Legal Information and Resources

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…)

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…)

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.

Further to my June 24 blog and as reported in the The Boston Globe, Harvard Medical School has joined the ranks of medical educational facilities that have enacted new, tough conflict-of –interest rules affecting the payment of educators and others by Big Pharma and Medical Device manufacturers. (more…)

Lawyers who bring claims for persons hurt by defective medical devices and drugs have long known that both industries provide significant funds—to the tune of 1.2 billion dollars—to finance continuing legal education for doctors. We also know that pharmaceutical and medical device companies sponsor “educational programs” for doctors that highlight their products with paid “though leaders” —physicians hand-picked by industry—as presenters at these programs. But some doctors and medical schools are finally saying enough is enough—no more industry money. (more…)

Partners Jonathan Miller and Michael Galpern were recently interviewed by Trial magazine of the American Association for Justice for their role in the recent Nicastro v. McIntyre Machinery victory. The full text of the article is found below:

March 4, 2010
New Jersey residents can sue foreign companies in state court, high court rules

Carmel Sileo

The New Jersey Supreme Court has ruled that a foreign manufacturer can be sued in New Jersey state court for selling dangerous products there. In affirming an intermediate court decision, the state’s highest court held that “a foreign manufacturer that places a defective product in the stream of commerce through a distribution scheme that targets a national market, which includes New Jersey, may be subject to the in personam jurisdiction of a New Jersey court in a product liability action.” (Nicastro v. McIntyre Machinery, 2010 WL 343563 (N.J. Feb. 2, 2010).) (more…)

Readers of beauty magazines are familiar with the articles and advertisements that feature physicians touting the “magical results” that come from using various products to correct conditions ranging from cellulite to droopy underarm skin, from yellow teeth to wrinkles. In response to escalating complaints from consumers, the FDA has launched a new effort to rein in the more extravagant claims—especially when the claims involve doctor-pitchmen or pitch-women, and the products are drugs.

The New York Times today reports that in a shot across the beauty and the doctor medical bow, FDA has issued a warning to a well known dermatologist and clinical researcher in Miami Beach alleging that she improperly advocated the use of an as yet unapproved drug she promoted for the “treatment” of wrinkles. Dr. Leslie Baumann was issued a warning letter advising the doctor that she engaged in promotion of an unapproved drug, which is a violation of FDA policy. Unfortunately, Dr. Baumann is rather the rule than the exception in an industry where media exposure is critical for both the sales of such products and to expand the clientele of the doctors that use them.

The New York Times reports today that the FDA, in a long overdue move, will require stricter test data from the manufacturers of medical devices used in humans. The Agency has long been under fire from Consumer groups and members of Congress who cite increasing problems in recent years with such devices as heart defibrillators, pacemakers and cardiac stents. These groups contend the problems with these devices should have been identified much earlier in the clinical testing phase so they could be remedied, or, at the very least, so doctors and their patients could be properly warned about potential negative effects. Some of these problems have lead to deaths in the patients who have used them. Other patients were required to undergo surgery to remove the defective devices and have them replaced.

This move by the FDA comes partially as a result of studies published electronically in JAMA, the Journal of the American Medical Association which detailed a number of inadequacies in the data and its analysis that is routinely performed by medical device companies and furnished to FDA for device approval. The issue of whether or not device manufacturer give sufficient information to FDA for device approval and monitoring has become a hot button issue since the United States Supreme Court’s ruling in the Riegel case which essentially stripped consumers of their rights to go to court for injuries related to defective devices.

Naturally, an industry spokesman has diminished the findings of the JAMA study and of FDA’s efforts to require more complete information. The spokesman noted that the information FDA requires is already rigorous and she said that industry would respond more specifically in the coming days.

In a recent study published Monday in the Archives of Internal Medicine several authors propose a new way of monitoring drugs that could increase the margin of safety for consumers. Utilizing internal documents from the Vioxx litigation, Dr. Joseph S. Ross of the Mt. Sinai School of Medicine in New York and others set out a method of analyzing clinical studies and post-marketing surveillance data that showed had Merck utilized their method, the cardiovascular risk of Vioxx would have been known two years before Merck withdrew the drug from the US market.
“How could we be doing post-market surveillance in a better way?” said Dr. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in Manhattan. “For drugs that we are concerned about, that are high risk, this could be a blueprint going forward.” The method used is called meta-analysis, which simply means analyzing a number of studies together in order to obtain a larger view of drug safety. DR. Ross and his co-authors looked at 30 placebo controlled studies in which Vioxx was administered for at least 4 week or longer in doses of 12.5 mg or greater. “Placebo controlled” means a group of matched subject were given a sugar pill and compared to subject given Vioxx in order to validate the study results. Utilizing this process, Dr. Ross and colleagues determined that the risk associated with Vioxx was evident 2 years before withdrawal.
Merck has questioned the research method and contends that its own meta-analysis did not reveal any risk until the time of withdrawal. Other critics note that “there are so many drugs on the market that it would probably be impossible, if not prohibitively expensive, to cumulatively track all of them, said Dr. Elliott M. Antman, a professor of medicine at the Harvard Medical School. Still, Dr. Antman said it would make sense for the agency to give conditional approval to certain new drugs, requiring drug makers to file cumulative analyses of safety and efficacy data several years later in order to obtain permanent approval.

As thousands of Americans descended on the National Mall this past Saturday to protest President Barack Obama’s health care agenda, the rallying cry for tort reform was again a popular theme. Who can forget the so-called ”medical malpractice crisis” in New Jersey back in 2004, when hundreds of doctors in their white coats picketed outside the Statehouse in Trenton. (more…)