The federal government seeks dismissal of a 2011 lawsuit filed on behalf of the victims of the Guatemalan medical experiments conducted by U.S. government researchers in 1946-1948. One day after the Department of Justices’ filing seeking dismissal, the U.S. Department of Health and Human Services (HHS), one of the defendants, announced it pledged $1.8 million to assist Guatemalan health authorities to fight STDs and improve research with human subjects.

Parker Waichman LLP, a national law firm, just announced its opposition to the motions. Last March, Parker Waichman LLP and a partner firm, filed the class action lawsuit in the U.S. District Court for the District of Columbia against HHS. The lawsuit also names eight current federal officials, including HHS Secretary, Kathleen Sebelius, and Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC). The filing was made on behalf of the Guatemalan medical experimentation victims (case number 1:11-cv-00527). As the government admitted, the lawsuit “arises out of a deeply troubling chapter in our nation’s history.”

In addition to compensatory and punitive damages for victims of the Guatemalan experiments and their descendants, the lawsuit seeks a declaration that the defendants violated human rights, and an injunction to prohibit further abuses against Guatemalan residents.

The U.S. government, in its initial response to the class-action, argued that it is immune to the lawsuit, noting that the harm took place in a foreign country and that the Guatemalans have not yet exhausted administrative solutions, explained CNN. Because of this, the government argued, the “U.S. has sovereign immunity under the Federal Tort Claims Act,” said CNN, citing the motion. According to the government, the Supreme Court “clarified” that the immunity statute “bars all claims based on any injury suffered in a foreign country, regardless of where the tortuous act or omission occurred,” according to CNN.

According to the federal complaint, between 1946 and 1948, U.S. government medical researchers working in Guatemala intentionally infected upwards of 1,300 prisoners, soldiers and psychiatric patients with syphilis and other sexually transmitted disease without their knowledge or permission in order to investigate the efficacy of penicillin in treating the diseases, Parker Waichman explained. The lawsuit cites two causes of action arising under the Alien Tort Statute for violations of the international prohibitions against medical experimentation on non-consenting human subjects and against cruel, inhuman degrading treatment; and two causes arising under the U.S. Constitution, for the violation of the victims’ right to due process and for subjecting them to cruel and unusual punishment.

The doctor who led the Guatemalan experiments, John C. Cutler, who helped coordinate the infamous Tuskegee, Alabama, study where 600 black men with syphilis were left untreated for decades starting in 1932, to follow the course of the treatable disease. The lawsuit alleges the decision to conduct research in Guatemala was part of a deliberate plan to continue the Tuskegee testing offshore, where it would not be subject to the same level of oversight as in the U.S., said Parker Waichman.

The study appears in the “FirstView” section of Psychological Medicine online. Benjamin J. Luft, M.D., an Edmund D. Pellegrino Professor of Medicine, and Medical Director of Stony Brook’s World Trade Center Health Program led the study in collaboration with Evelyn Bromet, Ph.D., Distinguished Professor at the Departments of Psychiatry and Behavioral Science, and Preventive Medicine at Stony Brook University School of Medicine, along with their team, said Medical News Today.

Those first on the scene to offer rescue and recovery assistance following the WTC attacks have suffered from a number of issues related to their exposure to the toxic dust that engulfed Ground Zero, noted NewsInferno. Current figures indicate that close to 60,000 people are enrolled in health-monitoring and treatment programs associated with the historic attack. Sadly, noted NewsInferno, many WTC responders have died as a result of their work at the sight.

The team noted that it was not just the toxic dust, but the very significant mental trauma that became part of what Medical News Today described as “an extraordinary environmental disaster.” The dangerous combination of combusting toxic jet fuel and debris fires along with the psychological havoc of experiencing severe death tolls and major destruction have led to the two ongoing and persistent health problems that have impacted responders both physically (respiratory illness) and psychologically (PTSD), said the study’s authors, wrote Medical News Today.

“This study illustrates the integral relationship between mental health and physical diseases that WTC responders suffer. The analysis not only shows that relationship but also connects PTSD as a possible co-factor in responders’ diseases, which reinforces our … that the illnesses suffered by 9/11 responders are a compilation of problems that often present as an entire syndrome of diseases and conditions,” said Dr. Luft, according to Medical News Today. 


The study, entitled “Exposure, Probable PTSD and Lower Respiratory Illness Among World Trade Center Rescue, Recovery and Clean-Up Workers,” involved a review of 8,508 traditional responders (mostly police officers) and 12,333 non-traditional responders (maintenance and transportation workers), between July 16, 2002, and September 11, 2008, explained Medical News Today. Reviews took place at WTC Health Program clinics, a New York Metro area network established by the National Institute for Occupational Safety and Health (NIOSH). Researchers analyzed linked patterns between exposures at the site; WTC-related PTSD; health risk factors, including obesity and smoking; and respiratory symptoms diagnosed by physicians that occurred following September and that continued at examination, along with abnormal pulmonary functioning measured by low forced vital capacity, said Medical News Today.

The team found an “extraordinary” link with respiratory symptoms and PTSD, along with proof that PTSD could possibly be involved in a “resolving role in the relationship between exposure and symptoms,” noted Medical News Today. “The results are indicative that PTSD appears to have a major and complex role in relation to respiratory illnesses in this patient population. Our findings mirror research results found in several veterans’ populations and in patients in primary care settings around the world. Mental and physical health are integrally linked. It is not always obvious which one is the driver, but in the end, what matters is that both mental and physical health are recognized and treated with equal care and respect,” concluded Dr. Bromet, a world-renowned expert in psychiatric epidemiology and disaster research, according to Medical News Today.

“The results are a first step in nailing down the exact relationship between PTSD and respiratory illness. We need to continue to study the relationship and its implications to help us to better treat responders who suffer from multiple mental and physical conditions,” added Dr. Luft.

The Insurance Journal explained that researchers utilized MRI (magnetic resonance imaging) testing to review cardiovascular risk in Ground Zero first responders.

The researchers used magnetic resonance imaging (MRI) to evaluate cardiovascular risk of WTC first responders. The data obtained was just presented at the American Heart Association’s Scientific Sessions 2011, which took place in Orlando, Florida. Findings reveal increased impairment in cardiac relaxation and coronary calcification in the Ground Zero group versus the population at large, said the Insurance Journal. This impairment was seen specifically in responders exposed to toxic dust at Ground Zero in the first two days following the 9/11 terrorist attacks.

“Using noninvasive MRI imaging, we were able to see a significant impact of the events of 9/11 on the cardiovascular health of the brave men and women who responded that day,” said Zahi Fayad, director of Mount Sinai School of Medicine’s translational and molecular imaging institute, the Insurance Journal wrote. “Now that we have visualized the risk and early development of vascular lesions, in a subset of subjects, we look forward to studying the use of imaging in the greater patient population,” Fayad added.

The study was conducted by researchers at Mount Sinai who have been reviewing cardiovascular health in Ground Zero first responders since 2007. The team evaluated the blood vessels of 19 responders exposed to high levels of particulate matter from the World Trade Center dust cloud; 12 responders exposed to lower particulate matter levels were also studied, said the Insurance Journal.

A recent Bloomberg News report stated that the 31 participants were considered fairly young, healthy, of an average age of 46, and part of a 2,500-person sub-set being followed since the terrorist attacks. Mary Ann McLaughlin, associate professor of medicine, is the study’s lead investigator.

. Of those studied, 19 high-exposure workers suffered from significantly worse endothelial dysfunction, a condition in which the membrane that lines the inside of heart and blood vessels works improperly, versus later responders, according to the study and a Mount Sinai press release. MRI scans revealed that patients with the most intense exposure revealed cholesterol plaques in their blood, indicating signs of increased blood vessel growth.

“This study defines physiologic change associated with greater exposure to the dust cloud at the WTC site,” said McLaughlin. “We are currently evaluating other predictors of cardiovascular risk in this population to gain a better understanding of the impact of particulate matter exposure on cardiovascular health,” reported the Insurance Journal.

The lawsuit alleges that, in 2008, Cedric Chan of California leased his pre-owned 2007 E63 AMG from a California dealer. Soon after, he complained of “loud, ticking noises from under the hood” and said the car suffered from an oil pressure drop, said Law360. When he brought his E63 in for repairs last year, mechanics found that the left-side camshafts and lifters were prematurely worn and needed replacement, according to Law360. Chan said he paid $4,600 on engine repairs to the left side of his car and, when the right-side engine had problems indicative of premature camshaft and lifter wear in June 2010, he traded the car for a $25,000 loss, said the lawsuit.

“As an owner or lessee of numerous Mercedes vehicles in the past, plaintiff expected to receive a product that conformed to the quality that Mercedes advertises for its AMG products,” the suit states, wrote Law360. “Alas, plaintiff did not even receive a vehicle that conformed to the lesser (but, still high) quality of Mercedes non-AMG vehicle line,” the complaint added. The vehicles sell from $60,000 to as high as $200,000.

The lawsuit alleges that the car maker violated the Magnuson-Moss Warranty Act and New Jersey state consumer protection laws; that Daimler was aware of the defects in the M156 engine as far back as its release to market in model year 2007, and that Daimler issued revisions to its service bulletins to mechanics over engine part replacement coverage, said Law360.

Mercedes-Benz USA LLC is a unit of Daimler and is New Jersey based. Daimler advertises the AMG series as a “high-performance vehicle” meant for automotive aficionados, according to the lawsuit, wrote Law360.

Earlier this week, the Presidential Commission for the Study of Bioethical Issues released results of its investigation of the Guatemalan research, following a White House briefing on the findings. The Commission has been investigating the Guatemalan experiments, at the order of President Obama.

The Commission said the PHS studies “involved intentionally exposing and infecting vulnerable populations to sexually transmitted diseases without the subjects’ consent.” Commission Chair Amy Gutmann, Ph.D., said that in the Commission’s “view, the Guatemala experiments involved unconscionable basic violations of ethics, even as judged against the researchers’ own recognition of the requirements of the medical ethics of the day. The individuals who approved, conducted, facilitated and funded these experiments are morally culpable to various degrees for these wrongs.”

Last year, research by Wellesley College professor Susan Reverby, discovered papers belonging to the project’s leader, Dr. John Cutler, in the University of Pittsburgh archives. When it was revealed that the PHS was a party to sexually transmitted disease research in Guatemala, the president asked Bioethics Commission to manage the probe on the studies. The complete report—“Ethically Impossible: STD Research in Guatemala from 1946-1953”—includes the Commission’s ethical analysis of the case, said the Commission. The report is posted on its website at www.bioethics.gov.

When some Guatemalan victims filed a lawsuit against the U.S. Department of Health and Human Services and other federal agencies this March, attorneys representing the victims, including the national law firm, Parker Waichman Alonso LLP, asked the Obama Administration to create a reparations claims process for the Guatemalan syphilis experiment victims/ The government did not respond to the request but, at a hearing last month discussing Guatemala investigation findings, the Commission urged the government to create a compensation system for people harmed from their research participation.

The Commission reviewed over 125,000 original pages of documents and 550 secondary sources collected from public and private nationwide archives and met with Guatemala’s internal investigation committee. The researchers conducted diagnostic tests on about 5,500 Guatemalan prison inmates, psychiatric patients, soldiers, prostitutes, and orphans and other children; 1,300 inmates, psychiatric patients, soldiers, and prostitutes were intentionally exposed to syphilis, gonorrhea, or chancroid, all sexually transmitted diseases. At least 83 died; however, the exact link between the research and their deaths remains unclear, said the Commission.

Cutler was also involved the well-known Tuskegee, Alabama, study in which 600 black men diagnosed with syphilis were left without treatment from 1932. To encourage participation in the Guatemala project, promised medical supplies and other perks to Guatemalan orphanages, prisons, and mental hospitals to allow the experiments. The panel’s stated noted that in 1943, the same team, also led by Cutler, conducted experiments on federal prison inmates in Terre Haute, Indiana. Inmates were intentionally infected with gonorrhea, but researchers in that case did seek consent. That was taken as proof that Cutler and his team must have known they had crossed ethical boundaries.

Following completion of the historical investigation, the Commission will continue its review of today’s standards for protecting human research participants. The report expected to be released to the President in December.

The religious court noted that parents should explain to their children that reporting
sexual abuse to a parent or rabbi is an obligation, but omitted any mention of making a report to police. Members of the Orthodox community consider this notice a sign of progress for a community that is accused of overlooking the topic of sexual abuse, but others feel it’s just more of the same.

An expert on sexual abuse in the Orthodox community criticized the Beit Din for not emphasizing the importance of reporting an incident to the police or youth-protection authorities.

“The Beit Din hijacks the criminal justice system because it supplants it and usurps the authority,” said Amy Neustein, editor of “Tempest in the Temple: Jewish Communities and Child Sex Scandals.”

Neustein believes the religious court is “proficient at obstructing justice.”
Supporters of the advisory believe the religious court should also urge people to contact the proper authorities.

However, the executive director of the rabbinical court, Rabbi Saul Emmanuel, defends the court’s suggestion saying, “The notice doesn’t discuss an incident. The notice talks about education.”

Emanuel believes advising the community on whether to report incidents of sexual abuse to the police is not within the court’s purview.

Since the recent brutal killing of eight-year-old Leiby Kletzky, the Orthodox community has faced national criticism of its position on reporting sexual abuse.

On July 12, Shmuel Kamenetsky, the vice president of Agudath Israel of America’s Supreme Council of Rabbinic Ages, addressed a crowd in Brooklyn and repeated the Agudath’s official policy which bans Jews from reporting sexual child abuse to police.

Now, Agudath is responding to the “misleading claims” saying, Kamenetsky’s statement “referred to rabbinic arguments that authorities should be notified when a certain threshold of evidence is met, but ‘where the circumstances of the case do not rise to threshold level…the matter should not be reported to authorities,’” reported the Jerusalem Post.

To determine if the threshold is met, Agudath advises that “the individual shouldn’t rely exclusively on their own judgment; rather, he should present the facts to a rabbi.”

Despite their clarification on the official law of reporting sexual abuse, some members of the Orthodox community are appalled by Kamenetsky’s comments and called on Agudath to issue a retraction.

Kamenetsky’s speech was made as the search for 8-year-old Lieby Kletzky was being conducted. The boy’s dismembered body was found the following day in a dumpster and in the apartment of Levi Aron, reported Jewish & Israel News. On July 21, Aron was indicted for the murder of Kletzky.

According to a report by the New York Post, Kamenetsky was repeating Agudath Israel of America’s official policy which bans Jews from reporting sexual child abuse to police. The Orthodox group believes that “someone who suspects sexual abuse by a community member must first consult a rabbi ‘with experience in these issues.’”

“There are prohibitions and a psychological fear about saying bad things about people or talking about negative things that bring shame,” said Michael Salamon, a Long Island, N.Y. psychologist.

The taboo of including the outside-world may result in tragic consequences for the Jewish community.

There are reports that Levi Aron tried to abduct another young boy near his house, but the incident was never reported to the police.

In November 2009, Motty Berger, 24, jumped to his death from a Williamsburg hotel after confiding to relatives that he was molested while attending a yeshiva; the allegations were never reported to the police.

In the early 1990s, David Kramer, a former teacher at the Yeshiva College in East St. Kilda, fled Australia after parents accused him of sexually abusing their sons, reported BigPond News.

The allegations were never reported to the police, and parents claim the risk of their children being removed from the school caused them not to involve law enforcement.

The Victorian police plan to meet with Jewish community leaders, in an effort to receive their approval for former students of the Orthodox school to come forward with similar accusations of abuse by Kramer.

In 2007, the runaway teach was incarcerated in the U.S. for molesting a 12-year-old boy, while Kramer was conducting a youth program in a St. Louis synagogue.

U.S. Representative Peter King (R-NY), chairman of the House of Homeland Security Committee, sent a letter to the FBI asking that they investigation whether Rupert Murdoch’s company used bribery and illegal wiretapping to access the voice mails of Sept. 11 victims.

Several elected officials have also asked FBI Director Robert Mueller to investigate News Corp.’s possible violation of the law by paying police for stories, reported Bloomberg.

The FBI’s probe came after claims emerged that the Murdoch media empire also hacked into the telephones of various individuals living in England.

Last week, Murdoch closed the 168-year-old The News of the World tabloid after reports revealed the publication’s employees hacked voice mails of murder victims.

King said, “If these allegations are proven true the conduct would merit felony charges for attempting to violate federal statutes related to corruption of public officials and prohibitions against wiretapping,” reported the LA Times.

According to the New York Times, the FBI field office in New York will look into the allegations under a squad that investigates cybercrimes and another that focuses on public corruption and white-collar crimes.

On July 19, Murdoch, 80, and his son, James Murdoch, are scheduled to testify before the U.K. Parliament regarding the hacking allegations.

News Corp. stock fell 2.8 percent in Australia, a total of 12 percent this week, says Bloomberg.

The justices were presented with the interesting issue of whether makers of generic drugs, whose products must mimic the warning labels of the corresponding brand-name drugs and who cannot alter those labels, should also be sued under state law for failing to warn users about the risks posed by their products,” reported the New York Times.

Justice Clarence Thomas agreed with the majority, concluding that “federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus pre-empt state claims.”

A similar issue was decided in Wyeth v. Levine, when the Court addressed whether federal law pre-empts state law in personal injury claims against drug manufacturers. The high court held that federal law did not preempt the plaintiff’s state claim; thus, allowing makers of brand-name drugs to be sued under state law for failing to adequately warn consumers.

In the present case, the companies relied on the fact that federal law requires generic drugs to have the same labels as their brand-name equivalent. They argued federal law barred such lawsuits since the U.S. Food and Drug Administration (FDA) approved the drugs; therefore, making it illegal for the companies to alter drug labels.

Unlike generic drug companies, brand-name drug makers are permitted to sometimes change the labels on their products without FDA permission, says the Times.

The high court recognized this issue and agreed the generic drug makers “had no choice but to use the same drug labels as the brand manufacturer,” reported Reuters.

The lawsuit was brought by women who took the generic equivalent of Reglan. The plaintiffs claimed defendants, Teva Pharmaceutical, UDL Laboratories and Actavis Inc., failed to warn consumers of increased risks of developing a neurological movement disorder, reported Reuters.

When the plaintiffs started taking the drug, the FDA approved label said that ‘“therapy longer than 12 weeks has not been evaluated and cannot be recommended;’” however, in 2004, it was changed to say therapy should not exceed 12 weeks. In 2009, the FDA ordered that a specific warning about the movement disorder be added to Reglan and its generic brand equivalent, metoclopramide.

Life settlements, also referred to as viatical settlements, are the sale of an existing life insurance policy to an investor. Companies similar to Life Partners will arrange to purchase life insurance policies from individuals and sell interest to investors. The investor pays a required premium on the policy and collects proceeds upon the insured’s death.

The firm’s methodology is under questions because the life expectancy estimate is integral in determining the value of a life settlement. The shorter an insured’s life span is, the more the firm can charge investors. However, if the insured lives longer than expected, the investor’s payout is delayed and they must continue to pay a premium until the insured dies.

As morbid as it sounds, the sale of life settlements is legal. According to the North American Securities Administration, which represents state securities regulators, life settlements are complex and dense making them prone to fraud. In 2009, the selling of life settlements made it to the Association’s list of top 10 investor traps.

The Wall Street Journal reported that since Life Partners was founded in 1991, the company has sold 6,400 policies at a face value of $2.8 billion to over 27,000 clients. The company promoted yearly returns of 10 to 15 percent; however, a large number of the insured outlived the life expectancy estimates.

The Wall Street Journal investigation also revealed that in 2002 the company brokered investments in 297 life policies, and in 95 percent of the policies the insured was alive at the end of the life expectancy estimate. “Actuaries say if life-expectancy calculations on a group of people are well done, half should die by their projected dates. Policies brokered in 2003 and 2004 show similar patterns.”

The Journal reported that Brian Pardo, Life Partners’ founder and chief executive, admitted many of the company’s life expectancy estimates “are probably wrong.” The company receives estimates “from a doctor in Reno, Nev., who has testified in court that he never checks the accuracy of his prior predictions.”

To provide investors a cushion, the company claims that it prices their life settlements “at a steep-enough discount to their face value” in the case the life expectancy estimate is incorrect. Life Partners also claims to warn investors that the insured may live pass the estimate. Pardo commented, “Even if an elderly insured lived 12 years” pass the life expectancy estimate, an investor would “still make as much as they would in a bank deposit.

The Journal provided an example of Life Partners flawed methodology. In September 2008, the company sold a $10.8 million policy for a 78-year-old insured male. The company gave investors a three to five year life expectancy estimate; however, two independent firms separately projected the man to live 11 years. Pardo denied any error in the estimate.

The SEC also recommended civil action against Pardo and general counsel and President, R. Scott Peden. Aside from the potential SEC lawsuit, Life Partners is being sued by several investors; some are seeking class action status.