Defective Medical Device Lawsuits

Each year, dozens of medical devices are recalled. Some of these recalls involve serious issues that can affect the lives and safety of thousands of patients. Recalls may involve permanently removing a device from the market or advising patients to have an implanted medical device removed and replaced.

Medical devices can be defective in several ways. Here are some of the possible defects that can impact a medical device and injure a patient:

• Design Defect – The medical device could have an issue with its design, making it unreasonably dangerous for the patient. An example of this is a hernia mesh implant that disintegrated and shifted in the body, causing damage to nearby organs.
• Failure to Warn – The manufacturer may have some knowledge or evidence that the product may be dangerous yet fail to alert the public. They have a duty to inform the people of the potential harms of the product.
• Manufacturing Defect – The medical device may be well-designed, but a mistake during the manufacturing process could cause a device to become dangerous or prone to fail.
• False Marketing – The manufacturer may advertise a device as safe and effective. However, when these statements turn out to be false, the patient can suffer injury.

There have been many instances of widespread harm that have resulted from a defective medical device. Many of these have been the subject of large-scale litigation. Here are some recent examples of defective medical devices that have been associated with widespread injuries:

• Defective Hip Implants – Thousands of lawsuits have been filed against negligent manufacturers such as Johnson & Johnson, Smith & Nephew, and Stryker. The lawsuits claim that the implants’ manufacturers should have provided adequate warnings about the risks of metallic toxicity build-up in the bloodstream.
• Defective Knee Implants – Patients who underwent knee replacement surgery claim that the manufacturers of the knee implants failed to create a safe product and misrepresented the product as safe. Reports of tibial loosening have been submitted to the FDA, and patients experiencing this complication required revision surgery.
• Essure – Thousands of complaints have been reported to the FDA by women who rely on Essure for birth control. These women have suffered severe side effects such as migration of the device, perforation of the uterus, perforation of the fallopian tubes, device breakage, severe allergic reactions, unintended pregnancies, ectopic pregnancies, and even death.
• Hernia Mesh -The FDA has initiated hernia mesh recalls, and some manufacturers have voluntarily recalled their devices from the market. Defective hernia mesh implants have been known to damage the intestines, bowels, and abdomen. These side effects may require additional (or revision) surgery.
• IVC Filter – These devices have been linked to life-threatening complications such as device migration, detachments, perforation of the inferior vena cava, and filter fracture. Lawsuits against IVC filter manufacturers claim that patients and doctors were not sufficiently warned about these devices’ serious risks.
• Transvaginal Mesh – Transvaginal mesh has been ordered off the market by the FDA due to the product’s tendency to disintegrate and move out of place. Several manufacturers of transvaginal mesh agreed to pay millions of dollars in lawsuit settlements.

Here are some notable jury verdicts and settlements in a few cases involving defective medical devices:

• January 2019 – A $41 million jury verdict was given to a plaintiff who received a transvaginal mesh implant and was injured when the mesh eroded in her body. She required nine surgeries to remove the mesh and correct the damage done to her body by the mesh.
• May 2019 – Patricia and George Mesigian were awarded $80 million in their Ethicon Prolift Pelvic mesh lawsuit against Johnson & Johnson
• August 2019 – A plaintiff in California received a $7.68 million verdict when his hip replacement failed due to a metal-on-metal design. He was forced to undergo two subsequent surgeries to remove and correct the hip replacement.
• August 2020 – Essure manufacturer, Bayer AG, agreed to pay a $1.6 billion settlement to resolve 90% of Essure lawsuits. Victims of Essure claimed injuries related to the device breaking, migrating in the body, and perforating their fallopian tubes.
• September 2020 – C.R. Bard, Inc. was required to pay a multistate settlement of $60 million to resolve allegations that the company deceptively marketed its transvaginal mesh implants to patients. 

Defective medical device settlements and awards can include several different things that are meant to compensate victims for their injuries. These awards can include the following:

• Lost wages, both past and future
• Costs of past and future medical care
• Pain and suffering, both past and future
• Loss of consortium damages for the spouse
• Possible punitive damages against the manufacturer in a jury award