Article on clinical drug trials

Back in August, I reported that a study in Pediatrics found more and more pediatric drug trials are being conducted overseas. See here. Now, the most recent edition of Vanity Fair has published an article titled "Deadly Medicine" in which the authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in what it calls "a lethal profit machine." The reason for this description is summarized in the article's first paragraph: "Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?" You can read the full article here. For a comment on the article by the PopTort go here.

9/11 Health and Compensation Act in danger

The 9/11 Health and Compensation Act, which already passed the House, is up for a Senate vote and still seems one vote short to prevent a fillibuster. The bill would provide $7.4 billion over 10 years to provide health care and payments to sick and dying 9/11 first responders (supplementing the recent legal settlement by covering care for far more victims). It calls for closing tax loopholes on foreign corporations to raise the money - a move opposed by Republicans. Go here for more on the story.

Possible tort reform in Florida

Bad news for victims of torts in Florida. The Legislature is apparently contemplating adopting a wide variety of reforms to protect defendants (mostly businesses and doctors) from liability. As reported in the St Augustine Record (here), the measures seek to increase the burden of proof for plaintiffs in "slip-and-fall" cases, to cap the fees that the attorney general's office can pay to outside attorneys, to provide some protections, perhaps through the state's sovereign immunity, to doctors who treat Medicaid patients and to make it more difficult for witnesses to qualify as expert witnesses. As all tort reform measures, these are designed to make it more difficult for plaintiffs to get representation, to get to bring claims or to recover. Thanks to the TortsProf blog for the link.

Pfizer sends new warnings to doctors in the UK but not in the US

Pharmalot is reporting that last week, Pfizer sent doctors in the UK a letter warning them of the risk of osteonecrosis, or jaw bone damage, in cancer patients who are being treated with its Sutent medication However, the letter was not distributed to doctors in the US. Pharmalot asked Pfizer why and received what it calls a "non-committal reply." Read Pharmalot's story here. As Pharmalot concludes, the bottom line is that "doctors and patients in the US . . . are not being alerted to the same possible side effects as those in the UK. Perhaps the FDA may want to take a closer look, since Pfizer appears unwilling to treat all patients equally."

Access to Facebook

Facebook appears to be in the news almost daily these days and, for a number of different reasons, it is now clear that all lawyers need to educate themselves (and their clients) on how to use it and not to use it. That includes me, but I do know one thing: very little (if anything) is private on the internet. For more on the issues related to professional conduct and social media go to this section of my Professional Responsibility blog, particularly to this post with examples of some of the uses of social media that have created problems for lawyers and judges recently. Now here is the latest, via the Legal Profession Blog: Last year, the Philadelphia Bar Association issued an opinion (available here) concluding that seeking to surrepticiously “friend” an opposing party or witness on social media (such as Facebook), personally or through an agent would constitute unethical conduct. However, a Pennsylvania Court of Common Pleas recently held that a party may be compelled through the discovery process to provide an opponent with access to his Facebook and MySpace accounts. In a decision in the case of McMillen v. Hummingbird Speedway, Inc., handed down September 9, 2010, President Judge John Henry Foradora of the Court of Common Pleas of Jefferson County held that access to one’s social networking sites is not protected by any privilege, and that the plaintiff in a personal injury action could be compelled to reveal the usernames and passwords of his Facebook and MySpace accounts to counsel for the defendants (but not to the defendants themselves). The court looked closely at the privacy and disclosure policies of the sites in question, and concluded that users are on notice that information posted on them may be revealed to persons who have access to such information by process of law. A New York trial court decision reached the same result by a very similar analysis.

Is Congress going to abolish the learned intermediary doctrine?

In a recent interview, I argued that the time has come to take a careful look at the concept of the so-called "learned intermediary doctrine" in prescription drug cases. I am clearly not alone on this. At least two states have abolished the doctrine and Professor David Owen, author of leading textbooks and hornbooks on Products Liability has argued that "[i]n this day of mass merchandising of prescription drugs in the media, where drug manufacturers have chosen to jump over doctors and market their drugs directly to patients, it seems that manufacturers logically should have a corresponding duty to supply warnings of dangers directly to patients, too." (See here). Not surprisingly, those who favor defendants in these types of cases, disagree. That's why the Drug and Device Blog calls a bill to abolish the learned intermediary doctrine "something completly stupid." For their arguments in favor of the doctrine you can go here and here. Apparently, Rep. Bob Filner (D-CA) has introduced a bill (H.R. 6421) that seeks to abolish the learned intermediary rule. In summary, the bill says that "[i]t shall not be a defense to any tort claim in any court in the United States that a manufacture of a product has fulfilled that manufacturer's duty of care when the manufacturer provides all of the necessary information to a learned intermediary who then interacts with the consumer of the product." Unfortunately, the bill is probably not going anywhere. I would be incredibly surprised if it did - not only because of Congress is in a "lame duck session" but because of the powerful lobbying by the pharmeceutical industry.

Illinois Supreme Court to decide on manufacturer's post sale duty to warn

About three weeks ago, the Illinois Supreme Court heard oral arguments in a very interesting case that asks the court to decide whether to impose a post sale duty to warn as recognized in the Restaement of Torts (Third). The case is called Jablonski v. Ford Motor Company. The plaintiff in the case sued Ford after the 1993 Lincoln Town Car she and her husband were driving in was rear-ended. The collision forced a pipe wrench in their trunk through the walls of the fuel tank, causing a fire that killed her husband and left her severely burned. The 1993 Lincoln Town Car was one of four Ford vehicles, including one specifically designed for police, that was built with a fuel tank behind the rear axle. (I could be wrong about this, but I think that was the same design that caused problems for the infamous Pinto model.) In 2002, Ford contacted the owners of one of its models (one manufactured mostly, if not exclusively, for police departments) to notify them of the risk of fire, but Ford did not notify the owners of the other models. Those notifications informed owners of the availability of an upgrade kit, which consisted of shields designed to protect the fuel tank, as well as a drop-in trunk liner and a series of recommendations on how to pack things in the car's truck to avoid item puncturing the gas tank -- precisely what happened in the plaintiff's case. In her complaint against Ford, the plaintiff argued that the car manufacturer should be liable for failing to warn her when it knew of the risk and had warned owners of a different model car. The oral argument is worth watching. You can listen to the audio by going here or watch the video by going here.

Dermatologist Group Says Accutane Health Risks Outweighed by Benefits

An organization representing U.S. dermatologists say that they believe that the potential risk of bowel problems and suicide from side effects of Accutane are outweighed by the benefits provided by the drug in fighting severe acne. Go here for the full story. The drug's manufacturer discontinued the drug in the United States in June 2009, citing the increased costs associated with litigation over alleged health risks associated with the medication (more than 1,600 people are currently pursuing an Accutane lawsuit), but a number of generic Accutane versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

Class action vs Toyota still alive

A federal judge has rejected a motion to dismiss Toyota class action lawsuits filed by people who claim that they suffered economic loss as a result of recalls issued due to the risk of sudden acceleration. Go here for the full story. UPDATE: Dec 10, 2010: AboutLawsuits.com has the story here.

Week's top stories

I am sorry I have not been updating the blog as consistently as usual during this week. I have been working on finishing my last few classes of the year and preparing for exams and other things. Hopefully, I will have a few days before I have to start grading to catch up. Meanwhile, here is a link to the TortsProf list of most interesting stories of the week. For my own list go here and scroll down.