Dangerous Products: Airline Safety; Medical Safety; Food Safety; Auto Safety; Environmental Safety
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Can Our Government Protect Us From Dangerous Products and Activities? Can We Rely on Our Government? Should Our Citizens Have Input as Jurors?
Introduction
No one wants to be saddled with gobs of red tape and government regulations. How can our Government protect us from unscrupulous corporations and ourselves? We know that most businesses care about their products and their customers, but what about those that do not? Large sums of money, subject to gain or loss, can test the moral fiber of big business. This is especially true when the very nature of the corporate structure prevents personal responsibility. The buck does not stop with an individual and, therefore, often does not stop.
Do we need private citizens to participate in the process other than at the point of sale? Do we need juries both in tort and contract cases to help regulate misconduct? Has the structure of our appellant courts, state and federal, rescinded the input of our citizens?
Well let us look at the track record of the executive, legislative, and even the judicial branch. Two of our three branches of government are composed of individuals who run for office--soliciting funds, support, and votes from the very entities they are to regulate. It is legal to lobby and attempt to persuade individuals in those branches to support certain positions. Although we cannot directly lobby individuals once they are on the jury, they already have been lobbied through the national tort reform campaign. Judges who are elected or appointed often find themselves in office as a result of their beliefs or political preference, rather than their scholarship and competence.
Airline Safety
In April 2008, Federal Aviation Administration (FAA) supervisors accused the FAA of ignoring safety lapses. The inspectors reported to Congress that when they complained about being dissuaded from pursuing complaints against a major Airlines’ failure to perform required safety checks, they were harassed on their jobs. According to the inspectors, the FAA supervisors knew of the safety problems. The inspectors further reported that the agency even threatened to discharge them. After this was revealed, two other major airlines grounded many of their planes for missed inspections.[i] This is not the first time we have seen the FAA bend to airline pressure.
Medical Safety
Earlier this year, the Food and Drug Administration (FDA) proposed a rule, which violated the intent of the FDA Amendments Act of 2007. The effort was to relax requirements for labeling and allow the claim of immunity for failure to warn of drug hazards. The FDA Amendments Act said the drug manufacturer was required to promptly update its drug label when aware of new safety information. The law was clear, but this proposed rule is another back door effort at tort reform that would not pass if offered. Once the FDA approves a drug for a specific purpose, the proposed rule would allow the drug to be used for conditions that the FDA did not approve. Although such can be good medicine, the problem is that what is known about a drug in one situation may not apply to another.
Preemption
Medical Devices
What is Federal Preemption? It means to take the place of state law. Some say it is a strategy to destroy the civil justice system. Others say it eliminates accountability and responsibility. If the state law allows the injured person to hold the wrong doer responsible and the federal law makes no provision to hold the wrongdoer responsible, how can the federal law effectively take the place of the state law?
The general public has no idea what preemption is. If they were told it means “that Americans are denied the right to hold companies accountable under the laws of their own states for the harm those corporations cause,”[ii] most Americans would not believe it. Especially since we have a conservative U.S. Supreme Court that supposedly believes in States Rights! Well in February 2008, the U.S. Supreme Court issued a landmark opinion; Riegel V. Medtronic, Inc.[iii] Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. Charlie and his wife sued the manufacturer, Medtronic, Inc. They alleged Medtronic knew the balloons were defective. Medtronic argued the Food, Drug, and Cosmetic Act protected them and the Riegels could not sue since the FDA had approved their marketing the device. Medtronic argued they should be immune from state-law claims. Charles later died and his estate continued to pursue the claim.
On February 20, 2008, in an 8 to 1 decision, written by the conservative Justice Antonin Scalia, the court protected Medtronic and the makers of medical devices from patients and consumers who allege they were injured by the device. Justice Ginsburg was the lone dissenter. The court has other cases pending involving drugs, cigarette makers, and the like. The decision was a change of direction for the court and the consumer, but seemed in line with other recent rulings favoring business interests and turning a jaundiced eye toward civil lawsuits. Scalia wrote “Allowing juries to award damages when something goes wrong, would be unfair. A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Chief Justice Jim Hannah of Arkansas in a recent opinion had this to say about Riegel, “I am also compelled to express my dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations. By a conclusory and incomplete analysis, our law is dismissed. In the place of well-reasoned judicial decisions reaching back to the England of Blackstone, injured plaintiffs are told that instead of looking to their common law for redress they must look to a regulatory agency that has no power to grant them any redress.“[iv]
Over adecade ago, the U.S. Supreme Court was not so anxious to promote preemption. In the ‘Lohr‘ case, many of the same Justices who disfavored preemption, sided with the majority in the Riegel decision. My how attitudes change, even on the U.S. Supreme Court.
What mechanism is there at the federal level to compensate for such injuries? Good question, I do not believe this decision reflects the intent of Congress. I hope they pass legislation to right this wrong soon.
Drugs
Scalia did not include drugs in his opinion, leaving that question for another day. Recently the Journal of the American Medical Association (JAMA) suggested that the maker of Vioxx, Merck & Co., advanced and promoted Vioxx in numerous academic articles that had actually been ghostwritten by Merck.[v] Through lawsuits, this information was revealed in discovery. Even so, the FDA is considering allowing manufacturers to distribute medical journal articles considering off-label uses. There is concern that some manufactures will only circulate positive articles and not studies that show risks and would not advance sales. For example, a drug manufacturer sought to market Paxil off label to children. One study illustrated positive results in depressed children. That study was published, but there was another study revealing Paxil was not effective for children. That study was not submitted for publication. Doctors who prescribe drugs must receive balanced information on the risks and benefits of the drug. Without safeguards, doctors may only receive information that talks about the drug’s benefits and that would be dangerous for all of us.
Food Safety
There have been many recalls and food-borne outbreaks in recent years. Consumers have lost faith in the Federal Drug Administration when it comes to food safety. The agency has faced safety problems with spinach, peanut butter, the blood-thinner drug Heparin, and contaminated pet foods made in China. Use of funds in other areas has starved the FDA financially and subjected the agency to much criticism for being beholden to big business.
Democrats have introduced legislation in the House of Representatives to bolster food and drug protection. The bill will focus on what has been called a “public health crisis”. The agency is responsible for 80% of the U.S. food supply. Country of origin labeling for produce and processed foods would be required. The food industry, the FDA, and Republican lawmakers are against parts of the bill, which include user fees.
Environmental Safety
Has the Environmental Protection Agency (EPA) been influenced by the American Chemistry Council? An EPA panel chair was forced to step down after the Council complained. Congressional committee hearings revealed that chemical makers fundmany of the scientists on EPA panels.
Lawmakers want to know why the EPA let scientists remain on expert panels but removed Deborah C. Rice, a public health scientist, after the American Chemistry Council requested she be removed. Rep. John D. Dingell said “If industry has undue influence over this science, then the public’s health is endangered.”
Rice, a toxicologist for the state of Maine, testified before the Maine legislature about health risks associated with deca, which is used as a fire retardant. Maine and the European Union banned the compound. Rice’s panel completed its work and a Vice President of the Chemistry Council complained. The EPA removed her from the panel and expunged her comments from the official record and even took them off the EPA web site.[vi] It was reported that at least nine scientists who received funding from chemical makers were allowed to remain on review panels.
By the way, the New Jersey Department of Environmental Protection will not be allowed to collect from a lawsuit approximately $800 million from W.R. Grace & Co. The company claimed there were no harmful levels of asbestos in a plant they closed in New Jersey. The EPA determined that was not true. However the Company asked for protection by the Bankruptcy Act passed by Congress. The judge granted protection.[vii]
Auto Safety
The National Highway Traffic Safety Administration (NHTSA) in 2007 issued safety rules regarding electronic stability control, door locks, tire pressure monitoring systems, occupant crash protection, head restraints, side impact protection, and others, all of which suddenly sought to preempt state common law product liability claims involving these important safety mechanisms. NHTSA continued this trend in 2008 attempting to preempt state law school bus crash protection, child restraint systems, lamps, and reflective devices.
Now NHTSA attempts to include preemption in Roof Crush Rules. “Currently, 10,000 people die and 24,000 people are injured in vehicle rollover accidents. Instead of acting to significantly reduce injuries, NHTSA proposed a weak roof crush standard that according to their own estimates may save an additional 13 to 44 people. The proposed rule went on to explicitly state that injured people should not be able to hold manufacturers accountable for defective products that otherwise meet this low standard.”[viii]
These rules try to nullify state and federal courts safety efforts and reveal how afederal agency can work on behalf of powerful corporate industries, rather than public safety concerns.
Other Product Safety
We have experienced pet food contaminated with melamine, toothpaste laced with diethylene glycol, toys coated with lead paint and tires that come apart, to mention just a few. U.S. agencies responsible for safety including FDA and Consumer Product Safety Commission are short staffed and under funded.
Conclusion
How can we protect ourselves? Many say government and industry have failed abysmally to protect consumer health. The judicial system has helped produce cases that made a difference. Courts have also provided information about problems that would not have been disclosed any other way. However many would say the judicial system has been influenced by an ideological business sea change. It seems weare experiencing pro-business justice. “…many Democrats and Republicans,… have come to share a relatively laissez-faire, technocratic vision of the economy and are suspicious of excessive regulation and reflexive efforts to vilify big business.”[ix]
Robin Conrad, heads the litigation efforts for the U.S. Chamber of Commerce. She is pleased that of 30 business cases in the U.S. Supreme Court last term, 22 were decided unanimously or with few dissenting votes. She expressed that liberal justices wrote most of the important decisions. She indicated that Justice Ginsburg, Breyer, and Souter went out of their way to criticize the use of lawsuits to challenge corporate wrongdoing.[x]
So it seems that it is the people, citizens who sit on juries that have slipped from the process. The three branches of government have certainly had special influence pressures from all sides. People who sit on juries have not escaped the anti-plaintiff, tort reform onslaught. We live and practice in perilous times. We must be dedicated to do all in our power to insure that those damaged by others, through no fault of their own, have a way to achieve justice.
[i] Wald, Matthew L., NY Times, 4/3/08 p
[ii] Beasley, Jere. Jere Beasley Report; “The Preemption Battle Won’t Go Away“
[iii] 128 S.Ct. 999 (2008)
[iv] Despain vs. Soundtec, inc. SC of Arkansas (no. 07-714, 4/10/08)
[v] Ross, Joseph J., et al, Guest Authorship and Ghostwriting in Publications Related to Rofecoxib, 299 J.A.M.A. 1800 (April 16, 2008); Bruce M. Psaty and Richard A. Kronmall, Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment, 299 J.A.M.A. 1812 (April 16, 2008)
[vi] Layton, Lyndsey, The Washington Post, 4/4/08
[vii] Associated Press, PhillyBurbs.com, 4/1/08
[viii] AAJ Press Release, March 27, 2008; AAJ Demands NHTSA Removes Preemption From Roof Crush Rules; AAJ Press Room
[ix]Rosen, Jeffrey “Supreme Court Inc.; How the nation’s highest court has come to side with business“. New York Times Magazine Mar.16, 2008: 40.
[x] Rosen, Jeffrey “Supreme Court Inc.; How the nation’s highest court has come to side with business“. New York Times Magazine Mar.16, 2008: 40.