Legal Information and Resources

On September 26, 2011, the FDA issued a notice that it was concerned about birth control pills with drospirenone and certain doses of estrogen causing blood clots. Yaz/Yasmin/Ocella are in this group. The preliminary results looked at by the FDA from an FDA-funded study showed women using those drugs face a 1 ½ times greater risk of blood clots than women using prior birth control pills. (more…)

The FDA Advisory Panel which met on September 9, 2011 called for changes in the warnings on Fosamax and other bisphosphonate drugs. The 17-6 vote, after four years of evaluation, may result in the FDA directing Merck and other companies to revise their labels. (more…)

On September 9, 2011, an Advisory Committee of the FDA studying drug safety will meet to conduct a review of bisphosphonates. These drugs include Fosamax, which was approved in 1995 and prescribed for osteoporosis and Paget’s disease of the bone. Some doctors have prescribed it for osteopenia. Studies have linked Fosamax with osteonecrosis of the jaw (ONJ) and femur (thigh bone) fractures. The FDA is considering “drug holidays” because of the risks of long-term use. Merck sells Fosamax and it will make a presentation to the Advisory Committee. Partner, Jim Pettit, is handling the firm’s Fosamax cases, and is filing them in Atlantic City, New Jersey. Mass Tort Judge Carol Higbee is managing all the Fosamax cases in the state.

Read the recent article in the New Jersey Lawyer from August 2011 answering the question, “Does medical monitoring still exist?”

On May 31, 2011, the FDA announced that it is reviewing two recent articles in the British Medical Journal on the issue of whether the progestin DROSPIRENONE (a component of YAZ, YASMIN, OCELLA and other birth control drugs) increases the risk of DVT (deep vein thrombosis) and of PE (pulmonary embolism). (more…)

In the January 25th issue of the Legal Intelligencer, Tom Gowen contributed an article about medical negligence reform, its illusory cost savings and the problems it presents. Several cost-saving alternatives are highlighted including the implementation of computerized physician order systems, prescription bar coding and smart pumps by medical facilities. (more…)

The fourth Fosamax case to go to trial in the country has just begun with jury selection before the Honorable Carol Higbee in Atlantic County, New Jersey. This is only the first non-federal court trial in the country. The first federal trial resulted in a mis-trial in 2009; the re-trial resulted in an $8 million verdict for plaintiff. (more…)

Natural gas provides heat and energy throughout the country but gas can be exceptionally dangerous either through its explosive powers or through its products of incomplete combustion–primarily carbon monoxide. Gas which is distributed through aging pipelines in many areas of the country can erupt with explosive force and destroy lives and buildings in seconds. Nationally, over 83,000 miles of distribution lines are untreated to prevent corrosion and are aging. Many of these mains are located in urban or heavily populated areas. (more…)

The plaintiffs in the Kiddie Kollege class action won victory today thanks to Jim Pettit and Pamela Lee of the Locks Law Firm, and counsel from several other firms. Jim Pettit was the Court-Appointed Lead Counsel. The class sought medical monitoring and were not seeking personal injury damages. (more…)

As reported in today’s New York Times Smith Kline Beecham (now Glaxo) utilized the services of professional medical ghostwriters Scientific Therapeutics Information located in Springfield, New Jersey to develop a timeline, outline and content for a medical textbook. The 269 page text, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care used to teach doctors how to treat psychiatric disorders with drugs has as its “official” authors two prominent medical authors. But an acknowledgment in the preface of the book for an “unrestricted educational grant” from SKB raised the investigative ire of lawyers suing Glaxo for damages related to its anti-depressant blockbuster drug Paxil.

As a result of documents obtained in those lawsuits, it is alleged that SKB hired STI to not only set up deadlines for the publication and to assist the authors, but also to write outlines and detailed chapter content. In essence, it is alleged that STI wrote the book, and the medical “authors” signed off on the transcript. Dr. David Kessler, former FDA Commissioner noted “To ghostwrite and entire textbook is a new level of chutzpah. I’ve never heard of that before. It takes your breath away.” Naturally, the authors and Glaxo claim that SKB “had no involvement in content” and that the authors themselves conceptualized the entire book and worked on all the content themselves.

As noted in some of my earlier blog posts, documents obtained in various drug lawsuits have shown that drug companies regularly use ghostwriting companies like STI (see Merck and the Vioxx litigation, for example, in which our firm was involved) to generate medical literature that supports, promotes and props up the use of a company’s drugs to doctors in order to increase sales. But as Dr. Kessler said, ghostwriting a whole textbook takes this to a new level.