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Questions We Should Be Asking About the Meningitis Outbreak

November 2, 2015

As the investigation by the U.S. House of Representatives’ Energy and Commerce Committee into the causes of a recent outbreak of fungal meningitis continues, it seems to be revealing more and more disturbing information about what happened and why. The investigation began after a Tennessee man was diagnosed with fungal meningitis. Since this type of meningitis is very rare, his doctor investigated further in addition to reporting it to the Tennessee Department of Health. Since the patient had taken a back injection shortly before developing meningitis symptoms, investigators looked at the plant where the injection was manufactured, the New England … More

Investigation Into Meningitis Outbreak Now Includes State Inspectors

November 2, 2015

The federal government’s investigation into the recently outbreak of fungal meningitis, which occurred after patients were treated for back pain with contaminated steroids, has expanded to the state regulators who were supposed to be monitoring compounding pharmacies in Massachusetts. The outbreak may be linked to steroid injections manufactured by the New England Compounding Center in Massachusetts. After a Tennessee man contracted fungal meningitis, federal investigators visited the NECC and found fungus in several vials of steroids. NECC voluntarily recalled the steroids; however, over 13,000 people had already received injections. Since the recall, 184 people have been diagnosed with fungal meningitis … More

Actos Increases Risk In Diabetes Patients

November 2, 2015

After becoming the best-selling diabetes drug worldwide in 2007, Actos has been banned in France and Germany. Since its release onto the market in 1999, studies have linked Actos to a 40 percent higher rate of occurrence for bladder cancer in patients who take the drug for an extended period. Consequently, France and Germany have ordered doctors to stop prescribing the drug due to the increased risk of developing bladder cancer. However, the European Medicines Agency, which regulates drugs in the European Union, has decided to perform a safety review, stating the drug may be safe in some instances. The … More

FDA Must Turn Over 4,000 Documents Due To Whistleblowers

November 2, 2015

Scientists working for the U.S. Food and Drug Administration claim the agency spied on them illegally. In a court ruling, U.S. District Judge James Boasberg has ordered the FDA to immediately turn over 4,000 pages of material that the scientists requested. This ruling, in essence, speeds up the discovery phase of the trial. Additionally, remaining documents must be produced by September 10. All of these documents are in addition to ones that have already been released to the public. The case started three years ago when it was discovered by the FDA that some researchers within the agency had contacted … More

Judge Orders Top Execs To Testify In Transvaginal Mesh Case

November 2, 2015

Last month, Honorable Judge Carol Higbee of the New Jersey Superior Court ruled that three high level executives at Johnson & Johnson will have to testify in the controversial transvaginal mesh lawsuits. Higbee is in charge of more than a thousand transvaginal cases, which have been merged for litigation. The three top executives of Johnson & Johnson are Alex Gorsky who is the Chief Executive Officer, Sheri McCoy who is the for Vice Chairman of the company and Gary Pruden who is the leader of the company's Ethicon franchise. Judge Higbee ordered all three executives to be prepared to give … More

$5.5 Million Ruling in First Transvaginal Mesh Case

November 2, 2015

A treatment for pelvic organ prolapse and stress urinary incontinence, the transvaginal mesh has been linked to many serious complications. This device is a piece of mesh, surgically implanted through the vagina. This hammock-like device supports organs such as the bladder, rectum, and uterus to keep them from dropping when a woman's pelvic muscles are too weakened to support them. With hundreds of state and federal lawsuits underway for the manufacturers of this device, a California jury has finally reached a verdict on the first of these suits. The jury ruled in the favor of Christine Scott, who will endure … More

Public Health Demands Reproducible Medical Research

November 2, 2015

Academic research as well as clinical scientific trials need to be reproducible to be credible. With many more errors in these areas today, the Scientific Exchange, which is based in California, has announced a new program that will fact-check experimental findings. Called the Reproducibility Initiative, a board of 10 scientists will review scientific findings and validate the deserving ones. This will improve the trustworthiness of reports and clinical papers. The Science Exchange is putting together this initiative along with two scientific publishing websites for an online marketplace for scientists. There is a general lack of incentives and opportunities for validation. … More

New Benicar Litigation Tele-Seminar

August 1, 2015

August 7, 2014 – 2:00pm EST The very popular blood pressure medication, Benicar, causes severe intestinal malabsorption requiring hospitalizations for many consumers. On July 3, 2013, the FDA forced the manufacturer to change its label to warn about this serious side effect. Thus, it is only now that most gastroenterologists are learning of this association, requiring patients to suffer for prolonged periods of time and undergo unnecessarily high-risk procedures and medical treatment. Please join us as we discuss this rapidly developing pharmaceutical drug case. Speakers: Daniel Nigh, Levin Papantonio Thomas Mitchell Rafferty & Proctor Rayna Kessler, Lopez McHugh Travis Lepicier, … More

Endoscopic Devices Found to be Source of Deadly Infections

April 14, 2015

In February of 2015, the FDA issued a safety communication warning regarding the use of the medical devices known as ERCP endoscopes (also called duodenoscopes). The device is used as a less invasive alternative to surgery to open and drain fluids from blocked pancreatic and biliary ducts. Blockages can be due to gallstones, cancerous tumors, and other conditions. The device is inserted through the mouth and threaded through the esophagus, stomach and into the small intestine (duodenum) to reach the blocked area. The design includes an elevator tip that can change the angle of the tip when exiting the accessory … More

GlaxoSmithKline Fraud In Connection With Zofran

March 20, 2015

In June 2012, GlaxoSmithKline (GSK)—maker of Zofran, also known as ondansedtron—plead guilty to federal criminal health care fraud. In a watershed claim, a whistleblower came forward claiming that GSK wrongfully promoted Zofran for off-label prescription to expectant mothers, while also paying kickbacks to the doctors who were prescribing it for such use. In what would was the single largest health care fraud recovery in U.S. history, GSK was levied $1 billion in criminal penalties $2 billion in civil penalties. Zofran was originally approved by the FDA to help mitigate nausea and vomiting for patients being treated with cancer; but, GSK … More