Researchers looking to explain the increased risk of colorectal cancer in individuals who have had gastric bypass surgery discovered that a new generation of weight-loss drugs may pose a similar risk.
A research team at Mt. Sinai Hospital in Toronto looked at the action of bile acids and hormones residing in the gut. These chemicals aid digestion, and some of them, including glucagon-like peptide-2 (GLP-2), also work as growth factor hormones, stimulating cell division in the intestines, Medical Daily reports. The researchers conducted an experiment using mice to explore the effects on the mice of increasing the hormone, or eliminating it. Continue reading
Two Recent Court Rulings Reject Previous Court’s Interpretation of ‘Public Disclosure Bar’ in Whistleblower Lawsuits
Two recent court decisions may make it easier for whistleblowers to pursue a qui tam lawsuit filed under the False Claims Act (FCA). The rulings focus on the “public disclosure bar”, a procedural hurdle that dismisses a whistleblower’s case if it is “based upon the public disclosure of allegations or transactions” in specific ways, including a government “report, hearing, audit, or investigation,”; this does not apply if the whistleblower is the original source of that information.
In 1999, the U.S. Court of Appeals for the Seventh Circuit ruled that the public disclosure bar was applicable if information given to a “competent government official” was “publicly disclosed.” This decision can be problematic for whistleblowers because it allows cases to be dismissed if information was disclosed to the government but never available to the general public. Continue reading
The Food and Drug Administration (FDA) has issued a warning to doctors about testosterone-boosting drugs for men. The popular treatments have not been established as safe or effective for treating common signs of aging like low libido and fatigue.
The FDA warned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problems, The Associated Press (AP) reports. The agency says drug makers must clarify that their drugs are approved only to treat low testosterone levels caused by disease or injury, not normal aging. The FDA has directed manufacturers to add information to the labels about the potential risk and directed them to conduct a long-term study of the issue. Continue reading
Class Action Lawsuit over Premature Failure, Defects, and Formaldehyde in Lumber Liquidators Flooring
In a class action lawsuit filed in U.S. District Court in Northern California, consumers allege that their Lumber Liquidators flooring is defective and may crack, split, warp, and shrink sooner than claimed in the product’s warranty. They also allege that Lumber Liquidators flooring contains significantly high levels of the carcinogen formaldehyde.
One of the named plaintiffs, a West Virginia homeowner, had 517 square feet of flooring from Lumber Liquidators installed in her living room dining room and two hallways. According to the legal complaint, she purchased the product after reviewing samples at the store and being told by a Lumber Liquidators manager that the flooring was durable, the best product available, and sold with 30-year warranty. But within a few weeks of installation, the homeowner noticed the flooring was delaminating, warping, splitting, shrinking, scratching and deteriorating in various places. The installer made four attempts to repair the floors but Lumber Liquidators would not replace the flooring. Continue reading
A recent decision by the Supreme Court is expected to stop several insurers from attempting to cite the legal notion of subrogation, which is when insurance companies seek reimbursement for benefits paid for the insured.
Last July, the U.S. Court of Appeals for the Second Circuit ruled that New York’s anti-subrogation law is not preempted by the Employee Retirement Income Security Act (ERISA). The court ruled that the law, which prevents private health insurers from seeking reimbursement for medical benefits paid out of a tort settlement, is applicable to health insurers providing ERISA coverage. The litigation stems from a class action lawsuit originally filed in New York State Supreme Court. The case was moved to federal court when the District Court granted the defendants’ motion to dismiss for failure to state a claim based on ERISA preemption. The case was remanded to the District Court on appeal by the Court of Appeals for the Second Circuit; the court found that the plaintiffs’ claims were not subject to complete ERISA preemption. Continue reading
Consumers should think twice before purchasing weight loss supplements, particularly Oxy Elite Pro, the U.S. Food and Drug Administration (FDA) warned on Friday. According to Youth Health, a sample of Oxy Elite Pro shipped from a different country was found to have fluoxetine.
Oxy Elite Pro, like many weight loss supplements, is a type of thermogenic. This means that it tries to boost the body’s metabolism and burn fat by increasing the body’s internal heat. Continue reading
The Food and Drug Administration (FDA) has warned cosmetic giant L’Oréal, for the second time in three years, about improper marketing of skin care products.
Cosmetic products are not subject to the same scrutiny and regulation as drugs, but cosmetics are limited in the types of claims they can make to consumers, according to Regulatory Focus (from Regulatory Affairs Professionals Society). Federal law describes cosmetics as products “intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.” Cosmetics are not intended to heal, cure or otherwise affect the body’s structure or function. But if a product is marketed for a therapeutic use, such as treating or preventing disease, it is a drug under the law. Continue reading
A two-car crash involving the SUV of a Long Island fire chief in Hauppauge leaves three people injured. According to Associated Press, a car headed south on Route 111 hit an SUV belonging to the Stony Brook Fire Department chief. Parts of Routes 111 and 347 were subsequently closed. The car was driven by a man with one passenger, who suffered serious injuries and was taken to the hospital. The driver did not have any life-threatening injuries. Continue reading
In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients with drug-resistant bacteria at Ronald Reagan UCLA Medical Center.
A duodenoscope is a long, flexible tube with a tiny camera attached at the end. It is inserted through the throat to help diagnose gastrointestinal tract disorders. According to NYT, these devices have been linked to serious infections at several other hospitals. In 2013, 39 patients at Advocate Lutheran General Hospital in Chicago were infected with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing procedures with duodenoscopes. This is the same bacteria that caused recent infections in Los Angles. In January, Virginia Mason Hospital in Seattle said that from November 2012 to early 2014, 32 patients were infected with CRE through the scopes. Eleven of these patients ultimately died, but it is unknown whether the infections were to blame because they were already critically ill. Continue reading
HeartWare International is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System controllers distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012.
The company has written to clinicians and patients to inform them that the affected clinical trial controllers are more susceptible to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or death, according to HeartWare’s news release. HeartWare has improved the design of newer controllers to improve immunity to ESD. The recall does not affect the newer controllers. Continue reading