Kathleen Seidel, of Neurodiversity Blog, has been subpoenaed by the plaintiffs' lawyer in a lawsuit claiming that vaccines caused autism. It appears that this subpoena may be retributive action from the lawyer for the plaintiffs, whom Seidel criticized a few weeks ago.
She has since filed a motion to quash the subpoena because she is uninvolved in the Sykes v. Bayer case other than as an independent blogger who has discussed issues related to neurobiology and autism.
This action has many potential impacts for the medical and legal arenas, and opens up the possibility of harassment and undue barriers for bloggers if they can be required to produce the amount of paperwork required in a subpoena at the drop of a hat by a bitter lawyer who perpetuates fraud.
More from:
* Pure Pedantry
* Pharyngula
Showing posts with label lawsuits. Show all posts
Showing posts with label lawsuits. Show all posts
Friday, April 04, 2008
Friday, March 07, 2008
Autism Vaccine Settlement
The parents of nine-year old Hannah Poling, daughter of a Georgia couple, speak out about the government's admission of responsibility for their daughter's vaccine-linked autism, and have agreed to pay an as yet undisclosed settlement amount to compensate the Poling's for their family's pain and suffering as a result. The CDC is calling the case an anomaly, not an outcome to be experienced by the majority of children receiving vaccines. What should be a reasonable settlement for these types of cases? What are the ethical issues facing parents fearing an autism-link to vaccines in the decision to vaccinate or not?
See the entire CNN article here.
Monday, February 25, 2008
Patient Responsibility for Medical Outcomes
Universal health care in the U.S. would be a step in the right direction toward solving some of our many problems in the area of costs and delivery. One of the numerous pressures on costs are malpractice and negligence lawsuits. Physicians pay astronomical liability premiums. A significant portion of hospitals' budgets is spent on in-house legal departments. All health care providers and facilities are at risk in our litigation-happy society.
The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.
Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.
In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".
A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.
This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.
Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.
Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".
On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".
These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.
The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.
Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.
We want a health care system based on best practices, not based on most money.
The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.
Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.
In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".
A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.
This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.
Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.
Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".
On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".
These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.
The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.
Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.
We want a health care system based on best practices, not based on most money.
Friday, February 22, 2008
Supreme Court Ruling Favors Medical Device Firms
Professor Elizabeth Malloy over at the Health Law Professors Blog sums up my reaction to the recent Supreme Court on medical devices manufacturers being shielded from liability:
I couldn't have said myself, Elizabeth -- thank you for posting this.
"The New York Times reports on the Supreme Court's decision in which the Justices ruled "that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury." The Times reports,
The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.
In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.
But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)
The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”
But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.
In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.
But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.
Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”
But, will the Supreme Court have the last word on this topic . . . we discover that perhaps not -
If I had a better feeling about how the people running our government, I probably wouldn't be upset by this decision but it doesn't appear that everyone is playing on a level field. With all the stories in the news about recalls for tainted products and food, I am a bit concerned about the regulators being influenced too greatly by those they are supposed to be regulating."“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”
I couldn't have said myself, Elizabeth -- thank you for posting this.
Sunday, January 27, 2008
do you sing the body electric?
A case going before the Ohio Supreme Court this week has the potential to change autopsies in the state - but also, potentially, surgeries and other procedures. At the heart of the matter is whether or not the state has the right to classify removed portions of the body as medical waste, and dispose of them in a timely fashion, or if those items of the body must eventually be returned to the family/loved ones. The specific plaintiff in this case is the family of a man who was buried without his brain.
The reason for this isn't as gruesome, nor as forensic show plot-y as it sounds. It's actually rather simple; when preparing a brain, during an autopsy, it typically takes longer to prepare the brain for viewing than it does to release the rest of the body for burial/cremation. Once the examination of the brain is done, and final cause of death has been determined, the brain is disposed of like most other medical waste - incineration.
But it raises a host of ethical, legal and social issues. Many people, backed by many different religions, believe that the body must be returned to the ground whole, for various reasons involving religious tenants and the afterlife/Resurrection. Others, perhaps fueled by media reports of wrongdoing on the part of funeral directors and the like, simply fear what is happening to those body parts - are they being used for research without permission? Unauthorized grafts or transplants? They want accountability for the whole of their loved one's body, and feel that it is well within our cultural history to demand it.
The defendants argue that this will severely harm their practice, of forensics and crime scenes, of autopsies, and perhaps more. After all, they point out, when a body dies, fluids - blood and more - are lost at the scene, and this is not collected for return. Likewise, there are times when the entire body simply cannot be returned, due to the natural of the death itself. Or most simply, as attorney Mark Landes has pointed out, it is a definitional impossibility to both do an autopsy and return the entire body.
Unfortunately, this is a situation of cultural and social beliefs hitting up against practical considerations and laws - we need to know how people died, particularly when it is a suspicious death, but we want to respect the religious and cultural beliefs of the people involved. And there are times when the two simply cannot be reconciled - and in those cases, what do you do?
I know what my decision would be - what's yours?
-Kelly
The reason for this isn't as gruesome, nor as forensic show plot-y as it sounds. It's actually rather simple; when preparing a brain, during an autopsy, it typically takes longer to prepare the brain for viewing than it does to release the rest of the body for burial/cremation. Once the examination of the brain is done, and final cause of death has been determined, the brain is disposed of like most other medical waste - incineration.
But it raises a host of ethical, legal and social issues. Many people, backed by many different religions, believe that the body must be returned to the ground whole, for various reasons involving religious tenants and the afterlife/Resurrection. Others, perhaps fueled by media reports of wrongdoing on the part of funeral directors and the like, simply fear what is happening to those body parts - are they being used for research without permission? Unauthorized grafts or transplants? They want accountability for the whole of their loved one's body, and feel that it is well within our cultural history to demand it.
The defendants argue that this will severely harm their practice, of forensics and crime scenes, of autopsies, and perhaps more. After all, they point out, when a body dies, fluids - blood and more - are lost at the scene, and this is not collected for return. Likewise, there are times when the entire body simply cannot be returned, due to the natural of the death itself. Or most simply, as attorney Mark Landes has pointed out, it is a definitional impossibility to both do an autopsy and return the entire body.
Unfortunately, this is a situation of cultural and social beliefs hitting up against practical considerations and laws - we need to know how people died, particularly when it is a suspicious death, but we want to respect the religious and cultural beliefs of the people involved. And there are times when the two simply cannot be reconciled - and in those cases, what do you do?
I know what my decision would be - what's yours?
-Kelly
Thursday, January 17, 2008
NYS Supreme Court Case Stirs Ethical Debate
As is being being reported in numerous outlets, the NYS Supreme Court will be hearing a civil case filed against NewYork-Presbyterian Hospital by a construction worker who underwent an involuntary rectal examination as part of his trauma assessment. The plaintiff is claiming assault, battery, and false imprisonment for being restrained, sedated, and examined against his wishes. The hospital's response, of course limited due to HIPAA requirements, is that the plaintiff was brought to the ER with head trauma, was combative, and needed to have severe head trauma ruled out. (Apparently a rapid way to assess injury to the nerves of the spinal cord is to check rectal sphincter tone.) The plaintiff resisted, was sedated, and when brought out of sedated, punched a doctor in anger, and was arrested for assault.
None of this in itself is particularly new or newsworthy; it is a continuing debate of what constitutes emergency care, standard care, informed consent, and what it means to have decision making capacity. These debates have been going on for years, and will likely continue for as long as any of us can envision.
No, the interesting thing actually comes from the commentary at City Room, the NYTimes local blog. Reading through the comments gives an eye-opening view into the way the general public perceives medicine, emergency medical care, and doctors. The most fascinating, and oft-repeated claim, is that if the patient (plaintiff) could be be arrested for assault, then he was obviously competent to decide his medical care - that, as one commenter put it,
Of course, the best retort to that (also brought up in comments) is that a drunk person is not competent to make decisions - yet is still responsible for the actions they take while drunk. (Also of note is that no one claiming specific background and training in medical ethics has spoken up in the thread. For those of you reading this, with the limited information available, what's your take on the situation?)
Obviously the message of personal autonomy and the basic idea of informed consent has permeated our society, but at a very simplistic level that might actually cause more misunderstanding and difficulty when treating emergency medical cases than potential good. The question becomes then, how do we increase the general knowledge level of the lay person while still emphasizing autonomy, while simultaneously acknowledging the education and superior knowledge of the physician without falling back on paternalism?
For anyone interested in this line of thought, the comments in that thread are well worth the read, and the contemplation.
-Kelly
None of this in itself is particularly new or newsworthy; it is a continuing debate of what constitutes emergency care, standard care, informed consent, and what it means to have decision making capacity. These debates have been going on for years, and will likely continue for as long as any of us can envision.
No, the interesting thing actually comes from the commentary at City Room, the NYTimes local blog. Reading through the comments gives an eye-opening view into the way the general public perceives medicine, emergency medical care, and doctors. The most fascinating, and oft-repeated claim, is that if the patient (plaintiff) could be be arrested for assault, then he was obviously competent to decide his medical care - that, as one commenter put it,
if the patient’s competence is questioned regarding his ability to make an informed decision, then it’s inconsistent to charge that same incompetent person with assault.
Of course, the best retort to that (also brought up in comments) is that a drunk person is not competent to make decisions - yet is still responsible for the actions they take while drunk. (Also of note is that no one claiming specific background and training in medical ethics has spoken up in the thread. For those of you reading this, with the limited information available, what's your take on the situation?)
Obviously the message of personal autonomy and the basic idea of informed consent has permeated our society, but at a very simplistic level that might actually cause more misunderstanding and difficulty when treating emergency medical cases than potential good. The question becomes then, how do we increase the general knowledge level of the lay person while still emphasizing autonomy, while simultaneously acknowledging the education and superior knowledge of the physician without falling back on paternalism?
For anyone interested in this line of thought, the comments in that thread are well worth the read, and the contemplation.
-Kelly
Friday, March 23, 2007
Doctors Dishing the Dirt
"I informed a patient's parents that we would call them when their child was off the heart bypass machine and back in the intensive care unit. That went down like a lead balloon as the child was in fact having spinal surgery. Oops...." (From http:/
An article in the Washington Post today examines the troubling trend of doctors blogging about their patients (sometimes rather harshly and crudely). The phenomenon is so new that medical boards, schools and professionals disagree on what is acceptable. The trend is troubling because not only because of the risk of compromising patient privacy but also because of potential liability for hospitals. I certainly could envision lawsuits -- can't you just see the latest lawyer ads? (Is your doctor talking about you behind your back? Dial 1-888-SueTheBastards or visit our website at www.SueTheBastards.com!)
For more on this (the Washington Post article, that is), click here.
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