C.R. Bard manufactures products for cardiovascular, urological and surgical markets. The company faces thousands of transvaginal mesh lawsuits filed by injured women.
C.R. Bard started when one importer decided to turn his attention from the fabric industry to medicine. The man was Charles Russell Bard, and the year was 1907. Charles was an American importer of French silks and had a keen eye for business. Today, his business employs 12,000 people, sells 8,000 products and operates in 90 countries.
After suffering from urinary discomfort related to tuberculosis, Charles Bard found relief with a European cure-all known as Gomenol. He imported Gomenol to New York City, and C.R. Bard was born. The business focused on treating urinary discomfort and would later expand to include vascular, oncological, urological and surgical care, selling everything from catheters to cancer treatments.
Despite a century of success and innovative products, there were moments that tarnished Bard’s reputation. In 1993, Bard was involved in the largest medical fraud case to date. And in 2012, Bard was a defendant in the first trial over dangerous transvaginal mesh products and was ordered to pay $3.6 million in damages.
After later settling thousands of additional lawsuits for hundreds of millions of dollars, Bard is now accused of hiding knowledge of defects in retrievable inferior vena cava (IVC) filters.
|Fast facts about C.R. Bard|
|Founder: Charles Russell Bard|
|Headquarters: Murray Hill, NJ|
|Size: 12,000 employees|
|2014 Revenue: 3.3 billion|
History of C.R. Bard
During World War I, Charles Bard built his business selling scalpels that were in high demand. He continued to import items that helped with urinary discomfort, including catheters from France. During the 1920s, Charles sold catheters and other instruments directly to urologists. With the help of Dr. Frederick E.B. Foley, the first balloon catheter was developed. The Davol Rubber Company, located in Providence, R.I., manufactured the Foley Catheter, and Bard was the only distributor of this and other Davol latex catheters.
In the decades that followed, C.R. Bard incorporated and produced its first company catalogue, which led to sales of more than $1 million. After Bard died in 1934, his company continued to prosper behind John Willits and Edson Outwin. The company continued to make unique catheter products with nylon and other synthetic materials, and it distributed the first American woven catheter made by Norman Jeckel. Jeckel’s company, the U.S. Catheter & Instrument Corporation (USCI), partnered with Bard to sell the catheters.
Prior to 1940, more than 85 percent of Bard’s products were imported. But by the 1950s all Bard products were made in the U.S. In 1958, Bard began selling an innovative item: pre-sterilized, packaged Foley catheters, which saved medical providers time and money and came ready for use. In 1961, the company built a 50,000-square-foot office in Murray Hill, N.J., centralizing the business, then a manufacturing plant, also in New Jersey, where sterile and disposable medical supplies were created.
Bard focused on partnerships and expansion, meeting international demand by establishing offices abroad. In Toronto, the company formed a new division called C.R. Bard Limited. Bard merged with USCI in 1966 after 25 years of working together and built a plant in Covington, Ga. Bard formed Medicon in 1972 with the Kobayashi Pharmaceutical Company Limited, enabling the business to sell Bard products in Japan. In the U.S., Bard acquired the William Harvey Research Corporation, expanding into open-heart and bypass surgery.
|With the continued buying of assets, other companies and through mergers, Bard developed products for urological, cardiovascular and surgical markets. These companies include:|
|Davol, Inc. (1980)|
|Catheter Technology Corporation (1989)|
|Angiomed AG (1994)|
|IMPRA, Inc. (1996) – the company’s largest acquisition supplies vascular grafts|
|Dymax, Inc. (1999)|
|Surgical Sense, Inc. (2000)|
|SourceTech Medical (2003)|
|ONUX Medical (2004)|
|Genyx Medical (2005)|
|Venetec International (2006)|
Bard turned 100 in 2007 and three years later made its second-largest acquisition, purchasing SenoRx., which gave Bard a place in the breast biopsy market.
Bard and Fraud
Any company with a century of history is likely to have faced adversity both economically and of its own decision-making, and Bard is no different. Today it faces charges for fraud and manufacturing dangerous products that put consumers at risk.
The company in 1993 pleaded guilty to 391 criminal charges in a medical fraud case that involved faulty heart catheters used from 1987 to 1990. The catheters, manufactured by USCI, one of Bard’s units, led to emergency surgeries and one death. The device has a wire and balloon-like tip that is threaded through a clogged coronary artery to allow blood to flow. The tip broke off in some patients and required immediate bypass graft surgery.
Bard officials did not report these or other problems to the U.S. Food and Drug Administration (FDA) and began testing another type of catheter before getting FDA approval.
Some company officials were indicted over the heart catheter problems, and Bard recalled the catheters in 1989 and 1990. Bard paid $61 million in fines for violating the Federal Food Drug and Cosmetic Act, the False Claims Act and the Civil Monetary Penalties Law. Part of the settlement involved agreeing to closer supervision to make sure the company followed the laws in the future.
“For over three years, Bard and several of its top officers, in their efforts to maximize profits, ignored the laws that protect the health and safety of all patients in the U.S.,” U.S. Attorney John Pappalardo said after the settlement.
Bard in 2007 recalled a large number of surgical patches known as the Composix Kugel Mesh Large Patches. Coil rings in some patches broke under stress, puncturing bowels and causing abdominal pain. While the company was not found liable in the first Kugel lawsuit, a second trial ended with an award of $1.5 million for the plaintiff. Davol and Bard still faced nearly 2,000 federal Kugel lawsuits and thousands more state cases at the time.
The company agreed to pay $48.2 million in 2013 to resolve claims related to a cancer-treatment business dedicated to rapid radiation. Bard brachytherapy unit was investigated because of allegations of questionable sales and marketing practices over a period of years.
Bard’s Transvaginal Mesh Products
Bard’s problems didn’t end with heart catheters, surgical patches and cancer products. Bard changed the lives of thousands of women, when it began marketing transvaginal mesh products that resulted in devastating injuries.
Transvaginal mesh products were introduced in the late 1990s to treat incontinence and pelvic organ prolapse, a condition in women in which weak pelvic muscles allow pelvic organs to drop into the vagina. However, the mesh comes with serious side effects — like erosion and organ perforation.
The FDA cleared mesh products with its 510(K) clearance process, which only requires that manufacturers show that products are similar to other approved items. The abbreviated process does not require extensive testing that might reveal design problems or complications.
|Mesh products by Bard that are associated with possible injury include:|
Bard stopped selling its Avaulta Plus mesh products in July 2012, and that same month a jury found the company liable for $3.6 million in damages in an Avaulta case. Christine Scott had received an implant that caused irreversible injuries. That was the first transvaginal mesh case to go to trial.
Nearly 11,000 federal Bard lawsuits were consolidated into multidistrict litigation (MDL) in West Virginia. After Scott, Donna Cisson won a $2 million jury verdict in 2013 after she claimed the company’s mesh injured her. Bard settled another lawsuit for $2 million just days later.
The company decided it would begin to resolve claims before they went to trial in 2014. Bard agreed to settle 500 lawsuits for $21 million in one of the first major mesh settlements. Later that year, U.S. District Court Judge Joseph Gordon told Bard it should settle more cases to prevent more major verdicts.
Bard resolved almost all of its remaining mesh cases in August of 2015, settling 3,000 cases for $200 million. It was the second-largest mesh settlement at the time.
Bard’s IVC Filters
During its transvaginal mesh cases and settlement negotiations, more trouble was building for Bard. Reports of adverse events regarding its retrievable IVC filters were growing, and studies started to show problems with its devices.
IVC filters are small, metal devices inserted into a patient’s inferior vena cava (one of the largest veins in the body) in order to trap blood clots before they reach the lungs or heart. They’re only used in patients who are unable to take anticoagulants (blood thinners). Retrievable versions of the filters are supposed to be removed when the risk for blood clots subsides.
|Bard IVC Filters Implicated in Lawsuits|
|G2 Express Filter|
Reports indicate that as early as 2002, when the FDA initially denied Bard’s application to market its devices, Bard knew of flaws with its product’s design. An expert regulator hired by Bard warned the company of problems, but Bard ignored them. An NBC investigation revealed the company may have forged the expert’s signature on an FDA application.
Another expert hired by Bard in 2004 warned the company that its products had high complication rates. Now, patients harmed by IVC filters claim the devices either punctured their veins or migrated to other parts of their body.
As the number of IVC filters lawsuits against Bard grew, courts consolidated lawsuits to a multidistrict litigation court in August 2015.
The Future of Bard
In spite of faulty products and bad press surrounding the transvaginal mesh and IVC filter cases, Bard continues to grow. In 2012 it established its sixth division, Bard Biopsy Systems (BBS). Originally, this unit was a part of Bard Peripheral Vascular. Through its acquisition of SenoRx, which makes stereotactic and therapeutic products, Bard established itself as a frontrunner in ultrasound-guided breast biopsy.
|Bard specializes in vascular, oncology, urology and surgical products through the following divisions:|
|Bard Access Systems||Davol|
|Bard Electrophysiology Division||Bard Peripheral Vascular|
|Bard Medical Division||Bard Biopsy Systems|
Bard operates in 90 countries, and in 2014 reached net sales of nearly $3.3 billion. CEO Timothy Ring summed up Bard’s place in the medical industry, saying, “We live in a very different world from the one that existed at the turn of the 20th century. But over the years, Bard has never changed its commitment to creating innovative, potentially life-saving products that improve the quality of life for patients worldwide.”