Johnson manufactured and marketed the DePuy hip implant product, consisting of a metal-on-metal device.

There are over 8,000 additional lawsuits pending against Johnson & Johnson regarding the DePuy hip implant device. The lawsuits have been consolidated in a Multi-District Litigation proceeding. This mechanism is similar to a class action in that it seeks to streamline the judicial process, but differs because each claimant receives an independent assessment of his or her particular claim.

Shortly after hitting the market, patients who received the DePuy device reported experiencing severe problems, including a tendency of the device to fail much more quickly than the company stated it would. The manufacturer advertised the hip implant device as being safe, durable, long-lasting, ideally suited for young patients, and ideal for individuals who lead an active lifestyle.

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The West Virginia legislature has passed a bill that adopts the learned intermediary rule for the state. This doctrine has major implications for liability in cases involving dangerous prescription drugs and defective medical devices. According to the learned intermediary doctrine, when a drug or device manufacturer provides a warning to the physician about the product, its intended uses, and its potential complications, and the doctor then interacts with the patient in regard to the drug or the device, the manufacturer cannot be held liable for damages arising from the consumer’s use of the drug or device.

Since its inception in 1995, the learned intermediary doctrine has been controversial. Opponents of the doctrine argue that it prevents consumers who have suffered severe harm due to a defective device or drug from recovering compensation from the manufacturer or distributor.

Proponents of the doctrine state that a physician who interacts with the patient after receiving instructions from the manufacturer or distributor is in the best position to inform the consumer. They also argue that manufacturers typically do not have direct routes to marketing their devices and pharmaceuticals to patients and consumers directly and that imposing a duty on the manufacturer would put an undue burden on the physician-patient relationship.

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Today, there are thousands of lawsuits being brought against the makers of transvaginal mesh products, including Johnson & Johnson. This month, a jury in Georgia returned a verdict against Johnson & Johnson in favor of the plaintiff, finding that the manufacturer was responsible for injuries that the plaintiff sustained after being implanted with a Mentor ObTape transobturator vaginal sling. While the manufacturer of the device discontinued it in 2006, countless women received the device prior to this time.

Due to the incredible volume of cases involving health complications linked to the Mentor ObTape product, they have been organized into a multi-district litigation (MDL) proceeding centralized in the Middle District of Georgia. MDLs are similar to class actions in that common questions of fact and law are resolved on a broader basis, but they are different in that each plaintiff’s claim is evaluated individually and subject to a unique determination of whether damages are appropriate.

In her complaint, the plaintiff alleged that her doctors prescribed and implanted a ObTape device to treat her stress urinary incontinence. Shortly after the surgery, the plaintiff began experiencing severe pain, infections, and a worsening of her urinary incontinence. She also required multiple follow-up surgeries to address these symptoms and will need extensive continued medical care well into the future.

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Fresenius Medical Care, a German medical company, has entered into a settlement agreement to resolve a landslide of cases brought against it involving its GranuFlo and NaturaLyte products used in dialysis treatments. Both of these products are dialysates and were used in thousands of dialysis clinics across the United States to treat patients experiencing kidney disease and kidney failures. Roughly one in every 500 Americans suffers from some illness that affects the kidneys and must undergo dialysis on a regular basis. Dialysis is a process that cleanses blood and eliminates toxins and wastes before returning it into the patient’s blood.

GranuFlo is a powder concentrate, and NaturaLyte is a liquid version of the same substance. The chemicals are used in dialysis machines to help neutralize the increased production of acid that can occur during the dialysis process.

In 2012, the U.S. Food and Drug Administration issued a Class I recall of both products after determining that the products posed severe threats to patients. Class I recalls are the most serious level of recall that the FDA can initiate and are appropriate when the product in question poses a substantial risk to patients, including the possibility of death.

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The news has been full of reports recently regarding a number of manufacturers’ vaginal mesh products. One of the largest manufacturers of these devices is Johnson & Johnson, which is facing numerous lawsuits in a multi-district litigation. The devices are intended to treat pelvic organ prolapse and urinary stress incontinence, but thousands of women reported experiencing severe complications after receiving the devices. These injuries included minor issues involving pain and very serious conditions that required additional surgeries and treatment.

A plaintiff who experiences severe injuries and damages as the result of a medical device may bring a product liability lawsuit to recover compensation. In a product liability case, the plaintiff may pursue three different theories of recovery. First, the plaintiff can show that the defendant designed the device in an unreasonably unsafe manner. Second, the plaintiff can establish that the specific unit that the defendant received suffered from a defect during the manufacturing process. Finally, the plaintiff can show that the defendant failed to provide sufficient warnings or adequate instructions regarding the device’s use and potential dangers. The plaintiff is not limited to one of these theories and may seek to establish all three.

Recently, a Philadelphia jury rendered a decision in the second lawsuit concerning Johnson & Johnson transvaginal mesh devices. In her complaint, the plaintiff alleged that she suffered severe pain and injuries after the mesh device eroded and that she was required to undergo three revision operations to remove the device.

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The U.S. Food and Drug Administration (“FDA”) has issued tighter regulations for surgical transvaginal mesh products that are designed to address pelvic organ prolapse, which is a condition that occurs when the pelvic floor is no longer able to support a woman’s pelvic organs. The surgical mesh is intended to strengthen the pelvic floor and wall, and to help keep the pelvic organs in place. The devices have been used for several decades in surgeries to treat pelvic organ prolapse and the stress urinary incontinence that results from the condition.

Common issues associated with the devices surfaced around 2002, involving devices implanted through the vaginal canal as opposed to through the abdomen. The method of implantation through the vaginal wall was touted as a more efficient way to implant the device that required less healing time and resulted in a smaller incision. According to the FDA, however, the veracity of these claims has not been proven.

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Wright Medical, the developer and manufacturer of the Conserve metal-on-metal hip implant, has asked the federal judge overseeing the multi-district litigation in Georgia to vacate the $11 million verdict that the jury returned during the first bellwether trial. A multi-district litigation (“MDL”) is a special proceeding used to consolidate numerous lawsuits that deal with the same complex product liability issues or disaster before one judge in a centralized forum. A bellwether trial is a trial that occurs in the MDL to test the parties’ claims and defenses. Usually, the case selected for the bellwether trial contains factual and legal issues that are common to the rest of the cases in the MDL.

In November 2015, the jury returned its verdict in the first ever federal case addressing claims that Wright Medical’s metal-on-metal hip implant resulted in injuries to a patient. The plaintiff alleged that although the hip implant was marketed as lasting from 15 to 20 years, she began to feel severe pain after only six years.

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