C.R. Bard (Bard) is a medical equipment manufacturer headquartered in Murray Hill, New Jersey. C.R. Bard manufactures equipment to treat a number of medical conditions, such as those affecting the urological, oncological, and vascular systems. C.R. Bard also sells a wide range of surgical supplies, from catheters to treatments for cancer. The company currently employs more than 12,000 people, earning roughly $2.8 billion in 2011.
C.R. Bard has faced a number of legal issues. In 1993, the company was involved in one of the largest medical fraud cases to date. In 2012, C.R. Bard was ordered to pay damages of $3.6 million after a trial over its transvaginal mesh products. The company currently faces thousands of additional lawsuits from injured transvaginal mesh patients.
C.R. Bard History
C.R. Bard was founded by Charles Russell Bard in 1907. He began selling medical supplies by importing a European drug called Gomenol. With Gomenol, he focused on the treatment of patients with urinary discomfort. In 1923, the company was formally incorporated.
Charles Russell Bard sold the company to Edson Outwin and John Willitis for $18,000 in 1926. Outwin and Willits expanded the business by selling catheters. Charles Bard passed away in 1934. The company became the sole distributor of the Foley catheter in the same year. One of its most well-known products, the Foley latex catheter, was manufactured by The Davol Rubber Company in Rhode Island.
In 1948, the company reached $1 million in annual sales. In 1957, C.R. Bard revolutionized 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 products within the fields of radiology, cardiology, and anesthesiology. In 1963, C.R. Bard went public. In 1968, it was listed in the New York Stock Exchange. Company net sales exceeded $1 billion in 1994.
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 violated a number of laws, including the False Claims Act; Federal Food, Drug and Cosmetic Act; and Civil Monetary Penalties Law.
Defective Transvaginal Mesh
C.R. Bard introduced transvaginal mesh products in the late 1990s. These products treated incontinence and pelvic organ prolapse. Pelvic organ prolapse 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.
While some patients found relief from transvaginal mesh products, a number of patients experienced debilitating side effects such as organ erosion and perforation. Many patients required revision surgery to remove the transvaginal mesh. Revision surgery often proved expensive, painful, and difficult. Furthermore, the patient’s tissue often grows around and through the mesh. As a result, many women require several operations before the mesh is completely removed.
C.R. Bard manufactures a number of transvaginal mesh products. The 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. Roughly 2,000 federal lawsuits against C.R. Bard were filed.