Boston Scientific has been making medical devices since its founding in 1979, but has faced a number of serious problems that have led to lawsuits and settlements. The company’s future is not certain after paying out billions of dollars in lawsuits for patent infringements and to patients who were harmed by the company’s transvaginal mesh. If you suffered because of a product made by Boston Scientific, you could be a part of the billion-dollar settlements helping patients recover monetary compensation.

Boston Scientific – Overview

Founded in 1979, Boston Scientific is a leading manufacturer of innovative medical devices, many of which are less invasive and less expensive than other options. Located in Natick, Massachusetts, the company employs nearly 24,000 people, has 12 facilities for manufacturing its products, and sells them in more than 100 countries.

Although Boston Scientific has developed a number of innovative devices and has grown thanks to acquisitions of other medical companies, it has also faced several legal and financial setbacks. From dangerous devices to patent infringements and defective devices made by an acquired company, Boston Scientific now faces an uncertain future.

Company History

Boston Scientific was founded in 1979 by Pete Nicholas and John Abele for the purpose of designing, manufacturing, and selling medical devise. Abele already worked in the medical field, and Nicholas brought investment money to the venture. The goal of the new company was to create medical devices that were less-invasive and that cost less than what was already available on the market.

The Taxus stent was one of Boston Scientific’s early successes, and was only the second drug-eluting stent to be approved by the U.S. Food and Drug Administration (FDA). Boston Scientific also found success and was able to expand through acquisitions of smaller companies, like Van-Tech, Endo-Tech, and Advanced Bionics. Eventually the stent and some of the acquisitions would cost the company money in legal disputes and settlements, but initially these helped Boston Scientific grow into an international medical business.

Transvaginal Mesh

Boston Scientific is just one of several companies that have come under fire for transvaginal mesh. This product is a type of surgical mesh, often as part of a kit with special tools that is used to treat pelvic organ prolapse and stress urinary incontinence in women. These conditions are treated by placing supportive mesh under certain organs, like the uterus or bladder neck to help hold them in place after the tissues that naturally support them have weakened.

Prior to the use of this procedure, surgeons treated these conditions by surgically inserting mesh through an incision in the abdomen. Transvaginal mesh is inserted through the vagina, requiring no incisions. A number of reports of adverse events and serious complications following transvaginal mesh procedures have been seen in recent years, which has led to several warnings from the FDA. In 2016 the agency reclassified transvaginal mesh as class III, making it a high-risk medical device.

Some of the complications seen with transvaginal mesh are bleeding, infections, pain, and worsening of the prolapse or incontinence that the device is supposed to treat. The most serious complications have been erosion and perforation. Erosion occurs when the mesh passes through tissues, like the wall of the vagina. Erosion can become serious enough that the mesh passes right through the tissue and perforates other organs.

Erosion and perforation cause bleeding, pain, and infections, and usually require surgery to treat the damage that is done. Those who have been harmed by transvaginal mesh claim that companies like Boston Scientific didn’t test the product, and knew about some of the risks, but marketed the kits as safe alternatives to surgery.

Guidant Defibrillators

Boston Scientific has faced other issues over the years, some related to companies they acquired. One of these was Guidant, which made and sold implantable defibrillators that later proved to be defective. The timing for Boston Scientific was poor, buying the defibrillator manufacturer just before the scandal became public.

Guidant made and sold several defibrillators between 2002 and 2005 that could short-circuit inside patients and fail at keeping heartbeat rhythms normal. The U.S. Department of Justice investigated and concluded that Guidant knew about the defect and sold the defibrillators anyway. The defective devices were implanted in Medicare patients and Guidant was found guilty of defrauding the government program. Boston Scientific bought Guidant for $27 billion and was then forced to pay $30 million in fines because of the fraud.

Patent Battles

Boston Scientific has faced a couple of battles over patents related to heart stents, devices used to strengthen weak arteries open up blocked arteries. In two separate cases, Johnson & Johnson and OrbusNeich, both manufacturers of stents, accused Boston Scientific of infringing on their patents with products like the Taxus, Express, Liberte, and Promus stents. The companies eventually settled their legal battles, with Boston Scientific paying billions of dollars for patent infringement.

Lawsuits

More than 70,000 women have filed lawsuits against six different companies that make transvaginal mesh products, including Boston Scientific. Several individuals have one millions of dollars from the company in jury trials. The company has also settled several thousands of other cases, to the tune of more than $100 million and more cases are likely to be settled in the coming years.

Boston Scientific has also paid out huge amounts of money in the lawsuits over the defective defibrillators and stent patent infringements. In the latter case, the company has had to pay Johnson & Johnson over $1.75 billion.

Boston Scientific’s Shaky Future

All of these legal and financial woes have put Boston Scientific in a tough spot. With slow sales due to controversial and dangerous products and the payouts in legal settlements and trials, revenues are way down for the company. In an attempt to recover, the company restructured in 2013. This came after reporting a loss of $5 million in the third quarter of that year. This wasn’t nearly as bad as the over $600 million loss the year before.

With so much financial loss, part of the restructuring of the company has involved letting employees go. Thousands of jobs have been cut over the last few years, saving millions in costs to operate the business. Additionally, the company has expanded into India and China in the hopes of earning more revenue in these emerging markets.