Posted in Drug & Medical Devices on December 12, 2013

German pharmaceutical company Boehringer Ingelheim has been fined $931,000 in federal court for withholding or failing to preserve documents sought by plaintiffs in hundreds of Pradaxa lawsuits. According to court documents, Boehringer failed to preserve or produce files belonging to a high-level scientist, sales representatives, consultants and others. The drugmaker also failed to provide...

Posted in Drug & Medical Devices on December 3, 2013

It seems you can’t turn on the radio without hearing an ad for dietary supplements claiming to help with everything from diabetes to erectile dysfunction. Sometimes scams are obvious, but such a distinction is not always as clear. Advertisements like these can confuse consumers because the Food and Drug Administration (FDA) regulates dietary supplements...

Posted in Drug & Medical Devices on November 5, 2013

In one of the largest payouts in history, people from three states will be taking home a share of the $167.7 million awarded to whistleblowers for exposing Johnson & Johnson’s use of improper marketing and kickbacks. $2 Billion Settlement In a press conference yesterday, Attorney General Eric Holder told reporters that Johnson & Johnson...

Posted in Drug & Medical Devices, Medical Malpractice on November 4, 2013

Nearly 30 patients in California have sued neurosurgeon Dr. Aria Sabit for medical malpractice; alleging he subjected them to needless spinal surgeries using implants supplied by a company from which he profited. Dr. Sabit has already settled six of the cases out of court for undisclosed amounts. In the latest suit, an elderly patient...

Posted in Drug & Medical Devices on October 9, 2013

The chemotherapy drug Doxil may soon be in short supply. That’s bad news for women battling ovarian cancer, patients with cancer of the blood, and those suffering from AIDS-related Kaposi’s sarcoma. Ben Venue Laboratories Inc., the sole manufacturer of Johnson & Johnson’s cancer drug Doxil, announced they will be shutting their doors by the...

Posted in Drug & Medical Devices on September 26, 2013

  FDA looking at mobile medical applications From programming your DVR to dealing with a car accident, these days there seems to be an “app” for everything. Now, according to the U.S. Food and Drug Administration, when a mobile device runs certain medical applications, it will be subject to FDA oversight. The FDA has...

Posted in Drug & Medical Devices on September 24, 2013

The Food and Drug Administration (FDA) has issued a new rule requiring that most medical devices distributed in the United States carry a unique code. The code, also known as a unique device identifier (UDI), will include information about each specific device, including: model number, lot or batch number, serial number, the date the...

Posted in Drug & Medical Devices on September 19, 2013

The U.S. Food and Drug Administration (FDA) announced that a federal judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group of Lewis Center, Ohio for manufacturing and labeling violations. The company repackages and distributes drug products to hospitals across the country. A consent decree is a legal agreement between...

Posted in Drug & Medical Devices on September 16, 2013

Former Johnson & Johnson executive claims he was fired for whistleblowing about product safety – he warned management 15 years ago that Ortho-Evra was dangerous. A three-judge appellate panel in New Jersey has overturned the dismissal of a whistleblower retaliation lawsuit filed against J&J and its subsidiary Ethicon by Joel S. Lippman. The former...

Posted in Drug & Medical Devices on August 23, 2013

New study shows children taking antipsychotics are three times more likely to develop diabetes. As if parents of children with behavioral issues didn't have enough to worry about, new research shows certain medicines prescribed to treat ADD and other disorders may lead to serious health problems. A recent study published in JAMA Psychiatry reveals...