Bard, officially known as C.R. Bard, Inc., is a maker of medical devices and technologies based in Murray Hill, New Jersey. Areas of focus for research, development and manufacturing for the company include urology, oncology, vascular products, and surgical products. In its more than 100-year history, Bard has produced a number of important an innovative devices, but it has also had its problems.
These include dangerous products that have spurred lawsuits against the company, like vaginal mesh and inferior vena cava (IVC) filters. Bard has also faced allegations of offering kickbacks and other types of fraud. These products and unethical practices have cost the company millions of dollars in settlement money and fines.
Bard – An Overview
C.R. Bard calls itself a multinational developer, a manufacturer and a marketer of medical technologies that are both innovative and that enhance lives. The company sells its medical products to individual health care professionals as well as medical centers like hospitals and extended care facilities. They focus on four major fields of research and product development: surgical specialty, oncology, vascular, and urology.
One of the things Bard has been known for is developing products that can be used effectively and economically on single patients for a single-use. While Bard has developed many innovative products over the years that have helped people, they have also been at the center of scandals. Dangerous products like transvaginal mesh and IVC filters have caused patients serious complications. And, the company has been less than ethical in committing several instances of fraud.
Charles R. Bard founded the company, C.R. Bard, Inc., in New York City in 1907. The first thing the company did was import a medication called Gomenol, used to treat urinary problems. Bard incorporated in 1923, but was sold to new owners just three years later. The new owners started developing catheters and found success with these products in the 1930s and 1940s.
Several innovations over the following decades helped the company, which had moved to New Jersey, grow and thrive. New styles of catheters were developed at Bard, and the company went beyond these to start making products related to other areas of medicine, like radiology and anesthesiology. The company went public in 1963 and first exceeded $1 billion in sales revenue in 1994. Bard has also expanded by acquiring several smaller companies, including Catheter Technology Corporation, Genyx medical, Venetec International, and several others.
Transvaginal mesh is a product that has proven problematic for a number of companies, including Bard. This product was designed to treat two conditions in women: stress urinary incontinence and pelvic organ prolapse. With the former condition, a weakness in the bladder or bladder neck leads to urine leakage, while with the latter, weakened pelvic tissues cause organs to fall out of place.
Before the 1990s surgeons would treat these conditions by inserting surgical mesh through abdominal incisions. The mesh was placed under the organs to give them more support. Eventually doctors realized they could avoid surgery for their patients by trimming mesh down to the right size and inserting it vaginally. Companies like Bard followed this up by creating mesh specifically for this procedure.
Although it was supposed to be less invasive and safer than traditional surgery, transvaginal mesh has proven to be dangerous. The U.S. Food and Drug Administration (FDA) even classified transvaginal mesh as a high-risk medical device. In addition to bleeding and pain, the mesh has caused erosion, infections, and perforation of organs, often requiring additional surgery to correct damage. Several of Bard’s products were found to cause these products: Avaulta, Collagen Matrix, Pelvicol Acellular, Pelvitex, Pelvilace, and Pelvisoft BioMesh.
Another product that proved to be harmful to patients was the IVC filter. Bard’s Recover filter, G2 filter, and G2 express filter have all been implicated in complications to patients. IVC filters are small devices that are implanted in the main vein that runs blood from the leg up to the heart. They catch and filter out blood clots before they can get to the heart or lungs where the can cause fatal blockages. Patients at risk for clots, but who can’t take blood thinners are often given one of these filters.
A major problem with some filters is that they can break away and either perforate the vein or move to another part of the body and cause a dangerous blockage. Bard has been accused of knowing about flaws in its IVC filters and of ignoring an expert’s advice on the risks the filter posed to patients. There is even some evidence that the company forged the signature of an expert on the application for FDA approval.
Along with defective and dangerous products, Bard has also faced several allegations of fraud. It was charged with, and plead guilty to, nearly 400 counts of medical fraud in a 1993 case. The case involved catheters that were faulty and used in patients in the late 1980s. Several patients had to have emergency surgery because of a defect in the catheters, and one patient died. The problem was that the catheters, used to thread a balloon into a clogged artery, had tips that could break off inside the patients.
Not only did Bard produce these defective and harmful products, but it failed to report the problems to the FDA. They also continued testing catheters without the approval of the agency. Although the company recalled the catheters eventually, it had to pay millions of dollars in fines for the actions violated several federal laws.
In 2013 the company had to pay nearly $50 million for allegedly offering kickbacks and making false claims to Medicare. A whistle blower in the case stated that the company was offering customers free medical equipment, grants, and rebate to buy their product even though it was more expensive than a competitor’s. Those kickbacks were a way to defraud Medicare, the program paying for the Bard product.
Bard’s transvaginal mesh products have been the source of many lawsuits against the company in recent years. In one case a woman was awarded $3.6 million by a jury for the irreversible damage a Bard mesh product caused. Thousands of other suits were consolidated into multidistrict legislation, but the company decided to settle many claims before they could go to court. Hundreds of millions of dollars ultimately went to the patients who suffered after having transvaginal mesh inserted.
The damage caused to patients by Bard’s IVC filters have also led to lawsuits, many of which were consolidated in a multidistrict litigation in 2015. With evidence that the company knew about defects in the filters, the plaintiffs have a strong case. The 2013 whistleblower case took nearly seven years to be resolved, but ultimately Bard was found to have been guilty and had to pay millions in fines.