Back in August I posted that the FDA was considering adopting new regulations that
would allow (and presumably encourage) generic drug manufacturers to add
or update the safety warnings on their products. At the time, they were
required to have exactly the same warnings as the name brand products. A new rule would allow manufacturers of generics to decide whether to use a different warning on their products. At the time of the proposal, some liked the idea (here), others did not (here).
Earlier this month, Pharmalot reported that the FDA has in fact proposed a new rule. The proposed rule will allow generic drugmakers to update labeling with
new safety information before an FDA review of the change. The agency
would then evaluate whether the proposed change is justified and make an
approval decision on the generic drug labeling change and the
corresponding brand drug labeling change at the same time.
As expected, the rule is controversial. Some agree that the new approach is a good idea (here, for example); others argue it is a bad idea (here and here, for example). For more comments see here.
One thing that bothers me about the discussion is that it seems to concentrate on whether the new rule will lead to more litigation, when I think the guiding concern should be whether it leads to more safety to consumers. The arguments based on the issue of litigation are based on the notion that litigation is per se a bad thing, forgetting that (a) not all litigation is unjustified and (b) sometimes the result of litigation is a safer product.
Back in March, 2012 I reported (here)
that Virginia Tech University had been found liable to the families of
students in a wrongful death claim for the University's negligent
response to the 2007 campus shootings. In June 2012, that verdict was upheld on appeal. Go here for more links.
Unfortunately for the plaintiffs in that case, however, the verdict was reduced to $100,000 for each family because of the state's damages cap,
an amount called by one commentator "an insulting amount of reduced damages that eliminated the deterrent
impact of such legal judgments."
And now, the Virginia Supreme Court has completely overturned the jury verdict on the ground that Virginia
Tech had no duty to warn the students. You can read the opinion here.
For a critical comment on it go here.
The Legal Talk Network has a podcast (here) on issues related to dog bite litigation including a discussion of the use of a
structured settlement in these specific cases and how these incidents
can be prevented.
The New Jersey State Appeals Court recently ruled that texting someone
while that person is driving may cause the sender to be liable if an
accident occurs. The Legal Talk Network has a podcast discussing the issue here.
The Dayton Daily News has a story on malpractice at
the Department of Veterans Affairs. The article notes that
VA health care providers are immune from lawsuits and details instances
of bonuses given to providers who had made medical errors or
administrators despite poor records at their facilities. The article
also quotes attorneys arguing that an early disclosure requirement and limits on
attorneys' fees (20% on settlements and 25% on awards) reduce the
amount of claims brought against the VA. VA med mal claims are paid from a federal treasury fund set aside for federal claims, not the VA budget. The article includes
poignant stories by individual victims of malpractice. Thanks to the TortsProf blog for the link.
Apparently, November 3 was "national sandwich day" and I didn't know. But, better late than never, in celebration, I will link to a story I posted way back in November of 2009 on the correct way to eat a sandwich.
And as a bonus, I will link to the famous "is a burrito a sandwich?" controversy, here and here.
As you probably know by now, there has been a good deal of discussion about whether it is possible for caffeinated drinks to contribute to, or cause, someone's death. (For my posts - and more links - on the issue go here, here, here, here, here, here, here and here.) Several cases have been filed over the issue, all of them involving young victims. Until now. The family of a 33 year old New York man has filed a wrongful death lawsuit against the makers of Red Bull, claiming that side effects of the energy drink caused him to suffer a fatal heart attack. AboutLawsuits has a summary of the complaint and some background information here.
For a better and more insightful comment you can read Max Kennerly's post here. He provides a detailed review of the complaint and the issues it raises. He concludes the design defect claim is weak but the warning one is a bit stronger.
One 250 ml can of Red Bull Energy Drink contains 80mg of caffeine, about the same amount of caffeine as in a cup of coffee. The defendant, no doubt, will use this fact to argue the product is not any more dangerous than coffee. The problem is that Red Bull is marketed differently than coffee. Kennerly's post discusses some of the marketing in Red Bull's own website and links to at least one scientific study that explores he consequences of the consumption of Red Bull.
As if that wasn't enough, though, there is another interesting aspect to the complaint. The complaint asked for $85 million in damages, when the law in New York bans requesting for specific amounts of money in complaints. As Eric Turkewitz argues when a lawyer asks for a specific amount in a complaint "[e]ither the lawyer is ignorant of the law or the lawyer is deliberately
violating it in the hunt for headlines. It’s your call as to which is
worse, ignorance or a potential ethics issue."
Eric's post is worth reading here.
He goes one to argue, correctly in my view, that the emphasis on the
amount of the claim detracts from the seriousness of the issue. The
story now becomes one about how much money the plaintiff's lawyer wants
instead of one about whether a product is in fact dangerous or whether
the defendant should change the way it markets the product.
Here is a link to a new article in Forbes on medical malpractice. It mentions many issues that anyone who has been paying attention to the issues knows already but that it doesn't hurt to repeat. (For more on those, click on the medical malpractice section of this blog and scroll down for the many posts on reports, studies and other sources that disprove the myths advanced by tort reformers). The article is long; the section on medical malpractice reform starts on page 3.
For example, the article points out that the cost of defending malpractice claims and compensating victims is a minimal part of overall healthcare costs, something every report on the subject has confirmed. The article also reminds us that only a
small percentage of the possible legitimate claims result in filed complaints, that so-called “defensive medicine” is one big myth, that state tort laws have no impact on where doctors decide to practice and very little, if any, impact on doctors’ insurance rates.
There are two other points that merit mentioning. The first one is also a point of constant contention in medical malpractice reform discussions: whether there is a problem with "frivolous lawsuits." The answer, depends, of course, on how you define frivolous. Tort reformers tend to define as frivolous any case that is won by the defendants or dropped by the plaintiffs. According to some reports doctors and hospitals win approximately 11% of all med-mal lawsuits filed and about 46% of the cases are dropped by the plaintiffs before trial. Does this suggest an abundance of frivolous cases?
The other interesting point in the article is something I had not heard before. The author argues that the shortening of the statute of limitations in some states (at urging of tort reform proponents) has resulted in more doctors getting sued. His reasoning is this: "as a way to stop the clock and preserve their rights, plaintiffs often include every conceivably liable doctor in the initial suit. But after more thorough investigation and discovery, plaintiffs recognize that many named parties did nothing wrong — and they drop the suit. In the meantime, the named doctors suffer the indignity and anxiety of having been included as defendants." According to this reasoning, allowing plaintiffs lawyers more time to prepare the cases would result in a more accurate determination of who should be included as defendants in the case.
I guess, the argument makes sense, but it is not necessarily true in every case. In many cases, it is not until discovery (after the case has been filed) that it can really be determined that a certain defendant should not be considered a possible tortfeasor.
The article also strongly criticizes the American College of Obstetrics and Gynecology, which it alleges, is an obstacle to patient safety.
The PopTort offers its own view of the article here.
A Philadelphia jury has ordered Johnson & Johnson to pay more than $4 million in damages for birth defects from Topamax, an anti-seizure medication that allegedly caused a child to develop cleft lip and other malformations as a result exposure before birth. Go here for more on the story.