Secrets behind the mask
[ Clarification: An article in the August 9 issue of U.S. News, "Secrets Behind the Mask," examined the performance record of a disposable respirator mask manufactured by 3M Co. A subsequent review of the article by the editors of the magazine, requested by 3M, disclosed several significant shortcomings and inaccuracies.
U.S. News referred to a test performed by 3M to measure the fit of the 8710 mask, a key element in determining its effectiveness. The article stated that "the results shattered 3M's claim that one size fits all, as fully a third of the subjects failed to get a good fit," and that the test yielded erroneous results, "telling workers the mask was fitting properly, when in reality, it wasn't." Those conclusions were based on a faulty reading of significant tests of the mask's fit. The report of the test results in question concluded that "it is possible to get false rejection of good fit, but no false acceptance of poor fit was experienced." The magazine failed to characterize those results properly.
With regard to lawsuits filed by plaintiffs against 3M seeking damages as a result of alleged malperformance of the 8710 mask, the article failed to offer a fully balanced presentation of the issues raised by the cases. The article should have noted 3M's assertion that many claimants did not wear the 3M mask exclusively and used masks from other companies as well and, in some cases, worked in hazardous environments with no mask protection at all. As a result, the possibility that some plaintiffs were subjected to "unprotected exposure" to hazardous workplace atmospheres, and became vulnerable to contamination, should have been seriously considered. Upon review, U.S. News is unaware of any clear evidence of causal connection between any particular person's injuries and a failure of a 3M mask. In litigation, of the seven cases brought to trial by plaintiffs alleging deficiencies in the performance of the 8710 mask, juries found in favor of 3M in six; the seventh is on appeal by 3M. In light of these facts, the article's subhead--"How a promising device designed to protect workers left many fighting for their lives" --was insupportable and unfair.
U.S. News stated that 3M "failed to meet government standards" for the 8710 respirator mask. Upon review, we believe this statement was misleading without additional information and context. 3M did meet government standards in securing its initial approval of the 8710 mask, in 1972, and maintained its certification by the government the entire time the mask was on the market. The federal government changed the procedures used to test respirator masks in 1974. 3M's 8710 mask (and other dust respirators then on the market, according to 3M) was unable to pass the new test because of the procedural changes. Regulators were aware of this and affirmatively extended the government certification of 3M's product thereafter. While 3M's 8710 mask did not pass the government's revised performance test for some period, it was inappropriate to say, without further clarification, that the 8710 mask "failed to meet government standards."
The article reported that 3M did not test the 8710 mask for all anticipated uses prior to marketing the device. This is true, but the article should have noted that 3M conducted numerous tests in the lab and in actual workplaces and also used a surrogate approved by regulators for testing respirator masks. According to 3M, the results indicated that the masks provided the "protection factor" established by the Occupational Safety and Health Administration, the government agency that regulates workplace safety.
The article referenced a Washington, D.C., federal appeals court opinion concerning the 8710 mask. The court did not "legally establish" that there was a defect in the mask. It affirmed OSHA's ability to regulate the use of disposable masks made by 3M and others in certain work environments.
U.S. News cited four individuals in the article who criticized the performance of the 8710 mask, but the magazine neglected to identify those individuals as having served as paid advisers to plaintiffs' counsel in litigation against 3M. Lastly, the article stated that "those who advise companies and their workers on respiratory protection say there is little doubt that users have died or suffered crippling lung disease because they depended on the 3M mask, known as the 8710." The statement should have said only that "some" hold that belief and should have identified any affiliations with plaintiffs' counsel.
"Secrets Behind the Mask" failed to meet U.S. News's acknowledged high standards of journalistic fairness and balance. Throughout its long history, U.S. News has enjoyed a reputation for honoring both qualities. That we failed to do so in this case is a cause of deep regret. - The Editors ]
[Clarification published 9/20/04] 20040920046046
Back in the 1970s, Larry Turley joined a revolution. The coal miner in Union County, Ky., switched from using a heavy, uncomfortable respirator mask to a soft, paper-like model that weighed just a quarter of an ounce. The new mask was hailed as a magic bullet, making unpleasant jobs more bearable and encouraging miners and workers in many other industries to wear their protection.
Turley certainly needed the mask. The dust that swirled through the mines was often so thick it turned the air black. But his new mask, hailed as a savior, failed him, Turley says: It didn't filter out the dust. Today, he has been diagnosed with the scourge of Kentucky coal country--black lung disease. He hasn't worked in six years, struggles to get by on Social Security disability payments, and says everyday tasks like walking or washing a car leave him short of breath. Time is not his friend. "With all the things that's wrong with me," says Turley, who has lived virtually all his life in western Kentucky, "I just thank the Lord every day I wake up. I'm just broke down. I'm 60; I feel like I'm 80."
As Turley's case suggests, the respirator mask that was to have revolutionized American industry in the '70s has today become a public-health calamity, and the dimensions of the problem are only now becoming apparent. The 3M Co., which produces everything from Post-it notes to Scotch tape, is one of America's best-known and most admired firms. Yet it also manufactured the mask that Larry Turley and hundreds of thousands of other American workers relied on to keep them safe. In a four-month investigation, U.S. News found serious problems with the safety and reliability of the company's mask, plus inadequate oversight by accommodating federal regulators. The inquiry is based on interviews, company documents, court depositions, government records, and an exhaustive examination of worker-safety standards.
The oversight lapses are striking. "These respirators are dangerous," wrote William Gribble, an inspector for the U.S. Occupational Safety and Health Administration, in a memo two decades ago. "The employee is lulled into a false sense of security. . . . many times, I have examined these respirators during and after employees have worn [them], to find nearly as much visible contaminant inside the mask as on the surface outside."
3M, which promoted its mask for a wide range of dangerous jobs, has not been found liable for the death or injury of a specific worker. But regulators and a federal appeals court have ruled that the mask could not be tested for fit--meaning that it could not be used safely. Only a handful of cases have made it to trial, as the company has settled thousands of claims at a cost that appears to reach hundreds of millions of dollars. New health claims--including a precedent-setting lawsuit by the state of West Virginia--are piling up by the tens of thousands. Those who advise companies and their workers on respiratory protection say there is little doubt that users have died or suffered crippling lung disease because they depended on the 3M mask, known as the 8710. And the toll will continue to grow, they say, because lung disease can develop years after exposure. "There is harm done," says John Hale, a former independent respirator consultant, "to untold numbers of people."
3M introduced the 8710 in 1972, and despite not having been tested for many expected uses, records and interviews show, company officials promoted it for use in conditions they did not fully comprehend. 3M also failed to tell users that the respirator did not meet government standards, or that it had other problems that could allow contaminants to harm workers, according to 3M documents and legal records.
3M said the 8710 offered workers absolute protection. It relied on shaky research in asserting the product's safety, according to the appeals court and OSHA. Despite specific government approval standards, 3M largely followed its own rules as it sought to develop the 8710 business, court records show. "This was their on-ramp," says Mike Martin, a Houston attorney who represents users of the 3M respirator. "If the 8710 was derailed, it would have undermined their entire market."
That's where lax oversight came into play. Regulators at the National Institute for Occupational Safety and Health found repeated problems with the 8710. But senior officials took a go-slow approach, records and testimony show, eschewing a crackdown and giving 3M "favorable treatment" rather than yanking its stamp of approval. One NIOSH safety research engineer, in a memo written several years after the 8710's approval, said that the government's actions were "impossible to defend" and that irregularities in the approval process jeopardized worker safety. Current NIOSH officials don't agree. "I have not seen anything improper," says Richard Metzler, director of NIOSH's National Personal Protective Technology Laboratory.
The 8710 mask was withdrawn from the U.S. market in 1998, after tougher safety standards took effect. 3M attorneys defend the product, saying it was rigorously tested, gave reliable protection, and worked even better than designed. "If this product did not work, we would have taken it off the market," says John Allison, 3M's assistant general counsel. "That's just how we do business, and that's how we've been successful for 100 years."
Others disagree. "3M came forward with a product that had some fundamental flaws, [and] their immediate focus was to sell that product, as widespread as possible," says Vernon Rose, an industrial hygiene consulting engineer and professor emeritus at the University of Alabama. "It was obvious they didn't consider how well it would perform in the workplace. There's no doubt in my mind it was [unsafe]."
Throwaway. Millions of Americans--miners, shipyard workers, textile workers--must use respirators to protect against contaminated air. The human respiratory system does well keeping out bigger particles. But smaller particles, measuring only minute fractions of the width of a hair, can get into the tiniest passageways of the lungs and lodge there, causing scarring that essentially causes victims to suffocate to death.
Cheap, lightweight, and meant to be thrown away after just one use, the 8710 was a hit with employers, while a high profit margin made it a winner for 3M. The company was first into the disposable-respirator market and dominated it for years. It sold at least hundreds of millions of 8710 masks--precisely how many, 3M won't say--while workers staked their health and safety on the claims 3M made about the mask.
Coal country was a lucrative marketplace for the 8710, but now it's a legal battleground for 3M. In West Virginia, state officials believe the company should share the cost of treatment for coal miners who have become ill. The state is suing 3M and other respirator manufacturers to recover costs of treating and paying benefits to more than 20,000 miners. The expense borne by the state's workers' compensation fund already has reached hundreds of millions of dollars, the lawsuit alleges, and the state's lawyers are seeking punitive damages on top of that. Frances Hughes, the state's chief deputy attorney general, likens 3M and the other firms to tobacco companies. "The manufacturers knew for a long time these masks didn't perform," she says. "We'll be able to prove that they knew and conspired to keep this information from getting out."
Many who worked around silica dust also are suing 3M. Silica, the second most common mineral in the Earth's crust, causes silicosis--a disabling, irreversible, and often fatal lung disease. At least 1.7 million U.S. workers are exposed to silica dust in jobs like construction, sandblasting, and mining, according to the government, and several hundred deaths are reported each year. As a shipyard supervisor, Alvin Gipson wore the 8710 for 10 years while overseeing tank-cleaning operations. But the mask provided him too little protection, he says, against silica. "You came up with a fog of dust that was so thick at times you could hardly see," he recalls--just the kind of "thick, choking dust" that 3M claimed, in ads, that the 8710 would protect against. In the late 1980s, Gipson says, his chest began to tighten, and breathing became difficult. Diagnosis: silicosis. "I know when I get tired, to stop--that's in everything I do," says Gipson, who won a confidential settlement from 3M. Still, Gipson, who is now retired and living near Houston, considers himself fortunate--he counts a dozen men who worked for him who battled respiratory woes and are now dead. All, he says, wore the 8710.
They weren't alone. Edgar Clough wore the 8710 for years while sandblasting tanks, bridges, and barges. He died from silicosis in 1994, leaving behind six children, after what his wife, Gean, describes as an excruciating ordeal. "When he couldn't breathe," she recalls, "he'd look up at me and just reach for my hand. He had a look, and a fear, in his eyes. I just never want to see that look in anybody else's eyes." The disease left them both helpless. "It's indescribable," she says. "It was such a horrible way of life, it kind of relieved me when he died. I know it sounds terrible, [but] the suffering is so bad." Clough won a confidential settlement from 3M, but by the time that happened his health was so bad he needed a wheelchair and oxygen to get around and could speak for only minutes at a time without resting.
3M officials acknowledge now that its respirator shouldn't have been used for sandblasting. But that's not what the company said when it sold the mask: "It stops sand and silica," declared one ad, with no warning against sandblasting. Another ad specifically cited sandblasting. Years later, Clough's widow says she still remembers the day her husband came home telling her of an amazing new product--the 8710--that was going to protect him. "He showed me how great it was," she says. "They weren't to go into a tank without it on."
Asbestos was another market for the 8710. 3M promoted the respirator for protection against this cancer-causing fiber commonly used in insulation, even battling federal regulators who wanted to limit the respirator's use against it. Elizabeth Grassley was among those who used the 8710 for asbestos protection. In the 1970s, she did a home-building project on the Big Island of Hawaii, where she also later ran a floor-sanding business. Repeatedly exposed to asbestos dust and fibers, Grassley came down with mesothelioma, a malignant tumor that invades the linings of the lungs and elsewhere. She died last December, and her mother and children are now suing 3M and other firms. Their suit claims 3M led Grassley and others astray: The company said the respirator would work and met government standards, when it didn't; the mask couldn't be checked for adequate fit; and 3M failed to issue warnings about the respirator's known limitations. "The respirator was sold to the public," the suits says, with "full knowledge by 3M that [it] could not and did not meet" government regulations.
Despite the 8710's problems, 3M was unequivocally upbeat in its marketing of it. In one advertisement, 3M declared that the 8710 "keeps lung damaging dusts out of the nose, mouth and lungs." In another, 3M proclaimed that its product stopped deadly dusts "from ever reaching the lungs." 3M also broadcast claims of the mask's key selling point--comfort--even as it collected data showing workers didn't like it. For instance, when the Eastern Associated Coal Corp. queried coal miners about the 8710, nearly 90 percent rated it unacceptable, chiefly because it was too hot, too fragile, and too hard to breathe through.
"Poor predictors." From its earliest days, the 8710's regulatory history is disturbing. In May 1972, it quickly won government certification. The standards, for one thing, did not require regulators to perform a crucial face-seal test. Regulators checked the 8710's filtering ability, but that test wasn't worth much, many experts say. The reason: Even if a mask passed the test, it didn't necessarily mean it was doing a good job. In testing, a mask became caked with contaminants, blocking flow through it. But until that caking took place, contaminants could enter.
Records and safety standards also suggest that regulators should never have granted approval because the mask could not be tested to ensure proper fit. Government standards in the 1970s were widely seen as obsolete, but they weren't updated until nearly a quarter of a century later.
Government approval was critical because without it, companies would have been reluctant to buy the 8710. In reality, however, the approval didn't represent much assurance. The agency's approvals, NIOSH Director J. Donald Millar wrote in a 1983 memo, "have frequently proved to be poor predictors of performance in the workplace."
3M publicly trumpeted the 8710's government certification in its advertising, but behind the scenes, the company was dismissive of such approvals. As a 3M executive said in an internal report: "It doesn't tell you anything" about effectiveness. Said another: "NIOSH approvals are a marketing device."
The story of the 8710 began long before the product ever won NIOSH approval. Early on, 3M developers traveled to the University of California's Los Alamos Scientific Laboratory in New Mexico, where they sought guidance from the lab's noted respirator expert, Edwin Hyatt. The results gave reason for pause. Lab tests showed that small, lethal particles penetrated the mask. The New Mexico researchers also didn't like that the 8710 came in only one size, because human facial features vary so widely. "Generally, our reports back to 3M were: 'This is really not a sound design, and it does not seem to be working very well,' " recalls Darell A. Bevis, who worked on Hyatt's team and later became a respirator consultant.
Those warnings were a sign of troubles to come. Indeed, the mask experienced serious problems for at least two decades, according to 3M and government documents. They included just about all areas--leakage, breathing resistance, collapsing on the face, manufacturing troubles, difficulties in monitoring quality, deterioration of the product after manufacture, problems with the one-size-fits-all approach, and trouble with the rubber straps that hold the respirator close to the face.
For at least several years beginning in the late 1970s, 3M's own testing showed that up to 100 percent of respirators examined failed one or more government standards, according to company records. Internal 3M documents disclose that the company conceded it couldn't measure up. As a 3M manager said in a 1975 internal report concerning one federal standard: "We . . . thoroughly examined the problem to determine if there was anything we could do technically" to comply. "The conclusion was that we could not." Patricia Gussey, a senior NIOSH official from the late 1970s, says that if she had known of the results, "there would be all kind of questions." One possibility, she says: revoking the 8710's certification. That very well might have torpedoed sales of the respirator.
Back then, and today, 3M says it did not have to meet federal standards because the government changed its test for respirators. But that's not what happened. The test requirements remained the same, but NIOSH tinkered with its testing equipment, adding a certain kind of fan to the test process. That was enough for 3M to conclude that the standards "did not apply" and that the company no longer needed to follow the rules, Donald Wilmes, a leader of 3M's respirator unit, said in a court deposition. He said 3M continued selling the 8710 with no caution to users because the masks were safe. 3M says this was done with the government's knowledge and approval, and there is no evidence the regulators sought to force compliance. Current NIOSH officials, however, reject the argument that 3M could simply declare itself exempt from the standards. "That would not be correct by any interpretation we have today," says NIOSH's Metzler, "and I would doubt seriously that would have been the interpretation in those days."
In any case, the 8710 was already having difficulties before the test-equipment change, company records show. 3M also failed to make good on its pledge to the regulators to promptly redesign the product, records and interviews show.
3M touted the 8710 for use against especially deadly small particles. "That is what these respirators should be designed against, and they're not," says Rodney Vincent, a New Orleans attorney who represents users of the 8710 and other disposable respirators. "If you're going to stop disease, you've got to keep them out." Yet in the 8710's case, 3M's own testing showed a high penetration rate for small particles--up to nearly 60 percent. 3M attorneys today acknowledge that small particles penetrated its respirator. But they call such conditions "extreme," saying they don't represent what actually took place in the field.
3M makes that claim about field conditions even though its managers didn't test how the 8710 would perform in many work environments, nor did they know all the various kinds of dust the mask would encounter, company attorneys acknowledge. "It's like GM making an automobile and never test-driving it before they sold the damn thing," complains Frank M. Parker III, chief executive of Caliche Ltd., a Texas health and safety consulting firm. "Anybody who manufactures a product ought to have some sense of its effectiveness in the uses for which it was intended."
When 3M did venture into the field, researchers found results that surprised them. In 1977, for example, five years after the respirator was introduced, 3M managers visited several textile plants in North Carolina to size up the 8710's performance. "A larger number of small particles were found in this mill than anticipated," they wrote in a report--in other words, the more dangerous kind of particle, and the one the 8710 had trouble handling.
By the mid-1980s, the news still wasn't good, 3M records show. In some of its most comprehensive testing ever, 3M studied the mask on subjects representing the range of faces in the workplace. The results shattered 3M's claim that one size fit all, as fully a third of the subjects failed to get a good fit. And, it showed that an important, 3M-designed safety check that users were supposed to do each time they donned their masks was giving erroneous results--telling workers the mask was fitting properly, when in reality, it wasn't.
3M also consistently claimed in interviews that breathing resistance--the issue in many of its failed tests--was not a safety issue. But industry experts have repeatedly concluded that breathing difficulties increase leakage in any respirator.
Perhaps 3M's sternest rebuke came in 1987, when it was legally established, over 3M's objections, that disposable respirators like the 8710 had a fundamental shortcoming. The U.S. Court of Appeals in Washington, D.C., in a decision cowritten by future Supreme Court Justice Ruth Bader Ginsburg, agreed with OSHA that there was no test for daily use to adequately ensure "the proper fit for disposable respirators." The ruling was pivotal, because in the world of respirators, it's a straightforward proposition: If you can't check fit, you can't be assured of protection.
Some government officials and respirator safety consultants who observed problems with the 8710 did raise concerns, but NIOSH's top regulators were not convinced: Government and company records show that NIOSH officials never seriously considered rescinding the agency's approval for the 8710. 3M's favored status at NIOSH became evident in a court deposition given last year by a former senior agency official named Robert Schutz. As chief of the testing and certification branch, Schutz was the agency's pivotal player for respirators. Retired for years, he testified that regulators gave 3M "favorable treatment" in the form of extra time to deal with problems--as long as several years. Regulators, in fact, took a remarkably hands-off approach. Once, after NIOSH discovered problems with the 8710, 3M met with Schutz and other regulators. A 3M memo recapping the meeting says: "They will in effect issue to their Q.C. people instructions that [breathing resistance] is not to be criticized." Schutz declined to talk with U.S. News. Current NIOSH officials could not explain his actions.
Perhaps most seriously, the government's testing program--minimal as it was--was plagued by irregularities. Nelson Leidel, chief of NIOSH's evaluation and review branch in the late 1970s, recalls an instance where, he says, he discovered that NIOSH allowed testing on the 8710 to continue until enough positive results were obtained to give the 8710 a passing grade. He urged the agency to reconsider its approval. The reply he got back, he says, was disturbing. "It is obviously impossible to defend that certification decision," wrote William Cook, a safety research engineer. "Unfortunately, this incident represents only the tip of the iceberg. We have reason to believe that our certification files are well populated with similar irregularities." Years later, Leidel remains angry and frustrated that nothing came of his efforts to compel greater performance of the 3M respirator. "This is the most damning indictment of a government agency," he said in a recent interview. "It's a public-health tragedy."
With Ann M. Wakefield and Monica M. Ekman
This story appears in the August 9, 2004 print edition of U.S. News & World Report.