Articles Posted in Medical Devices

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.

Continue reading →

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.

Continue reading →

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.

Continue reading →

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.

Continue reading →

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.

Continue reading →

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.

Continue reading →

Johnson & Johnson, a manufacturer of Ethicon brand transvaginal mesh products, has agreed to pay $120 million to settle the first 2,000 to 3,000 lawsuits filed against it alleging that the products caused the plaintiffs severe injuries and damages. This is the first time that Johnson & Johnson has entered into a settlement encompassing a substantial number of cases regarding the Ethicon product. In the past, it has settled a few cases on a one-at-a-time basis. Until now, the manufacturer has mostly declined opportunities to negotiate with plaintiffs and their counsel as well as the numerous other device manufacturers involved in transvaginal mesh disputes.

Transvaginal mesh products are designed to treat a number of conditions, including pelvic organ prolapse. The plaintiffs’ claims largely contend, however, that the products resulted in severe organ damage, constant pain, and other devastating injuries. In some cases, the transvaginal mesh device shrank after being implanted, resulting in severe pain and injuries. In June 2012, Johnson & Johnson agreed to remove some of its product lines from the market.

Continue reading →

Earlier this month, in Cisson v. C.R. Bard, Inc., the Fourth Circuit Court of Appeals upheld a jury verdict awarding $250,000 in compensatory damages and $1.75 million in punitive damages in a product liability case alleging that the plaintiff suffered damages as a result of a transvaginal mesh product.

The plaintiff was implanted with a Bard transvaginal mesh product to treat pelvic organ prolapse, one of the most common uses of mesh products. After suffering injuries and damages, the plaintiff filed a lawsuit against the product manufacturer in Georgia Federal District Court, alleging multiple theories of recovery, including negligence, design defect, failure to warn, and loss of consortium.

Continue reading →