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
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.