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On November 17, 2006, the Food and Drug Administration lifted a 14-year restriction on the sale of silicone breast implants in the United States, despite continued concern over the devices’ safety and implications for women’s health. The FDA order permits two companies, Mentor and Allergan, to begin marketing the devices.
Despite the recent approval, Director of the FDA’s Center for Devices and Radiological Health, Dr. Daniel Schultz, commented in a telephone interview reported by the New York Times that, “Women should know that breast implants are not lifetime devices,” and that, “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery.”
Many women’s health and consumer organizations expressed concern and anger over the decision to return silicone breast implants to the market in the absence of conclusive data guaranteeing their safety. Sybil Goldrich, a long time women’s health advocate and founder of the Command Trust Network, argued, “It is simply unacceptable to lift restrictions on the sale of these devices when there are so many known problems and so many unanswered questions.”
On June 21, 2006, Alliance for Justice released Independent Justice: How Our Civil Justice System Protects Consumers and Patients in Ways the Regulatory System Does Not. The report cites the experience of women injured by silicone breast implants and how they confronted the manufacturers. Using the courts they were able to peel away layers of secrecy, obfuscation and outright dishonesty to reveal the real danger of leaking silicone implants to the unaware public.
Before Congress adjourned for the elections in fall 2006, Alliance for Justice, the Center for Science in the Public Interest, and Public Citizen’s Congress Watch stopped a last-minute push by the restaurant industry to pass the so-called Commonsense Consumption Act (S.908) through the Senate. This bill, known by some as the "Cheeseburger Bill," would have prevented consumers and states from holding the food and dietary supplement industries liable for negligent and reckless conduct. In addition, it would have protected food manufacturers and restaurants from pending and future lawsuits to enforce state consumer protection laws.
Alliance for Justice, along with our coalition partners, sent a letter to Senate leaders encouraging them to oppose S. 908. Click here to read that letter.
The junk food industry claimed that S. 908 was needed to stop a flood of "frivolous" lawsuits. In fact, there has only been one instance of a lawsuit blaming a food company for making someone obese, and it was rejected by the court. This "flood" of frivolous lawsuits simply does not exist.
What the legislation really would have done is pre-empt state consumer protection laws and prevent state attorneys general from enforcing those laws. Under our Constitution, states have taken the lead in protecting consumers from unsafe products and unscrupulous advertising for hundreds of years. State attorneys general have diligently exercised that primary authority, and no evidence exists warranting such a dramatic usurpation of that authority.
As Senator Patrick Leahy (D-VT) stated in June 2006, "The incentives involved in litigation are one of the few remaining measures that lead to real corporate responsibility, not to mention accountability. The handful of lawsuits that would have been barred by this legislation actually resulted in settlements providing for more nutritious food in our schools, more accurate labeling for consumers and the removal of harmful trans fats from some of the foods we eat."
On June 21, 2006, Alliance for Justice released Independent Justice: How Our Civil Justice System Protects Consumers and Patients in Ways the Regulatory System Does Not
. Using the civil justice system, women injured by silicone breast implants confronted medical manufacturers. Plaintiffs peeled away layers of secrecy, obfuscation and outright dishonesty to reveal the real danger of leaking silicone implants to the unaware public.
To download a copy of the report, click here.
The report examines the history beginning in the 1960s when implants came on the market without any government approval, and continues through the onset of problems and the first successful lawsuit against a manufacturer in 1977. During the course of the litigation, company documents emerged that revealed strong internal concerns about the implants and established a startling lack of research into implant safety.
As the courts steadily uncovered information about implants, the FDA took halting steps before finally forcing manufacturers to do research that demonstrated their products’ safety. In the end, the manufacturers failed to do so, and the agency pulled implants from the general market in 1992. Only through the civil justice system was the general public made aware of the dangers that these implants could potentially pose to women’s health.
While reading this report, it is important to keep in mind that despite subsequent research that has confirmed that nearly all silicone implants eventually rupture, the FDA today appears poised to allow silicone-gel implants back on the market for cosmetic purposes.
The New England Journal of Medicine released a study in May 2006 that examined medical malpractice litigation. The study came out of the Harvard School of Public Health and is called “Claims, Errors and Compensation Payments in Medical Malpractice Litigation.” The authors determined that “portraits of a malpractice system that is stricken with frivolous litigation are overblown.” They went on to state that the tort system does a “reasonably well” job of “separating claims without merit from those with merit and compensating the latter.” Based on their research, the authors concluded that “moves to curb frivolous litigation, if successful, will have a relatively limited effect on the caseload and costs of litigation.”
Some media accounts, unfortunately, have misinterpreted the study. A USA Today headline screamed, “Study: 4 in 10 medical malpractice cases groundless.” But as clarified by the study’s lead researcher, David Studdert, in other media stories, “the findings challenge the view among tort reform supporters that the legal system is riddled with frivolous claims that lead to exorbitant payouts.” The study also noted that 97 percent of malpractice claims involve a severe injury or death.
On May 8, 2006,the Senate rejected a Republican-led effort to undermine the civil justice system by using the cloak of medical malpractice “reform” to pander to corporate interests as the November mid-term elections approached. Rather than offering real reform that expands healthcare solutions for ordinary Americans, the Senate rejected two bills that focused on limiting injured patients ability to hold doctors and insurance companies responsible for the negligent harm inflicted on them.
A cloture motion to end debate and proceed on the deceptively named, “Medical Care Access Protection Act of 2006” failed 48-42. A motion on a companion bill regarding OB-GYN care specifically, known as the “Healthy Mothers and Healthy Babies Access to Care Act,” failed 49-44.
These bills, modeled on Texas’s medical malpractice scheme, would have imposed a “one size fits all” cap on pain-and-suffering damages on every state that does not have an existing cap. The bills also failed to take into consideration the seriousness of varying injuries, and, not only limited liability for doctors and nurses, but also for HMOs, nursing homes, and the insurance industry.
Both bills would have capped non-economic damages at $250,000 on cases where only one medical institution or provider was at fault, which account for the vast majority of claims brought. In the rare case where multiple medical institutions were involved, the bill caped damages against all of the offending institutions at $500,000, with no one institution being responsible for more than $250,000 in damages. The second bill, directed at providers of obstetric and genealogical care, would have set similar restrictive caps for injured mothers and children.
The Alliance for Justice opposed these bills for several reasons:
- The impact of the legislation in Texas has been “brutal” to severely injured patients, especially elderly patients, stay at home moms and others who do not have high incomes. Because of these restrictive caps, many injured patients cannot find lawyers to take their cases because the potential recovery is so low, resulting in a lack of accountability for those who caused harm.
- These bills attempt to cap non-economic damages, which are currently awarded by juries. It should be up to individual citizens to determine these damages on a case by case basis, not up to law makers looking for a “one size fits all” solution.
- The assertion that there is a $750,000 cap is misleading since in an overwhelming majority of cases the cap would be only $250,000.
- These bills were an attempt to pander to political corporate interests in an election year and not an attempt at real reform. First of all, the sponsors of these bills attempted to move them forward to a vote without first going through committee or receiving necessary hearings and debate on the issue. Second, Senate Republicans did not introduce and acknowledge bills during “Health Week” that help to address the high cost of prescription drugs and healthcare or that many Americans are without basic healthcare.
Nursing home advocates released a report on April 28, 2006, that graphically illustrates the real consequences of nursing home resident abuse and neglect. The report by the National Citizen's Coalition for Nursing Home Reform is called "Faces of Neglect". For most of the elderly featured in the report, their only opportunity for justice came by turning to our legal system, often after government regulators failed to protect them. The tragic stories told by these seniors underscores the need for a vibrant and effective system of justice to hold long-term care facilities accountable for failing to provide adequate care.
In May 2006, consumer advocacy organization Public Citizen revealed how Senate Majority Leader Bill Frist (R-TN) and the Bush White House conspired with drug manufacturers to give the industry sweeping liability protection from lawsuits involving treatment of pandemic illnesses. Public Citizen's report, "Willful Misconduct: How Bill Frist and the Drug Lobby Covertly Bagged a Liability Shield," highlights internal documents from the Biotechnology Industry Organization to show the extent to which the drug industry exerted its influence to ensure passage of the shield provision. The provision was enacted into law late 2005.
Alliance for Justice opposed the provision at that time because it protected manufacturers from even gross negligence and reckless behavior, but provided no compensation for first responders and ordinary individuals who may suffer serious illness or death as a result of taking a public health emergency vaccine or other countermeasure. We also raised objections that the provision was put together in a backroom deal -- it was not passed by either the House or the Senate, nor ever debated on either Chamber's floor. To correct some of the unfairness of the legislation, Sen. Edward Kennedy successfully pushed for an amendment in the supplemental appropriations bill to provide a compensation fund for health professionals and first responders. Nonetheless, there are no compensation arrangements provided for others who may have injuries caused by the vaccine's side effects or by a defective batch of vaccine.
A group of doctors released an astonishing report in the April 2006 issue of Archives of Surgery on the problem of "wrong site surgeries." The report chronicles the instances when a surgeon will operate on an entirely wrong part, or side, of the body. Despite the increased public attention this issue has garnered, there is still no national standard to prevent this from occurring, causing, in some cases, serious injury to the patient.
Although most cases are not reported, at least one in 100,000 surgeries occurs on the wrong site, which, as Katie Couric noted, "If it happens to you, it's a big statistic."
While the horrors of patients waking up to find the wrong ear operated on or the wrong knee "fixed" shocks most Americans, it is important to point out that this is exactly the kind of horrors that the civil justice system works to correct and prevent.
In March 2006, Alliance for Justice released a comprehensive analysis of recent medical malpractice tort reform proposals circulating in Congress (find it here). AFJ’s groundbreaking study found that the current Health Courts plan would undermine the civil justice system by removing medical malpractice cases from courts and creating a complex new and untested administrative system to handle such claims. Legislation introduced in the Senate, S. 1337, would authorize federal funds that allow states to implement the Health Courts plan.
Alliance for Justice’s analysis found:
- The proposal takes away injured patients’ right to a jury trial without providing an alternative system that offers equal or better protection than our civil justice system.
- Because the proposal is modeled on the workers’ compensation system, it will likely suffer from the same flaws as the workers’ compensation system, which includes susceptibility to undue influence by powerful entities, like the insurance industry, whose interests are typically adverse to those of medical malpractice victims.
- By compensating victims according to a rigid pay-out schedule, the proposal imposes a de facto non-economic cap on injury claims.
- The proposal violates the principles of federalism. It contemplates supplanting centuries-old state tort systems with an unproven, federalized administrative system without good reason. There is no persuasive evidence that state court systems handling medical negligence claims are irremediably broken.
Alliance for Justice’s complete analysis and findings are available here.