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Johnson & Johnson’s Product Safety Issues and Ways the Company Can Address Those Issues

Monica Merli Anak James1, Daisy Mui Hung Kee2, Teoh Hui Xian3, Kwong Ching Han4,

Khor Kae Ching5, Maali Salem Alshammari6

Universiti Sains Malaysia1

Correspondence Email: m-momo98@hotmail.com Universiti Sains Malaysia2

daisy@usm.my Universiti Sains Malaysia3

janicehuixian@gmail.com Universiti Sains Malaysia4

chinghan1998@hotmail.com Universiti Sains Malaysia5

kckhor98@hotmail.com Kuwait University6

m3salisalem@hotmail.com

ABSTRACT Johnson & Johnson was founded in 1886, which is a multinational medical device, pharmaceutical and consumer packaged goods manufacturing company. This company has 250 subsidiary companies which operate in 60 countries and their products are sold over 175 countries. The company was performing well since their establishment; however, J&J is facing numerous quality issues in later years. The first product safety issues arose in 1982, seven individuals died in Chicago, after ingesting cyanide- laced Tylenol capsules, and the company make a large recall of the capsules from retailers and it was known as the first major recalls in the American history. In 2010, a subsidiary of Johnson and Johnson has recalled children ’s medicine after an inspection which claim that the products were not meet with the required manufacturing specification. Over the year 2016-2018, this company faced with numerous lawsuits related to its talcum powder products – Johnson’s Baby Powder and Shower-to-Shower body powder. The latest issue associated with this company was the powder contain harmful substances which might cause cancers. These issues had caused the public lost trust over the brand and the reputation was affected throughout the year. The purpose of this paper aims to analyse the product quality and safety issue and to discuss way to ensure pharmaceutical quality regarding Johnson & Johnson’s products. Besides quality control, company management also play a big role when facing this issue. Besides, we aim to find ways in which J&J could maintain its brand image and reputation as a trusted family company. Keywords: Drug safety issues, ethical issues,pharmaceutical control, brand reputation, quality control, company management Chapter 1 Introduction Johnson & Johnson is an American international company established in 1986 by three brothers: Robert Wood Johnson, James Wood Johnson and Edward Mead Johnson. And it headquartered is in New Brunswick, New Jersey in the United States. The company specializes in produce, Manufacture and sell products in the healthcare field. And it organized under three segments: Consumer, Pharmaceutical, and Medical Devices. The consumer segment includes products used in baby care, oral care, skin care and women's health care which sold and distributed throughout the world. While pharmaceutical segment focus on therapeutic areas such as: anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management and virology which sold directly to the retailers and health care professionals.

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The last one is Medical devices that include products used in orthopedic, surgery, cardiovascular, diabetes care, and eye health fields, those products sales directly to the hospitals. Johnson & Johnson has a vision that believe in "Be yourself and change the world", to encourage every person to share their unique experiences and backgrounds together to make solutions that create a better and healthier world. Their mission is about " Make diversity & inclusion how we work every day”, their mission is to make diversity and inclusion their way to doing business. And develop their own culture where openness and minds combine to give brilliant mix of people in every corner of Johnson & Johnson. The company operates the business under decentralization structure that gives the employees the authority to make decision that suitable for the business environment and develop their skills which lead the company to the innovation they needed to compete in the local and global market. With more than 250 operating companies that located in 60 countries, Johnson & Johnson is responsible to Maintain its commitment to a sustainable growth & investment. Chapter 2: Background of idea Background of company Johnson and Johnson (J&J), a holding company that manufactures and trades a wide range of product in pharmaceutical, consumer and medical fields. Its products either for drinking or external application are varies in types which includes drugs to treat immune disorder, medical products used in surgery, consumer products which comprises health and personal care products in beauty, skin care and just to name a few. J&J, a listed company which founded in 1986, with the effort of top management and high royalty consumer, it successfully expands its business from United State to Brazil, China, Canada and up to 60 countries. Illustration 1 shows major products and services of J&J: Illustration 1: J&J products. In order to maintain its status as top best brand in this sector, J&J always examine itself and identify its existing or potential competitor. This is because J&J thinks that it is vital for a business to learn something good such as design, quality of product and effective management

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from others. Competitive advantages of J&J lie in its product itself which has ‘No More Tears” formula patent. Safety, comfort, and gentleness have always been a top most priority in its products. Its products are free from harmful chemicals such as alcohol and soap, and its products go through rigorous clinical testing to make sure the highest standards in baby care. Table 1 shows major existing competitor of J&J on baby powder product:

2 Mamaearth Dusting Powder -100% natural ingredients

-soothe dry skin, help in healing diaper rashes

3 Chicco Baby Moments -has hypoallergenic formula, devoid parabens

4 Carrie Junior Baby Powder -enhanced with Fruito-E to soothe, nourish and

protect skin

Table 1: Competitor of J&J on baby powder product. Every product manufactured by a company must targeted specifically towards a group of people or a group which these people have a common characteristic in age, lifestyle, occupation and more. This will help the company in developing or producing new product which may fulfill satisfaction of consumers. Johnson’s baby powder in the same way is targeted towards a group of new parents and new born baby. Almost all segment parents who are affordable on its products are their target customer and more specifically is targeted on mothers who are between 24 to 32 years old. Positioning is where a brand occupies in the minds of the customers and how it is distinguished from competitors’ products. Johnson’s baby powder at different stages of this life cycle as used different positioning statements like ‘Mother’s Choice’, “Like Father, Like Child’, “Smooth Skin, Guaranteed”. Issues faced by company J&J had been facing several product safeties issues for several years. The earliest issue is on 1982, where a large recall had been made when first seven individuals died after using one of their products. In later years, product safety issues continued to exist where litigation cases had been faced by this company regarding their products. The issues are such as children product issues (2010), hip-replacement recall (2010), tylenol recall (2010) and so on. One of the major issues facing the company today is its baby powder issues. This company had been sued for several times for their baby powder issues because of causing cancer. The first case was happened during 2016, where J&J was ordered by the court to pay damages to a woman who died of ovarian cancer after using the baby powders. Though, this issue doesn’t end here. In December last year, 11700 people suing J&J over cancer caused by baby powder. They are accused of using asbestos (harmful chemical) which cause number of tumours, including lung, larynx and ovarian cancer. The company was forced to share thousands of notes and internal reports with lawyers. (Reuters, 2018) In 2018, J&J had become target of lawsuits regarding issues of opioid-related overdose death.

No Competitor Strength

1 Himalaya Herbals Baby -contain almond oil,olive oil and poppy seed which

Powder prevents excessive sweating and nappy rashes.

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Besides product safety issues, there are also ethical issues in this company. In many times, this company had failed to disclosed certain risk and problems of using their products,or they purposely hide the truth of their product problems. Take for example, in vaginal mesh implants case, 700 women suffer from pain and infection after using vaginal mesh implants devices. It was alleged that the company failed to warn patients the risk of using their products. They are aware of the risks long time ago but still went ahead and made the product available. (Devlin, 2018) In Motrin recall issues, they had misled customers and regulators by removed the Motrin pain killer from the market quietly rather than announce a broad recall. The company instructed field employees to fan out and buy the product off shelves, acting “like a regular customer.” (Reuters, 2010) They are accused of placing profits over the welfare of the customers. This case has affected consumer trust and spawned lawsuits against J&J, which is one of the United States’ most iconic companies and in business since 1886. (Reuters, 2010) While in baby powder cases, this company was forced to release internal documents after they had been sued for cancers caused by baby powder. It was found that J&J had been known about the presence of cancer-causing asbestos in its products for decades. The report also showed that this company had commissioned and paid for studies conducted on its baby Powder franchise and hired a ghost-writer to redraft the article that presented the findings in a journal. (Joseph, 2018) However, in response to this, they denied that they knew or hid information about the safety of talc. They also said that their powder was harmful chemical (asbestos) free and was safe to consume despite the fact that many plaintiffs allege that the amounts they inhaled when they dusted themselves with tainted talcum powder was enough to make them ill and the claim from The World Health Organisation which recognises no safe level of exposure to asbestos. (GENOWER, 2018) Health Canada also warned that talcum powder may harm the lungs and increase the risk of ovarian cancer. (Dyer, 2018) Until today, the company has forced to paid nearly billion dollars for the cases against it and faces many of the fines and consequences that have emerged as a result of the problem. Chapter 3: Justification of idea Johnson and Johnson had been recalled many types of drugs since a major recall in 1982 and being sued for its product’s safety problems over several years. These activities can have enormous and overwhelming effects on the company profits, for instance, the share price and brand perception will be negatively impacted. Company also have to pay several costs involving cost of investigate, retrieve, and destroy flawed products which are significant, while future costs involve lost revenue and the felt of market share. Manufacturers also face consumer litigation and brand reputation will be damaged that negatively affect business. At worst, it can lead to a company close down to prevent further loss. Manufacturers need to use the right ways to manage product problems for long-term profitability and sustainability. It is recommended that quality control measures can be implemented to comply with traceability regulations. The data acquired through these processes can serve a secondary purpose during a recall. A comprehensive control is needed in order to prevent the problems from happening. There are two type of control, namely company management internal control and the product quality control. 1. Company management A good company management is important when a crisis arise. Not only during a crisis, company management is also playing a significant role to minimize the occurrence of product safety issues. Thus, there must be an appropriate leader who is competent and experienced to handle the event to prevent the aggravation of the situation.

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Build an organization culture which emphasized strong ethical behaviour In many times, J&J had failed to disclose certain risks and problems of some of their products. For instance, in 2016 vaginal mesh implants case, some of the women suffer from pain and infection they had aware of the risks in years ago but didn’t disclose the facts and still went ahead and make the product available. In baby powder case, it was alleged that they had known the contamination of asbestos (a harmful chemical) in their powder and find ways to conceal the evidence from the public. To create an ethical culture within the company, the top management should set a good example and establish commitment to ethical value. If the top management itself did not practice ethical value, the employees will most likely to follow suit. In this case, the top management does not lead by example, for instance, they still made the product available in market even though that product is problematic (in baby powder case) According to Barton (Barton, 2001) to encourage ethical behaviour, three codes of ethics crisis that should follow. Management team members will honestly convey pertinent facts in a timely manner to key stakeholders, including customers, employees and the news media, even when the news is not favourable. Organization should be open to media, voluntarily to recall a product even though the company may face loss, and asking the public to trust the organization. Honest culture is important to maintain integrity and reputation of a company. Silence communicates (which means hiding something) and in the context of a crisis may be interpreted as guilty. An open and honest response that conveys compassion and concern is the best approach. If an organization is trying to hide something, most likely the media will find out and the organization’s crisis will escalate” (Ray, 1999) Honest communication should not only limit to media, important information which might affect various stakeholder should be voluntarily communicated to them, as well as to various constituencies internal. (Granville King, 2002) The second code of ethics stated that the confidentiality of key persons will be protected when that is both appropriate and needed. (Granville King, 2002) Still, victims’ names that suffer from negative consequences after using the company products should be released after local authorities and victims’ families have been notified (Barton, 2001). The team must able to inform official agencies, the victims’ families quickly and properly, and to release the names of the victims at an appropriate time (Ray, 1999) Therefore, the company must quickly contact the victim’s which suffer from negative implication after using consuming their products to provide relevant support and compensation to them. Any delay in contacting relevant authorities or releasing the names of victims might further deteriorate the situation. The failure to provide adequate care towards the victims can lead the media to report the incident which may affect the reputation of the company. For example, the media might quick to report such incidents, and will give an impression to public that this company is uncaring and insensitive. In J&J baby powder cases, the company didn’t voluntarily pay compensation to victims who suffered ovarian cancers after using the products. In fact, it was the court who order the company to award compensatory damages to the victims. This has shown that this company failed to provide adequate care to the victims, and this leave the organization with a bad image. So, how does the company can achieve this? By disclose of liability and accept responsibility, do not purposely hide the truth, rebuild confidence and credibility which will be discussed in more detailed in the next chapter. 2. Comprehensive Quality control Quality control is an ongoing process that touches everything from upstream to downstream. Quality control is important to minimize the issues of unsafety in products. Why quality control should be emphasized? When customers feel that the products had a consistent quality and it is safety, they're more likely to return again to purchase the product. To ensure consistent

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quality, hard work, attention to detail and appropriate systems for monitoring are required to assess whether the products meet the standards. There are a number of quality management system in which the company may implement. For example, lean manufacturing, six sigma, total quality management, HACCP system and so on. Those processes have the same purpose, which were to reduce waste and cut cost, and to avoid situations that cause harm to customers and lead to expensive liability claims and lawsuits For instance, pharmaceutical firm such as AstraZeneca which apply six-sigma based on DMAIC principle, which stands for define, measure, analyse, improve and control respectively. Each of these components addresses a different aspect of the overall improvement and breakthrough strategy (Reham M.Haleem, 2015) In the company, this initiative shifts their focus from output to customer alignment and service. Besides, cycle time and lead time had been reduced by 25%. Chapter 4 - Discussion of idea In this chapter, we will discuss on how the idea can be applied in the company and the relative benefit. 1. Role of company management i.) Disclose of liability information and accept responsibility In 2016, legal action had been taken against Johnson & Johnson after some women suffering serious complications following a vaginal mesh implant procedure aggressively marketed" the implants "failed to properly warn patients and surgeons of the risks or test the devices adequately. Investigation of the emails between executives show that the company was aware of the risks in 2005 but still ignore it and went ahead to made the product available (Devlin, 2018) Therefore, J&J should disclose problems earlier when they aware that their product’s risks and properly inform the consumers of the risks of using the product. The issues can be avoided if consumers aware of the consequences of using the products. Company should also take responsibility of consumer’s safety by cease of selling mesh implant after they had aware of the complication and pain warning from consumers. The company might conduct a voluntary recall by announce in a press release. Consumers should be refunded or a replacement product, or if already caused damage to public, they should compensate them. ii.) Do not purposely hide the truth In the baby powder case that involved this company(defendants) and the plaintiff, Rex Burlison, which is a judge held that “defendants knew of the presence of asbestos in products that they knowingly targeted for sale to mothers and babies, knew of the damage their products caused, and misrepresented the safety of these products for decades.” (SALTER, 2018) While in Motrin recall issues where the company of send private contractors into stores in the state to retrieve the defective products without the public knowing. This in turn had caused loss of trust from consumer as it give them an impact thinking that J&J would not want their customer to know that the products is unsafe to be used or consumed Therefore, Johnson and Johnson should disclose information openly to public. For example, they could use the media to alert people of the potential dangers of the products and also to stop producing of harmful product. In case of Motrin, they should have announced the recall

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openly and alerted stores and public of their recalls, not by sending their employees to act as a customer to buy back the products. Instead of thinking in financial terms, they should place the safety of consumers at first priority. Even though the company would lose profit temporarily from not selling their products, but in long term they will even gain more trust and support from their base customers, because the consumers will think that the company was not only thinking their own benefit, but also for act for the sake of consumers. It is utmost importance that the report always reflects accurate data in which product which has potential safety issues, incidents and test reports. A report should not state that the products had been complied with safety standards and passed safety test while in fact not, or concealing any safety issues in report. iii.) Rebuild confidence and credibility All these circumstances will affect the reputation of the company and some of the customers might not purchase products from this company again. To regain their credibility again, they need to utilize public relation programs so that interest of the public is protected. By this, media company will give full support to the company. The best way to achieve this is to disclose the truth and give an appropriate apology, and also inform the public of the alternatives to replace unsafe products. In short, the team should communicate to stakeholders on what they (stakeholders) need to do to protect themselves from the crisis, and their effort on correct the crisis. The benefits of voluntarily communicating information to key stakeholders includes (Granville King, 2002):

● The company will retain control of the crisis and prevent the domination of situation by media

● Public will not falsely interpret the situation

● To give an impression to the public that the company is knowledgeable,

competent, sincere and integrity ● Customers will return again in future when they know that their interest is protected

By knowing what happened, taking actions to help stakeholders, and taking the steps to correct the situation all reflect and image of the organization being in control (Granville King, 2002) 2. Role of Quality control i.) Regulation and standards

To assure product safety throughout the supply chain, proper policies must be adopted. Partnerships between business and government agencies will be required to improve safety and security in the supply chain (Sarathy, 2006) Therefore, before market a new product, it is advised that a thorough quality and safety check of the product by an independent external professional body should be conducted to ensure that the product is free from harmful chemical or ingredients and meet the safety standards. Sometimes quality check by internal body might arise problems, such as the organization conceal the true information of products intentionally, or amend the report by stating that the product is safe to use while in fact not.

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The benefit of standard includes (Jacques Trienekens, 2008) • Improve suppliers’ standards and avoid product failure • To eliminate multiple audits across the supply chain • To transfer specific demands to parties upstream in the chain • To provide traceability in cases the incident happens again. ii.) Manage supply chain well

J&J should manage the supply chain well, such as to check on whether their suppliers are qualified and meet the standard or not. Company should ensure that the supplier ’s obtain certification for the materials, request for test procedures, observing a supplier's test results, and regularly conduct a site check to a supplier's factory or third-party laboratory. One of the reasons that caused the faulty medical products can be because of the quality of materials used for manufacturing those products. Most of the time manufacture will want a cheaper supplier to decrease their cost but it is important to be aware of the quality of their materials and also their history. Besides, they should also record all their suppliers’ components whether is it new or old suppliers. Besides, J&J can use cloud-based enterprise quality management technology to connect with their suppliers in line with corporate quality initiatives. Suppliers’ data will sync with the manufacturer’s centralized database and this will enable operational professionals to check on the quality of raw materials and ingredients before they reached at manufacturer’s places. Not only a high-quality final product can be produced but also will achieve a maximum rate of production through the global supply chain while at the same time avoid recall problems. By using supply chain management database, the advantages include: • Transparency can be enhanced throughout the entire chain • To recognize errors quicker and more efficiently • It ensures that the specifications of raw materials meet all standard required • It also enhanced communication between supply chain channel members iii.) Establishing a Compliance Team It is recommended that the company establish a selected team of compliance specialists. It could be consisting of third-party consultants or in-house experts. Company should obtain reputable compliance specialists that have experience and knowledge in the pharmaceutical line of business and industry. Or alternatively, management can send their employees to training sessions to further enhance their knowledge in these fields. Although company need to allocate more resources to the new team, however in long run, the benefit of avoiding product recalls and improving safety might outweigh the costs of investing in the team. The advantages of using a compliance team include:

● Utilizing the knowledges from the expert in related field

● They are more experienced in managing risks and problem, and thus can provide useful views

● External consultants can provide a more objective views as they mostly consider from a variety of perspective and not only within the company

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However, there is still downside of the establishment of such a team. A compliance team might need to overcome many challenges such as complicated business models, conflicting point of view, strict industry rules and so on. iv.) Use alternative ingredients to replace harmful ingredients through R&D effort To compensate for the company lost profit of not selling their harmful products, Johnson and Johnson should conduct research and development to find alternative that can replace talcum powder. Talcum powder (baby powder) which produced by Johnson and Johnson was claimed to be harmful where it can cause ovarian cancer and respiratory problems in babies when inhaled much. This company also had been sued by over 10,000 people for cancers caused by this powder. J&J has no medical reasons to use it, they should consider other alternatives to replace talcum-based baby powder, such as baby powders made up of safety ingredients such as corn-starch powders, tapioca starch powders, oat flour, baking soda and zinc-based diaper rash creams for infants and toddlers. The company should stop using talcum -based powder as the research has indicate a positive relationship between talcum and cancer risk. v.) Quality management Lean six sigma quality management can be implemented in this company. This system will work by reducing batch size, which means that process pharmaceutical leads frequently in small batches so that management could accurately detect defect and to obtain feedback faster. Secondly, the company should focus on flow and not focus on what had planned in advance, monitor flow of work and build-up of queues and tried to adapt to changing environment, this is to save time and to respond promptly to issues such as technical and resources problems. Thirdly, pull strategy should be adopted rather than push strategy by producing products in response to demand. This is to save the resources and minimize costs. Furthermore, they should ensure fast feedback of new information so that scientists can control rapid development. The company should also have full time appointment of staff to Lean sigma-based role within R&D. (Stephen W. Carleysmith, 2009) The benefit of lean sigma quality management involves: • Increased capacity for project work from time saved on repetitive tasks • Reduction of cycle time • Improved team-working and individual involvement • Increased productivity by greater focus on value-adding activities Result/Discussion and Conclusion From the research done, we could come up with result on the ideas and how it helps J&J in their company. For the roles of company management that include disclose of liability information and accept responsibility, do not purposely hide the truth and rebuild confidence and credibility. All these solutions are important especially for the roles of company’s top management because the company’s performance depends on their decisions. The result of applying these enables the top managers of J&J to eventually have the customers trust and confidence back. Besides get the trust of customers back, the stakeholder of J&J will remain as they know that the company have retain control of the issues and would not affect much on the stock price. This enables to prevent the happening of loss of equity and drop of market price and the company reputation.

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Furthermore, taking responsibility on the issues and not trying to hide it also give the public a good image that the company actually care for the customer’s safety more than their own benefits. Customers will blame less on the company thinking it might be just an error during the manufacturing and not thinking that the company are trying to hide their wrong from the beginning. For the roles of quality control, it can be seen that we have listed few such as regulations and standards, manage supply chain well, establishing a compliance team, use alternative ingredients through R&D and quality management. Quality is an important factor when it comes to any product or service, which is why J&J should increase their quality control. The result of following and updated on the regulation and standard is to avoid product failure and ensure the product is safe to be use or consume. Besides, if J&J manage their supply chain well, they can ensure the quality of their supplier qualified and meet their product’s standard. This can save the time to check on the outcome of final product whether is it faulty or not and at the same time prevent wastage of material. A good supply chain management database also ensures the quality check of the supplier. Furthermore, an active Research and Development team can always find alternative way to replace a certain ingredients or method when an issue happened and at the same time know what caused the problem. This helps J&J top management to announced the problem and solution publicly and minimize company’s loss. In conclusion, we can conclude that the main 2 important roles for J&J is the role of management and the role of quality control.Through our research, we have listed few solutions for J&J and the ways they should applied in their company to prevent the happening of same problem. A good company performance is all depends on how the managers make their decision and how they solve the problems. Chapter 5: Recommendation From the research done we would like to give some suggestions to J&J to help them aware of the importance of management and quality control. A manager is to guide the organizations to do the right things and move in right way in order to accomplish their mission and objectives. Managers have to allocate the limited resources according the most importance of activities and make sure the activities work effectively. Besides that, management is important in playing role to control the quality of product or service. A higher quality of product will attract more buyers and also improve the company ’s reputation. Quality control means that managers need to control all the process and make sure each step meet the standard. It helps to reduce damage or injuries that may be faced by users. Moreover, quality of products is a competitive advantage when competing with other companies. It can be the market differentiator for buyers and users when selecting the product. Quality control not only be needed in process of production and also helps in developing the delivering system. Managers are responsible of the condition of products after delivering if they want to increase the customer satisfaction. Therefore, they need to control the quality of the whole system, beginning from production and ending with delivering to customers. This is also a way to improve the reputation of company among users.

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