Friday, June 11, 2010
After second try, judge approves 9/11 settlement
Almost three months after sending the lawyers back to the bargaining table because he said that their original $657 million settlement agreement paid too little to injured rescue and cleanup workers, Southern District of New York Judge Alvin K. Hellerstein has given his stamp of approval to a renegotiated settlement of suits filed by 10,000 plaintiffs who suffered respiratory and other illnesses in the wake of the 9/11 terror attacks. The new settlement has a minimum value of $625M with 95% participation by the claimants, and as much as $712.5M if other conditions are met. The original settlement was for $575M to $657M. For more on the story, go here and here.
Congress to investigate Wyeth's alleged illegal promotion of drug to African-Americans
About a week ago, I posted a note (here) about a lawsuit that alleges that Wyeth encouraged its sales force to promote Rapamune to doctors practicing heart, lung, liver, pancreas, and islet cell transplants even though the drug was never approved for patients receiving transplants of these organs.
Today, Pharmalot is reporting that the House Committee on Oversight & Government Reform has launched an investigation to determine if Wyeth promoted its kidney transplant drug for unaproved uses and, specifically, targeting African-Americans, even though this is a high-risk patient group. For the full story, go here.
Duty to inform lover's husband of STD?
From a story in Law.com:
A man who says he contracted a sexually transmitted disease after his wife had an affair with her allegedly infected psychiatrist can bring a negligence action against the doctor, a state judge has ruled. The man, [...] claimed that Dr. [...] had a duty to warn him that he had herpes simplex before having unprotected sex with Levine's wife.
I have no problem imposing liability, but doesn't this sound just a little odd? So the plaintiff is saying that his cheating wife's lover should give him a call before he sleeps with the wife to let him know....? I wonder how that call is going to go... "Hello, Mr. Doe. This is your wife's doctor. I am pretty sure I am going to have sex with her tonight. Just thought I'd let you know... Oh and by the way, I have an STD. Have a good day now....."
Also, given the quoted language, I have another question. Suppose the good doctor had used protection. Would that have elimanted the duty to make the call?
Labels:
Duty,
HIV/AIDS,
Medical malpractice,
Prima facie case
NJ Supreme Court recognizes a malpractice claim based on dissatisfaction with a settlement
Last week, the New Jersey Supreme Court allowed a legal malpractice suit to go forward, in a ruling that clarified the circumstances in which clients who become disenchanted with settlements can sue their attorneys for negligence. The case is called Guido v. Duane Morris.
Holding that "the existence of a prior settlement is not a bar to the prosecution of a legal malpractice claim" arising from the settlement. The court attempts to resolve the tension between the two leading precedents on the subject: Ziegelheim v. Apollo, 128 N.J. 250 (1992), which allowed a malpractice suit, and Puder v. Buechel, 183 N.J. 428 (2005), which did not.
For more on this story go to Law.com.
Preemption debate regarding generic drugs
In what promises to be a very important upcoming case, the U.S. Supreme Court has asked the U.S. Department of Justice to "express the view of the United States" on whether the FDCA preempts failure to warn claims against generic drug manufacturers. The drugmakers claim federal law preempts state lawsuits because otherwise they would be required to write labels that are different from what appears on the label of the brand-name medication.
Here is a quick background information to put the issue in its proper context.
Federal law or regulations require manufacturers of generic drugs to use exactly the same warnings used by the manufacturers of the original drugs. The original manufacturers, on the other hand, are permitted to update the warnings when newer information becomes available to them that suggests the warning should be improved or strengthened. But generic manufacturers can't do this; they can't change the warnings unilateraly.
Based on this, in 2008, a Court of Appeals in California ruled in Conte v. Wyeth that a brand-name drug manufacturer could be held liable for harm to individuals who take the generic version of their name-brand product for alleged deficiencies in the generic drug’s labeling. The decision was based on the notion that if the federal law requires generic drug labeling to be the same as brand-name labeling, then injured plaintiffs should be allowed to recover against brand-name drug manufacturers who could change their labeling to provide stronger warnings without violating the Act. Liability in such case would encourage original manufacturers to improve warnings which would be the only way to get generic manufacturers to improve theirs.
Since that decision, not one other reported case has followed its reasoning and there are several that explicitly reject it.
Then, late in 2009, the U.S. Court of Appeals for the Eighth Circuit decided a case called Mensing v. Wyeth, Inc (available here) in which the court rejected arguments that failure to warn claims against generic manufacturers are preempted by the FDC Act. The Court also rejected the reasoning set forth by the California Court of Appeal in Conte v. Wyeth and held that brand-name drug manufacturers were not liable for harm caused by a plaintiffs’ use of a generic version of the pioneer’s brand-name drug.
Shortly after the Eighth Circuit issued its decision in Mensing, the U.S. Court of Appeals for the Fifth Circuit came to a similar conclusion in Demahy v. Actavis.
The Supreme Court's request for comment came as part of the cert petition process in the Mensing case. The Petitions for Writ of Certiorari in Mensing are available here and here. Apparently, the other case has not been appealed yet.
This promises to be a very hot topic in product liability this year. Stay tuned...
Fore more information (with lots of comments and links) on the subject go to these posts in: Pharmalot, the FDA Law Blog, AboutLawsuits.com, the Drug and Device Law Blog and the Washington Legal Foundation.
UPDATE 7/9/2010: In the consolidated appeal of the Smith v. Wyeth, Wilson v. Pliva, and Morris v. Wyeth cases, the Sixth Circuit has formally requested the FDA's views on this subject, and has given the FDA until July 29, 2010 to file its brief.
UPDATE: 11-03-10. The Solicitor General has filed its brief. Go here for details.
Thursday, June 3, 2010
Lawsuit claims Wyeth targeted African Americans illegally for off label use of drug
Pharmalot is reporting that two former hospital sales reps have filed a whistleblower suit alleging Wyeth, which is now owned by Pfizer, illegally promoted its Rapamune kidney transplant drug for use with other organs and targeted African-Americans, even though this is a high-risk patient group. Go here for the full story.
Labels:
FDA,
Pharmaceuticals,
Products liability
Supreme Court agrees to hear case on seat belt preemption
In November 2010, the United States Supreme Court will listen to oral arguments in a case called Williamson v. Mazda Motor of America, Inc., which asks the Court to decide whether a claim for damages in state court caused by a car manufacturer's failure to install a three point seat belt in a 1993 car is preempted by federal regulations that allow vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions.
The main question in the case has been summarized like this: "Where Congress has provided that compliance with a federal motor vehicle safety standard “does not exempt a person from liability at common law,” 49 U.S.C. § 30103(e), does a federal minimum safety standard allowing vehicle manufacturers to install either lap-only or lap/shoulder seatbelts in certain seating positions preempt a state common-law claim alleging that the manufacturer should have installed a lap/shoulder belt in one of those seating positions?"
Stated this way, it seems to me the case will allow the Court to reconsider its decision in Geier v Honda (2000) (available here), in which a divided court (5 to 4) found that the federal regulation conflicted with the notion of recognizing a claim in state court and, thus, the claim was preempted. In that case, the federal regulation gave manufacturers the choice to install either seat belts or airbags. Given that the regulation allowed the manufacturer to make a choice, the Court found recognizing a claim for damages based on the lack of the system the manufacturer failed to choose was incompatible with federal law and, thus, preempted.
It will be very interesting to see if, in the wake of Wyeth v. Levine, the Court changes its view. It will also be an interesting element of the legacy of retiring justice Stevens who wrote the dissenting opinion in Geier and the majority in Levine.
Williamson v. Mazda Motor Corp comes from the Court of Appeals of California which decided against the plaintiff holding the claim was preempted under federal law. Here is a link to a copy of the California opinion.
For more on the case go to TortsProf, where guest blogger Catherine M. Sharkey, Professor of Law at New York University School of Law, has posted a very informative comment on the case. She concludes that "Williamson will narrow the reach of Geier implied obstacle preemption, but will not sound the death knell entirely..."
For up to date information and for all the relevant opinions, petitions and other documents go (and periodically continue to check) here.
Update on the settlement on claims for Avandia
Yesterday I reported on the settlement of certain claims related to damages caused by the drug Avandia. Here is a link to another account and update on the news, courtesy of the Drug Recall Lawyer Blog.settl
Labels:
Pharmaceuticals,
Products liability,
Settlements
Wednesday, June 2, 2010
When a doctor wants to file for medical malpractice
Here is a link to a very interesting story describing the experience of a practicing plaintiffs' lawyer during an interview with a doctor who wanted to file a claim for medical malpractice. You should read the full story, but the key to the story is that the doctor's expectations about the case were unreasonable and that his understanding of the legal system was faulty. The author concludes:
"He [the doctor] was mis-informed. For years and years and years he has been told that all it takes to win a malpractice lawsuit is to claim an injury, file a lawsuit, and a bunch of nincompoops on the jury will give you a check for millions of dollars. He was told that lawyers are greedy bastards, that they will file any lawsuit regardless of merit, and that they can extort money out of people who had done nothing wrong. He believed that because this was so, his case - his meritorious case, the case to right the wrong done to his beloved father - was thus worth millions, because if all those money-grabbing, deadbeat plaintiffs on public assistance can get money for nothing he should get more money for a real loss. He had been mis-informed for so many decades that it was part of his being.
I understand his frustration. He doesn't have the time to look at the real data about malpractice cases. He only knows what he is told. And what he has been told is wrong."
Labels:
Litigation/procedure,
Medical malpractice
Glaxo settles more cases on Avandia
AboutLawsuits.com is reporting today that "GlaxoSmithKline has reached additional Avandia settlements in an estimated 5,000 lawsuits over the side effects of their diabetes drug, which has been linked to an increased risk of heart attacks and other potentailly life-threatening injuries." This second batch of cases inolved claims scheduled for trial to begin later this month in Pennsylvania. The first Avandia trial is now expected to begin in October 2010, unless additional settlements are reached. Go here for more details on the story.
Labels:
Pharmaceuticals,
Products liability,
Settlements
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