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Examples of Defective Products Meeting
Federal Standards That Proved Inadequate to
Protect Consumers from Death, Injuries
Proposed Section 82.009 of H.B. 4 Leaves Consumers at Risk
April 14, 2003
There have been many examples of products in which federal regulatory standards failed to protect consumers from death and injuries. Many such products containing design flaws were later taken off the market, often exposed as dangerous by consumer lawsuits. Section 82.009 of H.B. 4 – which creates a rebuttable presumption against consumer lawsuits for products complying with federal standards – allows manufacturers to cut corners on safety and prevents consumers from holding such wrongdoers accountable.
If compliance with federal standards were made a defense in product liability lawsuits, then auto, tire, pharmaceutical, and many other manufacturers would be excused from liability for defects that kill and injure tens of thousands of innocent consumers. There are more than 50 Federal Motor Vehicle Safety Standards covering virtually every aspect of motor vehicle safety– from the tires and door locks to brakes and crashworthiness. Auto and tire companies have repeatedly tried to use compliance with National Highway Traffic Safety Administration safety standards to defend even the most defective products. But the courts generally do not find them preemptive, because as they examine the facts and evidence, they find what the Texas legislature should conclude – that broad government performance standards are not a reliable predictor of particular defective designs and should not be a shield behind which companies can hide to avoid liability for their negligence, or for intentionally making unsafe products.
The following are examples of products that were approved under federal standards but nevertheless proved dangerous to consumers.
Unsafe Drugs with FDA Pre-Market Approval
Duract
Duract, a pain management drug, was approved by the U.S. Food and Drug Administration in July 1997. Despite warnings about the risks associated with its long-term use, the drug became a common treatment alternative for chronic conditions such as osteoarthritis or rheumatoid arthritis. In February 1998, the FDA received reports of severe hepatitis, liver damage and death in patients taking Duract for more than 10 days. Specifically, FDA data revealed that serious liver damage was reported in one of every 10,000 people who were administered the drug. These alarming reports led the FDA and the manufacturer to withdraw Duract from the market shortly thereafter.
Redux
Redux was one of the two drugs making up the once-popular diet drug combination known as Fen-Phen. Approved by the FDA in April 1996, more than 2 million prescriptions were administered in the first six months alone. In September 1997, the FDA recalled Redux from the market after receiving widespread reports of primary pulmonary hypertension, heart valve problems, and neuropsychological damage to the brain in patients taking the drug.
Rezulin
Rezulin, a drug prescribed to maintain blood sugar levels in patients suffering from adult-onset diabetes, was approved by the FDA in 1997. Initially thought to be a breakthrough for patients who failed to respond to other therapies, the FDA later disclosed that at least 61 patients taking Rezulin died of liver failure, while another seven required liver transplants. New concerns have surfaced about Rezulin’s detrimental effect on the heart. The FDA has since revised its estimate and now suspects that Rezulin may be linked to more than 400 deaths.
Defective Motor Vehicles and Equipment Meeting
Federal Auto Safety Standards
Firestone Tires
In the 1990s, Firestone made the ATX and Wilderness tires for Ford’s new sport utility vehicle, the Explorer. Ford set the specifications and insisted on cost reductions, reducing the tires robustness. Because the Explorer was prone to rollover, Ford also reduced the recommended inflation from a maximum of 35 psi to 26 psi. With use, these tires degraded and the tread separated on some tires, causing catastrophic crashes, many of them rollovers. These tires passed the antiquated, 30-year-old federal tire safety standard. The U.S. Department of Transportation documented at least 200 deaths and 700 serious injuries from crashes involving these Firestone tires. A disproportionately large percentage (25%) of these occurred in Texas due to warm weather and long-distance driving of these heavy vehicles at high speeds, causing them to overheat. Even though they met U.S. safety standards, the DOT found them to be defective and required a recall.
The earlier Firestone 500 steel-belted radial tires, recalled in 1978, were defended by the company, which cited its 99% pass rate on Firestone’s compliance tests with Federal Motor Vehicle Safety Standard (FMVSS) 109. But it failed so often in actual use that it caused 3,300 crashes, 41 deaths and 125 injuries.
Sport Utility Vehicles/Rollovers
Every year more than 10,000 people – one-third of all occupant fatalities – die in rollover crashes, despite the fact that rollovers account for less than 3% of all crashes. Not surprisingly, the occupants of sport utility vehicles (SUV) are three times more likely to die in a rollover crash than occupants of passenger cars. This statistic is particularly shocking when we consider that the number of top-heavy, rollover-prone SUVs being driven by the public has skyrocketed since 1994 and now comprises more than one-half of all new vehicle sales.
A major area of current litigation is lack of roof strength. The government standard, FMVSS 216, is woefully inadequate. It is a static test that tests only one side with a procedure that relies on the windshield to provide 40% of the roof strength. In the real world, the windshield breaks during the first part of the first roll and the unsupported roof collapses on the occupant. National Highway Traffic Safety Administration (NHTSA) statistics show there are at least 7,000 deaths and serious injuries each year due to roof crush.
Despite repeated requests from safety advocates and members of Congress over the past two decades, NHTSA has failed to establish a standard for rollover prevention, implementing instead a weak consumer information program, and FMVSS 216 for roof crush prevention has never been upgraded to a dynamic test since it was issued in 1973, 30 years ago. Yet hundreds of lawsuits have documented the inadequacy of this standard.
GM Side-Saddle Gas Tanks
Over the years, 1,800 people have been killed in 1973-87 C/K side-saddle gas tank fire crashes (with at least half dying from fires, not trauma) — more such fatalities than seen with any other defective vehicle. About 30 people die in these crashes every year. An estimated 4 million of these trucks are still on our highways. It is astonishing that neither the government nor GM ever recalled these trucks – because there is a simple fix. GM has known from the beginning that it is feasible to fix the gas tanks but has refused to stop the slaughter of its customers on the highway.
The problem began when the trucks were redesigned in the late 1960s. At that time, the pickup truck gas tanks were inside the passenger cab, which of course was extraordinarily dangerous. As GM debated where to relocate the tanks, Executive Truck Engineer Alex Mair recommended in a 1964 memo that the new underbody gas tanks be placed as close as possible to the center of the vehicle, inside the frame rails. But the top brass at GM wanted to be able to advertise a truck that could hold more gas than the competitive Ford and Chrysler trucks, whose tanks were inside the frame rails for safety reasons. Ignoring safety, GM decided to place two 20-gallon tanks outside the frame, enabling them to boast in ads that GM truck owners could drive farther than in competitors’ trucks without having to stop for gas.
Placing gas tanks outside the frame makes them highly vulnerable to destruction in side-impact crashes. As one former GM employee said, these tanks split open "like melons." Crashes produce sparks that ignite spilling gas, leading to fires that literally roast helpless victims. Another GM engineer said that the only worse place to put a fuel tank would be on the front bumper.
In 1978, NHTSA required a side-impact fuel tank test at 30 mph for light trucks, but used a flat, wide barrier that spread the crash forces over the side of the pickup, failing to engage the side-saddle gas tanks in a side-impact crash.
Following a 1992 consumer petition for a recall and after evaluating all the evidence, the engineering staff at NHTSA agreed that the vehicles were dangerous and called on GM to voluntarily recall the C/K pickups. When GM refused, Transportation Secretary Federico Pena found, in 1994, that GM had known about this defect since the early 1970s, and he issued an initial determination of a safety defect, which would lead to a mandatory recall.
GM then swung into action, using its political muscle to maneuver a deal with the Justice Department, which overrode Secretary Pena. Under the deal, GM avoided a recall of the deadly trucks but agreed to spend $51 million for research and other safety programs. Nevertheless, numerous lawsuit and settlements have cost GM a half-billion dollars, money it should have spent to repair these vehicles and prevent hideous deaths and injuries.
Nissan Altima Air Bags
Records of detailed investigations involving seat-belted passengers show that 1994 and early 1995 Nissan Altima air bags have caused severe eye injuries to more than two dozen people. Last year, federal investigators knew of 32 such cases, and Public Citizen and the Center for Auto Safety have learned of others since then. The air bags have damaged retinas, caused irises to detach, led to permanently dilated pupils and can even rupture an eyeball. The victims have been left with blurred vision, light sensitivity and blindness in one or both eyes. Many people were completely blinded for weeks before regaining only partial vision. In most cases, the injuries occurred during minor, low-speed crashes in which the driver walked away unscathed. The vehicle passed the air bag safety standard, FMVSS 208, because the standard cannot measure the blinding effects on instrumented dummies used in the standards testing.
These Nissan Altimas have a serious eye-injury rate for passengers that is 20 times greater than other models surveyed. Although NHTSA has been investigating since March 2001, when Public Citizen and the Center for Auto Safety asked the agency to look into the problem, it has taken no final action. It is estimated that about 197,500, of the 249,000 made remain on the road.
Ford Pinto
The Ford Pinto was affordable, gas efficient, and stylistically pleasing-- but lacked one essential element: safety. Ford discovered fatal design flaws in the gas tank during a routine crash test performed right before production of the Pinto was to begin. Ford’s crash tests revealed that several design defects in the fuel tank and rear structure exposed consumers to serious injury or death in 20-30 mile-per-hour collisions. In April 1971, shortly before the 1972 Pinto was placed on the market, Ford’s vice president of car engineering, Harold MacDonald, chaired a product review meeting to discuss a report that had been prepared by Ford engineers. This report recommended deferring, from 1974 to 1976, the incorporation into all Ford cars, including the Pinto, of either a shock absorbent "flak suit" to protect the fuel tank at a cost of $4 per car, or a nylon bladder within the tank at a cost of $5.25 to $8 per car.
This deferral would allow Ford to realize a savings of $10.9 million. Ford’s management knew that the gas tank created a significant risk of death or injury from fire but decided to go forward and begin manufacturing the new Pinto anyway, knowing that these "fixes" were feasible at nominal cost.
That same year, in April 1971, Lee Iaccoca and Henry Ford met with President Richard Nixon. A Watergate tape reveals they asked him to not issue an upgrade to the fuel tank standard that was being considered. NHTSA didn’t issue it until 1974, and only under threat from Congress. The new standard required a 30 mph test in the rear (the original test applied only to the front) and took effect in 1977.
Ford’s 1971-1976 Pintos complied with the old minimal federal standard and had to be redesigned to meet the new one. Nevertheless, in June 1978, Ford recalled all 1.4 million 1971 through 1976 Pintos for fuel system modification, after it was required to do so by NHTSA. By the time of the recall, however, Pinto fuel-fed fires had killed at least 27 people and injured many others. It was a lawsuit – in which an enraged jury awarded a $125 million punitive damage award (rates reduced to $3.5 million) for Ford’s knowing refusal to protect occupants from fires – that had brought the problem to the attention of DOT.
During the same time Ford made the Pinto in the U.S., it manufactured the Capri in Europe – a vehicle of similar size. But the Capri was designed to pass a higher level of protection in Europe. Its gas tank was located above the rear axle years before the new U.S. standard took effect in 1977 that forced Ford to redesign the Pinto.
Automobile Seat Backs
Even auto manufacturers wouldn’t sell a vehicle that just barely meets the ridiculously weak federal standard for the vehicle seat back strength. This standard is so weak that lawn chairs meet its requirements, so weak that an occupant wouldn’t be able to put a wallet in his back pocket without breaking the seat back. Automakers make them stronger than the federal standard. But they still fail too frequently in rear-end impacts, sending front-seat occupants crashing into the roof or back window and sometimes crushing children in the back seat. Auto makers urge parents to place children in the back seat, even as they make weak seat backs. Numerous lawsuits have documented these failures, which can cause death, paralysis and quadriplegia. H.B. 4 would take away all claims brought by plaintiffs when seat backs collapse and kill children in even minor rear-impact accidents.
Child Car Seats
Child car seats are the most recalled product ever. Virtually all comply with federal standards. Yet we see infant seats where the carrier separates from the base; low shield boosters that even NHTSA says shouldn’t be used with kids 30-40 pounds that still meet the standards, but eject, or paralyze kids; and convertible seats that break at a couple of miles above the sled test, which does not mimic any car or crash pulse in existence for the last 30 years. Lawsuits filed on behalf of mangled children have documented many of these defects.
Rear Lap Belts
Rear-seat lap belts without shoulder harnesses met the DOT standard for cars and trucks in the outboard positions until model years 1990 and 1991, respectively, and in the center seats are still permitted for a few more years. Thousands have died or were paralyzed, mostly children, for this heinous design, which was banned in Australia decades earlier. U.S. manufacturers resisted installing rear shoulder belts until Congress, in the late 1980’s, demanded NHTSA issue a standard. Lawsuits have documented the need and the carnage.
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