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.

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…)

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…)

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.

Still another lot of Fentanyl Pain Patches has now been recalled. On October 21, Actavis, Inc (famous for its manufacturing defect of Digitek) recalled (but only to the wholesale level and the retail level) eighteen (18) lots of its Fentanyl Transdermal System 25 mcg/hour C-11 patches. Corium International (in the U.S.) was the company that manufactured the patches for Actavis. At least one lot (Control/Lot # 30349) was admitted to have at least one patch which released its active ingredient faster than the approved specification. That lot made it to market. Actavis, however, recalled 18 lots.

US and European regulators, in a highly unusual coordinated move have determined a course of action concerning Glaxo-Smith Kline’s diabetes drug Avandia, which was shown to be associated with an increased risk of heart attacks and stroke after Dr. Steven Nissen of the Cleveland Clinic performed an independent analysis of GSK’s own studies. European authorities will suspend the use of the drug and the FDA will severely restrict the use of the medication in the United States.

The New York Times reports today that the embattled diabetes drug will only be available to patients and their doctors in the US who attest that the drug is the last line of defense—that all other diabetes drugs have been tried in a patient without satisfactory results. Additionally, both patients and doctors will have to assert that the patient has been warned about the possible life-threatening side effects of Avandia.

GSK has been under fire for years as a result of its aggressive Avandia marketing efforts. After internal company documents were made public that revealed GSK’s efforts to hid negative test results, and a legal settlement which forced GSK to post drug study information on a website, Dr. Steven Nissen form the Cleveland Clinic performed an independent study that highlighted the cardiac dangers of the drug. FDA’s decision here highlights a new government tack that indicates Big Pharma may be under greater scrutiny in the coming years.

There have been five verdicts (four in New Jersey) in the Accutane litigation in plaintiffs’ favor, totaling $55 million. A couple of verdicts have, unfortunately, been reversed and sent back for a second trial. Most of the almost 1,000 cases are in New Jersey where manufacturer, Hoffman-LaRoche, is headquartered. (more…)

The Avandia news continues. Just last month, there was a meeting of a joint advisory committee reporting to the Food and Drug Administration (FDA) concerning the potential health risks of the diabetes drug Avandia. This was the second meeting of this committee. It originally met in July of 2007 and reported that Avandia was associated with an increased risk of heart attacks. Three years have now passed, and the committee has met again, and this time, although 12 members of the committee voted to withdraw Avandia from the marketplace, 21 members voted that it remain available for sale and use. (more…)