Introduction

St. Jude Medical Inc. was established in 1976 in St. Paul, Minnesota with the primary purpose of manufacturing of bi-leaflet implantable mechanical heart valves. It is recognized as the pioneer in heart devices production with its innovative heart valve design setting the ‘gold standard’ for mechanical heart valves. The company has grown into a universal leader in cardiac and neurological device expertise, expanding product variety through interior developments and calculated acquisitions. St. Jude Medical inc. has continued with its steady growth in the medical sector, dominating the heart sector and becoming a trusted entity in the development, manufacturing, and distribution of cardiovascular and implantable neuro-simulation medical devices worldwide. The company specializes in four health areas for which it develops the equipment. These areas include; Cardiac Rhythm management, Cardio Vascular, Atrial Fibrillation, and Neuro-modulation.  The cardiac rhythm management deals with cardiac arrhythmias, which basically means an irregular heartbeat. It is, therefore, the segment that develops defibrillator systems that provide treatment to patients suffering from lethal and life threatening heart conditions, such as, sudden cardiac arrest, cardiac resynchronization therapy devices to treat patients suffering from heart failures.

Defibrillators

These are devices used in defibrillation. Defibrillation is the standard treatment for acute cardiac dysrhythmias, ventricular fibrillation, and pulse less ventricular tachycardia. It involves delivering of a curative dose of electrical vigor to the affected heart using the defibrillator. Using this information, St. Jude developed the internal cardiac defibrillator, a device that could be inserted into the body. The design of this device allows it to recognize and respond to certain types of abnormal and irregular heart rhythms. It continually monitors the performance of heart and this continued observance, allows it to respond to any changes in the heart rhythm by sending electrical shocks to the heart, thus returning it to its normal heart beat. It detects irregular heart rhythms such as ventricular tachycardia, which is the rapid ventricular beating of the ventricles and ventricular fibrillation that is the rapid irregular beating of the ventricles (Jenifer, 2005).

A heart defibrillator is about the size of a small cassette which can be fixed within the body by far less intrusive techniques. The main purpose of an interior cardiac defibrillator is to regulate the heart tempo by delivering accurately regulated and timed electrical shocks, whenever needed, in order to restore a normal heartbeat. The ICD’s, therefore, allows for continued monitoring of the heart rhythm through the help of electrical shock waves, when the electrical manifestation of the heart activity exceeds the present number. They have electrode wires, which pass through a vein to the right chambers of the heart, usually wedged in the apex of the right ventricle.

The Decision to Use the Lead That Had Problems

Numerous problems had been documented regarding the lead used in the heart defibrillator devices which had been recalled at the end of 2010. The design changes in the heart device failed to stem the potentially life-threatening problems that had overwhelmed the earlier recalled versions of the product. The lead, called the Riata, was prone to another malfunction, a tendency for internal wires to break through the protective outer coating and cause electrical problems like unintended shocks in some patients. Therefore, the current heart device suffered the same malfunction, where wires could break through the protective outer coating and cause electrical problems to the patients. St. Jude was, therefore, prima facie wrong to use the same devices that had been recalled from the market. The risk that this decision posed on the patients was immeasurable (Michael & Wiklund, 1995).

However, St. Jude’s point of disagreement centers around the design changes in the new device which led to their belief that it was safer and more durable when compared to the old model. The argument was that the new heart device had leads which were coated with a new insulation material, Optim, which was more durable than the beleaguered Riata series. Dr. Hauser, however, indicates that this argument lacks sufficient back-up data to support the hypothesis of increased durability. Riata and Riata ST Leads connect an implantable cardiovascular defibrillator (ICD) to the heart in order to examine heart rhythms. Many of the problems will thus occur when the Leads, wires that connect the heart to implantable defibrillators, rub against other objects. Consequently, insulation will ware away when Leads rub against the bodies of the defibrillators, which as mentioned earlier, are matchbox-size devices that shock irregular heart rhythms back to normal.

The belief by St. Jude that Optim lead insulation may make it more secure is premised on the fact that, Optim lagging is a chemical co-polymer that combines the best features of polyurethane and silicon, which is designed to allow for increased durability of polyurethane and flexibility of silicon. It is more resistant to abrasion in lead-on-lead exposition than silicon insulation. Therefore, Riata ST defibrillation Leads are highly advanced ICD defibrillation Leads, designed to bring ease of implant, reliability and flexibility to patients. Based on this information, St. Jude were able to make design changes to the previous devices hoping to correct the flaws that existed in the recalled versions. The use of Optim insulation was, therefore, made to provide the solution to the problem of abrasion detected in the recalled versions which led to unintended shock waves on patients. However, the studies conducted by Dr. Hauser indicate that the Lead coating is not immune to abrasion just like the recalled version (Richard, 2001).

The lack of data enough to support the assertion by St. Jude medical inc. that the Optim coating was more durable makes the decision to use the Lead that had problems earlier on wrong. Being a corporate body, dealing with serious health matters where a simple mistake defines the difference between life and death, St. Jude had the duty to carry out further studies to ascertain the credibility of increased durability in Optim coated Leads.

The Legality of the Decision

The decision by St. Jude to use the Lead which had documented problems borders on the grounds of negligence and breach of duty of care owed to the patients. The act of placing defective products on the market despite having prior knowledge that they may be defective is a proof of negligent attitude. The Riata ST and its newer Durata ICD Leads have sometimes failed to function due to insulation failures. This is the information available to the manufacturers, and thus they ought to have taken sufficient measures. The failure of the heart device leads to numerous problems for the wearers of the device. Where the heart devices have failed, the patients may die; the patient may require intrusive surgery for the removal of the device. It may also cause faintness and rapid pumping of the heart which may lead to other complications.

The issue of legality of St. Jude’s actions has resulted in numerous court cases against St. Jude by the victims of the failed devices claiming damages for the suffering they have undergone. An example is the case of Richard Pinsonnealt v St. Jude Medical, Inc. and Pacesetter Inc. (case 0: 12-01717-SRN-JSM) in the United States District Court of Minnesota. In this case, the plaintiff brought an action for damages against the defendant for injuries caused by manufacturing defects in St. Jude Riata and Riata ST Leads. The plaintiff stated that he had been implanted with a defective Riata Lead and suffered injury and was forced to undergo intrusive surgery so as to remove and replace the defective Riata Lead (Christopher, 2012). This caused the plaintiff to suffer physical, emotional, economic and other damages.

In the case, the plaintiff raised grounds upon which St. Jude was liable for the damage that the plaintiff had suffered due to the defective heart devise. Firstly, the defendant was negligent in the process of manufacturing as they had the duty to produce the Riata Leads consistently and in conformity with the proper and approved conditions. The defendants breached this duty by manufacturing defective products that endangered the lives of the patients contrary to the required and approved standards.

Secondly, the defendants were also negligent per se. This is because Federal Regulation standards impose on the defendants the standards of care related to the manufacture, marketing, and sale of the Riata Leads. These Federal Regulations define the standard of care that St. Jude is required to comply with. The conditions set by the PMA are of vital importance in the production and subsequent sale of the medical devices. Thirdly, the defendant was negligent Res Ipsa Loquitar, which basically means that, there is no other way that the injury would have occurred unless it was caused by the negligence of the defendant. This is because the manufacturing defects found in the Riata Leads, could only occur while the device was under the control of the defendant (David & Norris, 2005). The plaintiff’s injury, in the ordinary course of events, would not have occurred had the defendant manufactured the Riata Leads consistent with the established standards for approval. The defendant was responsible for manufacturing the defective device that was the direct cause of the plaintiff’s injury and thus had to be held liable for such negligence.

The legality of the decision by St. Jude’s decision to use a device that had documented problems suffers a serious blow when tested against the precautions that the company took to observe the performance of the device and be able to set up interventional mechanisms that could mitigate the damage if it occurred. This decision, therefore, was illegal in as far as no disclosures were made to the patients concerning the potential failures of the device, and no further studies were carried to show that the device was safer than the one recalled from the market. This is negligence.

St. Jude’s Report to the Food and Drug Administration

St. Jude carried out a voluntary study of the performance of the new heart device and reported its findings to the FDA. The reports given to the FDA by St. Jude show 52 of Durata and Riata ST Optim defibrillations failures, including one that resulted in patient’s death. This report indicates that the risk resulting from the defective heart device is minimal and containable. It has to be remembered that this was a report prepared on a voluntary basis; and hence, it may not reflect the gravity of the real situation (Michael & Stephen, 2005).

This is especially true when this report is compared to the report carried out by Dr. Robert Hauser, a device-safety watchdog at the Minneapolis Health Institute. His report shows a higher death rate as a consequence of the substandard heart device.  The study links Riata failures to over 20 deaths compared to one death as reported by the company to the FDA. This is a clear example of a scenario where St. Jude may not have been truthful to the FDA (University of Wisconsin Madison, 1985). The company, therefore, withheld vital information to the regulatory agency and thus inhibiting its ability to issue an appropriate advisory opinion to the victims. By withholding information from the Food and Drug Administration, St. Jude was refusing to admit the existence of the problem and thus the situation became more aggravated. St. Jude had carried out continued research and was well aware of the existing problems in regards to the heart device.

Why St. Jude Used a Brand Similar to the One That Had Failed In 2011?

The new brand that St. Jude used to in the design of the new heart device had only few changes from the one that had failed in 2011. The study into the performance of the heart devices was reported by St. Jude in December 2010, when it issued a warning to all doctors that those wires inside Riata defibrillator Leads - cables that connect the heart to implantable defibrillators- were sometimes breaking through their insulation from the inside out. This was a problem which eventually led to the recall of the heart device in 2011. The problem was characterized by unnecessary jolts to the heart or failure to deliver life-saving jolts to the heart to turn chaotic heart rhythms to the normal heart beats.

Studies into this problem showed that the problem was caused due to the lack of insulation on the lead cables thus resulting in unnecessary shocks to the patients. According to reports by St. Jude, collected by the Food and Drug Administration, the company was well aware of the problem and had done extensive surveillance on the issue. Therefore, the introduction of a new heart device of similar brand was made to correct the existing problem. Several design changes had been made on the device and the key among this was the use of Optim coating on the lead defibrillator. The company believed that Optim, which was a mixture of silicon and polyurethane, was more durable and thus could prevent abrasion thereby solving the problem of the heart defibrillator. This opinion was not true according to studies done by Dr. Robert Hauser. The study reports that the belief that Optim could prevent abrasion was not true and was unfounded.  The studies show that proprietary insulation copolymer of silicon and polyurethane known as, Optim, cannot prevent insulation abrasions (Jack, Molly, Molly, 2007). This may result in Lead failure and other adverse clinical occurrences including inappropriate shocks and patient death. The Optim does not prevent insulation failures in Riata ST Optim and Durate Leads that are caused by friction by the can or other devices.

This report, therefore, cannot support the basis upon which St. Jude used a similar brand to the one that had problems in 2011. The company may not have carried sufficient research into the use of Optim as insulation against abrasions or the studies carried out may not have been conclusive hence the use of similar brands. This is because, the research ass to the behavior of the Riata series was well known to the company and thus using the same brand to make new heart devices would amount total disregard of the life of the patients for which the products were being made. In regards to the required industry practices, St. Jude may not have done any wrong as it followed the correct procedures in the manufacturing and design of the device. The only reason that makes sense as to why St. Jude used the same brand that had been recalled is that, the company may have strongly believed in the ability of the Optim to provide more protection to the lead wires, thereby providing durability and safety for the patients (Gerald & Enrico, 1993). The functioning of the Optim as insulation against abrasion is still subject of research as more data is required to ascertain its ability to be more durable. With the reputation that St. Jude has in the medical devices sector as a trusted manufacturer, the use of Optim could be a viable option if it works.

Did St. Jude Make the Right Decision?

The decision by St. Jude to use a product that had documented problems may have been prima facie wrong, when one considers all the warning signs that were available. However, in respect to the normal industry practices, St. Jude cannot be blamed for any misconduct in regards to the manufacture, marketing and sale of the heart devices. Normally, the Food and Drugs Administration has to approve the product before it can be sent to the market. The approval by the FDA signals that the product is fit for use by the public. Incidentally, the investigational report that was carried out by the FDA in 2006 in St. Jude’s manufacturing facility in California, clears the company of any manufacturing problems and consequently states that there were no potential design flaws (Reinaldo, 2002). The report also states that the insulation audit was adequate and up to standards. This, therefore, shifts blame from St. Jude Medical Inc. thereby ratifying its decision.

In conclusion, the problems appearing in the heart devices reflect the failures of the US monitoring system. This refers to the system that monitors products once they reach the market and assesses how they perform.  The handling of the Riata problems is a clear indication that the system of surveillance requires a major upgrade so as to detect the problems early on. It is the lack of such a system that exposes patients in the US to underperforming and potentially perilous medical devices after they have been approved by the Food and Drug Administration. The current surveillance system lacks the ability to detect defects early on until thousands of patients have been exposed to a new technology. A more robust surveillance system could help detect problems sooner. The current system relies on voluntary reports that often lack comprehensive and limited post-market research which make detecting problems difficult.

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