Boston Scientific, a medical manufacturer based out of Massachusetts, provides
various products for cardiovascular and urological needs. It began in
1979 by John Abele and Pete Nicholas. Today, the company refers to itself
as “the leading innovator of medical solutions.” However,
it faces great financial and legal troubles. In 2005, profits plummeted
after the company acquired Guidant, a mainstream heart defibrillator manufacturer.
Boston Scientific faces even more courtroom battles, mostly against its
transvaginal mesh devices.
Recalls Against Boston Scientific
Boston Scientific has had to endure a number of recalls on its products.
In 2010, the manufacturer recalled several models of its implantable heart
defibrillators after failure to notify the FDA of design changes. This
recall was made one month after the Department of Justice filed criminal
charges against Guidant LLC, a subsidiary of Boston Scientific, for hiding
information about two of its products. Guidant faced other recall problems
as well. The biggest concerns came from its bradycardia pacemakers. These
devices contained faulty capacitors that had the potential to fail.
One year later, the company recalled its iCross catheters. Numerous reports
claimed the catheter tips detached and caused serious injuries and death.
These devices were used during intravascular ultrasounds. A similar recall
involved its Expel biliary drainage catheters. Patients suffered from
device fragmentation, which led to great pain and suffering. The FDA explained
intervention was needed to remove pieces that broke off.
The same year, Boston Scientific recalled its Innova stents, which were
used in leg arteries. The FDA received complaints of no deployment or
partial deployment that resulted in vessel wall injuries or emergency
surgery to remove the stents. Innova is a self-expanding stent made to
treat lesions in arteries above the knee.
Some of the most serious recalls against Boston Scientific concerned its
transvaginal mesh devices. In 2012, the FDA issued post-market surveillance
study orders to all manufacturers of urogynecologic surgical mesh products.
Following this action, many companies withdrew devices from the market.
Boston Scientific’s ProtoGen was the first transvaginal mesh offered
to the public and the first to be recalled. It was pulled voluntarily
in 1999. In 2011, there was another Class II recall of its Pinnacle Pelvis
Floor Repair Kits. The needles in these kits were found to detach from
the mesh during placement. However, this was unrelated to the reported
side effects of transvaginal mesh devices.
Lawsuits Facing Boston Scientific
Since 2005, many lawsuits faced Boston Scientific. After its $27 billion
acquisition of Guidant, the company experienced numerous problems. A series
of Guidant’s heart devices faced scrutiny over faulty construction.
This prompted the Department of Justice to file a lawsuit that alleged
the company knowingly sold defective defibrillators to Medicare patients
between 2002 and 2005. The devices were used to correct irregular heartbeats
but often short circuited. Due to its negligent actions, many patients
were forced to undergo further surgeries to have the devices replaced.
After problems with its Innova stents, effected patients experienced pain
and suffering and underwent extended surgical procedures. Certain results
were fatal. Since these complications were quite severe, many innocent
victims are filing lawsuits to receive compensation for their injuries.
Boston Scientific is one of six major medical manufacturing companies facing
lawsuits from women who were injured by surgical mesh implants. Some of
the most serious complaints include organ perforation, nerve damage, and
mesh erosion. In March 2014, the first of 6,400 lawsuits went to trial.
The initial four trials were used as bellwether cases to set the stage
for future litigation.
Verdicts Against Boston Scientific
Boston Scientific has been forced to pay very high sums of money to settle
numerous lawsuits. For example, in 2007, the company agreed to a $241
million settlement for nearly 9,000 lawsuits to patients injured from
Guidant’s defective defibrillators. The payout exceeded the $195
million the manufacturer previously agreed to hand over to settle 4,000
personal injury claims. In response to allegations of Medicare fraud and
negligent behavior, Boston Scientific paid an additional $30 million to
settle the case. This placed a very dark shadow on the company’s
Recently, the manufacturer was hit with a jury decision that ordered the
company to pay $73.5 million in damages to an innocent victim suffering
complications from its transvaginal mesh products. This case is among
thousands of suits pending over the side effects and injuries caused by
the incontinence devices. In this particular instance, a woman claimed
she suffered nerve damage, constant pain, and chronic infections from
the implant. This is sure to be a long and expensive battle for Boston
Scientific and other manufacturers of transvaginal mesh devices.
Besides personal injury lawsuits, Boston Scientific has battled a patent
fight with OrbusNeich, a device maker that creates similar products. In
September 2013, it agreed to make a one-time payment to settle the long
dispute between the two companies. Under the terms, Boston Scientific
paid an undisclosed amount of money to the rival manufacturer to end all
stent-related suits. This concluded a year-long multinational fight that
alleged the Massachusetts company violated its stent patents. This payoff
comes three years after a different patent infringement battle with Johnson
FDA Sanctions Facing Boston Scientific
Boston Scientific enjoyed numerous successes and high profits until its
Guidant purchase. After that time, the manufacturer suffered many headaches.
Back in 2006, the FDA hit the company with numerous sanctions concerning
quality problems at its factory. Due to the high number of faulty defibrillators
brought to market, the FDA enforced a decision to stop allowing the company
to export or pre-market products until further inspections were made.
In July 2011, the FDA updated an earlier warning regarding transvaginal
mesh products. It cited the possible complications patients face when
using the devices. Also, the federal agency warned the public these types
of products pose the greatest risks to women with POP.
Following sluggish sales and massive settlement payouts, Boston Scientific
is trying to restructure its business and reverse its negative reputation
in the industry. It appears the company must pay more attention to customer
safety by placing quality assurance over profits.