Two more comments on Mutual Pharmaceutical v Bartlett

I missed these links before when I posted on the Supreme Court's decision in Bartlett so I am posting it now separately.  Pharmalot has a comment here.  Reuters has a report here.

Here is an interesting point in the Reuters report:  Consumer watchdog group Public Citizen said the Supreme Court decision on Monday undermines patient safety at a time when about 80 percent of U.S. prescriptions are filled with generic medicines.  "Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients," Michael Carome, director of Public Citizen's Health Research Group, said in an interview.

Comment on the relationship between the interests of the insurance industry, medical services and costs in the United States

The PopTort has a short comment on a recent article in the New York Times here discussing the fact that the United States has one of the highest rates of both infant and maternal death among industrialized nations.

New study challenges med mal reformers' "talking point" that fear of lawsuits results in "defensive medicine" and higher costs

A study published earlier this month by the medical journal JAMA Internal Medicine, researchers working with Veterans Affairs hospitals indicate that doctors at the government-run medical centers, who are generally shielded from the effects of most malpractice lawsuits, request just as many unnecessary medical tests as their peers in the private sector, who are far more vulnerable to lawsuits.  For more on the story go to AboutLawsuits.com.

Supreme Court decides Mutual Pharmaceutical v Bartlett, reaffirms protections for generic pharmaceutical manufacturers

For about a year and a half, I have been following the developments in Mutual Pharmaceutical v. Bartlett, the third case on preemption in the context of a claim for damages caused by a prescription drug.  (See my posts and links here, here, here, here, here, here, and here.  The difference in this case was that the claim was not based on the warning on the product but on a claim of defective design.

Last Monday, the Court finally decided the case and, in  a 5-4 decision, the majority saw the case as essentially a replay of last year’s decision in PLIVA, Inc. v. Mensing: All five of the Justices in the PLIVA majority held for the manufacturer here, and the four PLIVA dissenters would have held for the plaintiff.

For a copy of the opinion go here.  For a good summary of the ruling, go here. For more information, including links to the lower court opinion and the documents filed in the case, go here.

Federal Judge dismisses lawsuit against manufacturer of Fosamax on pre-emption grounds

In recent years, increasing evidence has linked the popular drug Fosamax (manufactured by Merck) to spontaneous breaks of the thigh bone after little or no trauma.  As lawsuits began to mount, more than 1,000 Fosamax femur fracture cases have been consolidated in the federal court system as part of a multidistrict litigation.  Many of those cases may now be threatened by a recent ruling by the federal judge presiding over the litigation granting summary judgement in favor of the defendant.

About Lawsuits is reporting (here) that the judge has ruled that one of the many claims that allege that Merck failed to adequately warn about the risk of sudden femur fractures is preempted by federal law because the FDA rejected a request to update the warning label.  

In his order, the judge (available here), the failure to warn claim is pre-empted by federal law because the FDA decided not to strengthen the Fosamax label in 2009, the year Glynn’s femur fractured. 

I am not sure, however, that this ruling is consistent with the US Supreme Court decision n Wyeth v. Levine, in which the Court held that a failure-to-warn claim related to a branded pharmaceutical was not preempted because the manufacturer was free to update the warning label at its discretion.

As I understand it, the state of the law is that if the manufacturer is not required to get FDA approval to update the label and can, therefore, decide to update the warning, then the claim would not be preempted.  If the manufacturer can't do that - if it needs to get FDA approval to update - then the claim would be preempted.  This was the holding in last year's PLIVA, Inc. v. Mensing (followedd last Monday in Mutual Pharmaceutical Co. v. Bartlett).

It is not clear to me that Merck was required to seek permission from the FDA in this case and, thus, that the clam must be preempted. 

What is different in this case is that regardless of whether Merck was required to seek permission from the FDA, it did ask the FDA and the FDA replied that there was not enough evidence to warrant a change in the warning.

So, the question for me is, what happens if a manufacturer decides it has enough evidence to change a warning and it wants to change the warning, but relies on the FDA's decision?  Should the court allow a claim against the manufacturer because it was not careful enough in reaching its own conclusions, or should it be excused from liability because it relied on the FDA?

Personally, I think that if the evidence shows the manufacturer had enough evidence to justify the change in the warning and that it had decided it should change it, the cause of action should be allowed. 

Insurance payments on motorcycle accidents up after changes to helmet law in Michigan

The Chicago Daily Law Bulletin is reporting (here) that the average medical claim from a motorcycle crash rose by more than one-fifth last year in Michigan after the state stopped requiring all riders to wear helmets, according to an insurance industry study.  According to the report, crash deaths are also on the rise

This should not be surprising.  The risk of injury is greater when people ride without helmets and, if there is an injury, it is likely to be worse. 

For more than 40 years, Michigan required all motorcycle riders to wear helmets. State legislators changed the law last year so that only riders younger than 21 must wear helmets.  The average insurance payment on a motorcycle injury claim was $5,410 in the two years before the law was changed and $7,257 after it was changed — an increase of 34 percent, the study by the Highway Loss Data Institute found. After adjusting for the age and type of motorcycle, rider age, gender, marital status, weather and other factors, the actual increase was about 22 percent relative to a group of four comparative states, Illinois, Indiana, Ohio and Wisconsin, the study found.

California jury awards $27.3 million in damages for second hand exposure to asbestos

AboutLawsuits is reporting (here) that a jury in California recently awarded $27.3 million in damages to a woman who developed mesothelioma as a result of "second hand exposure" to asbestos. As you probably know, mesothelioma is a rare form of cancer, which is only known to be caused by exposure to, and breathing of, asbestos fibers.

 

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 was the one exposed to the fibers at work. As a result of his work, the plaintiff's husband carried asbestos fibers home on his work clothes, which caused the plaintiff to develop mesothelioma years later.

 

These cases present 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?

 

If we apply the traditional proximate cause analysis, the question is whether the injury is a foreseeable consequence of the risk created by the negligent conduct. If the answer is that reasonable people can disagree, then the case survives a motion to dismiss and goes to the jury.

 

Since asbestos fibers cling to clothes, it can easily be argued that exposure to others who come in contact with the contaminated clothes is a foreseeable consequence of the risk created. The problem with this, defendants argue, is that this subjects them to unlimited liability. What if a worker had the custom of going to a public establishment - a diner, restaurant, bar, etc - after work to meet with friends before changing? Should the defendant be liable to anyone who participated in those gatherings (as long as they can prove cause in fact)?

 

The concept of proximate cause was created precisely to achieve a level of fairness when it comes to possible unlimited liability. At some point we must draw a line - as Cardozo and Andrews agreed in Palsgraf v LIRR - and the key for the courts if figuring out how and where to do so.

 

In an asbestos second hand exposure case, the plaintiff will argue we should extend the possible liability to include the members of the exposed worker's household. The defendant will argue that there is no reason to extend the possible liability beyond the duty owed to the worker and that extending it to anyone else would be going too far.

 

The California case is similar to a case decided by the Illinois Supreme Court last year called Simpkins v. CSX. The allegations in Simpkins were essentially the same: a wife who was exposed to asbestos due to contact with her husband's clothes. The Court's opinion concluded that the complaint had not alleged sufficient evidence to support the claim that defendant owed a duty of care to the plaintiff but remanded to give the plaintiff the chance to do so. The court explained that in order for the claim to survive a motion to dismiss it would have to show specific facts relating to defendant's knowledge of the potential harms of asbestos. Only then would the court be able to answer the question on whether the injury was a foreseeable consequence of the risk created by the defendant. You can read the opinion here. For more on the case go here.

 

In other words, the case was remanded and allowed to continue, but I do not know what has happened since. If it is still being litigated, I am sure the recent verdict in California will provide the plaintiff with some support for her claims and approach. It may also influence the defendant to consider settling the matter before taking chances with a jury.

 

Short comment on alternative approaches to medical malpractice reform

If you are interested in medical malpractice reform, take a look at the latest post at The Pop Tort in which they ask "[i]f you wanted to reduce deaths, injuries, claims and lawsuits, how would you do it?  Implement proven safety measures [to prevent medical mistakes]?  Or provide immunity to doctors ...?    Go here to read the full comment...

Reminder: Google Reader will not be available but you have alternatives

If you follow blogs as much as I do, you probably know by now that Google Reader will be shut down at the end of the month. If you are looking for a new way to keep up with your favorite blogs I recommend you take a look at Feedly which is very similar to Reader and, so far, has been working very well for me.  I hope it will continue to work well after Reader goes away.  For those of you who want to keep up with this blog in particular (and I hope that's all of you), the other alternative, of course, is to subscribe by e-mail, which you can do here by signing up on the lower right hand side of the blog.  Doing this will not inundate your inbox.  You will get one message a day and only if there is new content added to the blog. 

Oklahoma Supreme Court rejects med mal reform legislation

The Oklahoma Supreme Court recently invalidated a tort reform package related to medical malpractice claims. The PopTort praises the court for watching out for the interests of malpractice victims, the Legal Profession blog also celebrates the decision, while The American Tort Reform Association offers its typical unconvincing rhetoric in response. The case is called Wall v. Marouk and it is available here.