C.R. Bard

C.R. Bard is a medical device manufacturer based in New Jersey which was acquired by another medical products company, Becton Dickinson (BD) in 2017. Under the BD name, Bard manufactures medical products and equipment for a variety of medical, hospital and surgical settings. Bard was the original manufacturer of the Foley catheter, and still provides a number of urology, vascular and oncology products but has come under fire for some of its vaginal mesh devices and IVC filters.

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  • C.R. Bard Overview
  • C.R. Bard History
  • Bard Entry into Coronary Market
  • Becton Dickinson Acquisition
  • C.R. Bard Misconduct
  • Defective Transvaginal Mesh
  • Bard IVC Filter Lawsuits

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 2018, as part of BD which employees 65,000 and has a total annual revenue of about $16 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. In 2012, C.R. Bard was ordered to pay damages of $3.6 million after a trial over its transvaginal mesh products and in the past several years, serious concerns about Inferior Vena Cava (IVC) Filters has come to light. The company has faced thousands of lawsuits from injured transvaginal mesh patients and may be facing an unknown quantity of IVC Filter lawsuits.

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. With Gomenol, he focused on the treatment of patients with urinary discomfort and obtained distribution rights to a French urethral catheter during the same time. 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 the 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 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 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 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

Transvaginal mesh is a type of surgical mesh, used to treat 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.

Bard has manufactured a number of transvaginal mesh products including:

  • Avaulta
  • Pelvilace
  • Pelvicol
  • Pelvisoft
  • Pelvitex

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 and after losing the first two lawsuits for $5.6 million, 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 and in 2016, the FDA changed transvaginal mesh requirements by listing all TVM products as Class III or “high risk”.

Bard IVC Filter Lawsuits

Most recently, Bard has had difficulty with a product known as “Inferior Vena Cava (IVC) Filters” which are implanted to screen or filter blood in patients who are prone to blood clots, to prevent pulmonary embolism and death. Unfortunately, though the IVC Filter was intended to be a temporary implant, the basket-like device was left in place in many patients, in some cases for years.

Some of these patients experienced serious complications when portions of the device broke off and migrated to distant places to implant in the heart, kidney or other areas. This may have led to at least 27 patient deaths and hundreds of serious injuries, which were reported in a series of news segments on NBC News. NBC claimed that Bard knew of the issues and the TV show resulted in greater public knowledge and hundreds of lawsuits. Bard may be facing 1,800 or more federal lawsuits which have been consolidated into multidistrict litigation (MDL) in Arizona.

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