Legal Information and Resources

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…)

The good news keeps coming for Glaxo, the pharma giant that makes the diabetes drug Avandia. Yesterday the FDA ordered Glaxo to stop patient enrollment in a study that compared Avandia to a competing drug Actos, and to warn all patients already enrolled that Avandia may increase the risk of heart attacks.

Dr. Steven Nissen, whose 2007 study sounded the alarm about Avandia, was quoted in the New York Times today as saying he believed that the Panel’s findings about Avandia would eventually lead to suspension and abandonment of the study altogether. Nissen noted: “There was really no other action they [FDA] could take. Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”

Stay tuned.
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As a follow-up to my blog post of July 16, 1010, the Wall Street Journal today reports that an FDA panelist who voted to leave Glaxo’s diabetes drug Avandia on the US market with no additional restrictions received—wait for it folks—money from the drug maker for being a member of its “speakers bureau.” Philadelphia based endocrinologist David Capuzzi, M.D. told the WSJ that since he never gave talks “promoting” Avandia, he didn’t see any conflict of interest. Dr. Capuzzi was only one of three members of the 33 member panel who voted to leave Avandia on the market without further restrictions. (more…)

After 2 days of intensive hearings, the FDA Advisory Panel charged with oversight of the Glaxo-SmithKline diabetes drug Avandia (Rosiglitazone) recommend to FDA that the drug be either withdrawn or otherwise its use should be severely restricted. The ruling came as a result of analyses done of GSK studies and others which show that users of Avandia suffer a clearly increased risk of heart attack when using the drug. Some panel members also questioned the truthfulness of GSK in light of the questions raised by internal company documents that revealed Glaxo’s efforts to hide critical safety data. (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…)

The Philadelphia Inquirer recently interviewed partner, Jim Pettit, for a breaking news story arising from mercury contamination at a daycare center in Franklin Township, Gloucester County, New Jersey. Mr. Pettit is the court-appointed Lead Counsel in several class actions concerning Kiddie Kollege Daycare. In 2006 the state closed the daycare center upon learning that the children and were exposed to very high levels of mercury vapor. The daycare used to be a thermometer factory, and that was the source of the mercury contamination. On Friday, April 30, 2010, Mr. Pettit gained access to photographs of documents which had been left behind 4 years ago inside the building. The state had placed the documents inside a plastic bag when the building was razed and when the state then tested the air inside the plastic bag it found mercury levels that were too high to allow the lawyers in the litigation to touch the actual documents themselves. The state decided to photograph the documents and only then the photographs, not the documents themselves, were allowed to be viewed by Mr. Pettit. The NJ DEP spent about $700,000 cleaning up the site. Mr. Pettit represents a class of babies and children who attended Kiddie Kollege and is seeking payment for medical monitoring (surveillance) for the children. Trial is set for the fall of 2010.

Partner, Jim Pettit, was asked to join a speaker panel on the topic of Courtroom Technology. The seminar on April 27 was sponsored by the Camden County Bar Association. Mr. Pettit’s topic was Ten Technology Questions to Resolve Prior to Trial.

On April 5, 2010, NHTSA announced that it will seek the maximum possible penalty from Toyota – over $16 million. The government accused Toyota of a cover up. Under federal law, Toyota had five days to report problems with “sticking” gas pedals but instead waited months to take action. (Of course, this is separate and apart from the fact that there may be an internal electronic problem, not just “sticking” gas pedals.) Secretary LaHood blasted Toyota for knowingly hiding a dangerous defect. He accused Toyota of failing to take action to protect American consumers and drivers. This fine is the most the government could levy for the “sticking” gas pedals. Toyota also faces private lawsuits seeking many millions of dollars more. Should the fine be approved, it would represent the largest financial penalty ever imposed by the U.S. government on an automaker.

Is Toyota’s position that it should just fix its gas pedals sufficient? The National Highway Traffic Safety Administration (NHTSA) has already received ten (10) complaints of Sudden Unanticipated Acceleration (”SUA”) AFTER Toyota supposedly ‘fixed’ one million (1,000,000) recalled vehicles. If vehicles are still suddenly accelerating, then perhaps the “fix’ required is the far more expensive effort to fix the electronics.

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…)