Researchers with the U.S. Substance Abuse and Mental Health Administration (SAMHSA) pored through data from a public health surveillance system and found a near 220 percent increase from 2005 to 2010 in emergency room visits involving side effects related to these sleep aids.

Zolpidem-containing drugs include the brand names Ambien, Ambien CR, Intermezzo, Stilnox and Sublinox, as well as generic versions. The medication is used to treat insomnia and, in some cases, brain disorders. The drug works quickly – usually within 15 minutes – and has a short half-life of about two to three hours.

Adverse reactions to zolpidem-containing drugs includes hallucinations, dizziness, and drowsiness while driving. Women were the most affected by the drug’s side effects.

The Food and Drug Administration (FDA) has already raised red flags about the sleeping pills. In January, the agency recommended that the dosage be lowered for drugs that contain zolpidem, in particular for women as they seem to be more susceptible to the risk because their bodies eliminate the active ingredient more slowly than men.

Drowsiness is listed as a common side effect on the drugs’ labels, along with warnings that people who use the drug may still feel drowsy the day after taking the pill. People who take the drugs can also experience impairment of mental alertness the morning after use even if they feel fully awake.

Source: JAAPA

SOURCE: Righting Injustice › Sleeping pills land more people in emergency room than ever before

“We want to make sure that salon owners are aware that if they use these products, they have to implement protective measures such as air monitoring and training,” said Dr. David Michaels, the Occupational Safety and Health Administration’s (OSHA) Assistant Secretary of Labor. “What is very troubling to the agency is that some of these products clearly expose workers to formaldehyde even when the label states they are ‘formaldehyde free.’”

Formaldehyde can irritate the eyes and nose; cause allergic reactions of the skin, eyes, and lungs; and is a significant cancer hazard. Salons that choose to use products that may contain or release formaldehyde are required to abide by OSHA’s formaldehyde and hazard communication standards to keep workers safe.

However, the agency said it continues to respond to complaints about formaldehyde exposure in salons, beauty schools, and manufacturing facilities. In 2011, OSHA issued citations to 223 hair salon owners and beauty schools in Connecticut, Massachusetts, Pennsylvania, Florida, Illinois, New York, New Jersey, and Ohio with some fines topping $17,000 for failing to protect workers from potential exposure to formaldehyde and overexposure to formaldehyde.

Violations OSHA inspectors found in salons include failure to communicate the hazards of formaldehyde exposure, failure to provide needed protective equipment to workers, and failure to test the air’s formaldehyde levels. OSHA says that its inspections uncovered some instances in which stylists were exposed to levels of formaldehyde several times the maximum allowable limit, exposure times that exceeded the federally mandated 15-minute limit, and concentrations of formaldehyde in the air that went far above the 2.0 parts per million parts of air maximum.

In hair-product manufacturing and distribution facilities, OSHA inspectors found violations that included failing to protect workers from formaldehyde exposure in addition to not communicating the hazards of formaldehyde exposure to salons, stylists, and consumers. In some cases, the companies failed to list formaldehyde as a hazardous ingredient on the material safety data sheet, the hazard warning sheet provided to users such as salon owners and stylists, or include the required warnings on product labels.

“The best way to control exposure to formaldehyde is to use products that do not contain formaldehyde. Salons should check the label or product information to make sure it does not list formaldehyde, formalin, methylene glycol or any of the other names for formaldehyde,” said Dr. Michaels. “If salon owners decide to use products that contain or release formaldehyde, then they must follow a number of protective practices — including air monitoring, worker training and, if levels are over OSHA limits, good ventilation or respirators.”

Source:

The Occupational Safety and Health Administration

SOURCE: Righting Injustice › Salon industry workers often exposed to toxic levels of formaldehyde

The whistleblower case originated with Cori and Kerri Rigsby of Ocean Springs, Miss., sisters who worked for an Alabama contractor State Farm hired to assess damages after the hurricane. The borderline category-3 / category-4 storm was the costliest and most destructive storm in U.S. history. It decimated entire cities along the Gulf Coast from Louisiana to Alabama.

The sisters provided the court with evidence that State Farm was allegedly defrauding both policyholders and the U.S. government by fabricating engineer reports so that claims could be denied. By attributing damage caused by high winds to flooding instead, the company could shift its liability to the federal government, which provides flood insurance and covers flood-related damages.

According to the Associated Press, the Rigsbys pursued cases for several policyholders, but a federal judge in U.S. District Court in Gulfport, Miss., where the cases were filed limited the initial trial to just one case “because the sisters have firsthand knowledge of how the claim was handled.”

After nearly three hours, the jury returned a verdict in favor of the plaintiffs. State Farm was ordered to pay $250,000 to the U.S. government in the one case that was tried, involving a house in Biloxi, Miss., that was completely destroyed in the storm.

State Farm filed a motion asking the judge to void the jury’s findings. The company seeks a new trial.

An attorney representing the Rigsby sisters said that State Farm has filed numerous motions in the last seven years in an effort to keep the case from going before a jury.

“Now, after a unanimous jury from the coast decided in less than three hours that State Farm intentionally committed fraud against the United States government, State Farm is making the same arguments that have failed repeatedly prior to trial. The jury’s verdict should stand,” the lawyer told the Associated Press.

“As you will see from the papers filed by the Rigsbys, this verdict reveals only the tip of the iceberg regarding the depth and scope of State Farm’s fraud,” he added. “The Rigsbys have now proven that State Farm committed fraud. The only question left is how big was the fraud and how much money was involved,” he said.

The Associated Press reports that State Farm has filed a counter claim against the Rigsby sisters, claiming they took company documents when they became suspicious of what the company was doing with the claims.

Source:

The Associated Press

SOURCE: Righting Injustice › State Farm seeks new trial in Mississippi whistleblower fraud case

The “Tort Reform” movement, often sold to the public as a righteous attack on “frivolous” lawsuits, is, according to the AAJ, actually a “movement to shield corporations from accountability by eliminating access to the court for consumers, workers and patients.”

Corporations have used a number of strategies to keep Americans out of the courts. Many, for instance, legally bind consumers to forced arbitration as a condition for doing business with a company. This often means that customers who want a product or service must agree to give up their right to sue should they be harmed in any way. The agreement is often hidden in plain sight, tucked away in the small print.

Other attacks on civil justice come in the form of capped damages in the consumer’s state; using corporate money to influence Congress, political elections and judicial appointments; and key legislation that can restrict a citizen’s access to justice.

Take Justice Back spotlights five corporate front groups behind the giant push to rig the judicial system. According to AAJ, those groups are: the U.S. Chamber of Commerce’s Institute for Legal Reform (ILR), “whose sole mission is to eliminate the constitutional right to a trial by jury is the largest, most funded, and well-organized group working to restrict your rights at the federal level;” The American Legislative Exchange Council (ALEC), which AAJ calls “the ultimate shadowy front group pushing the tort reform movement at the state level;” the Civil Justice Reform Group (CJRG), which AAJ says is a “secretive” and “silent” group that has “no employees, no office, and leaves the lightest paper trail possible;” and the Searle Civil Justice Institute, which “coordinates empirical research efforts to limit your access to justice.”

The AAJ emphasizes that it is not anti-corporate, but it is solidly against the abuse of power wealthy corporations and their lobbies are wielding against the Constitutional rights of everyday Americans.

“Business built this great country into what it is today,” the Take Justice Back website explains. “But when corporations act irresponsibly they must be held accountable just like anybody else.”

Take Justice Back features an ongoing blog tracking developments pertaining to the erosion of legal rights in the U.S. and real-life stories of Americans who have fallen victim to unscrupulous policies and laws devised to shield corporations from accountability.

Source:

Take Justice Back

SOURCE: Righting Injustice › New website monitors how corporations, lobbyists are eroding our Constitutional rights

Children on dialysis have a much shorter life expectancy than adults receiving dialysis treatment. These children already face 30 percent greater risk of death compared to healthy children. Dialysis is the only life-saving therapy for them as they wait for a kidney transplant.

Researchers with Cincinnati Children’s Hospital Medical Center set out to determine if death rates had changed in these patients. Thus, they identified more than 23,000 children and adolescents younger than 21 with end-stage kidney disease who were initially treated with dialysis between 1990 and 2010. Then they reviewed deaths related to all-cause, cardiovascular events and infection.

They found that the all-cause mortality risk dropped progressively over time for both those younger than age 5 and those age 5 and older when treatment was started. They also found a decrease over time in cardiovascular and infection-related mortality in these patients. Researchers credit improved pre-dialysis care, advances in dialysis technology, and greater experience of dialysis clinicians.

Though improvements have been made in dialysis treatment, preventable problems can arise. Recently, the Food and Drug Administration (FDA) warned that the dialysis concentrate products GranuFlo and NaturaLyte made by dialysis services and products giant Fresenius Medical Care, had inadvertently been misused because instructions for use were confusing.

The products contain an ingredient that converts in the body to a substance known as bicarbonate. Elevated levels of bicarbonate in the blood can cause serious health consequences including sudden cardiac death. GranuFlo and NaturaLyte contain more of this ingredient than competitor products, which may lead to clinicians administering stronger-than-anticipated doses.

Fresenius is now facing numerous lawsuits for failing to adequately warn health care providers and patients of the serious risks associated with its products.

Source: Science Daily

SOURCE: Righting Injustice › Children on dialysis living longer than in years past

Depressed women

Women undergoing infertility treatments often battle depression. A study published in Medical News Today investigated depressed women undergoing infertility treatment and the risks to their fetuses while taking SSRIs. The new meta-analysis took a different approach than past studies, investigating the safety and efficacy of infertile women being treated with SSRIs.

Researchers culled through studies and found that SSRI is associated with lowered effectiveness of infertility treatment. It is also tied to an increased risk of miscarriage, difficulties during pregnancy, preterm birth, neonatal complications, and behavioral problems in babies exposed in utero. An increased risk of a lung defect known as newborn persistent pulmonary hypertension was also noted. In no instances was treatment with SSRIs shown to improve outcome for the pregnancies studied.

SSRIs include the brand names Paxil, Celexa, Lexapro, Zoloft, and Prozac. They are prescribed to treat major depressive disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, anxiety disorders, bulimia nervosa, and premenstrual dysphoric disorder (PMDD).

Researchers with the meta-analysis recommended that physicians who are caring for women with fertility issues consider the risks associated with SSRI use and consider recommending other treatments such as cognitive-behavioral therapy, physical exercise, and some form of counseling instead of the drugs.

Source: Oxford Journals

SOURCE: Righting Injustice › SSRI use during fertility treatments shows little benefit to mother or fetus

The company’s willful manufacture of 26 generic prescription drugs below the U.S. Food and Drug Administration’s (FDA) standards for strength, purity, and quality resulted in fraudulent claims submitted to Alabama’s Medicaid Agency as well as other state and federal health care programs.

“This settlement sends a strong message to international drug manufacturers that they must abide by the safety and quality standards of the United States, and if they violate these safeguards, they will be severely held to account,” said Attorney General Luther Strange. “I am pleased that we have recovered nearly $7 million in compensation to the Alabama Medicaid Agency for false and fraudulent claims that resulted from the Ranbaxy’s poor and unacceptable practices.”

The case originated with a whistleblower lawsuit filed in a federal court in Maryland under the False Claims Act and various state false claims laws. The False Claims Act contains a qui tam provision that allows whistleblowers with knowledge and evidence of wrongdoing to file a lawsuit on behalf of the federal government. The whistleblower is awarded a percentage of the recovery in successful cases, usually about 25 percent but as high as 30 percent.

The lawsuit alleged that Raxby knowingly made 26 inferior prescription drugs at its facilities in Paonta Sahib, India, and Dewas, India, between April 2003 and September 2010.

Ranbaxy agreed to pay $350 million in civil damages and penalties to resolve the allegations of its poor manufacturing practices and violations of U.S. safety laws. About $267 million of that will go back into Medicaid programs, which are jointly administered by the federal government and the states. Alabama will receive about $6.9 million of the funds recovered under the settlement.

Additionally, Ranbaxy USA, a subsidiary, pleaded guilty to seven felony charges alleging the company willfully violated the U.S. Food Drug, and Cosmetic Act, and agreed to pay $150 million in criminal fines and forfeitures.

The Ranbaxy case not only exposes fraudulent and potentially dangerous operations within Ranbaxy, considered to be one of the biggest and best of the generic drug makers, it also points toward the likelihood there may be other companies taking similar measures to cut costs and increase profits. It also underscores the woefully inadequate U.S. regulatory system, which typically inspects foreign drug making facilities once every 7 to 13 years.

This case also emphasizes the importance of whistleblower laws, which encourage people who see wrongdoing to report it. Whistleblowers are often the most effective “eyes and ears” for the detection of fraud, due to the inability of government regulators to provide effective and thorough coverage.

Sources:

Alabama Attorney General
New York Times

SOURCE: Righting Injustice › Generic drug maker settles whistleblower case for $500 million

Generic drug maker Ranbaxy Laboratories Limited

Ranbaxy pled guilty to making and selling adulterated drugs whose strength, purity or quality was inconsistent from the specifications. The company also admitted that it erroneously told the U.S. Food and Drug Administration (FDA) that it tested its drugs for impurities when in some cases the tests weren’t conducted until months later or were held on the same day.

Ranbaxy was fined $150 million plus $350 million to settle claims that it submitted false statements to Medicaid, Medicare and other government health care programs. A former Ranbaxy executive who alerted authorities to the case will receive about $49 million of that penalty.

The whistleblower, Dinesh Thakur, served as the Director of Project and Information Management at Ranbaxy. He says he discovered the company falsified drug data and systematically violated current good manufacturing practices and good laboratory practices eight years ago. When the company failed to correct the problem he notified health care authorities.

The penalty against Ranbaxy is the largest financial ruling against a generic drug company.

Source: PharmPro

SOURCE: Righting Injustice › Drug company fined $500 million for impure manufacturing practices

Victims

Transvaginal mesh, also known as surgical tape or bladder sling, is inserted through the vagina to hold up organs that have dropped. Since the device was first used, thousands of adverse events have been reported to federal agencies in both the United States and Canada.

Both the U.S. Food and Drug Administration and Health Canada issued safety warnings that the mesh may cause serious problems including erosion, organ perforation, hemorrhaging and even death. Many women have needed multiple surgeries to remove the mesh, and some never fully recover.

Rally participants held signs that read “Mesh hurt my mom,” and “Mesh injures women.” One woman enlarged Health Canada’s warning, highlighted sections and mounted it on a poster board.

“I had (transvaginal mesh) surgery four and a half years ago,” said Ami Johnson, who participated in the rally. “I wasn’t aware of the complications. (The procedure) was explained to me as a very simple, non-invasive, quick surgery.” Johnson and other rally participants say manufacturers of the mesh did not adequately warn people of the dangers associated with their products.

Thousands of women who allege they were injured by transvaginal mesh have filed lawsuits against the manufacturer. Attorneys say that time may be running out for victims to file claims. Any woman who has had surgery to implant the mesh and experienced problems should consult with a lawyer as soon as possible to determine if she may have a case against the manufacturer.

Source: Global News

SOURCE: Righting Injustice › Victims of transvaginal mesh hold rally to raise awareness

According to the case study filed with the Food and Drug Administration (FDA) Adverse Event Reporting Program, the woman developed avascular necrosis in her hips and right shoulder shortly after being implanted with the IUD. After the device was removed, the necrosis did not spread to her right shoulder. (Avascular necrosis tends to affect parallel joints.)

The woman had four surgeries in 2012 – three for core decompression and one hip replacement. She spent six months in a wheelchair and had to learn how to walk again. The condition is thought to have been an autoimmune response that led to blood loss in the bones.

There have been more than 47,000 adverse events reported with the Mirena IUD since it hit the market in 2000. Avascular necrosis is a highly unusual response. Most negative side effects associated with the Mirena IUD include device expulsion or dislocation, hemorrhaging, and abdominal pain. The device has also been associated with an increased risk for ectopic pregnancy, organ perforation and infection. In some cases, surgery and/or hospitalization was required.

Several women have filed lawsuits with Bayer Healthcare, maker of the Mirena IUD, claiming they were not adequately warned of the risks associated with the device.

Source: AdverseEvents

SOURCE: Righting Injustice › Woman’s bone disease linked to Mirena IUD