Cardiac Implants

Over time, the importance of medical devices will rise. Nearly 10,000 of consumers born between 1946 and 1964 (i.e. Baby Boomers) will retire each day (Friedburg, 2016), and there is a reasonable assumption that a necessary medical device is in the Baby Boomer’s future. Many will sustain a professional career later in life; and, as such, medical device designers will need to fashion products aligned with a mature population’s lively lifestyle (Kapec, n.d.). Johnson & Johnson (J&J) is aware of the upcoming importance of medical devices, and will look at price elasticity, non-price factors, the industry as a whole and its market equilibrium, and related decisions based on the information.

Businesses could be held liable for negligent tort if their product injury, harms consumers or is falsely represented. Nonetheless, when the circumstances warrant, parties that are not guilty of negligence or an unintentional tort can still be subjected to compensations when their products injure customers (Seaquist, 2012) Recall Negligence is an unintentional tort wherein one party is injured result to some actions of another. There are certain factors that must be considered to determines whether a corporation acted negligently. The elements are the following: a breach of that duty, legal duty to use due care, a reasonable close causal connection between the breach and the plaintiffs resulting in injury, and the actual loss or damage to the plaintiff. This paper is going to discuss a negligent tort due to a company’s recall of its product. The company may be considered liable for negligence if there was no recall on their product and the product caused bodily harm to a consumer (Benjamin, 2015). Throughout the paper will discuss the reason of Toshiba recalling their laptop computer battery packs due to burn and because of its potential to catch fire on March 30, 2016 and the recall number is 16-131. If the company did not make the decision to recall their laptop computer battery could have been diligent. To prove the negligent tort the consumer must prove factors such duty to care and defenses of negligence (Seaquist, 2012).

According to FDA.gov 2009, the definition of recalls is, an action taken by a company to remove a product from shelves. There are three classes of recalls and two other types of recalls mentioned on FDA.gov. Class I recall involves a situation in which there is a probability that the use of or exposure to a product will cause adverse health effects or death. (FDA, 2009) Class II recall involves a situation in which use of or exposure to a product can cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health effects is remote. (FDA, 2009) Class III recall involves a situation in which use of or exposure to a product is not likely to cause adverse health consequences. (FDA, 2009) Market

Jumpstater Inc had developed a product, Jumpstarter I, which was a pacemaker intended to regulate the heartbeat of an individual in the body. At the end of the nineties, the company discovered that the device became faulty when the body temperature increased above normal. To reverse the damage, the firm asked the medical facilities that had any unused product to return them to the company for credit. Additionally, Jumpstarter Inc. advised practitioners to remove any device that had already been implanted in the patients.

Zimmer Biomet is a product is a reverse shoulder implant designed to help patients restore arm movement. However, increased instances of failure have led to massive recall of this medical device along with lawsuits. Overall, there are three types of claims associated by recalled products, defective manufacture claim, failure to warn claim and defective design claim. The failure to warn claim occurs in cases where the manufacturer of a product fails to notify or educate users on the defect and risk associated with using the recalled product. Under the defective design claim, the product manufacturer is held responsible for failure to provide adequate information regarding product development and failing to test and foresee defects that may be caused by product failure.

One example of the cost of a device failure is a hospital bed. In this scenario, the mattress was not properly maintained during a routine inspection, and the device was deemed normal operation. Nevertheless, it had a leak in the air mattress, that leak created an ulcer on the patient’s bottom; the cost of an ulcer to be treated ranges from as low as $500 to $50,000 dollars. Besides finically losing money, they might have a longer/harder recovery because of a failure of the device. The healing process can take anywhere from 3 hrs. to years depending on the severity. Of course this example is a dramatization, and clinical staff are trained in methods to help prevent ulcers form forming. The patient’s family would have increased stress, as there love one recovery would be slower than expected. The University of Kansas Hospital treats people from all over the world on a daily basis. It is common for the family to travel to the hospital so their family can receive gold standard patient care; high travel cost adds up, the cost of extended stay due to faulty equipment, is another stressor that the family should not have to worry about such cost. I would be deliberately acting against

If the company had followed the proper protocols for medical devices and filed with the FDA in the first place, the recall could have possibly been avoided. This would have benefited both the company and the customers. If the company had filed with the FDA, they would have had to complete additional testing to prove the safety and effectiveness of the devices. This could have resulted in test results that showed the breakdown of the fibers in the filter and possibly, resulted in the improvement of the device. This same technology is used in their dialysis products and more tests should have been completed in order to test the difference in environmental factors between using it for water filtration and kidney filtration. In addition, without following the correct procedures, the company is in the

o The loss of revenue to doctors and researchers who use such equipment, and the

The response letter highlighted some of the restrictions placed on the device which include the following: 21 CFR 801.109 and 515(d)(1)(B)(ii) (sale and distribution), 515(d)(1)(B)(ii) (label devices for experience needed to operate), and 502(q) and (r) (requirements for a restricted device. The letter also informed that an Annual Report was necessary within section 21 CFR 814.84 for the PMA approval to stay in place. This Annual Report should have the following parts: number of devices distributed during the regulation period, the number of the devices implanted in people, the amount of deaths and explants, and a survival table. It is important to note that the deaths should be broken down into related to the pacemaker and not related. The explants should be broken down into those that no longer had battery, complications that could not be solved with programming, and other safety and efficacy problems. Other than the Annual Report the company should also perform a post approval study (PAS). The ending of the letter warns against the repercussions if some of these requirements are not met. It also informs the company of what steps need to be taken if the product was changed or if any safety and efficacy problems arose that made the product necessary for

Sample (sampling techniques, sample size, sample characteristics) Two authors independently reviewed the references to identify studies for inclusion and extracted data to assessed risk of bias in all included studies.

The type of recall will be determined by the severity of the situation. If there is a situation where the Vivofit athletic tracker does not seem it will cause health problems. If there is is a situation the Garmin Vivofit may cause temporary or medically reversible health consequences or the probability of serious health risks is remote. If there is a situation in which the Garmin Vivofit, with a reasonable probability, that the usage or exposure to the product will cause severe

The previous articles discussed the rate of infection among patients with pacemaker implant and the risk factors associated with cardiovascular implant electric device (CIED) infection. In the study done by Voigt, Shalaby, & Saba (2010), they stated that the rate of pacemaker has increased from 0% between 1996 and 2002 to 8.9% in 2003, to 15.8% in 2005 and 14.3% in 2006 but they claimed that the cases of CIEDs infections was faster than the implantation of those devices . Furthermore, Beddour et al (2010) found that the rate of CIED infection increased over time and it was estimated by 18% from 210 of patients having pacemaker implant. This rise was observed among patients with diabetes mellitus, immunosuppression caused by renal

Product recalls don't have to damage a manufacturer's reputation. When handled professionally and honestly, recalls have the potential to actually increase a company's favor with customers. The proper handling of recalls is especially important to those in the energy industry, as faulty energy devices can cause property damage as well as serious physical injuries. In order to find the silver lining in your product recall cloud, you must understand both how recalls work and how they can work for you.

In the article, my inference was: “medical devices manufacturers should be ashamed of themselves, and should foresee everybody else’s problems.” As evidenced by the introductory statement:

Product recalls have opened the company to numerous lawsuits from consumers that were hurt by the recalled products.