Boston Scientific

Boston Scientific is a medical device company which manufactures diagnostic and interventional treatment devices in a variety of therapeutic areas. The company is focused on less-invasive technologies for endoscopy, interventional cardiology and rhythm management, neuromodulation, peripheral therapies, urology, and pelvic health. Boston Scientific has faced a number of device injury lawsuits for their medical devices including thousands of transvaginal mesh lawsuits.

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  • About Boston Scientific
  • Boston Scientific History
  • Boston Scientific and Transvaginal Mesh
  • Boston Scientific Cardiac Devices

About Boston Scientific

Boston Scientific Corporation (BSX) is a Massachusetts-based medical device manufacturer. The company employs 36 thousand people worldwide with representation in 120 countries and on 6 continents. Boston Scientific manufactures diagnostic and treatment devices for a wide variety of health specialties including endoscopy, surgery, cardiology, gynecology, peripheral vascular disease and urology.

Boston Scientific has estimated global revenue of about $10.7 billion and about half of Boston of which is generated in the U.S. The company has developed more than 15,000 medical devices and products including a number of “firsts” such as the first angioplasty balloon in the 1970s.

Boston Scientific History

Boston Scientific was founded in 1979 as a holding company intended to purchase Medi-Tech, an interventional medicine company. The first Boston Scientific product was a polyethylene (flexible plastic) balloon used for peripheral angioplasty to open clogged arteries.

Within two years, the device was the “industry standard” and led to the development of several later generation cardiac interventional devices including the adult aortic valvuloplasty balloon which was listed as one of the nine most important regulatory approvals of 1990 by the FDA. It was the first of many cardiology products. The company has since developed additional interventional cardiology devices including the wildly successful “TAXUS Express”, drug-eluting coronary stent.

Through the 1980’s and 90’s, the company acquired several medical device manufacturers to expand its presence in cardiology and reach into other therapeutic areas such as urology, neurology and surgery. The company went public in May of 1992 and was producing an estimate $1.8 billion in annual revenue by 1997.

The most successful BSX product, the TAXUS Express, a drug-eluting stent which contained the drug paclitaxel and was used for coronary artery disease, was introduced in 2004 and was only the second of its kind. Though the company had high hopes for the product, of the original 100,000 units shipped, 85,000 had to be recalled.

In 2004, the company also acquired Advanced Bionics, a neuromodulation company and acquired Guidant, a manufacturer of implantable defibrillation devices for $27 billion in 2006 in a bidding war with the pharmaceutical giant, Johnson & Johnson. It was the largest company acquisition to date, but analysts believed it was overpriced and later resulted in a $5.5 billion antitrust lawsuit and a $1.3 billion tax dispute with the IRS which was settled by an agreement to pay $275 million. As part of the anti-trust agreement, the vascular business was portioned off to Abbott Labs and the claim was dismissed.

During that time period, the US Department of Justice was investigating Guidant for sales of defective defibrillators to Medicare patients which may have been hidden by Guidant executives. In 2011, Guidant (as assumed by Boston Scientific) pled guilty to federal charges and paid $254 million in DOJ fines.  Cases regarding the defective devices were settled in 2013 with a $30 million payment by BSX to patients and their families.

In 2010, the company was fined $600 thousand by the US DOJ after paying kickbacks to an Army physician for using Boston Scientific devices and recommending them to other doctors BSX has also been involved in patent litigation with a Chinese device manufacturer, OrbusNeich which claimed that BSX could not sell their products in certain markets. The claim of territory infringement resulted in the police being called to Boston Scientific German headquarters for product seizure, but the dispute was mutually settled in 2013 under undisclosed terms.

In the same year, the company paid $1.73 billion to Johnson and Johnson to settle a patent infringement lawsuit over heart stents and Abbott Labs accused Boston Scientific of employee poaching with the hiring of a former Vice President and several sales directors in Abbott’s cardiac division, resulting in a federal lawsuit.

In addition to troubles over its business practices, Boston Scientific has faced thousands of lawsuits regarding its transvaginal mesh products used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. Many of these lawsuits have been settled, as have thousands from other companies, however some may remain in court systems.

Boston Scientific and Transvaginal Mesh

Introduced in the 1990’s, transvaginal mesh was modeled after mesh that was in use for tissue stabilization in hernia and other surgical repair procedures. The first transvaginal mesh product, the ProtoGen Sling by Boston Scientific was approved in 1996 but was recalled just three years later due to safety concerns.

Transvaginal mesh is approved to treat pelvic organ prolapse and stress urinary incontinence in women. It is implanted “transvaginally” or through the vagina, rather than requiring a more invasive abdominal surgery. It was intended to improve the safety and efficacy of surgical treatments but has been shown to cause a number of serious adverse events which can result in permanent injury or even, death.

Boston Scientific transvaginal mesh products that may have caused injury include:

  • Advantage Transvaginal Mid-Urethral Sling System
  • Arise Vaginal Support System
  • Lynx Suprapubic Mid-Urethral Sling System
  • Obtryx Sling Systems
  • Pinnacle Pelvic Floor Repair Kit
  • Polyform Synthetic Mesh
  • Prefyx PPS System
  • ProtoGen Sling
  • Uphold Vaginal Support System

Many patients have been injured by transvaginal mesh products and several have died due to the devices. Some of the Boston Scientific transvaginal mesh products have been recalled, including the ProtoGen in 1999 and the Pinnacle Pelvic Floor Repair Kit in 2011. The FDA has also reversed a prior statement and says that transvaginal mesh products may pose greater risk to patients than traditional surgeries.

Boston Scientific has faced thousands of lawsuits regarding injury caused by transvaginal mesh products. Many of these lawsuits have been settled and by November of 2016, BSX announced that they had settled about half of the lawsuits for undisclosed amounts with total legal costs reaching to more than $2.9 billion but some may still remain in court systems.

Boston Scientific Cardiac Devices

Boston Scientific has also faced a number of issues with its cardiac devices including the Guidant implantable defibrillators. In 2007, shortly after Guidant was acquired, the company shipped 100,000 new defibrillators but had to recall about 73,000 of them due to draining batteries caused by faulty capacitors.

In 2014 and 2016, after several patients had died, Boston Scientific was forced to recall some of its Lotus heart valve systems. The line of devices was also recalled in 2017 due to a manufacturing defect.

No lawsuits regarding those devices have resulted in large-scale litigation but the company has hundreds of devices, some of which are used in critical therapeutic areas and high medical risk diseases.

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