E | Becton Dickinson and Needle Sticks | During the 1990s, the AIDS epidemic posed peculiarly | acute dilemmas for health workers. After routinely remov- | ing an intravenous system, drawing blood, or delivering an | injection to an AIDS patient, nurses could easily stick "themselves with the needle they were using. “Rarely a day. || goes by in any large hospital where a needle stick incident | isnot reported.”! In fact, needlestck injuries accounted for about 80 percent of reported occupational exposures to the ‘AIDS virus among health care workers.” It was conserva~ | sively estimated in 1991 that about 64 health care workers, "were infected with the AIDS virus each year asa result of -needlestick injuries? AIDS was not the only risk posed by needlestick in- “juries. Hepatitis B, hepatitis C, and other lethal diseases “were also being contracted through accidental needle- ‘sticks. In 1990, the Center for Disease Control (CDC) CASES estimated that at Jeast 12,000 health care workers wee annually exposed to blood contaminated with the heptis B virus, and of these 250 died as a consequence. Becwe. the hepatitis C virus had been identified only in 198, = mates for infection rates of health care workers wee sil guesswork but were estimated by some observers tobe around 9,600 per year: In addition to AIDS, hepais and hepatitis C, needlestick injuries can aso transit = merous viral, bacterial, fungal, and parasitic infections as well as toxic drugs or other agents that are devel through a syringe and needle. The cost of al such irs was estimated at $400 million to $1 billion a yer Several agencies stepped in to set guidelines & nurses, including the Occupational Safety and Hs Administration (OSHA). On December 6, 1991, OSH required hospitals and other employers of health wos(afe needle containers pronbt the Prac of reving pees he ai ne hand a inering the mph an rove information and Sjectick prevention to employees. eens ofthese guidelines was disputed” Fee coc chen pred ora bon were i =e ple needs and demands ofthese patients. In Beis ernst [Sine commended the agencies. For example, etre of neeenils the ecigue of 3 needle (after it has been Beapon used) by hold- a eS one band and inserting che needle Kees jer hand. OSHA guidelines waned aginst Zrvotanded rechnique of recapping and recom- vend that the eap be placed on a surface and the [eee coehanded “searing” anes to replace “lowver, arses were time and, eae roping an exposed contaminated needle is [east ? dangerous, yet seeing no ready surface on which Sere penile cap, they Would recap the needle using | Peo hunded technique. Socal analysts suggested that the nurse’ work enei~ wot nade it unlikely that needlesticks would be pre- [Sor dvough mere guidelines. Dr. Janine Jaegger, ‘pero cedlestic injuries, argued that “trying to teach ‘ihcre workers to use a hazardous device safely isthe ‘smi of tying to teach someone how to drive a de- ‘Soesnomobile safely... Until now the focus has been ‘xr are worker, with finger wagging at mistakes sen oan on the hazardous product dein, : eda whole new array of devices in which safety is 8 “pl purt ofthe design.”® The Department of Labor ‘of Health and Human Services in a joint ges chat “engineering controls should be used tary method to reduce worker exposure to harm a of contracting life-threatening. diseases by son etles and syringes in health care settings had eytamened since the early 1980s ‘articles in /sgg-2ums in 1980 and 1981, for example, reported Magic °F “needle stick and puncture wounds eran Seren ares 198) in IN g risk of i jospital wor pind go tees and sharp ober Ailes mane ounding higherpicsher & larms 0 ase ot hepa, Band AIDS cases 160" sali, patter of all the needles and syringes used Dente workers Becton Seas seen ot “TMoshange the design ofits needles and #YT"8 Te THe Enincs oF Consune Conse Proouction Ate Mi SUCTION AND Mamerrns 298 dating the ea 1 ly eet 98 Ter + nw design wold me itesmenes bar cn eee, Peookng, and marking wontd nts bt would mean ofring 2 nex prod: tht smtioge. Ao Bc laa product, the standand Z rt Sathopalos who was an em Boeer tHe Dickson fw 1972 to 1986, the com y wanted “to minimize the expical outiay” om any device.!? During most of Sectors Racial of the 1980s, therefore, Becton Dickinson opted todo no more than ncade in cach box of ‘ilsindefe gen irotindd one ‘On December 23, 1986, the U.S. Patent office issved patent number 4,631,057 ro Norma Sampson, 3 nurse ne Carls B Mitchel an engines, fora syringe with 2 oe surrounding the body of the syringe that could be polled downto cover and protec the needle om the syringe. Ie ws Sampson and Mitchells assessment that their invention ‘was the most effective, easily usable, and easily manufac tured device capable of protecting user rom needles, pared in emergency penis ror om of stress’ syringe designs, theirs was shape ocuaine essnued grote deny oe with standard syringe design would have lide difficulty adapsing it. “The year after Sampson and Michell patented heir gringe, Beewon Dickinson purchase from them an exch~ ‘he lcense to manufacrare it. A few months later, Becton Dickinson began Beld tests of early model ofthe seine ting a 3-ce model. Nurses and hospital personnel weve Cnthasiasc when shown the product. However, they ‘Shived that if the company priced the pratt too highs hospital, with pressures on thir badges sing: cool not Dickinson had to decide Past with dhe proecie sleeves, Sleeves coukl be put oo Al ofthe major seinge sites nding U. Sx beuand i reve, the company decided t0 a 10sce singe Tome preci seers The BoC > oY accunted for about bal of ll eeinge ‘sed ab he rer tees od LOE TENTS rares when drawing blood feed ty a rd 186 wl remarked ae "Suk Lak Synge an 90k 6 nospitals ind doctors ffces FOE BETES SO an 78 e888 pecs and doen Dickson cate on Be ay a est A unit, Ar the Hime ae wee [es heed at wenn a TANTS Late abo the cost ot veanuicrari we sb “ Feo alg ‘each Saety- bok 9 ‘204 _ BUSINESS AND ITS EXTERNAL he pice a tinge and the “premium” price ofthe safety SF * mn for hospital buyers. To ‘gwitch to the new: safety Sringe would increase the hospital’ costs For ee syringes bby a factor of 3 to 7. An equally important innpediere lopron was he face thatthe spinge was aval E07 wearer ne, and ao, a one study suggested it had “im 2 eppcaons” Hospi are reuse to adopt, 2m ‘apt ta produc that snot availble forthe whole 08" ‘of applications the hospital must confront: In particular, Tootals often needed the larger Sce and 10-eedlesticks and needlestick infections. The Center for Disease Control (CDC estimated that each needlestick ‘which the worker was not infected by any disease cost + foil as mach as $2,000 for testing, treatment, count. ‘ing, medical costs, and lost ee plus epacge 5 ‘emotional trauma, anxiety, and abstention from sexs eel oe se eae ck the itm was infected by HIV, hepaits B ot Cor some ‘ther potenialy lethal infection, cost a hospital between 503000 09 more than $1 million and cost the vice 807 ny ics from dg therapy apse i oe etrcabies syringe completly eliminated ll of Wes ‘081, Because all of che other syringes then on t Hower lnkuding Becion Dickinson's Safety-Lok, stil lone ome needlesticks wo occur, they ‘could not completely all che cons associated with necdlesicks and #0 ere not as cost-effective, (A CDC study found (hat Becton Dickinson's Safety-Lak, when ested by hosel ‘THe Etwcs oF Consumer Prooucrion aNO MARKETING health workers in three cities from 1993 to 1995, had cut needle-stick injuries only from 4 per 100,000 injections down to 3.1 per 100,000 injections, a reduction of only 23 Percent, the worst performance of al the safety devices tested.) An econometric study commissioned by Re- tractable proved that its safety syringe was the most cost- cflecive syringe on the market In October 1999, ECRI, the nation’s most respected Jaboratory for testing medial products, rated Becton Dickinson's Safety-Lok syringe “unacceptable” asa safety syringe, saying it might actually cause an increase in needlesticks because it required two bands to use it and ‘one hand might accidently touch the needle. I simultane- ‘ously gave Reeractable’sVanishpoine syringe its highest rating sa safer syringe, the only safety syringe to achieve this highest level, Becton Dickinson objected strenvovsly to the low rating ofits own syringe, and in 2001, the test- ing lab raised the rating forthe Safety-Lok a notch to “not recommended.” Retractable’ Vanishpoint syringe, how- ever, continued o receive the highest rating. In spite of being recognized a the best and most cost-effective tech- nology for protecting health care workers from being in- fected through needlestick, Retractable stil found itself blocked out of the market by the long-term deals char Becton Dickinson had negoited with the major GPOs.!* T1999, California became the fist state to require its hospitals to provide safety syringes to its workers. Theo, in November S000, he Neclesack Safery and Prevention ‘Act was signed int lav. The at required the use of safety syringes in hospitals and doctor offices. In 2001, OSHA, incorporated the provisions of the Needlesck Safety and Prevention Act, nally requiring hospitals and employers tows salty syringes and significantly expanding the mar et for safety syringes, a developmen that is expected to tring lower prices. Noe ofthis eislaton required a spe cic ype or brand of syringe and Becton Dickinson's safety devices were stocked by most GPO member hospitals. Contining to find itself locked out of the market by Becton Dickinson’ contracts with Premier and Novation, Retractable sued Premier, Novation, and Becton Dickinson in federal cour alleging tha they violated antitrust laws and harmed consumers and numerous healthcare workers by using the GPO sytem to monopole the safety needle amatket!” In 2003, Premier and Novation setled with Retractable ou of our, agresing to henceforth allow ts tnember hospitals to purchase Retractable safety sytinges hen they wanted. In 2004, Becton Dickinson ao seed out of court, agrecing to pay Retractable $100 milion in compensation forthe damage Becton Dickinson inited ‘on Retractable, During the 6 years that Becton Dickinson contacts prevented Retractable and other manufacturers from selling thei safety needles to hospital ad clinics, thousands of health workers coatied to be infected by neaesticks each year. 295BUSINESS AND ITS EXTERNAL EXCHANGES: ECOLOGY AND CONSUMERS "1 Tn your jadgment, did Becton Dickinson have an obli- | gation to provide che safey syringe inal ts sizes in 41991? Explain your position, using the materials from this chapter and the principles of uitarianism, rights, justice, and caring. . 2, Should manufacrrers be held able fr fling to mar- eet all the products for which they hold exclusive patents when someone's injury would have been avoided if they had marketed those products? Explain your answer Tn your judgment, who was morally responsible for Maryann Rockwood’ accidental neelestick: Maryann | Rockwood? The clinic that employed her? The gov- crament agencies that merely issued guidelines? Becton Dickinson? “4. Evaluate the ethics of Becton Dickinson’ use of the GPO system in the late 1990s, Are the GPO’ monop- lies? Are they ethical? Explain. | 1. J-R Roberts, “Accidental Needle Stick,” EM & ACM, May 1987, pp. 6-7. 2. R.-Mareus, “Surveillance of Health Care Workers Exposed to ‘Blood from Patients Infected with the Homan Immunodef- ‘ciency Virus,” N. Eng 7. Med, October 1988, v. 319, n. 17, pp. 1118-23. 3. “Special Report and Product Review; Needle Stick-Prevention Devices?” Health Devices, May 1991, .20,n.§, p15, 4. Ibid 46, Kathy Sullivan and Diana Schnel, “Needleless Systems,” "usin, October 1994, pp. 17-19. (6, “Rules and Regulations,” Federal Regier, December 6, 1991 235, pp. ONT5-C4182, n 8 9. 10. nr 2 B. 4 1s. 16. 17. 18, 19 “Needle Stick Injuries Tied t0 Poor Des cine, December 1, 1987, Wid Quoted in Healt Devices, p. 154. J.S. Reed et al, "Needle Stick and Puncrare Wound Dg ition of the Problem,” Am. J. Infect. Contr, 1980, 101-106; R. D. McCormick et, “Epidemilony sp? Steck njesin Hospital Personne” An Ma mt pp. 928-932 J.T. Jacobson eta. “Injuries of Hospital Employes fem ‘Needles and Sharp Objects,” Infectious Contra, 1985 4 100-102; FL. Reuben et aly “Epidemiology of a Needle Puncture Wounds in Hospital Worker.” dna} ‘Med, Sei, 1983, v. 286, n.1, pp. 26-30; B. Kirkman-Lierd, “Hepatitis B—What Price Exposure?” Am 3. Nis, Aap 1984, pp. 988-990; S. H. Weiss etal, “HTLV-II lotion ‘Among Health Care Workers: Association with Needle Sit Injuries,” JAMA, 1985, v. 254, n. 15, pp, 2089-209, ‘Reynolds Holding and William Carlsen, “High Profs. What Cost? Company markets unsafe needles despite ered risks,” The San Francico Chronicle, Api 14,198, pA US. Patent 4,631,057, Mitchel. ‘In 1991, the device carried a published list price of 2 cas sce Health Devices, p. 170. Assuming an extremely coer tive 20 percent margin, this would imply a manufewrig cx of about 20 cents; assuming a margin similar tise syringes of $0 percent would imply « manufatuig ost about 12 cents. Health Devices, p. 170. Reynolds Holding and William Carlsen, “Watchdogs Hreath Workers: How safer needles were kept out of bo tal,” The San Francisco Chronicle, Apri 5, 1998, p41 Barry Meier and Mary. Williams Walsh, “Queso $1 Million Fee in a Needle Deal,” The New tort Ton) 1 crn 19, 2002, p. 1. Ibid. ‘Mark Smith, “Medical Innovations: Clash of Blo, No Patients Take Back Seat to Costs, Critics Say,” The He (Chronicle, April 18, 1999, p. 1.