Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who were implanted with potentially defective St. Jude defibrillators and leads that may cause serious side effects, including cardiac tamponade. The defective medical device lawyers at Parker Waichman are also investigating possible fraying defects associated with the St. Jude Durata Lead and battery failures in its Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) devices.
ICDs and CRT-Ds are implanted devices the size of a stopwatch that are placed in the upper chest under the skin. Insulated wires, known as “leads” connect the ICD or CRT-D to the heart to deliver therapy. Patients suffering from bradycardia (a dangerously slow heart rhythm) need pacing, while patients with tachycardia (a fast heart rhythm) need an electrical shock or pacing.
2017: FDA: For Years, St. Jude Medical Minimized Defibrillator Failures
According to the U.S. Food and Drug Administration (FDA), St. Jude Medical—now owned by Abbott Laboratories—minimized defibrillator defects and failures for years before the devices were recalled last year, an FDA warning letter indicates. Abbott acquired St. Jude in January 2017 for about $25 billion, according to The New York Times.
The agency discovered that St. Jude neglected to advise its own management and a medical advisory board that the defibrillator battery problems led to the death of one patient. The FDA also indicated that St. Jude Medical had indicted that it was taking appropriate action to correct the issues that led to the delayed recall and ordered St. Jude to provide a new reporting plan within 15 days, The New York Times reported.
Removal of defective defibrillators and other implanted devices is a potentially dangerous process as removal requires surgery that, in some cases, may be riskier than leaving the defective device in the body. When St. Jude announced the recall in October, the agency recommended that physicians closely monitor their patients’ devices for any issues, The New York Times wrote. While the device maker indicated that the malfunction did not appear to be widespread, the FDA warned that “patients could be at greater risk of complications from the surgical procedure required to replace the device.”
FDA spokeswoman, Angela Stark, recently said that nearly 200,000 people in the United States have been implanted with a defibrillator involved in the recall. The recalled devices include models in the company’s Fortify, Unify, and Assura defibrillator lines, noted The New York Times.
Physicians at Duke University reported two cases of battery problems with the devices in 2014 and in 2015, a team at the University of Illinois concluded that lithium in the battery formed clusters that caused short circuits. In 2015, St. Jude corrected the problem in its new defibrillators; however, it never recalled the defective devices or alerted doctors or patients concerning the potential problem until October. Because of this, physicians were continuing to implant the defective devices in patients. “What bothers me most about this is that the doctors and the patients weren’t told about the potential” for failure, said Dr. Robert G. Hauser, a retired cardiologist who is an advocate for improved safety of medical devices. “And clearly this is for St. Jude’s benefit. They can sell products rather than scrapping it,” he told The New York Times. Dr. Hauser faulted the federal regulator for not looking into St. Jude’s activities sooner. “They should have been in there years ago, looking at all the raw data in order to determine if the incidence was low enough to allow these devices to be shipped and implanted,” he said.
Ms. Stark said the FDA did not insist on an earlier recall because it had relied on information St. Jude Medical provided at the time. The agency now says St. Jude misrepresented the risk; however, Ms. Stark told The New York Times, “I don’t think we can speculate on how that might have changed the decision almost two years ago.”
Defibrillators comprised about one-third of St. Jude’s sales in 2015, or roughly $1.6 billion, according to The Minneapolis Star Tribune. Abbott indicated that it was reviewing the agency’s warning letter and is committed to addressing the issues raised.
The agency’s letter notes that St. Jude understated the issue, concluding that reports concerning failing batteries were “unconfirmed” despite that the battery manufacturer, Greatbatch (now known as Integer Holdings), discovered that lithium clusters were the culprit. Also, the company did not include the “unconfirmed” cases when calculating the possibility of the devices malfunctioning, which made the defect appear to be less severe than it was, according to the agency’s letter, wrote The New York Times.
The agency also found that the company was aware of one patient’s death in 2014 related to the defect but did not disclose that information to St. Jude Medical management or a medical advisory board. “Both presentations stated there were no serious injury or death directly related to lithium cluster formations,” the letter indicates. Also, the agency wrote that St. Jude still had not fully addressed concerns that were raised in January, when the FDA warned that hackers could potentially access St. Jude’s defibrillators and remote monitoring system, causing the devices to deliver unnecessary shocks, according to The New York Times.
This is not the first time the device maker has been accused of being slow to warn the public about a faulty defibrillator. In 2011, St. Jude came under scrutiny after being accused of not quickly recalling faulty wires that connect the defibrillator to the heart.
The Star Tribune reported on the FDA warning letter that also indicated that regulators are not satisfied with the med-tech company’s response to problems at its Sylmar, California, plant. BizJournal noted that the FDA’s letter could create new problems for Abbott. An analyst told The Star Tribune that it is possible the FDA might delay approval of new Abbot defibrillators should it become concerned over manufacturing issues.
2016: Premature Battery Failure Reported with St. Jude’s ICD and CRT-D Devices Linked to Two Deaths
On October 11, 2016, St. Jude Medical warned of a battery defect affecting its Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. According to a safety alert posted on the FDA’s website, the batteries on these heart devices may fail sooner than expected. St. Jude is urging patients and caregivers to respond to the Elective Replacement Indicator (ERI) alert as soon as it goes off. Normally, the patient has three months to receive a new battery when the ERI alert is active; however, St. Jude has received reports of the battery failing as early as 24 hours after receiving the ERI alert. A recall and correction was initiated.
According to the FDA safety alert, the following ICD and CRT-D models manufactured before May 2015 are affected:
- 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
Lithium batteries provide charges to the devices’ capacitors. These capacitors deliver the high-voltage shocks needed to bring a patient’s heart to normal rhythms, noted QMed. The chemical reaction leads to the formation of lithium particles—so-called “lithium clusters”—that may accumulate in a location that causes a short circuit, such as within the batteries of ICDs and CRT-Ds during high-voltage charging. This may cause premature battery depletion and rapid battery failure over the course of anywhere from one day to a few weeks after the patient received an ERI alert. This defect may be fatal; if the battery drains, the device will be unable to provide a life-saving shock. “The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent,” the alert notes.
All defibrillators with lithium-chemistry batteries are vulnerable to the formation of an accumulation of lithium outside of the power cell. St. Jude’s engineers found that if the electrically conductive lithium accumulation formed on the batteries in a location on the device that connects its two main components: The anode and cathode. This may create a short circuit that quickly depletes the battery. On occasion, the lithium cluster disappears after the short circuit, which makes it challenging to locate the issue. A design change involved the insulation inside the battery and adding an internal barrier to resolve the risk of a lithium deposit causing a short.
More battery-related cases:
Nearly 400,000 ICDs and CRT-Ds devices were sold worldwide. Out of the 398,740 devices sold, 841 were returned for early battery depletion and analysis. At the time of the recall, the defects were linked to two patient deaths—one in the U.S.—when the battery was unable to deliver a life-saving shock. As of October 2016, there were 10 reports of patients fainting and 37 reports of dizziness when the battery was unable to provide the necessary therapy. The alert noted that these figures may be an underestimation because issues are not always reported to the manufacturer.
2016: St. Jude Aware that Old Versions of Recalled ICDs Were Implanted Following Recall
In one case, a 61-year-old woman, a mother of five, who was implanted with a St. Jude Medical heart defibrillator learned that, although St. Jude corrected the issue in 2015 that led the recall, St. Jude also continued selling the older units. She was implanted with one of the older units, according to a November 2016 The Star Tribune report.
Meanwhile, the two confirmed cases of patient deaths were made when the battery issue caused their St. Jude devices to fail to administer life-saving shocks. One death occurred in 2014 and another in earlier 2016. While St. Jude indicated that the failure rate is very low, the FDA indicates that the incidence rate remains unknown, according to The Star Tribune.
In November 2016 interviews. St. Jude executives indicated that they moved rapidly when they discovered the issue, immediately advised physicians globally regarding the recall decisions, and continued to review the matter since the problem was first published in 2014. Yet, St. Jude also admits that its shipment of old devices continued for 17 months after upgrading the device’s design to stop the unexpected power loss, according to The Star Tribune.
It remains unclear when St. Jude began selling cardiac devices with the new batteries and if there was a time frame in which both versions were sold simultaneously and with no disclosure of the difference.
St. Jude executives said that the battery design was changed on May 23, 2015 in response to the issue discovered in 2014; however, they also indicated they were unaware if the problem would become so widespread as to impact 350,000 devices implanted in patients worldwide, St. Jude Medical’s Chief Medical Officer, Dr. Mark Carlson, said, according to The Star Tribune. Of the total 349,852 affected devices, approximately 199,642 involve United States patients, according to FDA, wrote QMed. “We have a device that, at that time, is performing well, and we are making it even better,” Dr. Carlson said in November 2016, describing the decision in May 2015 against advising the public about the change in design.
According to The Star Tribune, the design change received regulator approval, which included approval by the FDA. FDA spokeswoman Angela Stark wrote in an email that the federal regulator did not mandate St. Jude to recall the old devices after the design change because data at the time revealed that the rate of issues was low. Data revealed since showed that the risk was higher than first believed, according to Ms. Stark. “St. Jude is no longer selling the affected devices, and has instructed health care providers not to implant any unused affected devices and to send them back” to the manufacturer, Ms. Stark wrote. Neither St. Jude nor the FDA yet knows how many unused devices will be returned.
Physicians complained that the timing of the St. Jude recall is concerning because they only learned about the ICD battery issue at around the same time the public was made aware. This means that doctors were implanting patients with the devices constructed with the older, defective batteries, including patients whose ongoing health was contingent upon their defibrillators working as pacemakers to improve their heart’s oxygenated blood output, noted The Star Tribune. “I’m very angry because those patients put their lives in my hands,” said Dr. Kevin Campbell, a North Carolina cardiac electrophysiologist who told The Star Tribune that he unknowingly implanted the older devices in patients after St. Jude created the improved design. “If it’s a big-enough deal to change the manufacturing process, then pull it off the shelf,” he added. Dr. Campbell also said the Heart Rhythm Society is creating medical guidelines on defibrillator treatment in patients whose devices contain the old batteries.
Both the FDA and St. Jude Medical recommend that St. Jude patients whose defibrillators are equipped with older batteries be placed on home monitoring. This will enable reading of the device’s battery level when the patient is in range of a monitoring device. All patients implanted with the affected St. Jude devices must seek immediate care if they feel the vibratory alarm in their chest, which may mean that the battery may short out and completely deplete in under 24 hours.
2013: FDA Issues Warning On Durata and Riata ST Optim High Voltage Implantable Cardiac Leads
On January 10, 2013, the FDA issued a Warning Letter to the then-president of St. Jude Medical, Eric S. Fain, of the Cardiac Rhythm Management Division (CRMD).
The FDA indicated that, during an inspection of St. Jude in Sylmar, California, from September 25, 2012 through October 17, 2012, agency investigators determined that St. Jude Durata and Riata ST Optim high voltage implantable cardiac leads are adulterated under the Federal Food, Drug, and Cosmetic Act because “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation” do not conform with “current good manufacturing practice requirements of the Quality System regulation found in the Code of Federal Regulations.”
The FDA also indicated that it received responses from Mr. Philip Tsung, Vice President of Quality Assurance at St. Jude, dated November 7, 2012 and December 7, 2012 regarding observations noted by the FDA on its List of Inspectional Observations.
Note that “(b)(4)” is an indicator that protects proprietary trade secrets and intellectual property.
The FDA wrote that St. Jude failed to ensure—“when the results of a process cannot be fully verified by subsequent inspection and test”—that the process will be validated with a high degree of assurance and will be approved in accordance with established procedure. St. Jude created multiple and different holders to hold its leads, but did not specify how the holders were installed or indicated how the device maker ensured they met their intended use. The FDA indicated that it reviewed St. Jude’s responses and found them to be inadequate, pointing out that the device maker did provide evidence that it performs a first article inspection of the (b)(4) produced with these holders; however, it did not provide evidence that it challenged the process and did not perform testing to demonstrate adequacy of the (b)(4) produced using these holders. The agency also wrote that St. Jude did not provide a description or evidence of consideration of a systemic corrective action.
St. Jude was advised that it failed to “establish procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required” by the Act. The FDA wrote that it reviewed St. Jude’s response and concluded it to be inadequate and that St. Jude did not provide evidence of implementation of the promised corrective actions or consideration of a systemic corrective action.
The agency also wrote that St. Jude indicated that it would establish and maintain adequate procedures for verifying the device design and that design verification will confirm that the design output meets the design input requirements as required under the Act. St. Jude was advised it “failed to validate the (b)(4) test methods implemented during the Durata design verification testing.” The regulators pointed out that the testing methods were created in-house to verify St. Jude’s design inputs; however, the methods were not based on, and did not follow, a national standard. Also, according to the FDA, St. Jude did not follow its test procedure released on May 9, 2003 during design verification testing. The procedure mandated each lead to be tested five times with the average of the five tests to be considered the result; however, St. Jude tested each lead just once. Also, St. Jude performed design verification of the Durata lead prior to establishing design inputs and specifically, St. Jude performed the design verification study on June 7, 2007 to ensure the (b)(4) was not excessive, prior to establishing the design input that “the (b)(4) of the (b)(4) shall be (b)(4)” on July 16, 2007. The FDA also noted that the adequacy of St. Jude’s responses could not be determined at the time the letter was written. “Your firm stated that it will prioritize and conduct the test method validations for this and other product lines … and “will perform a systematic review of completion dates of key phases in design history files to identify and remediate any gaps” … but did not provide any evidence of these corrective actions.
St. Jude was also advised that it did not establish and maintain a design history file for each type of device, as required under the Act. According to the FDA, the adequacy of St. Jude’s responses could not be determined at the time of the letter and that St. Jude indicated that it would “conduct a systematic review of the design history files for currently manufactured products to identify any required remediation” and would “create and add a summary document” outlining “the gate completion dates for design inputs, outputs, verification, validation, and transfer to each design history file. According to the FDA, evidence of these corrective actions was not provided.
The FDA found St. Jude failed to establish and maintain procedures for implementing corrective and preventive action in compliance with the Act, including the device maker’s Corrective and Preventive Action Procedure (CAPA) dated May 30, 2012 that indicates that a CAPA Product Improvement Request (PIR) closure memo would “include a statement of effectiveness of the CAPA.” St. Jude’s CAPAs known as PIR 12-004 and PIR 11-013 were closed on August 16, 2012 and September 14, 2012, respectively.” Closure was conducted with no statement or reference to a verification of efficacy and the procedure indicates that an effectiveness check would be performed on any closed PIR. An exception to this would be if justification exists that no effectiveness check is mandated; however, the procedures were closed on September 10, 2012 and September 11, 2012, respectively, and state that “no effectiveness check is required” without any documented justification.
St. Jude wrote that its CAPA procedures do not mandate a determination as to if the action taken adversely affects the finished device. The FDA found that the adequacy of St. Jude’s answer could not be determined at the time of the response and that St. Jude provided its revised procedure, which requires a determination be made if the action taken adversely impacts the finished device. St. Jude indicated that it would conduct a retrospective review of CAPAs to identify and respond to gaps in verification of effectiveness activities, yet evidence of corrective action was not provided.
The FDA also noted that its inspection revealed that St. Jude’s Durata lead is misbranded under the Act, in that the device maker failed or refused to furnish material or information indicating that the device that is required by or under the Act and Medical Device Reporting (MDR). Significant deviations include, but are not limited to:
St. Jude’s failure to report to the FDA no later than 30 calendar days after the day that the device maker received or became aware of information, from any source, that reasonably suggested that a device St. Jude markets malfunctioned and that this or a similar device that St. Jude markets would likely cause or contribute to a death or serious injury, if the malfunction were to recur. The FDA pointed to four complaints that referred to Durata lead malfunctions. The FDA also wrote that, “There is no information in your firm’s complaint file that justifies why the malfunctions referenced above would not be likely to cause or contribute to a reportable death or serious injury were they to recur. An MDR should have been submitted for each of the referenced complaints.”
St. Jude was advised by the FDA to “take prompt action to correct the violations addressed in” its letter and that a failure to “promptly correct these violations” may lead to regulatory action without further notice and may include “seizure, injunction, and civil money penalties.”
2012: St. Jude Durata Lead Wire Fraying Injury Reports
St. Jude Medical Inc.’s Durata Lead Wire, which is used to connect an internal defibrillator to the heart, is raising concerns following a report that a Durata Lead frayed in at least one patient. The fraying of the St. Jude Durata Lead resulted in the wire becoming exposed through its insulation. If other Durata Leads suffer from a similar fraying defect, there is a risk that exposed wires could cause an implantable defibrillator to emit shocks at inappropriate times, or fail to do so when necessary. Either scenario could result in serious injury to, or death of, patients who have had Durata Leads implanted along with an internal defibrillator.
St. Jude introduced the Durata Lead Wire as a replacement for its controversial Riata Leads. St. Jude stopped selling Riata Leads in December 2010, and recalled them one year later, after the company received reports of the wires penetrating the device’s insulation. When the Riata Leads were officially recalled in December 2011, at least two patient deaths had been attributed to the defect. The Durata Lead was made with a new type of insulation coating called Optim, which was meant to prevent fraying.
In June 2012, a physician reported to the FDA that a Durata Lead Wire had frayed in a patient. “Non invasive programmed stimulation of ICD, revealed under sensing of ventricular fibrillation after induction,” the report indicated. “Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.” According to the report, the incident occurred on April 18, 2012. No other details were given.
The report sparked concern that the Durata Lead Wire could suffer from the same problems that resulted in the Riata Lead recall. The report also raised questions about the use of St. Jude’s smaller diameter leads when other, more reliable, leads are available.
2009: St. Jude Defibrillator Side Effects Include Cardiac Tamponade
In April 2009, St. Jude Medical Inc. identified a memory chip problem in some of its older devices. While no deaths or serious injuries were reported to the company as a result of the problem, St. Jude indicated in a government filing that the FDA may classify the problem as a recall.
The problem stems from a memory chip that St. Jude used through 2002. Some of the chips were susceptible to background radiation. The St. Jude ICDs that may be affected by the radiation problem are certain older generations of the company’s Photon DR, Photon Micro VR/DR, and Atlas VR/DR models. As of 2009, 60 devices were affected, the company wrote in the filing. Nearly 26,000 of the devices remain in patients. St. Jude also notified doctors and federal regulators of a software problem in some models of its implantable defibrillators that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.
St. Jude indicated that it discovered the two anomalies during a routine product evaluation. In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patient’s heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices, on average, last four to seven years before they need to be replaced. A second problem could cause a temporary increase in the device’s pacing rate. In addition to its shocking therapy, some patients need an ICD that is able to pace their hearts, as well.
The affected models include: Epic DR/HF (V-233/V-337/V-338); Epic Plus DR/VR/HF(V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350); Atlas DR (V-242); and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).
2007: St. Jude Riata Defibrillator Lead Wires Tied to Heart Perforations
In November 2007, reports emerged that St. Jude Riata Defibrillator Lead wires had perforated the hearts of some patients. That month, the medical journal Pace published a report detailing four instances in which the St. Jude Riata Defibrillator Lead wire detached and perforated the heart wall. In one instance, the defective St. Jude Riata Defibrillator Lead wire not only perforated the heart, but it nearly poked through a patient’s skin.
When a defibrillator lead wire becomes detached from the heart, the device will fail to emit needed electrical shocks to the heart, leaving a patient at risk of death. If the detached St. Jude Riata Defibrillator Lead perforates the heart tissue, the heart may bleed into the pericardial sac that surrounds the heart. This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing the heart from beating effectively. In an editorial accompanying the Pace article, Dr. Stephen Vlay, a cardiologist for Stony Brook University, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an inherent design flaw, at least in some models of the Riata Lead.
Earlier in 2007, the medical journal Heart Rhythm reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer. According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8 percent—or five out of 130 for the St. Jude Riata Defibrillator Lead. Doctors from New York Hospital Queens also reported to Heart Rhythm that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated. New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.
Legal Help for Victims of the St. Jude Durata and Riata Defibrillator Lead Wires and St. Jude ICD and CRT-D Battery Failures
If you or someone you know sustained an injury that may be related to a frayed St. Jude Durata Lead Wire, defective St. Jude Defibrillator Lead, or defective batteries in St. Jude ICD and CRT-D devices, you may have valuable legal rights. For a free, no obligation lawsuit evaluation with one of the experienced medical device lawyers at Parker Waichman LLP, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).
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