Monday, June 8, 2015

FDA panel recommends approval of controversial drug FDA has rejected twice already

Almost exactly five years ago I reported on a German pharmaceutical company's attempt to market a drug claiming it helps treat a disorder related to female sexual desire while others argued that the pharmaceutical company were trying to take advantage of women to sell them something they did not need (and potentially endanger their health) in pursuit of billion dollar profits.  The FDA eventually rejected the proposal after a study showed the drug failed to meet agreed-upon criteria to establish its effectiveness.  Go here for my report, which includes the trailers of a documentary on the controversial drug.

After the failed attempt to introduce the drug in the American market, the German pharmaceutical company dropped the drug. However, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. The FDA nixed it, again.

Yet, just a few days ago, an FDA advisory panel voted to recommend approval of the drug.  The FDA does not have to follow the advise of the panel but it usually does.

It will be interesting to see if the FDA does approve the drug this time around, since none of the reports I have seen mentions that there are different studies supporting a different conclusion than the ones available when the drug was rejected in the past.  If approved, I am sure the controversy discussed in the documentary mentioned in my earlier comment will be revived.  And when the drug is shown to cause injuries, it will inevitably result in litigation.  (Yes, I said "when" rather than "if" on purpose.  As has been discussed elsewhere, and reprinted in Smithsonian magazine "the drug also comes with side effects like sudden drops in blood pressure, sleepiness and fainting spells, it's unclear whether the benefits outweigh risks.")

For more information on the controversy, go here.  For more on the approval process, NPR has a story here.  For more on the drug itself, Smithsonian has a story here.

UPDATE 6/13/15:  The New York Times has published a short editorial on this subject here.  Among other things it concludes that "the panel’s recommendation was laced with so many caveats that it seems clear that this particular drug — flibanserin — is only marginally effective and carries some risk of serious adverse effects."

Possible liability of parents for denying medical care to child due to religious reasons, and issues related to vaccines, ... again

I have posted a number of comments on the possibility of imposing liability on parents when they cause an injury to a child when refusing to provide medical care because of religious beliefs. See here.  I have also posted on the relationship of this issue and the debates on vaccines.  See here

Here is an update: The California state Senate just overruled a long-standing law that permitted parents with religious and philosophical reservations to send their children to public and private schools without their shots.

Slate has a recent article on the issue called "Faith Healing Kills Children."  You can read it  here.

Thursday, May 21, 2015

Illinois Supreme Court holds proximate cause applies to intentional tort claims, which precludes claim for death caused by suicide but contradicts itself in the process

Back in April I wrote a comment on an oral argument before the Illinois Supreme Court in an interesting case that asked the court to recognize a cause of action for wrongful death when the defendant’s alleged intentional infliction of emotional distress caused the decedent to commit suicide.  As I explained there, Illinois has decided that, in the context of a negligence claim, a suicide is unforeseeable as a matter of law, which means that it always operates as a superseding cause that defeats the element of proximate cause.  What made the case before the Court different, however, is that it was brought as an intentional tort claim based on intentional infliction of emotional distress.  The case is called Turcios v. DeBruler Company

In my original post, I quoted a popular Torts hornbook which states that “[a]uthority is sparse as to when, if ever, proximate cause will preclude liability for intentional torts. In light of the greater culpability inherent in intentional wrongdoing, court appear, at the very least, ready to stretch to find liability."

It is now clear that the Illinois Supreme Court is not willing, much less, ready, to make this “stretch.”  In reaching its decision, the Court first concluded that the concept of foreseeability, embodied in the doctrine of proximate causation, limits the liability of both negligent and intentional tortfeasors, holding that “[p]laintiffs’ view, under which legal cause plays no role in the liability of an intentional tortfeasor, essentially creates open ended and limitless liability for injury, no matter how abnormal, extraordinary, irregular, or remote the injury may be.” [Interestingly, the court noted that plaintiffs conceded during the oral argument that some line drawing must be made, and that an intentional tortfeasor is not necessarily liable for all  consequences flowing from the defendant’s conduct. You can listen to the oral argument here.]

Having decided that intentional tort liability should be limited by applying the concept of proximate cause, the Court then applied the proximate cause analysis to the context of the case and concluded, as it has done consistently in the past, that because the death of the decedent was the result of a suicide, it was unforseeable, and therefore the plaintiff failed to satisfy the element of proximate cause.

In reaching this conclusion, however, and perhaps without noticing it, the Court contradicts its long held position on suicide and opens the door for future arguments against it when it states:
"Because an intentional tortfeasor’s liability is limited by the concept of foreseeability embodied in the doctrine of proximate causation, a cause of action for wrongful death predicated on a suicide allegedly brought about by the intentional infliction of emotional distress is subject to the general rule that suicide is unforeseeable as a matter of law. Thus, the plaintiff bears a heavy burden of pleading and proving facts that would overcome application of the rule.

....

Accordingly, we hold that where, as here, a plaintiff seeks to recover damages for wrongful death based on the decedent’s suicide allegedly brought about through the intentional infliction of emotional distress, the plaintiff must . . . plead facts which, if proven, would overcome application of the general rule that suicide is deemed unforeseeable as a matter of law. In other words, a plaintiff must plead facts demonstrating that the suicide was foreseeable, i.e., that it was a likely result of the defendant’s conduct."
Here is what I find interesting about this.  If a plaintiff can argue that the suicide is foreseeable, then by definition, the suicide is no longer unforeseeable as a matter of law.  If it can be argued that in some cases it is foreseeable while it is not in others, then the court is implying that reasonable people could disagree as to whether it is foreseeable at all, making the question one for the jury.  Doesn't that, by definition take the question out of the realm of "a matter of law"?  And, if this is the case, then what the court is implying is that when applying the proximate cause analysis to cases where the injury is death by suicide, the analysis should be the same as in all other cases, ie, to determine if the injury is a foreseeable consequence of the risk created by the conduct.

Thus, the way I am reading this, while reiterating its long held position on whether suicide is foreseeable, the court is actually abandoning it.

The case is Turcios v. DeBruler Company and you can read the opinion here.

Tuesday, May 19, 2015

Jury awards $3.5 million in case involving a wife getting exposed to asbestos in her husband's work clothes

A Washington state jury has awarded $3.5 million to the estate of a woman who died of mesothelioma she contracted from exposure to asbestos carried home on her husband’s work clothes.  AboutLawsuits has the story here.

Most asbestos cases involve plaintiffs who were exposed to asbestos at work, but the plaintiff in this case was exposed to asbestos due to her contact with her husband, who as a result of his work, carried asbestos fibers home on his work clothes.  In a case like this, the issue of whether the possible liability of the defendant should be limited to the person exposed to asbestos directly at work. In the end, the issue is one of proximate cause or duty. Should the duty of the defendant extend to include the injuries suffered by anyone exposed to the fibers, or just to the injuries of those exposed at work?

The case is similar to a case in California in which the jury awarded $27.3 million in damages, and a case in Illinios in which the court remanded the case to allow the plaintiff a chance to support its allegation of duty.  You can read my comment on those cases here.

Friday, May 15, 2015

G.M.’s Ignition Switch Death Toll Hits 100, but many claims may be dismissed because of the effect of the company's 2009 bankruptcy

The consequences of General Motors’ long-delayed recall of defective small cars hit a grim milestone recently, when the company’s compensation fund said it had approved the 100th death claim tied to faulty ignition switches. The toll far exceeds the 13 victims that G.M. had said last year were the only known fatalities linked to ignitions that could suddenly cut off engine power and disable airbags.  The New York Times has the full story here. However, a large number of lawsuits filed against GM may be dismissed following a recent bankruptcy court ruling blocking lawsuits filed against General Motors over actions that predate its 2009 bankruptcy, declaring that “New GM” and “Old GM” are two different companies and that the new company is not liable for the actions of the old one. AboutLawsuits has that story here.

Tuesday, May 12, 2015

Comment on new book on tort reform and health care costs

The PopTort has a good comment on Steven Brill's new book on health care, called “America's Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System,” in which he concludes, apparently without attempting to support that conclusison, that “Democrats resistance to ‘sensible Tort reform’” is a major reason why we have out of control health care costs.  As anyone who has been paying attention to the topic of tort reform and health care over the last few years know, this claim is not supported by the evidence.  And so it was pointed out in a recent Sunday New York Times book review of “America’s Bitter Pill.”   The PopTort has a comment on the book and the book review here.

For more on the issue of tort reform and medical costs go to my section on med mal (here) and scroll down.  Be patient and take your time.  There are more than 200 posts in that section including many with links to studies and reports clearly debunking the mythical relationship between tort reform and health care costs.

Tuesday, April 28, 2015

Missouri adopts new caps on damages

The TortsProf blog is reporting on another cap on damages legisltation, with an interesting "twist" -- it sounds like the cap is essentially optional, something I had never seen before:
In 2012, the Missouri Supreme Court struck down that state's med mal damage cap.  The legislature has passed a replacement, and it is now awaiting Governor Jay Nixon's decision whether to sign it.  In sum:  The bill, if signed into law, would place a $400,000 cap on noneconomic damage awards in medical malpractice cases. The cap would be raised to $700,000 for catastrophic and wrongful death cases. Both caps would then increase by 1.7 percent each year.
There is a catch to the law. A jury would still be able to award an amount greater than the allowed caps. If a motion is then made contesting the award, the trial court will determine whether the limitations apply in that case.
The reason I say this sounds like an "optional" cap is that the jury apparently will not be told of the cap and it will only be applied if the affected party requests it AND the court decides to apply it.  I assume that a decision not to apply it will be reviewable (and I also assume under an abuse of discretion standard, but I don't know).

UPDATE 5/12/15:  The bill has been signed into law.  Details here.

Monday, April 27, 2015

Parental immunity for "free range parents"?

Maybe it was just a coincidence, but just as I was due to teach the issues related to parental immunity in class, I have seen a number of stories related to torts involving parents and children.  I recently posted stories on a possible duty to vaccinate (here and here), possible liability for parents who expose a child to an exorcism (here), and issues related to pre natal torts (here).

Now, here is a story about "free range parents" from Above the Law (with lots of links including one to a recent article in the Washington Post).  It discusses "examples of clashes between parents who believe their kids deserve some autonomy and child protective services workers who are charged with taking every potential threat to a child’s safety seriously."

When we talk about parental immunity, we invariably discuss the policy behind the immunity as being that parents should have the right to make decisions on how to raise their children without undue interference from the state.  Parents also have the right to make mistakes and not have to be liable in all cases.  Obviously, the question then becomes when does the interference of the state ceases to be "undue" and becomes justified.

This is precisely the policy question behind the debate on free range parenting.

In addition, another by product of the debate is the possibility of using criminal or child welfare statutes as expressions of a duty in tort law (by applying the so called "negligence per se" doctrine). 

Update on the issue of vaccines

I recently commented on whether there should a cause of action against the parents of a child who do not vaccinate their children.  See here.  In that comment I wrote that "In California, . . . a bill is making its way through the system that would allow children to opt out of mandatory school vaccinations only if they have a medical condition that justifies an exemption. (NPR has the story here.) "

As an update to the issue, here is a link to an article in the New York Times on the bill in California.  

Maryland legislature approves increasing cap on damages in cases vs municipalities

As reported in the TortsProf blog, "[t]he current cap in place for Maryland's municipalities is $200,000 per claim/$500,000 per incident.  The House passed an increase to $300,000/$600,000 and the Senate passed an increase to $500,000/$1,000,000.  Perhaps not surprisingly, a conference committee approved $400,000/$800,000 and that passed 89-45 in the House and 33-14 in the Senate.  The bill also extends the filing period from 6 months to 1 year.  HB 113 awaits the governor's signature."

On fetal homicide and pre natal torts

As has been reported elsewhere, "[i]n the wake of a savage attack on a pregnant woman and the removal of her fetus, Colorado lawmakers are planning to introduce a bill that would criminalize fetal homicide. If the bill passes, the state would join nearly 40 others that make fetuses a distinct class of victims."  (Here is a short clip for the tv show Law & Order in which the characters discuss the issue.)

The question of whether an unborn fetus should be considered a person is very interesting and can have important implications for tort law also.  As you probably remember from your torts class in law school, many jurisdictions have addressed the question of whether we should recognize a cause of action for the wrongful birth of a stillborn fetus either by common law or statute.  And, as you probably remember also, there are three approaches to the question:  there is no cause of action because the fetus is not a person since it was never alive, there is a cause of action if it can be shown the fetus was viable and there is a cause of action because the fetus is a person from the moment of conception.

The question becomes even more interesting when the person who causes the death of the fetus is the mother.  In Illinois, for example, even though the state recognizes the right of the next of kin to claim for the wrongful death of a fetus, the Supreme Court has found that this right could not be claimed against the mother.  This holding was reaffirmed last year by the state's Appellate Court.  I wrote about that case, and the law in Illinois, here.

I am writing today about this topic again because a few days ago, the New York Times published a piece criticizing the proposed Colorado statute based on the same arguments the courts in Illinois have used to reject the right to recover against a mother who negligently causes an injury to her unborn child.  The article is called "How not to protect pregnant women" and it is available here.  You should read the full article, but here is the gist of the argument:
Opposition to the creation of fetal victimhood has focused largely on the threat to abortion rights. This is a legitimate concern, but affording victim status to a fetus has implications beyond the erosion of abortion rights. Legally severing a fetus from the pregnant woman has the effect of pitting her interests against the fetus’s.
Over time, this move has increased the state’s power to interfere in the lives of pregnant women. . . .
Granting personhood to fetuses makes women criminally responsible, not only for the life of the fetus, but also for its well-being. This is a particularly high burden. Pregnancy in our society tends to be idealized and women counted on to provide a perfect uterine environment.
Fetal rights can be employed to justify punishing any deviation from this standard. This is not hypothetical: Pregnant women have already been prosecuted for using drugs, refusing a cesarean section, having sex against a doctor’s recommendation and attempting suicide.
Prosecutors could, in theory, use the notion of “prenatal abuse” to pursue pregnant women who consumed too little folic acid; neglected exercise; gained too much or too little weight; continued on a course of anti-depressants; or had a stressful job. Under the mantle of fetal protection, pregnancy could become subject not only to criminal sanction but to pervasive state regulation.
These are essentially the same reasons why Illinois has rejected a possible cause of action in tort against a mother for fetal injury.