Archives for January 2013
by: Julie Andrews, Attorney
Two cases have recently appeared in the media sparking an interesting debate about the issue of child support for children who have been conceived via sperm donors. The question of the sperm donor’s legal responsibility to financially support the artificially conceived child has interesting considerations. The court decisions of these cases may surprise you.
by: Jonathan Knoll, Attorney
On January 10, 2013, the United States Court of Appeals for the Ninth Circuit sitting en banc found that the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (“FDCA”) did not preempt a plaintiff’s state-law failure to warn claim when the state-law duty “parallels” a manufacturer’s duty under federal law. In doing so, the Ninth Circuit reversed an earlier decision by a panel of the Court that had upheld the district court’s holding that the plaintiff’s claims were preempted by the MDA.
What do you remember from your high school science class? You probably remember designing and conducting experiments. You might even remember the partner that was assigned to you (hopefully someone smart). In your science class you learned about how a well-designed experiment could answer a question. You learned the importance of creating a set of procedures that would give you reliable data across several points. The outcome of your experiment was measured against a control group that did not receive special treatment so you would have a good model of comparison.
Is it possible for a drug or medical device manufacturer to conduct a study on the efficacy of its product without showing bias? Consider a study to compare three different branded drugs that are used for the treatment of a disease. If Company A sponsors the drug trial, will there be bias present to show that drug A is more effective?
Bias in clinical trials can be a very bad thing. A lot of money goes into the research and development of new drugs and medical devices. When the product reaches the clinical trial phase, a lot is riding on the results.