Becton Dickinson and Needle Sticks
Case – 4
Becton Dickinson and Needle Sticks
During the 1990s, the AIDS epidemic posed peculiarly acute dilemmas for health workers. After routinely removing 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 is not reported. “ In fact, needlestick injuries accounted for about 80 percent of reported occupational exposure to the AIDS virus among health care workers.2 It was conservatively estimated in 1991 that about 64 health care workers were infected with the AIDS virus each year as a result of needlestick injuries.3
AIDS was not the only risk posed by needlestick injuries. Hepatitis C, and other lethal diseases were also being contracted through accidental needle sticks. In 1990, the Center for Disease Control (CDC) estimated that at least 12,000 health care workers were annually exposed to blood contaminated with the hepatitis B virus, and of these 250 died as a consequence.4 Because the hepatitis C virus had been identified only in 1988, estimates for infection rates of health care workers were still guesswork but were estimated by some observers to be around 9,600 per year. In addition to AIDS hepatitis B, and hepatitis C, needlestick injuries can also transmit numerous viral, bacterial, fungal, and parasitic infection, as well as toxic drugs or other agents that are delivered through a syringe and needle. The cost of all such injuries was estimated at $400 million to $1 billion a year.5
Several agencies stepped in to set guidelines for nurses, including the Occupational Safety and Health Administration (OSHA). On December 6, 1991, OSHA required hospitals and other employers of health workers to (a) make sharps containers (safe needle containers) available to workers, (b) prohibit the practice of recapping needle by holding the cap in one hand inserting the needle with the other, and (c) provide information and training on needlestick prevention and training on needlestick prevention to employees.6
The usefulness of these guidelines was disputed.7 Nurses worked in high-stress emergency situations requiring quick action, and they were often pressed for time both because of the large number of patients they cared for and the highly variable needs and demands of these patients. In such workplace environments, it was difficult to adhere to the guidelines recommended by the agencies. For example, a high-risk source of needle sticks is the technique of replacing the cap on a needle (after it has been used) by holding the cap in one hand and inserting the needle into the cap with the other hand. OSHA guidelines warned against this tow-handed technique of recapping and recommended instead that the cap be placed on a surface and the nurse use a one-handed “spearing” technique to replace the cap. However, nurses were often pressed for time and, knowing that carrying an exposed contaminated needle is extremely dangerous, yet seeing no ready surface on which to place the needle cap, they would recap the needle using the two-handed technique.
Several analysts suggested that the nurse’s work environment made it unlikely that needle sticks would be prevented through mere guidelines. Dr. Janine Jaegger, an expert on needlestick injuries, argued that “trying to teach health care workers to use a hazardous device safely is the equivalent of trying to teach someone how to drive a defective automobile safely…. Until now the focus has been on the health care worker, with finger wagging at mistakes, rather than focusing on the hazardous product design…. We need a whole new array of devices in which safety is an integral part of the design.”8 The Department of Labor and Department of Health and Human Services in a joint advisory agreed that “engineering controls should be used as the primary method to reduce worker exposure to harmful substances.”9
The risk of contracting life-threatening diseases by the use of needles and syringes in health care setting had been well documented since the early 1980s. articles in medical journals in 1980 and 1981, for example, reported on the “problem” of “needle stick and puncture wounds” among health care workers.10 Several articles in 1983 reported on the growing risk of injuries hospital workers were sustaining from needles and sharp objects.11 Articles in 1984 and 1985 were sounding higher-pitched alarms on the growing number of hepatitis Band AIDS cases resulting from needle sticks.
About 70 percent of all the needles and syringes used by U.S. health care workers were manufactured by Becton Dickinson. Despite the emerging crisis, Becton Dickinson decided not to change the design of its needles and syringes during the early 1980s. To offer a new design would not only require major engineering, retooling, and marketing investments but would mean offering a new product that would compete with its flagship product, the standard syringe. According to Robert Stathopulos, who was an engineer at Becton Dickinson from 1972 to 1986, the company wanted “to minimize the capital outlay” on any new device.12 During most of the 1980s, therefore, Becton Dickinson opted to do no more than include in each box of needles syringes an insert warning of the danger of needle sticks and of the dangers of two-handed recapping.
On December 23, 1986, the U.S. Patent office issued patent number 4,631,057 to Norma Sampson, a nurse, and Charles B. Mitchell, an engineer, for a syringe with a tube surrounding the body of the syringe that could be pulled down to cover and protect the needle on the syringe. It was Sampson and Mitchell’s assessment that their invention was the most effective, easily usable, and easily manufactured device capable of protecting users from needle sticks, particularly in “emergency periods or other time of high stress”13 Unlike other syringe designs, theirs was shaped and sized like a standard syringe so nurses already familiar with standard syringe designs would have little difficulty adapting to it.
The year after Sampson and Mitchell patented their syringe, Becton Dickinson purchased from them an exclusive license to manufacture it. A few months later, Becton Dickinson began filed tests of earl models of the syringe using a 3-cc model. Nurses and hospital personnel were enthusiastic when show the product. However they warned that if the company priced the product too high, hospital, with pressures on their budgets rising, could not buy the safety. With concerns about AIDS rising, the company decided to market the product.
In 1988, with the filed test completed, Becton Dickinson had to decide which syringe would be market with the protective sleeves. Sleeves could be put on all of the major syringe sizes, including 1-cc, 3-cc, 5-cc, and 10-cc syringes. However, the company decided to market only a 3-cc version of the protective sleeve. The 3-cc syringes accounted for about half of all syringes used, although the larger size-5-cc and 10-cc syringes-were preferred by nurses when drawing blood.
This 3-cc syringe was marketed in 1988 under the trademarked name Safety-Lok Syringe and sold to hospitals and doctors’ offices for between 50 and 75 cent, a price that Becton Dickinson characterized as a “premium” price. By 1991, the company had dropped the price to 26 cents a unit. At the time, a regular syringe without any protective device was priced at 8 cents a unit and cost 4 cents to make. Information about the cost of manufacturing the new safety syringe was proprietary, but an educated estimate would put the costs of manufacturing each Safety-Lok syringe in 1991 at 13 to 20 cents. 14
The difference between the price of a standard syringe and the “premium” price of the safety syringe was an obstacle for hospital buyers. To switch to the new safety syringe would increase the hospital’s costs for 3-cc syringes by a factor of 3to 7. An equally important impediment to adoption was the fact that the syringe was available in only one 3-cc size, and so, as one study suggested, it had “limited applications.”15 Hospitals are reluctant to adopt, and adapt to, a product that is not available for the whole range of applications the hospital must confront. In particular, hospitals often needed the larger 5-cc and 10-cc sizes to draw blood, and Becton Dickinson had not made these available with a sleeve.
In 1992, a nurse, Maryann Rockwood (her name is disguised to protect her privacy), was working in a San Diego, California, clinic that served AIDS patients. That day she used a Becton Dickinson standard 5-cc syringe and needle to draw blood from a patient known to be infected with AIDS. After drawing the blood, she transferred the AIDS-contaminated blood to a sterile test tube called a Vacutainer tub by sticking the through the rubber stopper of the test tube, which she was holding with her other hand. She accidently pricked her finger with the contaminated needle. A short time later, she was diagnosed as HIV positive.
Maryann Rockwood sued Becton Dickinson, alleging that, because it alone had an exclusive right to Sampson and Mitchell’s patented design, the company had a duty to provide the safety syringe in all size and that by withholding other size from the market it had contributed to her injury. Another contributing factor, she claimed, was the premium price Becton Dickinson had put on its product, which prevented employers like hers from purchasing even those size that Becton Dickinson did make. Becton Dickinson quietly settled this and several other, similar cases out of court for undisclosed sums.
By 1992, OSHA had finally required that hospitals and clinics give their workers free hepatitis B vaccines and provide safe needle disposal boxes, protective clothing, gloves, and masks. The Food and Drug Administration (FDA) also was considering requiring that employers phase in the use of safety needles to prevent needle sticks, such as the new self-sheathing syringes that Becton Dickinson was now providing. If the FDA or OSHA required safety syringes and needles, however, this would hurt the U.S. market for Becton Dickinson’s standard syringes and needles, forcing in to invest heavily in new manufacturing equipment and a new technology. Becton Dickinson, therefore, sent its marketing director, Gary Cohen, and two other top executives to Washington, D.C., to convey privately to government officials that the company strongly opposed a safety needle requirement and that the matter should be left to “the market.” The FDA subsequently decided not to require hospitals to buy safety needles.16
The following year, a major competitor of Becton Dickinson announced that it was planning to market a safety syringe based on a new patent that was remarkably like Becton Dickinson’s. Unlike Becton Dickinson, however, the competitor indicated that it would market its safety device in all sizes and that it would be priced well below what Becton Dickinson had been charging. Shortly after the announcement, Becton Dickinson declared that it, too, had decided to provide its Safety-Lok syringe in the full range of common syringe sizes. Becton Dickinson now proclaimed itself the “leader” in the safety syringe market.
However, in 1994, the most trusted evaluator of medical devices, a nonprofit group named ECIR, issued a report stating that after testing it had determined that although Becton Dickinson’s safety-Lok syringe was safe that Becton Dickinson’s own standard syringe, nevertheless the safety-Lok “offers poor needle sticks protection.” The following year this low evaluation of the safety –Lok syringe was reinforced by the U.S. veteran’s Administration, which ranked the Safety – Lok Syringe below the safety products of other manufacturers.
The technology for safety needles took a giant step forward in 1998 when Retractable Technologies, Inc., unveiled a new safety syringe that rendered needle sticks a virtual impossibility. The new safety, invented by Thomas Shaw, a passionate engineer and founder of Retractable Technologies, featured a syringe with a needle attached to an internal spring that automatically pulled the needle into the barrel of the syringe after it was used. When the plunger of the syringe was pushed all the way in, the needle snapped back into the syringe faster then the eye could see. Called the vanishpoint syringe, the new safety syringe required only one hand to operate and was acclaimed by nursing groups and doctors. Unfortunately, it was difficult for Retractable to sell its new automatic syringe because of a new phenomenon that hand emerged in the medical industry.
During the 1990s, hospitals and clinics had attempted to cut costs by reorganizing themselves around a few large distributors called Group Purchasing Organizations or GPOs. A GPO is an agent that negotiates prices for medical supplies on behalf of its member hospitals. Hospitals became members of the GPO by agreeing to buy 85 percent to 95 percent of their medical supplies from the manufacturers designated by the GPO, and their pooled buying power then enabled the GPO to negotiate lower prices for them. The two largest GPOs were Premier, a GPO with 1,700 member hospitals, and Novation, a GPO with 650 member hospitals. GPOs were accused, however, of being prey to “conflicts of interest” because they were paid not by the hospitals for whom they worked, but by the manufacturers with whom they negotiated prices (the GPO received from each manufacturer a negotiated percentage of the total purchases its member companies made from that manufacturer). Critics claimed that manufacturers of medical products in effect were paying off GPOs to get access to the GPO member hospitals. In fact, critics alleged, GPOs such as Premier and Novation no longer tried to bring their member hospitals the best medical products nor the lowest-priced products. Instead, critics alleged, GPOs chose manufacturers for their members based on how much a manufacturer was willing to pay the GPO. The more money (the higher percentage of sales) a manufacturer gave the GPO, the more willing the GPO was to put that manufacturer on the list of manufacturers from which its member hospitals had to buy their medical supplies. 17
When Retractable tried to sell its new syringe, which was recognized as the best safety syringe on the market and as the only safety syringe capable of completely eliminating all needle sticks in a nursing environment, it found itself blocked from doing so. In 1996, Becton Dickinson had gotten Premier GPO to sign an exclusive, 7 ½-years, $1.8 billion deal that required Premier’s member hospitals to buy at least 90 percent of their syringes and needles from Becton Dickinson. Around the same time, Becton Dickinson had signed a similar deal with Novation that required its member hospitals to buy at least 95 percent of their syringes and needles from Becton Dickinson. Because hospitals were now locked into buying their syringes and needles from Becton Dickinson, or suffer substantial financial penalties, they turned away Retractable’s salespeople, even when their own nursing recommended Retractable’s safety product better as and more cost-effective than Becton Dickinson’s.
Although Retractable’s safety syringe was almost double the cost of Becton Dickinson’s, hospitals that adopted Retractable’s syringe would save money over the long run because they would not have to pay any of the substantial costs associated with having their workers suffer frequent needle sticks and needlestick infections. The Center for Disease Control (CDC) estimated that each needlestick in which the worker was not infected by any disease cost a hospital as much as $2,000 for testing, treatment, counseling, medical costs, and lost wages, plus unmeasurable emotional trauma, anxiety, and abstention from sexual intercourse for up to a year. Those needle sticks in which the victim was infected by HIV, hepatitis B or C, or some other, potentially lethal infection, cost a hospital between $500,000 to more than $1 million and cost the victim anxiety, sickness from drug therapy, and, potentially, life itself. Retractable’s syringe completely eliminated all of these costs. Because all of the other syringes then on the market, including Becton Dickinson’s Safety-Lok, still allowed some needle sticks to occur, they could not completely eliminate all the costs associated with needle sticks and so were not as cost-effective. (A CDC study found that Becton Dickinson’s Safety-Lok, when tested by hospital 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 all the safety devices tested.) An econometric study commissioned by Retractable proved that its safety syringe was the most cost effective syringe on the market.
In October 1999, ECRI, the nation’s most respected laboratory for testing medical products, rated Becton Dickinson’s Safety-Lok syringe “unacceptable” as a safety syringe, saying it might actually cause an increase in needle sticks because it required two hands to use it and one hand might accidentally touch the needle. It simultaneously gave Retractable’s Vanishpoint syringe its highest rating as a safety syringe, the only safety syringe to achieve this highest level. Becton Dickinson objected strenuously to the low rating of its own syringe, and in 2001, the testing lab raised the rating for the safety-Lok a notch to “not recommended.” Retractable’s Vanishpoint syringe, however, continued to receive the highest rating. In spite of being recognized as the best and most cost-effective technology for protecting health care workers from being infacted through needle sticks, Retractable still found itself blocked out of the market by the long-term deals that Becton Dickinson had negotiated with the major GPOs.18
In1999, California became the first state to require its hospitals to provide safety syringes to its workers. Then, in November 2000, the Needlestick safety and Prevention Act was signed into low. The act required the use of safety syringes in hospitals and doctor’s offices. In 2001, OSHA incorporated the provisions of the Needlestick Safety and Prevention Act, finally requiring hospitals and employers to use safety syringes and significantly expanding the market for safety syringes, a development that is expected to bring lower prices. None of this legislation required a specific type or brand of syringe and Becton Dickinson’s safety devices were stocked by most GPO member hospitals.
Continuing to find itself locked out of the market by Becton Dickinson’s contracts with Premier and Novation, Retractable sued Premier, Novation and Becton Dickinson in federal court alleging that they violated antitrust laws and harmed consumers and numerous health care workers by using the GPO system to monopolize the safety needle market.19 In 2003, Premier and Novation settled with Retractable out of court, agreeing to henceforth allow its member hospitals to purchase Retractable’s safety syringes when they wanted. In 2004, Becton Dickinson also settled out of court, agreeing to pay Retractable $ 100 million in compensation for the damage Becton Dickinson inflicted on Retractable. During the 6 years that Becton Dickinson’s contracts prevented Retractable and other manufacturers from selling their safety needles to hospitals and clinics, thousands of health workers continued to be infected by needlesticks each year.
Questions
- In your judgment, did Becton Dickinson have an obligation to provide the safety syringe in all its sizes in 1991? Explain your position, using the materials from this chapter and the principles of utilitarianism, rights, justice, and caring.
- Should manufacturers be held liable for failing to market 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.
- In your judgment who was morally responsible for Maryann Rockwood’s accidental needlestick: Maryann Rockwood? The clinic that employed her? The government agencies that merely issued guidelines? Becton Dickinson?
- Evaluate the ethics of Becton Dickinson’s use of the GPO system in the late 1990s. Are the GPO’s monopolies? Are they ethical? Explain.
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