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Pacemakers – small, electronic devices planted into the chest to assist with electrically regulating the heart’s function – inherently come with risks. Because the recommended operation involves implanting the device below the collarbone and running its leads directly to the heart, the patient must be informed about the potential for injury or even death.

However, pacemakers, which use electrodes to transmit small electrical currents to the heart, continue to evolve with technology, and as such, models become out of date, malfunction, or, with increasing reliance on online features, have potential to get hacked. With these points in mind, patients who have received defective models or had been implanted with an older, less reliable one have been filing product liability or malpractice lawsuits against doctors and medical device manufacturers.

Background

Since their inception, pacemakers have offered a solution for treating conditions involving irregular heartbeats, including bradycardia, Tachy-brady syndrome, and heart blocks, which delay or block entirely the body’s electrical signal pathway to the heart. The pacemaker, instead, sends such electrical currents to the heart to essentially reset a slower beat, and should it go too fast, the device further acts as a monitor, collecting and storing data for medical analysis.

Because of these factors, a pacemaker may be recommended if a patient:

  • Takes medications that slow down the heart rate.
  • Lives with an aging-, heart disease-, or heart attack-related heart block.
  • Becomes unconscious over a heart-related condition.
  • Has sinus node dysfunction, in which a heart abnormality affects cardiac impulses.
  • Has already had a procedure to treat atrial fibrillation.

In all cases, the implantation procedure comes with bleeding and infection risks, as well as the potential for damaged blood vessels or a punctured lung.

Malpractice Lawsuits

Yet, as long as a patient gets informed of the above risks and medical professionals respond accordingly, medical malpractice likely didn’t occur. However, the device itself and its associated side effects do open up potential for such a scenario:

  • After the patient sustains heart or lung damage, the doctor who performed the operation refuses to correct the issue or refer the patient to a specialist for further treatment. In the meantime, the patient’s health continues to worsen.
  • The pacemaker isn’t correctly implanted. In this instance, the patient may experience a lower quality of life, including frequently lightheadedness, fainting spells, and incapacitating heart palpitations. From this point on, a patient may no longer be able to work and may have challenges with day-to-day functioning.
  • The doctor doesn’t monitor the patient’s systems after the procedure and adjust the device accordingly. Ideally, a pacemaker should let a patient continue to live a more active lifestyle, but in certain cases, an incorrectly operating device leads to returning symptoms and even death.
  • The doctor knowingly gives a patient a recalled or faulty pacemaker.

Product Liability Lawsuits

In more recent years, the FDA and medical device manufacturers have recalled multiple pacemaker models:

Guidant Defibrillators

Guidant’s implantable cardiac defibrillators have come under fire several times over the past 15 years. In 2002, the company, now a subsidiary of Boston Scientific, discovered a design defect within its Ventak Prizm model, after receiving multiple reports of device failure. While Guidant fixed its issues, it failed to recall the older models, thus keeping both on the market for the time being.

Guidant’s lack of forthrightness, however, didn’t get swept under the rug. Rather, a lawsuit filed in 2008 alleged the company made false claims about its defibrillators from 2002 through 2005, and by 2010, the U.S. Justice Department pursued the company for concealing its product’s defects. At the time, Guidant paid a $296 million settlement for the claim. Three years later, a False Claims Act lawsuit over the same issue resulted in Boston Scientific agreeing to pay a $30 million settlement.

Medtronic Pacemakers

For its EnRhythm and EnRhythm MRI pacemaker series, manufacturer Medtronic issued a recall for 60,000 units of its products. Multiple complaints show that a cleaning solvent used during the manufacturing process changed or shortened the device’s circuitry, leading to partial or total failure.

As well, a battery malfunction led to inaccurate voltage readings. In response, several patients ended up having their devices unnecessarily replaced.

In addition to these issues, the U.S. Department of Justice pursued Medtronic, on the grounds that the manufacturer provided kickbacks to physicians recommending their products. Allegedly, from 2001 through 2009, they compensated doctors for speaking at their conferences, provided them with marketing and business plans, and even gave them tickets to sports games. As a result, Medtronic settled these claims for $9.9 million in 2014.

St. Jude Implantable Cardioverter-Defibrillators

More recently, the FDA went after both the St. Jude Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device (“CRT-D”). For both pacemakers, a battery provides patients with a short warning for replacement, prematurely fails, and doesn’t reliably operate in crucial situations, thus leading to various injuries and a number of fatalities.

What went wrong? Both St. Jude pacemakers featured lithium batteries designed to go without replacement for several years. Ideally, the device would send patients a notification roughly three months before that point, allowing for enough time to make an appointment with a doctor for said replacement. Yet, for many, these pacemakers lost their charge far before the stated five- to seven-year mark and only offered hours for the patient to get a new battery.

Because of these factors, the FDA issued its first Class 1 recall at the end of 2016, encompassing 400,000 models manufactured from 2010 through 2015:

  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Unify
  • Unify Quadra
  • Unify Assura
  • Quadra Assura
  • Quadra Assura MP

By April 2017, the FDA issued a second warning, this time stating that St. Jude went against good manufacturing practices and FDA guidelines. Specifically, following the first recall, St. Jude intentionally miscategorized battery failures for the returned devices, marking pacemakers with premature depletion as “unconfirmed.” As a result, as St. Jude looked for a solution, this distinction let the company continue to sell the defective pacemakers.

At the same time, the FDA put out a second recall in 2017 involving St. Jude’s RF-enabled pacemakers. The statement identified cybersecurity vulnerability risks that, if exploited by unauthorized outside parties, could allow access to a patient’s device and its stored medical information. With this data available, an unauthorized individual could reprogram the pacemaker, which could then result in premature battery depletion or signals that affect its pacing.

Have you been living with a defective pacemaker? Whether you learned about the recall after surgery or found a doctor had implanted you with a defective device, Trantolo & Trantolo’s team is here to help. To learn about filing a medical malpractice or a product liability claim, contact us today.