Back in 2010 I posted a few stories on the possible health hazards soldiers were getting exposed to in Iraq and
Afghanistan as a result of the burning of hazardous and medical waste. See here and here, for example. Two years later, I reported on an $85 million verdict against a military contractor for negligently exposing soldiers to a
cancer causing toxin. See here.
The issue is now back in the news. NPR has posted a story here, or you can listen to it below by pressing the play button.
Saturday, December 26, 2015
Short podcast on driverless (self driving) cars
Friday, December 25, 2015
American Museum of Tort Law, interview with Ralph Nader (video)
Earlier this year the American Museum of Tort Law opened its doors in Connecticut. Here is a short introduction by Ralph Nader:
A conversation with four Fordham Law professors about tort law
The Fordham Law News just published a conversation among four
torts professors: Ben Zipursky, Howard Erichson, Michael Martin, and
Jed Shugerman. They answer questions about frivolous lawsuits,
efficiency, insurance, and more. Check it out here.
Thanks to TortsProf Blog for the link!
Thanks to TortsProf Blog for the link!
Tuesday, December 22, 2015
Two interesting stories about driverless, or self driving, cars
I have posted a couple of stories on possible legal issues related to driverless cars before (see here, for example). So, to follow up on that, in case you haven't seen them, here are two interesting recent stories about issues related to driverless, or self driving, cars:
Self-Driving Cars Have Twice The Accidents, But Only Because Humans Aren't Used To Vehicles Following The Rules
The Ethical and Legal Dilemmas of Self-Driving Cars
Self-Driving Cars Have Twice The Accidents, But Only Because Humans Aren't Used To Vehicles Following The Rules
The Ethical and Legal Dilemmas of Self-Driving Cars
Sunday, December 13, 2015
On the possible liability of parents who don't vaccinate their children, again
Long time readers of this blog know I have posted a series of comments on whether there should a cause of action against parents who do not vaccinate their children. See here, here, here and here. With that in mind, here is a link to an article in Slate on tolerance of anti-vaccine parents. It starts: "Tolerance of racial and cultural diversity is good. Tolerance of those who endanger the community by refusing to vaccinate their kids is not. An Australian primary school just learned that the hard way."
In a newsletter to parents, the school’s principal directly told parents that they should tolerate the vaccine dodgers among them stating "[w]e expect all community members to act respectfully and with tolerance when interacting with other parents and carers who may have a differing opinion to their own. This includes an opposing understanding about child immunisation."
As the article then states, those words may sound “respectful” and “admirable,” ... until 25 percent of your school is suddenly infected with chickepox within two weeks (which, of course, is what happened).
In a newsletter to parents, the school’s principal directly told parents that they should tolerate the vaccine dodgers among them stating "[w]e expect all community members to act respectfully and with tolerance when interacting with other parents and carers who may have a differing opinion to their own. This includes an opposing understanding about child immunisation."
As the article then states, those words may sound “respectful” and “admirable,” ... until 25 percent of your school is suddenly infected with chickepox within two weeks (which, of course, is what happened).
Tuesday, December 8, 2015
Article on whether universities have, or should have, a duty to protect students -- UPDATED
Back in October I posted that a California appeals court issued an opinion
(with one dissenting judge) reaffirming the generally accepted view that
state public colleges and universities do not have a general duty to
protect adult students from violent acts by other students. Go here to read my original post.
In that case, the court ruled that "While colleges and universities may properly adopt policies and provide student services that reduce the likelihood such incidents will occur on their campuses, they are not liable for the criminal wrongdoing of mentally ill third parties, regardless of whether such conduct might be in some sense foreseeable." And I stated that this approach is not surprising and appears to be the majority view on the issue, whether because the conduct of the actor is considered a superseding cause or whether because of the long standing (although often criticized) rule that there is no duty to help.
In response to the case, the blog "New Private Law" has published a very well written post arguing the case was wrongly decided. It argues that the case was wrongly decided because the issue in the case is "by far" closer to Tarasoff than to any of the cases that hold universities do not have a duty to protect students. In support of this conclusion, it argues that "the gist of the complaint is not that the University failed to do enough to enforce general policies (such as those against underage drinking), but rather that the University had reason to believe that a particular student posed a serious danger to his fellow students and other members of the university community.
You can read the full post here.
UPDATE (12-7-15): As I reported elsewhere, the Washington Supreme Court is currently considering whether the extend the notion of a therapist's duty to warn identifiable possible victims under a Tarasoff approach, to a duty to warn the general public. See here.
UPDATE (12-8-15): Here is another article on the decision in University of California v. Superior Court of Los Angeles County, in which the court rejected the request to impose a duty on a university.
In that case, the court ruled that "While colleges and universities may properly adopt policies and provide student services that reduce the likelihood such incidents will occur on their campuses, they are not liable for the criminal wrongdoing of mentally ill third parties, regardless of whether such conduct might be in some sense foreseeable." And I stated that this approach is not surprising and appears to be the majority view on the issue, whether because the conduct of the actor is considered a superseding cause or whether because of the long standing (although often criticized) rule that there is no duty to help.
In response to the case, the blog "New Private Law" has published a very well written post arguing the case was wrongly decided. It argues that the case was wrongly decided because the issue in the case is "by far" closer to Tarasoff than to any of the cases that hold universities do not have a duty to protect students. In support of this conclusion, it argues that "the gist of the complaint is not that the University failed to do enough to enforce general policies (such as those against underage drinking), but rather that the University had reason to believe that a particular student posed a serious danger to his fellow students and other members of the university community.
You can read the full post here.
UPDATE (12-7-15): As I reported elsewhere, the Washington Supreme Court is currently considering whether the extend the notion of a therapist's duty to warn identifiable possible victims under a Tarasoff approach, to a duty to warn the general public. See here.
UPDATE (12-8-15): Here is another article on the decision in University of California v. Superior Court of Los Angeles County, in which the court rejected the request to impose a duty on a university.
Washington Supreme Court to decide whether doctors have a duty to warn “all foreseeable victims” of potentially dangerous patients in their care
Last month the Supreme Court of the State of Washington heard oral arguments in a case called Volk v. DeMeerleer which raises the issue of whether doctors have a duty to warn “all foreseeable victims” of potentially dangerous patients in their care. In the case, a psychiatrist was sued after one of his patients shot and killed an ex-girlfriend and her son before killing himself. The trial court dismissed the complaint (on summary judgment) on the grounds that the doctor did not have a duty because the patient haad made no specific threats the victims during his treatment. The appeals court reversed (with one judge dissenting), however, holding that the plaintiff could support a cause of action because the patient's conduct was foreseeable and holding that "a question of fact exists as to whether Dr. Howard Ashby and his employer, Spokane Psychiatric Clinic, P.S., owed a duty to protect the general public, including plaintiffs, from violent behavior of patient Jan DeMeerleer." You can read the full appeals court's opinion here.
Leaving aside the fact that this is an odd ruling because the question of whether there is a duty is usually thought of as a question for the court, not the jury, the issue before the court is very interesting. It calls for the court to expand on the doctrine created by Tarasoff v Regents of the University of California, which I am sure you are familiar with. In that case, the California Supreme Court held that a therapist does have a duty to protect an identifiable victim. The plaintiffs in Volk are asking the court to extend this notion further because the victims were not identifiable. The plaintiffs are asking for a duty to "protect the general public."
Tarasoff is a well known case, and a popular one, but it has been rejected by a number jurisdictions. Also, back in 1979 the Washington Court of Appeals decided a case in which it refused to expand the reach of the Tarasoff doctrine in a case where the victim already knew of the possible threat to her safety. (Interestingly, that case involved a lawyer, rather than a therapist) who arguably had confidential information about a client's intent to harm someone else.) For these reasons, it would not be entirely surprising if the Washington Supreme Court reverses the Court of Appeals. Yet, it will be very interesting to see what happens.
A finding for the plaintiff will have serious implications for the medical profession, and potentially for the legal profession too, because such a ruling will affect the principle of confidentiality. It is because of the importance of confidentiality that courts have either rejected Tarasoff or refused to expand its reach. Take a look at Thapar v Zezulka, 994 SW2d 635 (Tex 1999) (medical profession) and Hawkins v. King Cty. Dept. of Rehabilitative Services, 602 P.2d 361 (Wash. Ct. App. 1979) (legal profession).
The New York Times published an Op-Ed piece on this case written by a doctor in which he argues the court should reject the plaintiffs' claim and protect the value of confidentiality in the doctor-patient relationship. You can read it here. The argument is a good one, although the author makes a horrible mistake in his analysis when he illustrates his duty of confidentiality by telling a story of a time when he destroyed illegal drugs handed to him by a patient in order to help the patient avoid arrest. In doing so, the doctor was not protecting the patient's confidentiality but, at helping someone destroy evidence of a crime; but I suppose that is another story. (The article generated two letters to the editor, one of which points out this issue.)
On the question of a possible duty in tort, I do agree the court should rule for the defendant. Even if the duty recognized in Tarasoff applies in the jurisdiction, a duty to warn the general public when there is no indication of specific plans or specific possible victims is too broad.
Leaving aside the fact that this is an odd ruling because the question of whether there is a duty is usually thought of as a question for the court, not the jury, the issue before the court is very interesting. It calls for the court to expand on the doctrine created by Tarasoff v Regents of the University of California, which I am sure you are familiar with. In that case, the California Supreme Court held that a therapist does have a duty to protect an identifiable victim. The plaintiffs in Volk are asking the court to extend this notion further because the victims were not identifiable. The plaintiffs are asking for a duty to "protect the general public."
Tarasoff is a well known case, and a popular one, but it has been rejected by a number jurisdictions. Also, back in 1979 the Washington Court of Appeals decided a case in which it refused to expand the reach of the Tarasoff doctrine in a case where the victim already knew of the possible threat to her safety. (Interestingly, that case involved a lawyer, rather than a therapist) who arguably had confidential information about a client's intent to harm someone else.) For these reasons, it would not be entirely surprising if the Washington Supreme Court reverses the Court of Appeals. Yet, it will be very interesting to see what happens.
A finding for the plaintiff will have serious implications for the medical profession, and potentially for the legal profession too, because such a ruling will affect the principle of confidentiality. It is because of the importance of confidentiality that courts have either rejected Tarasoff or refused to expand its reach. Take a look at Thapar v Zezulka, 994 SW2d 635 (Tex 1999) (medical profession) and Hawkins v. King Cty. Dept. of Rehabilitative Services, 602 P.2d 361 (Wash. Ct. App. 1979) (legal profession).
The New York Times published an Op-Ed piece on this case written by a doctor in which he argues the court should reject the plaintiffs' claim and protect the value of confidentiality in the doctor-patient relationship. You can read it here. The argument is a good one, although the author makes a horrible mistake in his analysis when he illustrates his duty of confidentiality by telling a story of a time when he destroyed illegal drugs handed to him by a patient in order to help the patient avoid arrest. In doing so, the doctor was not protecting the patient's confidentiality but, at helping someone destroy evidence of a crime; but I suppose that is another story. (The article generated two letters to the editor, one of which points out this issue.)
On the question of a possible duty in tort, I do agree the court should rule for the defendant. Even if the duty recognized in Tarasoff applies in the jurisdiction, a duty to warn the general public when there is no indication of specific plans or specific possible victims is too broad.
Charlie Sheen’s Ex-Fiancée Sues Over Sheen’s Failure to Disclose HIV Status; does she have a case?
FDA delays implementation of the generic drug labeling rules until July 2016 (at least)
Back in November, 2013, I posted that the FDA proposed a new regulations that would allow (and presumably encourage) generic drug manufacturers
to add or update the safety warnings on their products. Go here for my most recent post on the background on the controversy.
The rules were supposed to be finalized this month, but the FDA recently confirmed that implementation of the generic drug labeling rules will be delayed until at least July 2016. This is not entirely surprising given the tremendous pressure the pharmaceutical industry has exerted on this issue and since it has taken this long to even get to this point. It is disappointing, though, since the announcement back in 2013 gave some hope that the FDA would do something to improve the current state of the law.
As reported in AboutLawsuits.com, "[t]he prominent consumer watchdog group Public Citizen criticized the move in a press release issued December 3, indicating that the FDA’s decision to once-again delay implementing rules originally proposed several years ago, which would allow generic drug makers to up date their warning labels, will place consumers at serious risk."
The rules were supposed to be finalized this month, but the FDA recently confirmed that implementation of the generic drug labeling rules will be delayed until at least July 2016. This is not entirely surprising given the tremendous pressure the pharmaceutical industry has exerted on this issue and since it has taken this long to even get to this point. It is disappointing, though, since the announcement back in 2013 gave some hope that the FDA would do something to improve the current state of the law.
As reported in AboutLawsuits.com, "[t]he prominent consumer watchdog group Public Citizen criticized the move in a press release issued December 3, indicating that the FDA’s decision to once-again delay implementing rules originally proposed several years ago, which would allow generic drug makers to up date their warning labels, will place consumers at serious risk."
Monday, December 7, 2015
Maryland legislature task force recommends creation of a no fault system for handling birth injuries caused by malpractice
A task force created by the Maryland legislature is recommending the creation of a birth injury compensation fund, which would prevent families from filing medical malpractice lawsuits for injuries caused to the baby during delivery. The proposal is to create a fund that would provide compensation for birth injuries. The no-fault fund was recommended in a report issued on December 1, by the Maryland Work Group To Study Access to Obstetric Services, which is a group consisting of representatives from the health care, insurance and legal services industries. For more details you can go to AboutLawsuits.com.
Creating a fund and a no-fault system is not necessarily a bad idea and it may, in fact, result in a more efficient way to solve disputes. However, like any other no-fault system, its efficacy would depend on whether it is sufficiently funded and implemented efficiently and fairly. If neither of these conditions are met, the new system will fail to provide proper remedies and compensation to the victims and will only allow defendants and their insurance companies to avoid having to fully compensate for the injuries they cause.
I have not seen anything yet to suggest how these two criteria would be met under the proposal. And, what I have read is that the proposal is based on the premise that medical liability costs linked to birth injury malpractice lawsuits constitute a threat to healthcare access, which is an argument that has been proven false time and time again. (If you are interested in information about that, go to the "medical malpractice" tab on the right side and scroll down. You will find many posts with links to studies on the issue.)
The proposal is just one page (Appendix D) in a 24 page report and it is summarized in the report as follows:
Are the insurance companies ready to fund the system for the benefit of the victims? Evidently not. In a statement filed with the report the Medical Mutual Liability Insurance Society of Maryland explained it abstained from supporting the proposal because it was concerned that it would be funded by imposing a surcharge on liability premiums. That won't do! As they suggest in the statement, such a fund could benefit the entire populace but there is no evidence of "proportionate benefit" to them. This was the approach of an earlier attempt by Maryland to address the issue and the MMLIS did not support it then. My guess is they abstained here because the source of the fund for this proposal has not yet been determined.
In contrast to the short-on-details proposal, and the very lukewarm support from Medical Mutual, the Maryland Association for Justice filed a critical statement which addresses the concerns I have mentioned and more. It appears in Appendix E of the report. On the issue of funding it states that, as I suspected, the task force failed to reach a consensus on how to pay for the costs of injuries (in other words on how to fund the fund from which compensation would be provided to victims), and that the task force "overwhelmingly reject[ed] a proposal that a birth injury fund should be paid for by hospitals (the funding mechanism proposed in the last legislative session). Under earlier proposals, the costs of a birth injury fund would be borne by Maryland’s small businesses and working class families , in the form of higher health insurance costs. MAJ opposes any funding mechanism that would increase costs to Maryland’s small businesses and working class families."
Creating a fund and a no-fault system is not necessarily a bad idea and it may, in fact, result in a more efficient way to solve disputes. However, like any other no-fault system, its efficacy would depend on whether it is sufficiently funded and implemented efficiently and fairly. If neither of these conditions are met, the new system will fail to provide proper remedies and compensation to the victims and will only allow defendants and their insurance companies to avoid having to fully compensate for the injuries they cause.
I have not seen anything yet to suggest how these two criteria would be met under the proposal. And, what I have read is that the proposal is based on the premise that medical liability costs linked to birth injury malpractice lawsuits constitute a threat to healthcare access, which is an argument that has been proven false time and time again. (If you are interested in information about that, go to the "medical malpractice" tab on the right side and scroll down. You will find many posts with links to studies on the issue.)
The proposal is just one page (Appendix D) in a 24 page report and it is summarized in the report as follows:
"The work group recommends the establishment of a No-Fault Birth Injury Fund to stabilize medical liability costs and provide a clear and critical incentive for hospitals to continue to provide this vital community service. Such a fund would provide, direct, timely compensation, medical care and other services, without the uncertainty of protracted litigation, to children who suffer a devastating birth injury. In addition, providers covered by the fund would receive a credit discount on medical liability premiums, a direct incentive to continue practicing obstetrics."I don't know about you, but in my mind this does not even begin to address the major concerns that the proposal raises. There is no evidence to support its conclusion and no indication on how the fund would be, well, funded. Since we are talking about "devastating" (and life long) injuries here, to be able to provide adequate funding, the fund will have to have a tremendous amount of money available. Where is that money going to come from? It seems evident, to me at least, it should not come from raising taxes on the general public since that means that Maryland residents, including possible victims of malpractice, would be covering part of the compensation that should be paid by the tortfeasors. Thus, to be fair, the fund needs to be funded by the insurance companies, who more than likely would then turn around and pass on the costs to the insured doctors, no? Is that an efficient way to minimize healthcare costs? Maybe it is; I just don't know and the report does not address it.
Are the insurance companies ready to fund the system for the benefit of the victims? Evidently not. In a statement filed with the report the Medical Mutual Liability Insurance Society of Maryland explained it abstained from supporting the proposal because it was concerned that it would be funded by imposing a surcharge on liability premiums. That won't do! As they suggest in the statement, such a fund could benefit the entire populace but there is no evidence of "proportionate benefit" to them. This was the approach of an earlier attempt by Maryland to address the issue and the MMLIS did not support it then. My guess is they abstained here because the source of the fund for this proposal has not yet been determined.
In contrast to the short-on-details proposal, and the very lukewarm support from Medical Mutual, the Maryland Association for Justice filed a critical statement which addresses the concerns I have mentioned and more. It appears in Appendix E of the report. On the issue of funding it states that, as I suspected, the task force failed to reach a consensus on how to pay for the costs of injuries (in other words on how to fund the fund from which compensation would be provided to victims), and that the task force "overwhelmingly reject[ed] a proposal that a birth injury fund should be paid for by hospitals (the funding mechanism proposed in the last legislative session). Under earlier proposals, the costs of a birth injury fund would be borne by Maryland’s small businesses and working class families , in the form of higher health insurance costs. MAJ opposes any funding mechanism that would increase costs to Maryland’s small businesses and working class families."
American Medical Association calls for an end of direct to consumer advertising -- UPDATED
The American Medical Association, which represents 250,000 doctors, has called for an end to direct-to-consumer advertising for prescription drugs, a
$4.5 billion-per-year industry in the United States, AdWeek reports. The US is one of very few countries in the world that allows such a practice. Of course, the AMA does not dictate policy for the FDA or Congress but its position may have some influence.
UPDATE (12/7/2015): Torts Today and AboutLawsuits.com have more on the story.
UPDATE (12/13/15): The New York Times has a short editorial on the issue here.
UPDATE (12/7/2015): Torts Today and AboutLawsuits.com have more on the story.
UPDATE (12/13/15): The New York Times has a short editorial on the issue here.
Sunday, December 6, 2015
Illinois Supreme Court Agrees to Clarify When Workers’ Comp Settlement Eliminates Contribution Claim from Third-Party Tortfeasor
According to Illinois law, when a party settles a claim in good faith against one tortfeasor, the
finding of good faith automatically discharges that tortfeasor from any
liability for contribution to another tortfeasor. Now, the Appellate Strategist is reporting that the Illinois Supreme Court had agreed to clarify whether a workers’ compensation settlement eliminates the right to a contribution claim the same way. Go here for the full story.
Take the test: the most recent PopTort medical malpractice quiz is available now; Dept of Defense expands program to encourage alternative dispute resolution of med mal claims
The PopTort has its most recent quiz on medical malpractice issues here. Go and see how well you do.
The last question in the quiz asks "how often do medical providers voluntarily disclose errors to patients?" You can go take the quiz to find the answer ... but along that theme, the TortsProf blog reported recently as follows: "The Department of Defense is expanding a program, already underway at eight facilities, in which conversations are encouraged between medical practitioners and patients about medical injuries. The program allows patients and providers an avenue to discuss injuries and apologize. Alternative dispute resolution is also provided. The program does not require a waiver of malpractice actions, though the Feres Doctrine already prevents active-duty troops from suing for med mal. Pursuant to the program, no determinations about negligence are made. Military Times has the story."
The last question in the quiz asks "how often do medical providers voluntarily disclose errors to patients?" You can go take the quiz to find the answer ... but along that theme, the TortsProf blog reported recently as follows: "The Department of Defense is expanding a program, already underway at eight facilities, in which conversations are encouraged between medical practitioners and patients about medical injuries. The program allows patients and providers an avenue to discuss injuries and apologize. Alternative dispute resolution is also provided. The program does not require a waiver of malpractice actions, though the Feres Doctrine already prevents active-duty troops from suing for med mal. Pursuant to the program, no determinations about negligence are made. Military Times has the story."
FDA approves drug for sexual condition in women even though it has been found barely effective -- UPDATED
Long time readers of this blog will remember that since back in 2009, I have been following the debate as to whether the so-called
Hypoactive Sexual Desire Disorder in women is really a medical
condition or something the pharmaceutical industry came up with
in order to convince women to buy a product they don't need. See here.
The drugmaker (Boehringer Ingelheim) geared up an enormous publicity
effort to promote the pill, but the FDA was not impressed and decided
the pill was neither safe nor effective. See here.
What appears below is the same story I originally posted in August of this year. The UPDATE appears at the end.
At that time, all 11 members of the FDA advisory committee decided the side effects of the drug were unacceptable, and 10 ruled the pill is not effective. For the full story up to that point (including links to more information), go here.
Because of this failed effort, the manufacturer decided to discontinue development entirely. For more on the story go here.
Soon thereafter, however, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. Since there was no new evidence to contradict the earlier findings, the FDA rejected it, again.
Somehow, however, with still no new evidence, two years later, the FDA has indeed approved the drug. How, or why, did this happen?
Sprout smartly enlisted thousands of women’s activists and members of Congress in a campaign about gender double standards and sexual politics, in an attempt to avoid the discussion of the fact that the medical evidence that the drug actually works safely is weak and that the FDA rejected drug twice because its minimal benefits failed to outweigh the safety risks.
Converting the discussion from one about health and safety into one about gender (based on the argument that it’s time that the agency gave the same priority to drugs to treat women’s sexual problems as it has to drugs for men) apparently provided enough pressure on the FDA to change its ruling, even though the scientific evidence is still the same.
It has been reported that the FDA approval comes with a requirement that the company take steps to ensure doctors prescribe the drug carefully and make women aware of its health risks. But isn't that true of all drugs? That statement adds absolutely nothing to current standards of the medical profession.
The FDA is also mandating that the drug will have with a black box warning — the strongest FDA warning language — to highlight the risk of severe blood pressure drops and fainting in patients who drink alcohol or use certain other drugs during treatment. That is a good thing, but perversely, because of the state of the law regarding preemption in cases based on inadequate warnings, it will make it more difficult for plaintiffs to recover for injuries caused by the drug.
So, as I said in one of my recent posts on the subject, when the drug is shown to cause injuries, and the medical evidence and past history shows it more than likely will, it will inevitably result in litigation. The story is just beginning.
For more on the story you can go here, here and here.
Go here for videos on a documentary about this issue.
UPDATE (12-5-15): The website VITALS has a very good overview of the debate and controversy over the now approved drug, which is now officially called "Addyi" here. The article is called "Is the “Female Viagra” Worth It?" and it concludes that for most women, given the risks, costs and uncertainty, the answer is no. If you are interested in the topic, the article (and the comments) are well worth reading.
What appears below is the same story I originally posted in August of this year. The UPDATE appears at the end.
At that time, all 11 members of the FDA advisory committee decided the side effects of the drug were unacceptable, and 10 ruled the pill is not effective. For the full story up to that point (including links to more information), go here.
Because of this failed effort, the manufacturer decided to discontinue development entirely. For more on the story go here.
Soon thereafter, however, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. Since there was no new evidence to contradict the earlier findings, the FDA rejected it, again.
Somehow, however, with still no new evidence, two years later, the FDA has indeed approved the drug. How, or why, did this happen?
Sprout smartly enlisted thousands of women’s activists and members of Congress in a campaign about gender double standards and sexual politics, in an attempt to avoid the discussion of the fact that the medical evidence that the drug actually works safely is weak and that the FDA rejected drug twice because its minimal benefits failed to outweigh the safety risks.
Converting the discussion from one about health and safety into one about gender (based on the argument that it’s time that the agency gave the same priority to drugs to treat women’s sexual problems as it has to drugs for men) apparently provided enough pressure on the FDA to change its ruling, even though the scientific evidence is still the same.
It has been reported that the FDA approval comes with a requirement that the company take steps to ensure doctors prescribe the drug carefully and make women aware of its health risks. But isn't that true of all drugs? That statement adds absolutely nothing to current standards of the medical profession.
The FDA is also mandating that the drug will have with a black box warning — the strongest FDA warning language — to highlight the risk of severe blood pressure drops and fainting in patients who drink alcohol or use certain other drugs during treatment. That is a good thing, but perversely, because of the state of the law regarding preemption in cases based on inadequate warnings, it will make it more difficult for plaintiffs to recover for injuries caused by the drug.
So, as I said in one of my recent posts on the subject, when the drug is shown to cause injuries, and the medical evidence and past history shows it more than likely will, it will inevitably result in litigation. The story is just beginning.
For more on the story you can go here, here and here.
Go here for videos on a documentary about this issue.
UPDATE (12-5-15): The website VITALS has a very good overview of the debate and controversy over the now approved drug, which is now officially called "Addyi" here. The article is called "Is the “Female Viagra” Worth It?" and it concludes that for most women, given the risks, costs and uncertainty, the answer is no. If you are interested in the topic, the article (and the comments) are well worth reading.
Thursday, December 3, 2015
Plaintiffs suing General Motors over faulty ignition switches can seek punitive damages despite GM's reorganization after bankruptcy
Back in May I wrote about the possibility that a large number of lawsuits filed against General Motors could be dismissed
following a ruling blocking lawsuits filed against GM 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. The back story on that is here, here and here. But the Chicago Daily Law Bulletin is reporting now that "[a] federal bankruptcy judge has ruled that people suing General Motors over faulty ignition switches can seek punitive damages that could cost the company millions of dollars or more. When General Motors emerged from a 2009 bankruptcy, it became known as “New GM.” The new company essentially was shielded from liabilities of the old company that was left behind. But Judge Robert Gerber in New York ruled Monday that employees and knowledge transferred from the “Old GM” to the new company. Plaintiffs, he ruled, can seek punitive damages if they can show that “New GM” knew of the faulty switches but covered it up."
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