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C.R. Bard Company Information

C.R. Bard is a major manufacturer of products used in urological and cardiovascular markets. The company began in 1907 as Charles Bard entered the world of medicine. After suffering side effects from tuberculosis, Bard imported Gomenol, a European panacea. He used this drug as the basis for other ideas and developed a brand of catheters and other urological supplies. Over the years, this business grew and expanded its operations to 90 different countries. Although many of Bard’s products enjoyed success, the company’s reputation has been overshadowed by numerous lawsuits and allegations of fraud.

Products Recalled by C.R. Bard

Throughout its long run in the medical industry, Bard has been forced to recall a few products. One terrible scandal that rocked the manufacturer involved its faulty heart catheters developed between 1987 and 1990. Patients had to undergo emergency heart surgeries to correct injuries caused by the devices. The products contained balloon-like tips that were threaded through blocked arteries. Many times, these tips broke and caused the need for emergency grafting surgeries. Bard failed to report these issues to the FDA and started testing a different catheter before receiving approval. Although the products were recalled, the company still faced over 390 criminal charges of medical fraud.

In 2007, a large number of Composix Kugel Mesh surgical patches were recalled. These devices were used to treat hernias with the help of a “memory coil ring.” However, many cases reported a break in this ring that caused bowel perforations and a condition called “chronic enteric fistulae.”

Most recently, Bard faced issues with its Avaulta Plus mesh device, which was used to treat pubic floor disorders and incontinence. Although no recalls were ever issued, the manufacturer stopped selling the product among fears of mesh erosion, infection, organ perforation, internal bleeding, and other possible problems.

Lawsuits Facing C.R. Bard

Bard is among multiple pharmaceutical manufacturers facing lawsuits for its transvaginal mesh and sling products. Its Avaulta mesh has been associated with severe health concerns. Effected victims have filed lawsuits that allege the device causes painful injuries. Evidence suggests Bard failed to properly test the product before bringing it to market. Plaintiffs believe the mesh had defective warnings as well. Product liability law states manufacturers must warn consumers about all possible dangers.

Besides bladder mesh lawsuits, Bard has faced litigation against its Composix Kugel Mesh. One of the biggest cases involved a man who showed proof he experienced severe internal injuries and a sepsis infection after the patch broke inside his body. Besides this particular instance, an additional 3,600 claims with similar evidence have been filed in courts across the country.

Back in the 1990s, Bard was sued over its cardiac catheters. Many patients faced painful bypass graft surgeries after its devices broke without warning. The U.S. Attorney John Pappalado explained Bard and several of its top administrators tried to maximize profits and ignore laws made to protect the safety and well-being of the public. Innocent victims have a right to receive fair compensation for Bard’s blatant negligent behavior.

One of the latest legal actions against Bard involves its brachytherapy unit. The manufacturer was investigated over questionable sales and marketing practices. Charges allege the manufacturer paid illegal kickbacks to doctors who used its radioactive “seeds” as a prostate cancer treatment. These seeds were to be placed inside the body so that they could release appropriate radiation to fight cancerous cells. Besides the alleged pay offs, doctors and hospitals did not receive enough instructional information to adequately use these seeds. It is estimated that over 98 treatments were botched. As a result, some patients received weak doses of radiation therapy, and other seeds were implanted in wrong body locations.

Verdicts Against C.R. Bard

In 2013, Bard agreed to settle its kickback scheme concerning its radioactive “seeds.” This whistleblower lawsuit accused the manufacturer of paying doctors and hospitals in the form of free supplies, rebates, and marketing assistance. Since hospitals billed Medicare patients for the seeds, the Department of Justice accused Bard of Medicare fraud. The manufacturer paid $48 million as punishment.

In response to the large number of Kugel hernia patch lawsuits, Bard negotiated an agreement to settle approximately 2,600 cases. The average payment to each plaintiff was $70,000. Unfortunately, the settlement did not include the other 1,000 lawsuits still being fought. In total, it is estimated that Bard will pay a total of $300 million to patients who were injured from a defectively designed memory coil in the device.

Another major dent was placed in the integrity of Bard over its heart catheter issues. The company paid $61 million in fines over violations of the Federal Food Drug and Cosmetic Act, the Civil Monetary Penalties Law, and the False Claims Act. The settlement also included provisions the company must be supervised to make sure it follows future laws.

Some of Bard’s biggest headaches are coming from its Avaulta mesh litigation. It was determined this manufacturer was aware of the product’s risks and marketed it as safe and effective. Internal documents suggested Bard knew certain materials in the mesh were unsafe for human use. In July 2012, the first verdict was handed down. The jury forced Bard to pay $2.5 million to an Avaulta victim. Two additional bellwether trials awarded compensation to the plaintiffs as well. As these suits continue to be filed, it is not known how much Bard will lose from the injuries caused by its devices.

FDA Sanctions Against C.R. Bard

Some of the most serious FDA sanctions against C.R. Bard concerned its vaginal mesh products. The FDA has ordered this manufacturer and other vaginal mesh makers to analyze the amounts of damage and complaints linked to the devices. The federal agency plans on placing stricter safety requirements on these type of products as well.

Today, Bard refuses to admit the company ever purposely introduced items that brought harm to the public. It continues to grow and introduce innovative products. Hopefully, stricter FDA rules and enforcement will encourage the manufacturer to place customer safety in higher regard.

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