The Best of 2012, A Year In Review

This is the perfect time to take a look back at the year that has come to an end and feel gratitude for all the good fortune that has come my way. Each year since I started my firm the blessings continue to flow. Before We Start…. THANK YOU I would like to thank my wonderful team. I could not accomplish …

Oregon Court Allows 510K Application Into Evidence

We take a look at the admissibility of FDA 510(k) application in a medical device product liability case.  Case:  McClellan v. I-Flow, Inc., 2010 WL 3954092 (Dist. Ct. 2010) (U.S. District Court of Oregon) Plaintiff filed a Motion to Admit Newly Discovered Evidence to introduce documents received from the FDA in response to a FOIA request for the regulatory …

States To J&J: Off-Label Promotion Is Off-Limits

J&J recently settled with 36 states over claims that it marketed the antipsychotic drug Risperdal for unapproved uses (a/k/a Off-Label). J&J agreed to pay $181 million to the states. What is interesting about this settlement is that one provision, for the first time ever, restricts the way J&J markets their antipsychotics. J&J agreed to not distribute reprints of peer-reviewed scientific …

The Role Of The FDA In Drug Approval

What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of clinical trials. The FDA Doesn’t …

What’s The Deal With BPA In Baby Bottles?

The chemical BPA is leeching into our food and poisoning our babies! Run! Hide! BPA is everywhere. The FDA finally made the decision to ban the chemical from baby bottles joining the European Union and Canada. But what is BPA? Is it really a risk to our health? What Is BPA? BPA is a chemical used to make plastics. Water …

Big Pharma’s New 10 Point Credibility Initiative Isn’t Enough

Let’s face it: the pharmaceutical industry has a credibility gap.  In a recent article, Mayo Clinic Proceedings, they even admit that the credibility of industry-funded research has suffered greatly in recent years.  The article’s authors outline 10 recommendations to repair the reputation of industry-funded research. Transparency is the clear focus of the recommendations.  The general theme is to empower physicians and other scientists …

Drug Sales Down? Change The Disease

The definition of addiction is getting a re-write in the Diagnostic and Statistical Manual of Mental Disorders (“DSM”). This change would result in coverage for treatment of these illnesses by Medicaid, Medicare and other health insurers. While some of the changes are welcome, such as recognizing that gambling is an addiction, there are those that are suspect. There is discussion …

Mercury Poisoning Linked To Skin Products

FDA says that many anti-aging, smoothing, skin-lightening, and beauty lotions and creams sold at ethnic beauty shops and online have dangerous levels of Mercury. Mercury Poisoning Linked to Skin Products View more documents from Law Offices of Sadaka Associates LLC.