The Politics of Product Safety: Top Management Team Political Ideology and Serious Medical Product Recalls

References

• Ahuja VA, Alvarez C, Birge JR, Syverson C (2021) Enhancing regulatory decision making for postmarket drug safety. Management Sci. 67(12):7493–7510.Link, Google Scholar
• Andrews I (2018) Valid two-step identification-robust confidence sets for GMM. Rev. Econom. Statist. 100(2):337–348.Crossref, Google Scholar
• Baginski SP, Conrad EJ, Hassell JM (1993) The effects of management forecast precision on equity pricing and on the assessment of earnings uncertainty. Accounting Rev. 68(4):913–927.Google Scholar
• Ball G, Shah R, Wowak KD (2018) Product competition, managerial discretion, and manufacturing recalls in the U.S. pharmaceutical industry. J. Oper. Management 58(1):59–72.Crossref, Google Scholar
• Ball G, Wowak KD, Mukherjee U (2022) Product Recall Research: Dimensions, Methods, and Regulator Implications, INFORMS TutORials in Operations Management (INFORMS, Catonsville, MD), 116–132.Google Scholar
• Ball GP, Bavafa H, Blanco C, Park H, Wowak KD (2024) Gender and serious drug recalls: A textual sentiment analysis of drug reviews on WebMD. Production Oper. Management 34(4):698–710.Crossref, Google Scholar
• Baum CF, Lewbel A (2019) Advice on using heteroskedasticity-based identification. Stata J. 19(4):757–767.Crossref, Google Scholar
• Beasley MS (1996) An empirical analysis of the relation between the board of director composition and financial statement fraud. Accounting Rev. 71(4):443–465.Google Scholar
• Beer R, Qi A (2024) To communicate or not? Interfirm communication in collaborative projects. Management Sci. 70(5):3225–3244.Link, Google Scholar
• Bermiss YS, McDonald R (2018) Ideological misfit? Political affiliation and employee departure in the private-equity industry. Acad. Management J. 61(6):2182–2209.Crossref, Google Scholar
• Boivie S, Bednar MK, Aguilera RV, Andrus JL (2016) Are boards designed to fail? The implausibility of effective board monitoring. Acad. Management Ann. 10(1):319–407.Crossref, Google Scholar
• Bonica A (2019) Are donation-based measures of ideology valid predictors of individual-level policy preferences? J. Politics 81(1):327–333.Crossref, Google Scholar
• Breusch TS, Pagan AR (1979) A simple test for heteroscedasticity and random coefficient variation. Econometrica 47(5):1287–1294.Crossref, Google Scholar
• Briscoe F, Joshi A (2017) Bringing the boss’s politics in: Supervisor political ideology and the gender gap in earnings. Acad. Management J. 60(4):1415–1441.Crossref, Google Scholar
• Briscoe F, Chin M, Hambrick DC (2014) CEO ideology as an element of the corporate opportunity structure for social activists. Acad. Management J. 57(6):1786–1809.Crossref, Google Scholar
• Bun MJ, Harrison TD (2019) OLS and IV estimation of regression models including endogenous interaction terms. Econometric Rev. 38(7):814–827.Crossref, Google Scholar
• Burton T (2014) Medical device recalls nearly doubled in a decade. Wall Street J. (March 21), https://www.wsj.com/articles/SB10001424052702304756104579452062734883356.Google Scholar
• Busenbark JR, Bundy J, Chin M (2023) Director departure following political ideology (in) congruence with an incoming CEO. Strategic Management J. 44(7):1698–1732.Crossref, Google Scholar
• Busenbark JR, Lange D, Certo ST (2017) Foreshadowing as impression management: Illuminating the path for security analysts. Strategic Management J. 38(12):2486–2507.Crossref, Google Scholar
• Cameron AC, Trivedi PK (2010) Microeconometrics Using Stata (Stata Press, College Station, TX).Google Scholar
• Campbell R, Busenbark JR, Graffin S, Boivie S (2021) Retaining problems or solutions? The post‐acquisition performance implications of director retention. Strategic Management J. 42(9):1716–1733.Crossref, Google Scholar
• Castellanos S (2021) Virtual reality puts drug researchers inside the molecules they study. Wall Street J. (September 7), https://www.wsj.com/articles/virtual-reality-puts-drug-researchers-inside-the-molecules-they-study-11631023212.Google Scholar
• Certo ST, Busenbark JR, Kalm M, LePine JA (2020) Divided we fall: How ratios undermine strategic management research. Organ. Res. Methods 23(2):211–237.Crossref, Google Scholar
• Chakravarty A, Saboo AR, Xiong G (2022) Marketing’s and operations’ roles in product recall prevention: Antecedents and consequences. Production Oper. Management 31(3):1174–1190.Crossref, Google Scholar
• Chao GH, Iravani SM, Savaskan RC (2009) Quality improvement incentives and product recall cost sharing contracts. Management Sci. 55(7):1122–1138.Link, Google Scholar
• Chen L (2015) The most profitable industries in 2015. Accessed April 29, 2024, https://www.forbes.com/sites/liyanchen/2015/09/23/the-most-profitable-industries-in-2015/?sh=1e596b5c6b73.Google Scholar
• Chin M, Semadeni M (2017) CEO political ideologies and pay egalitarianism within top management teams. Strategic Management J. 38(8):1608–1625.Crossref, Google Scholar
• Chin MK, Hambrick DC, Treviño LK (2013) Political ideologies of CEOs: The influence of executives’ values on corporate social responsibility. Admin. Sci. Quart. 58(2):197–232.Crossref, Google Scholar
• Chin M, Zhang SX, Jahanshahi AA, Nadkarni S (2021) Unpacking political ideology: CEO social and economic ideologies, strategic decision-making processes, and corporate entrepreneurship. Acad. Management J. 64(4):1213–1235.Crossref, Google Scholar
• Chow DYL, Petrou AP, Procopiou A (2022) Gender salience and recategorization of new directors: The role of political ideology. J. Management 49(8):2695–2726.Google Scholar
• Corr P, Williams D (2009) Conflict of Interest in Medical Research, Education, and Practice (National Academies Press, Washington, DC).Google Scholar
• Daily CM, Johnson JL, Ellstrand AE, Dalton DR (1998) Compensation committee composition as a determinant of CEO compensation. Acad. Management J. 41(2):209–220.Crossref, Google Scholar
• Darby JL, Ketchen DJ Jr, Ball G, Mukherjee U (2023) CEO stock ownership, recall timing, and stock market penalties. Manufacturing Service Oper. Management 25(5):1909–1930.Link, Google Scholar
• Davidson WN, Worrell DL (1992) Research notes and communications: The effect of product recall announcements on shareholder wealth. Strategic Management J. 13(6):467–473.Crossref, Google Scholar
• Department of Justice (2010) Medical device manufacturer Guidant charged in failure to report defibrillator safety problems to FDA. Accessed April 29, 2024, https://www.justice.gov/opa/pr/medical-device-manufacturer-guidant-charged-failure-report-defibrillator-safety-problems-fda.Google Scholar
• Department of Justice (2011) Medical device manufacturer Guidant sentenced for failure to report defibrillator safety problems to FDA. Accessed April 29, 2024, https://www.justice.gov/opa/pr/medical-device-manufacturer-guidant-sentenced-failure-report-defibrillator-safety-problems#:∼:text=Boston%20Scientific%20Subsidiary%20Sentenced%20to,District%20Court%20Judge%20Donovan%20W.Google Scholar
• Eilert M, Jayachandran S, Kalaignanam K, Swartz TA (2017) Does it pay to recall your product early? An empirical investigation in the automobile industry. J. Marketing 81(3):111–129.Crossref, Google Scholar
• FAERS (2024) FDA Adverse Events Reporting System (FAERS) public dashboard. Accessed April 29, 2024, https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis.Google Scholar
• FDA (2015) Expedited safety reporting requirements for human drug and biological products. Accessed April 29, 2024, https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/expedited-safety-reporting-requirements-human-drug-and-biological-products.Google Scholar
• FDA (2018a) Learn about drug and device approvals. Accessed April 29, 2024, https://www.fda.gov/patients/learn-about-drug-and-device-approvals.Google Scholar
• FDA (2018b) The device development process. Accessed April 29, 2024, https://www.fda.gov/patients/learn-about-drug-and-device-approvals/device-development-process.Google Scholar
• FDA (2018c) The drug development process. Accessed April 29, 2024, https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process.Google Scholar
• FDA (2019) Medical device safety. Accessed April 29, 2024, https://www.fda.gov/medical-devices/.Google Scholar
• FDA (2020a) Guidance document: Product recalls, including removals and corrections. Accessed April 29, 2024, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-recalls-including-removals-and-corrections.Google Scholar
• FDA (2020b) Product recalls, including removals and corrections. Guidance for industry. Accessed September 16, 2024, https://www.fda.gov/media/136987/download.Google Scholar
• FDA (2020c) Recalls, corrections and removals (devices). Accessed April 29, 2024, https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices.Google Scholar
• FDA (2022a) Drug recall. Accessed April 29, 2024, https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.Google Scholar
• FDA (2022b) Instructions for completing Form FDA 3500. Accessed April 29, 2024, https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500#Section%20B:%20Adverse%20Event%20or%20Product%20Problem.Google Scholar
• FDA (2022c) Safety. Accessed April 29, 2024, https://www.fda.gov/safety.Google Scholar
• FDA (2024a) About Manufacturer and User Facility Device Experience (MAUDE). Accessed April 29, 2024, https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude.Google Scholar
• FDA (2024b) Searchable fields. Accessed April 29, 2024, https://open.fda.gov/apis/drug/event/searchable-fields/.Google Scholar
• Greene WH (2018) Econometric Analysis, 8th ed. (Pearson, New York).Google Scholar
• Gupta A, Briscoe F (2020) Organizational political ideology and corporate openness to social activism. Admin. Sci. Quart. 65(2):524–563.Crossref, Google Scholar
• Gupta A, Wowak AJ (2017) The elephant (or donkey) in the boardroom: How board political ideology affects CEO pay. Admin. Sci. Quart. 62(1):1–30.Crossref, Google Scholar
• Gupta A, Briscoe F, Hambrick DC (2017) Red, blue, and purple firms: Organizational political ideology and corporate social responsibility. Strategic Management J. 38(5):1018–1040.Crossref, Google Scholar
• Gupta A, Briscoe F, Hambrick DC (2018) Evenhandedness in resource allocation: Its relationship with CEO ideology, organizational discretion, and firm performance. Acad. Management J. 61(5):1848–1868.Crossref, Google Scholar
• Gupta A, Nadkarni S, Mariam M (2019) Dispositional sources of managerial discretion: CEO ideology, CEO personality, and firm strategies. Admin. Sci. Quart. 64(4):855–893.Crossref, Google Scholar
• Gupta A, Wowak AJ, Boeker W (2022) Corporate directors as heterogeneous network pipes: How director political ideology affects the interorganizational diffusion of governance practices. Strategic Management J. 43(8):1469–1498.Crossref, Google Scholar
• Hambrick DC, Fukutomi GD (1991) The seasons of a CEO’s tenure. Acad. Management Rev. 16(4):719–742.Crossref, Google Scholar
• Hasan MM, Taylor G, Richardson G (2022) Brand capital and stock price crash risk. Management Sci. 68(10):7221–7247.Link, Google Scholar
• Haunschild PR, Rhee M (2004) The role of volition in organizational learning: The case of automotive product recalls. Management Sci. 50(11):1545–1560.Link, Google Scholar
• Herwartz H, Theilen B (2014) Health care and ideology: A reconsideration of political determinants of public healthcare funding in the OECD. Health Econom. 23(2):225–240.Crossref, Google Scholar
• Hora M, Bapuji H, Roth AV (2011) Safety hazard and time to recall: The role of recall strategy, product defect type, and supply chain player in the U.S. toy industry. J. Oper. Management 29(7):766–777.Crossref, Google Scholar
• Jarrell G, Peltzman S (1985) The impact of product recalls on the wealth of sellers. J. Polit. Econom. 93(3):512–536.Crossref, Google Scholar
• JFKLibrary (2022) John F. Kennedy quotations. Accessed April 29, 2024, https://www.jfklibrary.org/learn/about-jfk/life-of-john-f-kennedy/john-f-kennedy-quotations.Google Scholar
• Johnson AF, Roberto KJ (2018) Right versus left: How does political ideology affect the workplace? J. Organ. Behav. 39(8):1040–1043.Crossref, Google Scholar
• Josefy M, Kuban S, Ireland RD, Hitt MA (2015) All things great and small: Organizational size, boundaries of the firm, and a changing environment. Acad. Management Ann. 9(1):715–802.Crossref, Google Scholar
• Jost JT (2006) The end of the end of ideology. Amer. Psych. 61(7):651.Crossref, Google Scholar
• Jost JT, Andrews R (2011) System justification theory. Encyclopedia of Peace Psychology (Wiley-Blackwell, Hoboken, NJ).Crossref, Google Scholar
• Jost JT, Glaser J, Kruglanski AW, Sulloway FJ (2003) Political conservatism as motivated social cognition. Psych. Bull. 129(3):339–375.Crossref, Google Scholar
• Jost JT, Napier JL, Thorisdottir H, Gosling SD, Palfai TP, Ostafin B (2007) Are needs to manage uncertainty and threat associated with political conservatism or ideological extremity? Personality Soc. Psych. Bull. 33(7):989–1007.Crossref, Google Scholar
• Jun M, Cai S, Shin H (2006) TQM practice in maquiladora: Antecedents of employee satisfaction and loyalty. J. Oper. Management 24(6):791–812.Crossref, Google Scholar
• Keller A (2022) Drugs & devices. Accessed April 29, 2024, https://www.consumernotice.org/drugs-and-devices/.Google Scholar
• Kennedy P (2008) A Guide to Econometrics, 2nd ed. (Blackwell, Oxford, UK).Google Scholar
• Keown A (2020) Pharma more profitable than other large industries, study shows. Accessed April 29, 2024, https://www.biospace.com/article/how-profitable-is-the-pharma-industry-a-new-report-shows-the-industry-is-more-profitable-than-most-other-large-companies/.Google Scholar
• Kim JH, Siegel JI (2024) Paying for legitimacy: Autocracy, nonmarket strategy, and the liability of foreignness. Admin. Sci. Quart. 69(1):131–171.Crossref, Google Scholar
• Kolbert E (2021) How politics got so polarized. New Yorker (December 27), https://www.newyorker.com/magazine/2022/01/03/how-politics-got-so-polarized.Google Scholar
• Lansdowne LE (2020) Exploring the drug development process. Accessed April 29, 2024, https://www.technologynetworks.com/drug-discovery/articles/exploring-the-drug-development-process-331894.Google Scholar
• Lemieux P (2021) The problem with politicizing corporations. Accessed April 29, 2024, https://www.cato.org/regulation/summer-2021/problem-politicizing-corporations#.Google Scholar
• Lewbel A (2012) Using heteroscedasticity to identify and estimate mismeasured and endogenous regressor models. J. Bus. Econom. Statist. 30(1):67–80.Crossref, Google Scholar
• Lewbel A (2018) Identification and estimation using heteroscedasticity without instruments: The binary endogenous regressor case. Econom. Lett. 165:10–12.Crossref, Google Scholar
• Lichtenberg FR, Philipson TJ (2002) The dual effects of intellectual property regulations: Within-and between-patent competition in the U.S. pharmaceuticals industry. J. Law Econom. 45(S2):643–672.Crossref, Google Scholar
• Lim JM, Song H, Yang JJ (2024) The spillover effects of capacity pooling in hospitals. Management Sci. 70(11):7692–7711.Link, Google Scholar
• Marešová P, Klímová B, Honegr J, Kuča K, Ibrahim WNH, Selamat A (2020) Medical device development process, and associated risks and legislative aspects-systematic review. Front. Public Health 8:308.Crossref, Google Scholar
• Martins AM, Pires CP (2023) Do CEO characteristics matter in product recalls? Internat. J. Econom. Bus. 30(3):207–232.Crossref, Google Scholar
• Mayo K, Ball G, Mills A (2022) CEO tenure and recall risk management in the consumer products industry. Production Oper. Management 31(2):743–763.Crossref, Google Scholar
• Meyer AG (2017) The impact of education on political ideology: Evidence from European compulsory education reforms. Econom. Ed. Rev. 56:9–23.Crossref, Google Scholar
• Morey AC, Eveland WP Jr, Hutchens MJ (2012) The “who” matters: Types of interpersonal relationships and avoidance of political disagreement. Polit. Commun. 29(1):86–103.Crossref, Google Scholar
• Mukherjee UK, Sinha KK (2018) Product recall decisions in medical device supply chains: A big data analytic approach to evaluating judgment bias. Production Oper. Management 27(10):1816–1833.Crossref, Google Scholar
• Papke LE, Wooldridge JM (1996) Econometric methods for fractional response variables with an application to 401(k) plan participation rates. J. Appl. Econom. 11(6):619–632.Crossref, Google Scholar
• Park UD, Boeker W, Gomulya D (2020) Political ideology of the board and CEO dismissal following financial misconduct. Strategic Management J. 41(1):108–123.Crossref, Google Scholar
• Pearson K (1896) Mathematical contributions to the theory of evolution: On a form of spurious correlation which may arise when indices are used in the measurement of organs. Proc. Roy. Soc. London 60(359–367):489–498.Crossref, Google Scholar
• Quigley TJ, Graffin SD (2017) Reaffirming the CEO effect is significant and much larger than chance: A comment on Fitza (2014). Strategic Management J. 38(3):793–801.Crossref, Google Scholar
• Reis LAMd (2020) Political ideology and overconfidence in decision-making. Doctoral dissertation, Universidade Católica Portuguesa, Lisbon, Portugal.Google Scholar
• Rhee M, Haunschild PR (2006) The liability of good reputation: A study of product recalls in the U.S. automobile industry. Organ. Sci. 17(1):101–117.Link, Google Scholar
• Ridge JW, Aime F, White MA (2015) When much more of a difference makes a difference: Social comparison and tournaments in the CEO’s top team. Strategic Management J. 36(4):618–636.Crossref, Google Scholar
• Saad L (2021) Americans’ political ideology held steady in 2020. Accessed April 29, 2024, https://news.gallup.com/poll/328367/americans-political-ideology-held-steady-2020.aspx.Google Scholar
• Schulz AC, Wiersema MF (2018) The impact of earnings expectations on corporate downsizing. Strategic Management J. 39(10):2691–2702.Crossref, Google Scholar
• Schwartz A (2019) Rose-and blue-colored glasses: Childhood exposure to political ideology and CEO overconfidence. Preprint, submitted February 5, https://dx.doi.org/10.2139/ssrn.3313622.Google Scholar
• Semadeni M, Withers MC, Trevis Certo S (2014) The perils of endogeneity and instrumental variables in strategy research: Understanding through simulations. Strategic Management J. 35(7):1070–1079.Crossref, Google Scholar
• Shah R, Ball G, Netessine S (2017) Plant operations and product recalls in the automotive industry: An empirical investigation. Management Sci. 63(8):2439–2459.Link, Google Scholar
• Sonawane KB, Cheng N, Hansen RA (2018) Serious adverse drug events reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 database. J. Managed Care Specialty Pharmacy 24(7):682–690.Crossref, Google Scholar
• Stock JH, Wright JH, Yogo M (2002) A survey of weak instruments and weak identification in generalized method of moments. J. Bus. Econom. Statist. 20(4):518–529.Crossref, Google Scholar
• Swigart KL, Anantharaman A, Williamson JA, Grandey AA (2020) Working while liberal/conservative: A review of political ideology in organizations. J. Management 46(6):1063–1091.Crossref, Google Scholar
• Thirumalai S, Sinha KK (2011) Product recalls in the medical device industry: An empirical exploration of the sources and financial consequences. Management Sci. 57(2):376–392.Link, Google Scholar
• Trievr (2020) Why product recalls cost medical device manufacturers $5,000,000 a day. Accessed April 29, 2024, https://trievrrecallmanagement.com/why-product-recalls-cost-medical-device-manufacturers-5000000-a-day/.Google Scholar
• Villadsen AR, Wulff JN (2021) Are you 110% sure? Modeling of fractions and proportions in strategy and management research. Strategic Organ. 19(2):312–337.Crossref, Google Scholar
• Wall Street Journal (2020) How politics has pulled the country in different directions. Wall Street J. (November 10), https://www.wsj.com/graphics/polarized-presidential-elections/.Google Scholar
• Wall Street Journal (2021) CEOs vs. shareholders. Wall Street J. (April 6), https://www.wsj.com/articles/ceos-vs-shareholders-11617748454.Google Scholar
• Wang X, Jiang M, Han W, Qiu L (2022) Do emotions sell? The impact of emotional expressions on sales in the space‐sharing economy. Production Oper. Management 31(1):65–82.Crossref, Google Scholar
• Wooldridge JM (2011) Fractional response models with endogeneous explanatory variables and heterogeneity. Stata Conf. (Stata Users Group, College Station, TX).Google Scholar
• Wowak AJ, Busenbark JR, Hambrick DC (2022) How do employees react when their CEO speaks out? Intra- and extra-firm implications of CEO sociopolitical activism. Admin. Sci. Quart. 67(2):553–593.Crossref, Google Scholar
• Wowak AJ, Mannor MJ, Wowak KD (2015) Throwing caution to the wind: The effect of CEO stock option pay on the incidence of product safety problems. Strategic Management J. 36(7):1082–1092.Crossref, Google Scholar
• Wowak KD, Ball G, Post C, Ketchen DJJ (2021) The influence of female directors on product recall decisions. Manufacturing Service Oper. Management 23(4):895–913.Link, Google Scholar