Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions. The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug.
The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain. Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions. When Ms. Bartlett’s pharmacist filled the prescription, however, it gave her the generic version of the drug sulindac, rather than the brand-name drug. Under federal law, the generic version of sulindac had to be chemically and biologically equivalent to the brand-name version that had been approved by the FDA.
Not long thereafter, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns over 60-65 percent of her body. For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma. During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind. Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.Full text
[[Ed. Note: This post is a reprint, with minor updates, of McGarity’s post one year ago on the first anniversary of the proposed silica rule arriving at OMB. Little has happened on the issue in the past year – except more people have been sickened or killed by silica exposure.]]
Today marks the second anniversary of an event that received little media attention, but marked a major milestone in the progression of a regulation that is of great importance to thousands of Americans whose jobs bring them into contact with dust particles containing the common mineral silica. Exactly two years ago today the Occupational Safety and Health Administration (OSHA) completed a proposed rule requiring employers in the mining, manufacturing and construction industries to protect their employees from silica dust particles as they engage in such activities as sandblasting, cutting rocks and concrete, and jackhammering.
Silica dust is no newcomer to the growing list of workplace hazards. Public health professionals have known for more than one hundred years that exposure to airborne silica dust can cause a debilitating disease caused silicosis.
In 1929, as the nation entered the Great Depression, hundreds of workers made their way to Gauley Bridge, West Virginia to work on the Hawk’s Nest diversion project, a massive digging operation that created a three-mile long tunnel through Gauley Mountain to divert the flow of the New River for a Union Carbide power generation facility. Before the project was completed, more than one hundred workers had died of silicosis, and many more faced the prospect of slow and painful deaths as a result of their exposure to silica dust.
The Hawk’s Nest tragedy inspired public health officials to establish limitations on workplace exposures to silica dust, but they did not prevent workers from contracting the dreaded disease. Scientists estimate that thousands of workers still contract silicosis, resulting in hundreds of deaths, every year. And silica dust exposure has been linked to other diseases, like cancer, as well.Full text
When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions. Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions.
That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4. According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.
The proposed rule, which was required by the landmark Food Safety Modernization Act of 2010, would for the first time establish legally enforceable standards for produce farmers. The standards set out requirements for sanitizing tools and equipment, for ensuring that agricultural water is safe and sanitary, for using animal-based fertilizers (e.g., compost) on food crops, for reducing contamination from domesticated and wild animals, and for training field workers and ensuring that they employ sound hygiene practices.Full text
This post was written by Member Scholar Thomas O. McGarity and Senior Policy Analyst Matt Shudtz.
The Mercatus Center has recently published a report on OSHA that simply rehashes the same old discredited arguments that industry apologists in academia and think tanks have been making for thirty years. Not surprisingly, they reach the conclusion that voluntary compliance programs and worker education efforts are better uses of OSHA’s limited resources than rulemaking and enforcement.
The report contains no original research, and (with one exception) it relies exclusively on studies finding little or no correlation between OSHA activity and reductions in worker injures. At the same time, the report ignores much of the evidence tending to show OSHA regulations and enforcement are effective. The simple (and frustrating) fact of the matter is that it is almost impossible to design a study using available occupational injury statistics to measure with much confidence the extent to which enforcement of OSHA standards is or is not associated with a reduction in workplace injuries or deaths. It is therefore not surprising that the studies reach mixed results. The Mercatus report ignored some reports showing a positive correlation and belittled a recent study showing a highly positive correlation.
By law, the agency has reviewed a number of standards issued over the last forty years. The cotton dust standard virtually eliminated byssinosis, at a cost to industry far less than expected. The standards controlling exposure to ethylene oxide resulted in reduced risk to employees and lower-cost sterilizers available to employers, even as industrial production of the chemical increased. OSHA’s inspections have also been proven effective, with studies (among others, here, here, and here) indicating that injuries and standards violations decrease following the inspections – by as much as 50 percent.Full text
The saga of the missing FDA food safety regulations continues with a new government filing in a lawsuit challenging FDA’s failure to promulgate regulations implementing three critical programs that Congress established in the Food Safety Modernization Act of 2011.
As I noted in a previous posting, the three sets of regulations are currently bottled up in the White House Office of Information and Regulatory Affairs (OIRA), where they have gathered dust for a year.
Well before the statutory deadlines, FDA sent OIRA proposed regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs, requiring growers to comply with “science-based” minimum sanitation standards, and for importers to verify that their products were produced under conditions that complied with FDA food safety requirements. But the deadlines came and went while OIRA sat on the regulations to avoid criticism from Republicans during the 2012 election season.
Last summer, the Center for Food Safety and the Center for Environmental Health sued FDA (and the White House) for failing to meet the deadlines and asked the court, the U.S. District Court for the Northern District of California, to order FDA to promulgate the rules by a date certain.Full text
One of the crowning legislative achievements of the Obama Administration’s first term was the enactment of the Food Safety Modernization Act.
Like any safety statute, however, the new law will have no practical bite until the implementing rules are issued. In this case, that’s until the Food and Drug Administration (FDA) promulgates regulations fleshing out the obligations of growers, producers and importers of food. Unfortunately, after almost two years, the regulations for the three most critical programs enacted by the new law have been written, but have not yet been promulgated.
On Thanksgiving Day, one set of implementing regulations will have been bottled up at the White House’s Office of Information and Regulatory Affairs (OIRA) for exactly one year. Two other critical sets of regulations will pass the one-year milestone between Thanksgiving and December 9.
Signed by President Obama in January 2011, the new law was enacted in response to a series of crises throughout the Bush Administration involving, among other things, peanuts contaminated with Salmonella during processing at a Georgia facility, fresh vegetables contaminated with an especially virulent form of E. coli bacteria, and Salmonella-contaminated imported jalapeno peppers.
The FSMA tells the Food and Drug Administration (FDA) to write regulations requiring most food processors and manufacturers to come up with hazard analysis at critical control point (HACCP) programs and to write “science-based” minimum sanitation standards for growers to follow during the production and harvesting of fruits and vegetables. The new law also told FDA to write regulations requiring importers to verify that their products were produced under conditions that complied with FDA food safety requirements.Full text
In the week before Christmas last year, 14-year-old Anais Fournier went to Valley Mall in Hagerstown, Maryland with some friends. While there she purchased and consumed a 24-ounce can of an energy drink manufactured by the Monster Beverage Corporation. She returned to the mall the next day and consumed another Monster energy drink. Later that evening, while she was watching a movie at home with her boyfriend, she went into cardiac arrest. She died four days later on the day before Christmas Eve. An autopsy concluded that she had died of “cardiac arrhythmia due to caffeine toxicity.”
Thanks to the efforts of her mother to get to the bottom of the matter, Anais’s untimely death may stimulate new efforts to regulate sports drinks and other potentially dangerous dietary supplements and to hold companies accountable in courts of law for their irresponsible marketing strategies.
Anais’s mother was convinced that the Monster energy drinks caused her daughter’s death. Last week, she and Anais’s father filed a lawsuit against the company, and on Monday the New York Times published documents she received in response to her Freedom of Information request for FDA’s adverse event reports on Monster drinks. It turns out that FDA had received reports of five deaths caused by those drinks since 2009. These reports are by no means definitive, and they do not establish a cause-effect relationship between the consumption of highly caffeinated sports drinks and increased mortality risk in humans.Full text
Yesterday afternoon, the D.C. Circuit Court of Appeals issued a long-awaited decision on the validity of EPA’s “Cross-State” rule governing interstate transport of pollution.
The EPA has been trying for more than two decades to come up with a solution to the vexing interstate transport problem, but every attempt has failed. The court has now vacated EPA’s most recent (and most ambitious) attempt to protect the residents of “downwind” states (primarily in New England and the mid-Atlantic) from two pollutants (ozone and fine particulate matter) that can cause a number of adverse health effects, ranging from minor eye irritation to premature mortality. EPA’s rule was estimated to prevent 13,000 to 34,000 premature deaths every year.
Worse, the court interpreted the Clean Air Act in a way that ensures that EPA may never be able to implement it with the analytical tools currently at its disposal. If the Obama Administration is serious about protecting children, the elderly, and other vulnerable Americans, it must ask the entire membership of the D.C. Circuit to overturn the panel’s decision. Failing that, it must appeal the decision to the Supreme Court of the United States.
As states along the East Coast struggled over the years to fulfill their obligation under the Clean Air Act to write state implementation plans (SIPs) capable of achieving the national ambient air quality standards (NAAQS), they discovered that the sources of the pollutants were located in upwind states and were therefore not subject to any legal requirements promulgated by the downwind states. The complexity of the problem was magnified by the fact that the relationships between upwind state emissions and downwind state ambient air quality were not well understood.Full text
The Occupational Safety and Health Act of 1970 is one of the surviving monuments of the era of progressive social legislation (extending from the mid-1960s through the mid-1970s) during which Congress enacted the nation’s foundational health, safety and environmental laws. That statute empowered the Occupational Safety and Health Administration (OSHA) to write safety and health standards designed “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions.” A separate “general duty clause” required every employer to provide a workplace that was “free from recognized hazards” that were likely to cause “death or serious physical harm.”
During the ensuing four decades, OSHA’s efforts to implement that statute have brought about substantial reductions in workplace injuries and illnesses, but far too many workers are still hurt or killed.
According to the Bureau of Labor Statistics, U.S. private sector employers in 2010 reported nearly 2.9 million injuries and around 200,000 workplace illnesses. The actual numbers are likely much higher because some employers underreport workplace injuries, and doctors frequently fail to inquire into the likelihood that particular diseases, like cancer, have a workplace origin. A total of 4,690 workers died on the job, which represents a fatality rate of about 3.6 deaths per 100,000 full-time employees. These rates declined slightly during the recession of 2009, but were on their way back up in 2010
The sad fact of occupational life in the United States is that OSHA has not lived up to its potential, primarily because for the 30 of the past 40 years, OSHA has been the subject of unrelenting attacks by the business community. These attacks have rendered OSHA largely incapable of promulgating new occupational safety and health standards and only barely able to enforce existing standards the general duty clause. In 2010, the Center for Progressive Reform published a report detailing serious regulatory dysfunction in OSHA due primarily to a lack of resources, a weakened regulatory process, intrusive review by the White House, and an outmoded statute.
Today we publish The Next OSHA: Progressive Reforms to Empower Workers, offering a wide variety of suggestions for how Congress, OSHA, and workers themselves can make the nation’s workplaces safer and healthier. I co-authored the report with fellow CPR Member Scholars Martha McCluskey, Sidney Shapiro and Rena Steinzor, and CPR Senior Policy Analyst Matthew Shudtz.Full text
The Government Accountability Office (GAO) released a report today detailing the challenges that the Occupational Safety and Health Administration (OSHA) faces in writing regulations to protect America’s workers from unsafe and unhealthful workplaces. The report was released at a hearing of the Senate Health, Education, Labor and Pensions Committee, chaired by Senator Tom Harkin (D-Iowa), on “Delays in OSHA’s Standard-Setting Process and the Impact on Worker Safety.” Both the GAO report and testimony presented at the hearing tell a depressing tale of an agency that, after 30 years of constant attacks from the business community, conservative think tanks, and reactionary members of Congress, has very nearly folded its rulemaking tent.
The GAO found that between 1981 and 2010, the time that it took for the agency to develop and promulgate occupational safety and health standards ranged from 15 months (for an easily promulgated safety standard) to 19 years, and averaged more than 7 years.
How have we come to this pass?
OSHA got off to a very good start. During its first ten years of existence, the agency promulgated 21 safety standards and 13 important health standards (one of which addressed 14 different carcinogens), all of which continue to afford substantial protection to workers. By the late 1970s, however, the Chamber of Commerce, the National Association of Manufacturers, and the National Federation of Independent Businesses had made OSHA the poster child for their demands for “regulatory reform.”Full text