December 9, 2022
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614
WASHINGTON, D.C. – Sally Greenberg, NCL’s Executive Director, testified before the D.C. Council Committee on Judiciary & Public Safety yesterday to express support for the “Sunshine in Litigation Act of 2022.
By NCL Health Policy intern Alexa Beeson
This June, the House Energy and Commerce’s Consumer Protection and Commerce Subcommittee held a hearing in which they considered seven different bills concerning product safety. The hearing was motivated by a commitment to removing life-threatening products from the market, which–somehow–remain in circulation for purchase. Most notably, the bills address furniture tip-over (H.R. 2211), crib bumpers (H.R. 3170), inclined infant sleepers (H.R. 3172), and fire safety (H.R. 806).
The witnesses included Will Wallace, a manager at Consumer Reports; Crystal Ellis, a devastated mother and founder of Parents Against Tip-Overs; Chris Parsons, the president of Minnesota Professional Fire Fighters; and Charles A. Samuels, a member of Mintz, a law firm that represents manufacturers of some of the products implicated in various accidents.
Ellis was especially moving. She lost her son, Camden, five years ago on Father’s Day in a tip-over accident involving an unstable dresser. The day she testified would have been her son’s 7th birthday. Camden’s death and the deaths of many others in tip-over accidents catalyzed the founding of Parents Against Tip-Overs, which advocates for children who were victims of unsafe consumer products. Ellis recounted the devastating loss of her son and pleaded that the committee act to protect other children from suffering the same fate. Ellis urged the committee to evaluate the standards set forth by the Consumer Product Safety Commission (CPSC), which are not regulated enough to prevent tip-overs.
Furniture tip-over is a more widespread problem than you might realize. According to the CPSC, an estimated annual average (2014-2016) of 9,300 children ages 0-19 were treated in the emergency department for furniture tip-over injuries, not including televisions or appliances. If you include television and other appliances, which were not covered in the bills at the hearing, the number jumps to more than 15,000. From 2000-2016, furniture tip-overs killed 431 children.
These deaths could have been prevented by enforcing stricter safety regulations. The current CPSC regulations do not demand mandatory safety standards for tip-over prevention. The product manufacturing industries are only held to a voluntary standard. Additionally, products under 30 inches tall are exempt from any such safety regulations. However, as found by a Consumer Reports investigation, shorter furniture still causes major tip-over accidents.
The Stop Tip-overs of Unstable, Risky Dressers on Youth (STURDY) Act would seek to change these standards. The bill would require the CPSC to mandate manufacturers to produce more rigorous testing of their products; to perform more “real-world” testing and to revise consumer warning requirements, ensuring higher standards of product safety and transparency.
The National Consumers League thanks the Consumer Protection and Commerce Subcommittee for taking measures to hold industry accountable with regards to product safety standards. One positive message that everyone can take away from this hearing is that times are changing. Industry will be held accountable, and consumers will be protected. It looks like the time for the CPSC to take charge in handling consumer safety and protection–instead of letting industry set its own rules–is just around the corner, to paraphrase Rep. Frank Pallone (D-NJ).
Alexa is a student at Washington University in St. Louis where she studies Classics and Anthropology and concentrates in global health and the environment. She expects to graduate in May of 2020
en, corporations are able to settle lawsuits brought against them in secret, paying off litigants and hushing up the hazards that lurk in their products. Consumers deserve more transparency and accountability from these corporations. USA Today editorialized last week on this very problem, focusing on a product I’d never heard discussed in this debate, ironically a rifle.
In 2000, a nine-year-old Montana boy, Gus Barber, on a family hunting trip, was killed when his mother released the safety on a Remington 700 rifle to unload it and the gun discharged. Gus’ father later discovered that the company knew they had a safety problem for decades and never changed the design, admitted the problem, or recalled the rifles. By the time Gus was shot, more than 100 people had been injured and two-dozen killed. All these cases were buried through secret settlements, with judges sealing these confidential settlements, thus depriving the public from knowing about this deadly hazard.
The practice of sealing health and safety hazards, many of them deadly is unconscionable and dangerous. NCL and our fellow safety advocates have supported legislation introduced over the years in Congress to stop this practice, requiring judges to reject requests from plaintiff and defense lawyers to enter into secret settlements where dangerous products remain in the marketplace.
Gus Barber’s case is so outrageous that Montana joined four other states in adopting an anti-secrecy statute that prohibits their state courts from concealing information about public hazards.
Things may finally be turning around on this issue. In a recent case in Missouri, federal judge Ortrie Smith refused to seal a case against Remington for safety issues. That’s a hopeful sign. If we could get a federal bill passed, every judge would be required to follow Judge Smith’s example and refuse to deprive citizens of critical safety information that could have saved nine-year-old Gus Barber’s life.
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By Sally Greenberg, NCL Executive Director
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.