C.R. Bard Overview
C.R. Bard (Bard) is a medical device manufacturer headquartered in Murray Hill, New Jersey which was acquired by Becton Dickinson (BD) in 2017. Under the BD umbrella, Bard manufactures equipment and products used in the treatment of a number of medical conditions, such as those affecting the urological, oncological, and vascular systems.
Bard also sells a wide range of surgical supplies, from urinary catheters to drug delivery products for treatment for cancer. The division currently employs more than 12,000 people, earning roughly $4 billion in 2021, as part of BD which employees 75,000 and has a total annual revenue of about $20 billion.
C.R. Bard has faced a number of legal issues over the life of the company. In 1993, the company was involved in one of the largest medical fraud cases to date and has faced thousands of lawsuits from transvaginal mesh patients and IVC Filter recipients who were injured by the devices. Many of the thousands of Bard transvaginal mesh lawsuits and some Bard IVC Filter lawsuits have been settled but others may still remain in federal, state and local courts.
C.R. Bard History
C.R. Bard was founded by Charles Russell Bard in 1907 who was an importer of French scarves. He began selling medical supplies after using a product for tuberculosis-related urinary discomfort and subsequently imported the European cure-all, Gomenal which had relieved his symptoms. Along with Gomenol, he focused on the treatment of patients with urinary discomfort and obtained distribution rights to a French urethral catheter. He partnered with Morgan Parker for distribution of a surgical scalpel which became popular as WW I surged, cutting off access to European medical supplies.
Parker bought Bard out the scalpel business as Bard-Parker and C.R. Bard went on to continue distribution of catheters and urinary devices from French suppliers, incorporating in 1923. Charles Russell Bard sold the company to Edson Outwin and John Willitis for $18,000 in 1926.
Outwin and Willits expanded Bard’s business by selling products developed by other companies, some of which were manufactured to Bard specifications. Charles Bard passed away in 1934 and the company became the sole distributor of the Foley catheter in the same year. The Foley latex catheter, one of Bard’s most well-known products, was actually manufactured by The Davol Rubber Company in Rhode Island.
Bard Entry into Coronary Market
In 1948, the company reached $1 million in annual sales and in 1957, C.R. Bard revolutionized urinary catheters by selling them in sterile packaging for the first time. After a series of developments and innovations in the catheter industry, C.R. Bard expanded beyond catheters in 1961. The company began manufacturing most of its products within the fields of urology, radiology, cardiology, and anesthesiology. In 1963, C.R. Bard went public and in 1968, it was listed in the New York Stock Exchange, the same year it acquired USCI, manufacturer of the first IV heart catheter.
During the 1970s, Bard acquired a number of companies which allowed for expansion into new fields and technologies. One of the biggest developments was the rights for manufacture and marketing of the Gruntzig angioplasty catheter, used for a less-expensive and less-invasive treatment of heart blockage.
By 1990 however, Bard was forced to recall a number of coronary devices, including some cardiac catheters, events of which led to an investigation by the U.S. Food and Drug Administration (FDA) and Department of Justice (DOJ). The coronary business unit never recovered from the disaster and was sold to another device company, Arterial Vascular Engineering, later to be acquired by Medtronic.
The 2001 acquisition of a company called, Surgical Sense which made Kugel hernia surgical mesh products brought another round of issues, resulting in Bard issuing recalls for Kugel mesh device in 2005, expanding the recalls in both 2006 and 2007 and offering a $184 million settlement to resolve about 3,000 lawsuits.
Becton Dickinson Acquisition
Despite the difficulties, Bard net sales exceeded $1 billion in 1994 and a number of acquisition offers were made When a deal with Tyco International fell through in 2001 due to plummeting to Tyco stock, Bard acquired another 15 separate companies and the company went on to become a $4 billion per year company.
Bard was purchased by Becton Dickinson (BD), another large supplier of medical and surgical equipment, in 2017 for $24 billion.
C.R. Bard Misconduct
In 1993, C.R. Bard faced 391 criminal charges for medical fraud. The company manufactured faulty heart catheters that were used from the period of 1987 to 1990. The catheter featured a wire and a balloon-like tip. It allowed blood to flow by being threaded through a patient’s clogged coronary artery. In these specific catheters, the tip broke off in several patients. Many required emergency bypass graft surgery. One patient died from the malfunction.
C.R. Bard officials failed to report these occurrences to the FDA. Additionally, the company began testing a different catheter without prior FDA approval. As a result, C.R. Bard faced $61 million in fines. The company had violated a number of laws, including the False Claims Act; Federal Food, Drug and Cosmetic Act; and Civil Monetary Penalties Law.
Separately, Bard was accused of paying kickbacks to doctors between 1998 and 2006 for the purchase of Bard’s brachytherapy seed and filing Medicare claims to pay for them. Brachytherapy seeds were radiation-containing pellets which were placed into patient tissues for the treatment of prostate cancer. Bard settled the charges for $48.26 million in penalties and fines with the DOJ.
Defective Transvaginal Mesh
C.R. Bard introduced transvaginal mesh products in the late 1990s and increased the size of the division after it became successful.
Transvaginal mesh is a type of surgical mesh, used to treat stress urinary incontinence and pelvic organ prolapse. Stress urinary incontinence (SUI) occurs when urine leaks during moments of physical activity or pressure such as laughing, coughing or exercise. Pelvic organ prolapse (POP) is a condition during which a female patient’s pelvic muscles become too weak to support surrounding organs. As a result, the organs can become dislocated and protrude into the vagina.
Transvaginal mesh is a surgical mesh implanted through the vagina rather than through an incision in the abdomen. Transvaginal mesh and bladder slings are used to stabilize tissues in surgical repair of SUI and POP.
While some patients found relief from implantation of bladder slings and transvaginal mesh products, a number of patients have experienced debilitating side effects such as organ erosion and perforation. Many patients have required revision surgery to remove the transvaginal mesh. Revision surgery is often expensive, painful, and difficult. When the patient’s tissue has grown around or through the mesh, multiple operations may be required to remove the mesh and repair tissue damage.
Bard has manufactured a number of transvaginal mesh products including:
Avaulta transvaginal mesh has proven to be one of the most problematic. In July 2012, C.R. Bard stopped selling this line of products. During the same month, the company was ordered to pay $3.6 million in damages during an Avaulta case. This case was the first transvaginal mesh case that went to trial. Since that time, a number of bellwether cases have occurred, some of which were decided for Bard, others were decided for the plaintiff.
Roughly 2,000 federal transvaginal mesh lawsuits against C.R. Bard were ultimately filed and in 2014 the company agreed to settle 500 lawsuits for $21 million. Bard offered a 2015 settlement for about $200 million to resolve remaining lawsuits.
In 2016, the FDA changed transvaginal mesh requirements by listing all TVM products as Class III or “high risk”. The FDA later determined that the risks outweighed any benefit and required that transvaginal mesh be removed from the U.S. market.
Bard IVC Filter Lawsuits
Inferior Vena Cava (IVC) Filters are implanted to screen or filter blood in patients who are prone to blood clots, to prevent pulmonary embolism and death. IVC filters were initially thought to be permanent, however in the early 2000s, concerns began to be raised about the safety. As a result, manufacturers began introducing temporary IVC filters.
Even though they were intended to be temporary, many IVC Filters were left in place in many patients, in some cases for years. This led to serious complications in thousands of patients including device breakage or fracture leading to parts which broke free and migrated to distant places to implant in the heart, kidney, or other areas. Serious IVC filter injuries included lung and organ perforation, stroke, hemorrhage, and at least 27 deaths.
In 2010, the FDA issued a safety alert warning of the dangers of failing to remove temporary IVC filters, stating that serious adverse events occur in up to 80% of patients whose temporary IVC filter was not removed within two months.
In a series of national television news segments regarding IVC Filter Safety, NBC claimed that Bard knew of the issues. The TV broadcasts show resulted in greater public knowledge of IVC filter dangers and hundreds of lawsuits for Bard/BD and other IVC Filter manufacturers.
Though warnings have been issued, neither the FDA nor Bard/BD have recalled IVC filters. Past troublesome Bard IVC Filters named in lawsuits have included the G2, G2X, Recovery, Meridian, Eclipse, and Denali. Only the Denali IVC filter is still listed as available in Bard’s product line. Bard and parent company, BD may be facing 1,800 or more federal lawsuits which have been consolidated into multidistrict litigation (MDL) in Arizona. Multiple IVC Filter bellwether trials have been conducted, however COVID-19 delayed additional trials and no large settlements have been offered.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.