Articles Posted in Pharma

Prosecutors for Uncle Sam have charged that Swiss drug maker Novartis have paid massive kickbacks to 26,997 physicians including money, free dinners and entertainment to steer patients to Starlix and two of its hypertension pills, Lotrel and Valturna.

Under the Stark Act, an Anti-kickback law, it is not legal for a drug company to pay doctors to induce them to write prescriptions for the company’s drugs that are reimbursable under federal health care programs. Continue reading

The United States Food and Drug Administration (FDA) is now investigating reports of serious testosterone side effects and now major lawsuits have been filed against Abbott labs and AbbVie Inc. The suits allege that the companies which make AndroGel testosterone replacement hid major risks.  According to reports men  between the ages of 50 and 65, are claiming that they suffered serious side effects as a result of using AndroGel. Among the alleged side effects were heart attacks, stroke and a mini-stroke.

According to the case of  Aurecchia v. AbbVie Inc.,case number 1:14-cv-772, filed in Chicago,  AbbVie and Abbott “misrepresented that AndroGel is a safe and effective treatment for hypogonadism or ‘low testosterone,’ when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.” Continue reading

Pharma companies Endo Pharmaceuticals and Endo Health solutions will pay $192.7 million to resolve criminal and civil charges over their marketing of Lidoderm, a topical patch to relieve pain.

One it is applied, Lidoderm causes a loss of feeling. It is often used with surgery in treatment of emergency heart rhythm problems. It was only approved by the FDA for relief of post herpetic neuralgia.  According to Uncle Sam, the companies marketed the product for off label uses. Fraudulent bills were submitted to Medicare and Medicaid which were the false claims. Continue reading

The Food and Drug Administration is now concerned about the safety of drugs manufactured in India and is examining the products flooding the U.S. markets as a result of safety lapses, falsified drug test results and the selling of fake medicines.

India’s pharmaceutical companies supplies over 40 percent of the over-the-counter medicines in the U.S. The heightened concern by U.S. regulators stems from recent findings that some drugs entering our market were adulterated including the acne drug Acutane and the pain drug Neurontin. The generic versions of these drugs were banned from being imported from India.

Ranbaxy, India’s largest drug manufacturer pleaded guilty to feloney charged and paid a $500 million charge last year after being caught falsifying information to the F.D.A. Continue reading

Carefusion will pay $40.1 million to settle a government lawsuit and whistleblower allegations under the False Claims Act, that the company paid kickbacks to increase sales of its pre-surgical skincare product ChloraPrep.

In addition, the company is alleged to have promoted the product unlawfully for uses not approved by the FDA. In this situation it is alleged that it was marketed for pre-surgical treatment despite the fact that the FDA only approved it for preparation of a patient’s skin prior to surgery or injection.

The whistleblower in this case is  Dr. Cynthia Kirk a former vice president of regulatory affairs. She will receive $3.26 million as her qui tam award pursuant to the False Claims Act.

The whistleblowers at Johnson & Johnson who helped the federal government obtain $2.2 billion in fines from the company for bribing physicians, pharmacies and long term care managers to encourage sales of antipsychotic drugs will receive more than $20 million each.

The first who filed will each get $29 million from the settlement and the sixth will receive over $20 million.

Whistleblowers still have to pay their legal counsel and taxes. The lead whistleblower in the J& J Risperdal case Judy Doethert wore hidden microphones to J&J sales meetings .

The U.S. Food and Drug Administration is now warning consumers against a dietary body building supplement Mass Destruction found to contain a synthetic anabolic Steroid. The alert came just after a death which has been blamed on the product.

According to the FDA liver injury is a side affect of steroid use, others being testicle shrinkage, infertility, breast enlargement and increased risks for heart attach and stroke.

Mass Destruction in marketed through Blunt Force Nutrition. The manufacturer was not identified.

 

USPlabs LLC, has recalled specific OxyElite Pro dietary supplement products, marketed as an aid to losing weight and building muscles, after receiving a letter from FDA stating that the products have been linked to liver illnesses. FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

The FDA reviewed 46 medical records, submitted by the Hawaii Department of Health, and found that 27 patients had taken a dietary supplement labeled as OxyElite Pro before becoming ill. Seventeen of the patients reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

Judith Doetteri and Camille McGowan, both little known sales representatives for Johnson & Johnson turned whistleblowers and are credited now with exposing the largest pharmaceutical fraud scheme ever resulting in payment of over $2.2 BILLION in civil and criminal fines.

For nine long years, Doetteri and McGowan kept their secret, working under cover with federal investigators.

The allegations and evidence showed that J&J and one of its units Janssen Pharmaceuticals marketed Resperdal for unapproved uses and then paid kickbacks to doctors and pharmacists who prescribed and pushed the drug.

Johnson & Johnson has agreed to pay more than $2.2 BILLION to resolve state and federal charges of improper selling of prescription drugs for uses other than approved uses by the FDA and for paying kickbacks to doctors and a pharmacy to increase sales.

The settlement is the largest of its kind for health care and relates to sales of Risperdal, approved for use by the FDA for schizophrenia but marketed by J&J’s subsidiary to treat elderly dementia patients to treat symptoms of anxiety, agitation, depression and confusion. The government investigation revealed that Janssen, the subsidiary, emphasized symptoms and minimized any mention of the FDA approved use for schizophrenia.

The company also promoted the drug for use in children and the government said the company knew it posed special health risks for children. The company instructed its representatives to call on child psychiatrists and to market Risperdal as safe and effective for symptoms of various childhood disorders. The drugs was not approved for use in children for any purpose.