Friday, December 4, 2020

Medek LLC, Resource Recovery&Trading LLC, and AJR Trading: Hand Sanitizer Recall (2020)

Ethics Case Controversy 



Consumers using hand sanitizer 
            What we are looking at is to see if Medek, LLC, Resource Recovery & Trading LLC and AJR Trading acted ethically when they were producing methanol contaminated hand sanitizer. Digging a little bit deeper, we know that the major increase of hand sanitizer demand caused companies to start producing a variety of hand sanitizer to distribute the product faster. So, was the use of methanol and accident because they were trying to work fast or was it purposely used to create a stronger disinfectant? We can see why there would be the need for a stronger disinfectant because of the COVID-19 outbreak. The desire for better hygiene and keeping hands clean made people desperate to try anything that killed the most bacteria. 


damaged hands from sanitizer

Medek LLC “voluntarily” began to recall their hand sanitizer nationwide when the FDA performed an analysis on the product and found “the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.” Using any product comes with a risk but the side effects to methanol exposure became very dangerous very fast. “Substantial Methanol exposure can result in nausea, vomiting headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death.” A major concern was the exposure of the product to young kids who would very likely ingest said hand sanitizer which would increase the likelihood of methanol poisoning. Medek notified the customers and distributors about the recall on the methanol contaminated hand sanitizer and suggested that they all stop using, purchasing, or providing the product until they knew it was safe again. The FDA also gave a hotline number that provides information to those with questions about the product to help people fill in the blanks that came with the recall.

    Resource Recovery & Trading LLC also,  recalled their hand sanitizer when the question of a presence of methanol in the product came to surface. “The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreases bactericidal and virucidal activity. The health consequences can result in the opposite effect, an increase in infections. The product is used to “decrease germs when soap and water is not available” but small children can ingest the product or adults/adolescents drink the product because of the alcohol, increasing the probability of poisoning. RR&T LLC put out a notice telling all consumers, buyers, and providers to stop using the product and return all hand sanitizer to the location in which it was purchased again, once the FDA came to the conclusion their hand sanitizer was dangerous. 

“According to the Food and Drug Administration (FDA), AJR Trading issued a recall on 2,004 units of Advance Hand Sanitizer currently in US distribution.” The lot of hand sanitizer based test and met all the appropriate specifications and requirements. That being said with a possibility of the presence of methanol in other lots of hand sanitizer that has been recently produced, they recalled everything. AJR classifies young children and teenagers as high risk to the problem as they are most likely the ones that will physically end up with the methanol substance in their bodies rather than adults who just use it on their hand. The FDA was taking no chances when the question of methanol surfaced with any company. With the safety of the consumers their main priority they wanted all potential harmful sanitizers recalled. 

COVID-19

With the outbreak of COVID, many hand sanitizer companies have been rushing and speeding up their production time to distribute hand sanitizer. “In these uncertain times of critical personal hygiene caused by the COVID-19 pandemic, some manufacturers have sought to profit by selling a variety of ‘hand sanitizer’ products containing dangerous amounts of a toxic and potentially lethal chemical.” Methanol is indeed a type of alcohol, it used to make industrial products such as solvents, antifreeze, and different types of fuels. That being said, all those products are not meant for humans to consistently apply to their skin like hand sanitizer. “Human exposure can occur through both ingestion and skin absorption” which can result in serious health consequences. The FDA came forward and said that methanol is not an acceptable ingredient for the use of making hand sanitizer and has found at least 75 hand sanitizer products that possibly contained methanol. “The FDA advises that these products should not be used and should be disposed of as a hazardous waste.” If a human has used a methanol contained hand sanitizer the FDA highly recommends that they seek medical attention, even if they are not showing poison symptoms, so they can reverse the damage before it is too late. 


FDA Logo
“The FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol.” On top of that, the FDA has taken action to prevent particular hand sanitizer from entering the US by putting hand sanitizer on an import alert. “Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products.” The FDA made an 
announcement which overall concluded that hand hygiene is important but we need to be careful with what products we actually use. The list of dangerous hand sanitizers is constantly being updated because methanol doesn’t usually appear on product labels. If a hand sanitizer manufacturer fails to recall dangerous sanitizer that places consumers in danger they can be held responsible for the resulting health consequences of said consumer. When looking at the FDA provided list consumers need to look for Manufacturer name, product name, and national drug code to see if the sanitizer is safe. 

 

Stakeholders

            In this dilemma, there are three groups of stakeholders. The first group consists of Medek LLC, Resource Recovery & Trading LLC and AJR Trading. They are the ones providing the methanol hand sanitizer to the public ultimately putting all the consumers at risk. Then we have the FDA. The FDA made the companies recall their products because it was harmful to the people. Last are the consumers that used the product. By using the hand sanitizer they were put at risk of major health problems that could have been avoided. 

 

Individualism

            The overall goal of the Individualist Theory is to maximize a stakeholders profit/happiness and for everyone to act rationally/ in their best interest. All three companies maximized their happiness and profit by letting consumers buy their products as the demand for the hand sanitizers continued to rise. The companies were happy because they were bringing lots of money in. Although they were happy, they were not acting rationally/in their best interest. Medek, RR&T, and AJRT manipulated their consumers and let them buy a product that was dangerous.  

            If the companies had taken their time to produce safe hand sanitizers they wouldn’t be in the situation they are in now. Currently, they lost money by having to recall their hand sanitizer and start from scratch to make sure what they were producing is safe for their consumers. Both the producer and consumers were being hurt because of the loss of money on the business end and the health problems on the consumer side. If they acted rationally from the beginning they wouldn’t be out money and their consumers would have been safe. 

 

Utilitarianism

         When talking about the Utilitarian Theory, the goal we need to have in mind is to create or promote happiness to as many people as possible. As we have seen Medek, RR&T, and AJRT have done the complete opposite. Due to failure of producing safe sanitizer, many of their customers found themselves or a loved one in the hospital. Babies were ingesting said sanitizer and parents were watching their kid suffer from poisoning that they weren’t aware of. Adults were having extreme headaches and found themselves in coma’s, again, because of poisoning they were not aware of. Obviously, if someone is in the hospital for poisoning, there is no happiness. 

            That being said the sanitizer companies weren’t happy when their products were on recall. As the FDA made announcements telling consumers to throw out or bring the hand sanitizer back to the distributer, RR&T, AJRT, and Medek saw money going down the drain. Knowing they lost money and were the reason many people came down with Methanol Poisoning surely didn’t bring them happiness. 

 

Kantianism

            Ethical decisions that are motivated by the idea of a rational decisions is the idea behind the Kantianism Theory. The Kant Theory also is revolved around the idea of the “Formula of Humanity.” This idea tells us that we should treat others the way we want to be treated and not as means. If you treat someone as a mean you are not acting ethically because you are using them to amplify your own happiness without paying any attention to how others are affected. 

 When taking the actions of the three hand sanitizer companies into consideration we can see they are unethical under the Kantianism theory. These companies were motivated by self-interest (getting the sanitizer out quickly to stores and consumers) rather than their duty (making sure the product was safe to go out to the market). The rational decision for them to quickly produce hand sanitizer and ship it off knowing it contained methanol is not ethical. If the rational decision is not ethical it fails to meet the requirements of Kantianism. 

            If they had acted ethically, the result of this error would be different. For starters, the companies should have recalled the sanitizers not the FDA. When the FDA made the announcement it made the companies look like they were trying to cover their error. Ethically, Medek, RR&T, and AJRT should have taken responsibility for their error before the FDA. Also, if they had taken a second to look at what they were producing, they could have found how methanol was ending up in their product. Instead, they continued working without giving it a second thought. 

 

Virtue Theory 

         The Virtue Theory revolves around four characteristics: courage, honestly, self-control, and justice/fairness. The first aspect is Courage and what this basically is, is the willingness or willing to take a risk for the right actions or ideas. The companies took a risk by producing hand sanitizer that was dangerous to the consumers. By producing the methanol contaminated sanitizer and not giving the methanol problem a second thought they took a risk. The thought of the safety of the consumers who would use the produce was not a thought in the producers minds otherwise they would have checked over the sanitizer to make sure it was safe. 

            Honesty on the Virtue Theory is described as being truthful with the public. Obviously, we can tell that this was not the case. There was not honesty with the public because the companies let their customers use a dangerous product without giving a warning. Ethically, if the companies were going to continue to sell the hand sanitizers with methanol, there should be a warning on the bottle telling the consumers. If there is a warning, the consumers are buying the product at their own will BUT they are informed about the potential dangers of using the product. 

            Self-Interest (AKA Temperance) are the expectations and desires the employees have for their companies. We see here that those desires don’t line up with the society’s expectations. Although, our producers wanted to maximize their profit, they were taking the wrong steps. The goal in which they had, has two paths to get to it. One, caring about the people as much as they care about their company and two, doing whatever they need to do to get to the top. They got to their goal by taking the unethical path. 

            Finally, the hard work, ideas, and fair practice all fall under the last virtue, Justice. The companies were working to make good hand sanitizer to kill germs/virus’ like COVID-19. Even though they were trying to make a good product, they ended up doing more harm than good. They had the right idea by trying to kill germs but the lack of effort to make the product safe is where they fall short. 


Justified Ethics Evaluation: 

            After researching this problem. I believe that the companies could have prevented the recalls. If Medek, RR&T, and AJRT had a closer eye on their product all the health problems that were reported could have been prevented. Also, they shouldn’t have waited for the FDA to announce a recall, they should have done it themselves. With them waiting for the FDA, they made it seem as if it wasn’t as big of deal as it was. It is better if a company does their own recall I also feel that both of the companies didn’t have the consumers best interest when they were producing the hand sanitizer. If they did, there would have been a notice on the bottle so they aren’t taking the choice away from consumers to buy a safer product. Under the four ethical theories I had discussed, I believe that in every situation the actions that were observed in this study are ruled to be unethical. 

 

Company Action Plan

Currently, the FDA has published a list telling consumers what brands of hand sanitizers not to buy. They are aware of the health consequences that can result from methanol and are on high alert monitoring the producing companies, distributors, and consumers. This is best compared to the contact tracing we do for COVID positive patients. The FDA watches where the hand sanitizer goes so if someone gets methanol poisoning they can trace it to the right back to the production facility. The investigation to find more companies that use methanol in their hand sanitizers is still ongoing. The FDA is advising that anyone who has come down with symptoms to get medical treatment immediately and to report their symptoms so sanitizer can be traced back.

“FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:

  • The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products. 
  • Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
  • Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
  • Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
  • Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
  • Products labeled with harmful or poisonous ingredients, such as methanol.”

The above data comes straight from the FDA and their exact plan to limit the amount of hand sanitizers that contain methanol that get distributed to the public. That being said, the FDA is aware of the problem and are doing everything they can to make sure only safe hand sanitizers are in the market. They advise to keep an eye on their “Do-Not-Buy List” and to call them or your health providers with any questions you may have. 

    The FDA has a mission to get the methanol problem under control to keep the consumers safe and healthy. This mission shows that the FDA has the consumers best interest and is doing everything in their power to stop the production and purchasing of hand sanitizer that contains methanol. As the FDA is working extremely hard they are taking several core values into consideration as well. These values include: customer safety, integrity, and respect. As mentioned before the FDA is taken all these actions just to keep customers/consumers safe. They show integrity to the public by providing the “Do-Not-Buy” list. The FDA is aware of methanol coming from certain companies so, as they get that information they are reporting it out right away. With that, the FDA is also following the value of respect. They are telling the public honesty information out of respect for the consumers. The employees of the FDA sure wouldn’t want to use dangerous sanitizer themselves so they are making it known to the public. 

            To ensure ethical productivity and monitoring of ethics in the future to prevent this problem from reoccurring the FDA should push new training programs on all the companies that find themselves on the DO-NOT-BUY list. The new training should include extra supervisions of the production of the hand sanitizer and testing procedures that will show if there is a harmful chemical within said hand sanitizer. When it comes to the hiring, firing, and promotion system, the managers will really need to evaluate the employees. Hire those who are willing to give 110% and want to keep the public as safe as possible. Fire those who seem to be doing a careless job. With the promotions, give employees an incentive to strive to do their best work possible.

            As companies are recollecting themselves the FDA should promote or market an updated DO-NOT-BUY list. On top of that, said company should take it upon themselves to promote the new and improved hand sanitizer that will be coming to the market. These companies have to get back on their feet and regain consumer trust. In order to do that, they will need to be completely honest and open about their product. By taking these actions the companies will not only regain consumer trust but also begin to improve profits and productivity levels. If the FDA pushes the core values and new training system the consumers will start to be willing to buy products from those companies again. As the honesty of the companies grow, so will the loyalty of the consumers.







 

 

References

Center for Drug Evaluation and Research. “FDA Updates on Hand Sanitizers Consumers Should Not Use.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use. 

Center for Drug Evaluation and Research, Medek Company. “Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels.” U.S. Food and Drug Administration, FDA, Sept. 2020, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medek-llc-issues-voluntary-nationwide-recall-m-hand-sanitizer-due-potential-presence-methanol-wood. 

Center for Drug Evaluation and Research. “Resource Recovery & Trading, LLC.,Issues Nationwide Recall of Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotency Ethyl Alcohol Company Announcement.” U.S. Food and Drug Administration, FDA, July 2020, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resource-recovery-trading-llcissues-nationwide-recall-hand-sanitizer-due-potential-presence-methanol.

Commissioner, Office of the. “Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products.” U.S. Food and Drug Administration, FDA, Sept. 2020, www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-warning-about-dangerous-alcohol-based-hand-sanitizers.  

FDA. Hand Sanitizer Lawsuit - Kazan Law, 2020,  www.handsanitizerattorneys.com/?gclid=Cj0KCQiA-rj9BRCAARIsANB_4AD-JoJPX3lTvtmdPQlMY7qWlhq6Uy1wt5DHDFc6QA79wGjn_Uq1EbcaAkInEALw_wcB. 

Impelli, Matthew. “Hand Sanitizer Recall Expanded to Include Another Brand Due to Possible Presence of Methanol.” Newsweek, Newsweek, 4 Sept. 2020, www.newsweek.com/hand-sanitizer-recall-expanded-include-another-brand-due-possible-presence-methanol-1529687. 

 

 

 

 

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