C.R. Bard: Devices, Recalls & Lawsuits

C.R. Bard is a medical technology company specializing in vascular, urology, surgery and oncology devices. Becton, Dickinson & Co. acquired C.R. Bard Inc. in 2017 for $24 billion. Bard medical devices include about 15,000 products.

Bard lawsuits have produced millions in settlements and jury verdicts for states and injured individuals. In 1993, the company pleaded guilty to 391 criminal charges stemming from accusations that Bard sold defective heart catheters, hid the problems with the devices from the U.S. Food and Drug Administration and conducted illegal experiments on humans.

After selling off most of its heart-related device manufacturing, Bard switched its focus to vascular, urology, cancer-related and surgical specialty devices. The company continues to face litigation due to complications from its products, including its Kugel mesh devices, transvaginal mesh and Inferior Vena Cava (IVC) filters.

Hernia mesh is a flexible medical device that supports damaged tissue around a hernia. Surgeons attach hernia mesh during surgical hernia repair. Tissue grows over the mesh as the patient heals.

Doctors use hernia mesh in 90% of hernia surgeries annually in the U.S. Surgeons prefer using hernia mesh for repair over sutures alone because it leads to shorter recovery times, less pain and reduced chances of recurrence.

Bard currently makes more than a dozen hernia mesh products, including the Composix Kugel hernia patch, to repair ventral, incisional and inguinal hernias.

Complications

Poorly designed hernia mesh can result in hernia mesh complications.

Defective protective coating on the mesh may fail to prevent adhesions and other problems. Revision surgery may be necessary in more severe cases.

Recalls

Bard device recalls for the Composix Kugel hernia patch include an initial recall in 2005. According to the recall notice, the memory recoil ring on the patch could break and cause bowel perforations and fistulas. Bard widened the recall in 2006 and 2007 to over 137,000 total units.

Lawsuits & Settlements

Bard currently has 23,641 hernia mesh cases pending in multidistrict litigation over claims that its defective hernia mesh products injured plaintiffs. Drugwatch’s legal partners have stopped accepting new hernia mesh cases and global settlement talks are ongoing.

The Bard PowerPort is an implantable catheter device used for intravenous delivery of fluids or medicine. Health care providers use the PowerPort for treatments such as chemotherapy, which requires frequent access to the patient’s bloodstream. Using the PowerPort helps prevent damage to peripheral veins.

Complications

Defective PowerPort products may fracture or migrate, causing serious injuries. As fractured pieces of the catheter travel in the bloodstream, they can damage and rupture blood vessels, causing bleeding.

If this bleeding occurs in an artery that feeds a sensitive organ, such as the brain or lungs, it can be fatal. Bacteria may enter the body when the device fractures or degrades, leading to life-threatening infections.

The complications patients experience often correlate with their overall health. The most serious complications are rare.

Recalls

In March 2020, the FDA announced a Class 2 recall for three Bard PowerPort models. According to a recall notification from Becton Dickinson (BD) — the medical technology company that manufactures and sells the PowerPort — and Bard in 2019, incorrectly sized tips could dislodge from the catheter and prolong the attachment procedure.

Lawsuits & Settlements

Patients filed PowerPort lawsuits against Bard, alleging that they marketed a defective device without making necessary changes or providing adequate warnings to patients. According to lawsuits, the manufacturer should have recalled these devices.

As of July 2024, 299 active lawsuits were pending in Arizona multidistrict litigation. Law firms are actively accepting cases for Bard PowerPort. Though Bard requested a delay, Federal Judge David G. Campbell ordered attorneys for both sides to submit candidate cases for bellwether trials to the court by July 1, 2024.

Transvaginal mesh is a net-like implant that treats stress urinary incontinence and pelvic organ prolapse (POP). Its most common use is to support the vaginal wall, urethra or bladder neck. Complications with POP repair led the FDA to ban mesh sales for this use in 2019.

Though the FDA banned the use of transvaginal mesh for POP repair, surgeons can still use it to treat urinary incontinence. Surgeons usually use a type of mesh called a bladder sling for this treatment.

Complications

A 2015 review of several studies from the Journal of BioMed Research International estimated that as many as one in four women implanted with mesh during transvaginal POP surgery may experience complications.

The most reported transvaginal mesh complication is vaginal mesh erosion, which occurs when the plastic, net-like device erodes through vaginal tissue and becomes exposed. This can cause continued pain and require a second surgery to remove a portion of the mesh.

As mesh erodes through internal tissues, it can perforate other organs. This usually happens to the bladder, urethra, bowel or rectum. Doctors consider this one of the most serious complications of mesh surgery because of the risk of infection and organ damage.

Revision surgery removes or repairs transvaginal mesh implants, but it’s complex and may cause significant pain compared to the initial mesh procedure. While these revision surgeries can ultimately alleviate patient pain, complete mesh complication correction is not guaranteed.

Recalls

While the FDA required Bard to withdraw its POP mesh kit from the market, there are no transvaginal mesh recalls on transvaginal mesh devices. The FDA’s action did not apply to mid-urethral slings or abdominal surgeries to support the vaginal wall.

Lawsuits & Settlements

During November 2019, over 100,000 transvaginal mesh lawsuits were active in the MDLs against Bard and other manufacturers. Mesh manufacturers have paid nearly $8 billion in settlements.

Bard resolved most cases in settlement or dismissal. However, lawyers continue to accept transvaginal mesh cases and file lawsuits in state courts across the country, and a few federal cases exist in a New Jersey MDL.

Bard has also faced lawsuits for other medical devices it manufactures, notably including its IVC filters and the BD Alaris Infusion System.

IVC Filters

IVC filters are cage-like devices implanted in the inferior vena cava, the largest vein in the body, to catch blood clots before they reach the lungs or heart. A 2015 NBC News investigation linked Bard Recovery and G2 filters to 39 deaths.

The company never recalled either device. Instead, it replaced them with similar models. Bard IVC filter lawsuits allege that the devices have defects that make them more likely to fracture or perforate a vein leading to blood clots, organ damage and even death.

Bard settled or resolved 8,600 lawsuits. As of March 2024, the Arizona MDL for Bard remains open, though zero cases remain active. Notable settlements include $926,000 in May 2021 and $3.6 million in an April 2018 bellwether trial.

BD Alaris Infusion System

The BD Alaris System is an infusion pump system that delivers fluids, medications, blood and blood products to adults, children and babies. Hospitals and health care facilities across the U.S. depend on these infusion pumps to deliver lifesaving fluids and medications to patients.

Between 2019 and 2020, Becton, Dickinson and Company recalled millions of its BD Alaris Infusion System devices for defective software, hardware and other issues because of serious injuries and at least one death. It also reported 1,186 complaints related to its Alaris PC Unit Model 8015.

In March 2018, a jury awarded Sherr-Una Booker $3.6 million in the first BD Alaris lawsuit. Since then, Bard has won three bellwether trials and settled a fourth case for an undisclosed amount.