Author Archive for Howard S. Richman


Bush, Obama and why Wyeth v. Levine is so important

Doug Kendall, founder and President of the Constitutional Accountability Center, puts the Wyeth v. Kendall case currently before the Supreme Court into a broader context, and analyzes how presidential politics has contributed to – and may ultimately change – the way product liability litigation against pharmaceutical companies are decided.

Kendall notes that this case is an illustration of both “the importance of Supreme Court rulings to ordinary Americans and the aggressive efforts of the outgoing Administration to use the Court and its own regulatory authority to protect corporations from being held accountable for the harms caused by their products.”

As he goes on to explain, the Federal Food, Drug & Cosmetic Act (FDCA), the federal statute governing drug approval, labeling and safety regulations, is the relevant statute in this case. But when it was originally enacted by Congress back in 1938, all remedies available to consumers under state law were consistent with the FDCA, unlike today where there are numerous conflicts between federal law and the law in each state (as is the case in Vermont).

In the past seventy years, Congress has amended the statute numerous times, and yet has managed to avoid addressing the critical issue of whether the FDCA expressly preempted state law claims against pharmaceutical companies such as Wyeth in this case. Kendall does point out, however, that it did choose to include an “express preemption clause regarding medical devices” (as per Riegel v. Medtronic).

This revision of long-standing FDA policy on preemption in the drug labeling context was made over the objection of career agency officials, including the highest official in the drug review process, who warned that “much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”  [. . .]

According to a report released today by the House Committee on Oversight and Government Reform, “the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts.”

This attempt to achieve “preemption by preamble” not only places Americans’ health and safety at risk, but it also circumvents Congress and the Constitution–the Supremacy Clause, after all, states that the laws of the United States are supreme, not federal agency preambles.

But here is where it gets really interesting: Could the Bush Administration’s policy of “preemption by preamble” be reversed next year, regardless of the high court’s ruling? Kendall argues that: 

“A top priority of the new administration should be to review the preemption decisions by the Bush Administration and reverse them unless Congress has declared clearly in federal law its intent to displace state law. And Congress can overturn any holding by the Court in Wyeth, as well as a long-list of other bad preemption decisions by the courts in recent years, by amending the laws in question and clarifying that the states should not be inappropriately displaced by federal law.”

The Court needs to do its job and rule for Diana Levine in Wyeth. But the results of the election held the day after the Wyeth argument should have an equally great impact on the ability of states to serve as laboratories of democracy and the availability of remedies for individuals who are harmed by corporate wrongdoing.

It has been reported that the court is not expected to rule on the case until next June, and that the justices are “torn” over how they will make their decision, and yet the most important question to ask is actually whether the incoming Obama administration and new Congress will decide to take Kendall’s advice and push forward legislation that will effectively reverse a potential ruling in favor of the defendant.


New CDC data reveals scope and seriousness of treating falls for elderly

Be sure to check out this important article from today’s New York Times. Writer John Leland reports on some recent data released on the website of the federal government’s Center for Disease Control and Prevention (CDC) on the long-term – and often unreported – physical, emotional and psychological impact of certain injuries sustained by the elderly.

Once considered an inevitable part of aging, falls are now recognized as complex, often preventable events with multiple causes and consequences, calling for a wide range of interventions, both psychological and physiological, that many patients never receive.

Even falls that cause only minor injury “need to be taken as seriously as diabetes,” said Dr. R. Sean Morrison, a professor of geriatrics and adult development at Mount Sinai School of Medicine in New York, because “they can be a real warning sign that something serious is wrong.”

And according to Dr. Mary E. Tinetti, a falls expert at Yale University medical school:

[C]ompared falls to strokes in their harmfulness, adding that people do not always report them or seek help, for fear their families will try to put them in nursing homes. For some people, Dr. Tinetti said, admitting that they fall is tantamount to admitting that they are no longer competent to take care of themselves.

Each year, 1.8 million Americans over age 65 are injured in falls, according to the Centers for Disease Control and Prevention. Some rebound as if the injury never happened. But for some, the fall sets off a downward spiral of physical and emotional problems — including pneumonia, depression, social isolation, infection and muscle loss — that become too much for their bodies to withstand.

In 2005, the last year for which statistics are available, 433,000 people over 65 were admitted to hospitals after falling, and 15,800 died as a direct result of the fall. Less visible are the many who survive the fall but not the indirect consequences.

Other important statistics reported by the CDC include:


  • One in five hip-fracture patients over age 65 die within a year after surgery, according to the C.D.C.; one in four have to spend a year or more in a nursing home.
  • When younger people fall, they tend to break their wrists catching themselves, but in older people, who have slower reactions and less upper-body strength, the weight more often falls on their hips or heads. Any underlying conditions, like heart disease or respiratory problems, increase the chances of a downward health spiral.

  • Psychological factors can be just as devastating as physical trauma, and can lead to the injured individual becoming “socially isolated and depressed.”
  • The period of immobility after a fall is particularly dangerous    


Supreme Court to rule in Wyeth v. Levine

The Supreme Court has now finished hearing oral arguments from the defense and plaintiff in Wyeth v. Levine, a case with profound implications for product liability litigation – specifically in the pharmaceutical industry. The decision will also set an important precedent for constitutional law, specifically in the way lower courts will interpret the doctrine of implied preemption in the future.

Derived from the Supremacy Clause of the Constitution, the doctrine of Preemption bars individuals injured by a product from filing a civil action in state court if the product complied with federal safety standards. Attorneys practicing in the field of product liability law, especially those who represent individuals injured by dangerous drugs should be closely following this development.

First, some background on the facts and procedural history of the case. The plaintiff, musician Diana Levine, began suffering from migrane headaches and turned to a local health clinic for treatment in April 2000. There, she was prescribed pain medicine as well as Phenergan, a drug manufactured by Wyeth for treating nausea. However, the physician’s assistant who administered the latter drug injected it into one of her arteries, rather than a vein — despite warnings on the drug’s label that doing so could lead to irreversible gangrene.

Tragically, as a result of receiving this negligent care, Levine ended up with gangrene and needed to have one of her arms amputated below the elbow. She filed a civil suit against the clinic and the PA for malpractice and received an undisclosed settlement out of court.

Then, in 2004, a jury in her home state of Vermont found that Phenergan’s label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug and awarded her $6.7 million from Wyeth. The Vermont Supreme Court upheld the jury’s verdict in 2006.

This is where Levine’s lawsuit becomes enmeshed in the complexities of constitutional law, and why the Supreme Court agreed to hear the case. All of this will be fleshed out in a series of posts over the next few days. Stay tuned.

Here is some online reading for further background:


Hinchey’s offers legislation to reform Feres Doctrine

Although it has to date received scant media coverage, a legislative battle may be shaping up and attorneys, especially those who represent either veterans or active members of the armed services, ought to be on the lookout. Back in May of this year, CBS News reported that Congressman Maurice Hinchey (D-NY) had introduced a bill named the Carmelo Rodriguez Military Medical Malpractice and Injustice Act in order to address the Feres Doctrine’s judicial bar on “medical malpractice,”

First, some background on the Feres Doctrine is warranted for those who may be unfamiliar with the term. In Feres v. United States, 340 U.S. 135 (1950), the Supreme Court ruled that the federal government was not liable under the Federal Tort Claims Act, 28 U.S.C.§ 1346(b) and 28 U.S.C. § 2671–2680 for anyinjuries to members of the Armed Forces sustained while they are on active duty, and/or resulting from the negligence of others in the Armed Forces that are incident to service.

Since the Supreme Court decision over half a century ago, the Feres Doctrine has complicated efforts to ensure our brave soldiers receive adequate redress for injuries they suffer when the medical care they receive falls below accepted standards of care. Why? The doctrine effectively bars service members from successfully collecting damages for personal injuries, when the care they receive is outside accepted standards of medical care.  This holds true whether the injury suffered was received as a result of non combat or military duties.  Imagine a service member who seeks out care at a military medical hospital for a growth on his skin that is ignored.  If the tests are not run and the diagnosis is not made and later it is discovered the service member had a cancer and it went untreated that service member is barred whether or not they were suffered in the performance of their duties. To make matters worse, it also bars families of service members from filing wrongful death actions in federal court in the event that their loved one is killed or injured as a result of that misdiagnoses. 

The bar does not, however, extend to killed or injured family members, so a spouse or child may still sue the United States for tort claims (for example, in a case of medical malpractice), nor does it bar service members from filing either in loco parentis on their child’s behalf or filing for wrongful death or loss of consortium as a companion claim to a spouse or child’s suit.

Nevertheless, the fact that so many of our brave men and women are being injured or killed while serving on the front lines of the War on Terror in Iraq, Afghanistan and other dangerous conflict zones across the globe ought to provoke a public discussion as to whether the Feres Doctrine needs to be reformed for the 21st Century. Since these soldiers risk their life and limb in order to protect this country, shouldn’t they at the very least have standing to sue the government in the event they are injured or killed while serving due to negligent medical care? And wouldn’t allowing this bar to be lifted create an additional incentive for the government to improve care in the first place?

This brings us back to Representative Hinchey. As a result of a misdiagnosis by a military doctor treating him while he was deployed in Iraq, Marine Sgt. Carmelo Rodriguez did not receive adequate medical care for his melanoma, leading to his tragic death. Missing the signs that Rodriguez had melanoma, his doctor instead had diagnosed him with having warts.

And of course, since he was on active duty at the time he was   subjected to this negligent care, his family cannot seek redress for his wrongful death because of the Feres Doctrine. This prompted Congressman Hinchey’s office to release a press release  announcing his intention to introduce legislation to reform Feres.

Having Congress provide such legislative reform for Feres was a goal that already had the support of many in the legal community, including supported the Washington, DC Bar Association, but since Hinchey’s bill was introduced almost six months ago, it has fallen off the media’s radar. Right now, it is unclear what the status of the bill is today. This is most likely a result of Congress and the White House being enmeshed right now in crafting a legislative and regulatory response to the nation’s financial crisis, as well as being preoccupied with the November elections. It is safe to say that hearings on the bill will begin until the next session of Congress at the earliest.

This blog will be closely following any developments and will report when hearings will be held, as well as whether or not the bill ultimately passes and in what final form. In the interim, here is some suggested reading to give you further background on the issue:

  •  The legal blog TalkLeft opines on the need to reform the Feres doctrine here.
  • Here is the complete text of Hinchey’s bill.
  • A series of posts by law professor and commentator Jonathan Turley from his blog here, here and here.


What is the quality of medical care for soldiers?

In the aftermath of al-Qaeda’s horrific attacks on New York City, Pennsylvania and Washington, DC on September 11th, George W. Bush announced to the world that his administration’s response would involve a long-term, preemptive* military response against terrorist networks across the globe which posed a threat to US interests, as well as any states that harbored terrorists. As this first iteration of the Bush Doctrine indicated, the prosecution of the War on Terror has for the past seven years relied heavily on the members of its armed forces, including the National Reserves and National Guard.

For those brave and women who have contributed – and in many cases, sacrificed – such a disproportionate amount for this war, the American public ought rightly ask how the administration, Congress and the federal courts have fulfilled its obligations to provide veterans as well as those currently active with the medical care they need.

Getting an answer to this question and addressing any flaws in policy or implementation obviously has profound implications for these citizens, and the attorneys who ultimately provide them.

There are two separate questions for us to ask. First, what is the scope of care that is offered and what determines who is eligible to receive care and under what circumstances?  Second, what is the adequacy, or quality of those services that are provided?

More posts will follow in the near future which will discuss this important topic more expansively, and in particular discuss recent developments in the legislative and regulatory environment, as well as important court decisions, that may change the way future care is ensured and provided. But for now, consider this an open thread for discussion.

As with all other posts on the blog, this discussion will not be moderated to exclude the expression of views or opinions that the editor disagrees with.  However, any offensive or completely unrelated/off-topic content will be deleted.

*A speech given by President Bush on June 1, 2002 contained statements that have been interpreted as extending the basis for a “preventative” military response to protect US interests from any terrorist attack that was not imminent but rather foreseeable.


Violations Reported at 94% of Nursing Homes

The New York Times reports that according to data just released by the Department of Health and Human Services in 2007, over 90% of nursing homes in the US were cited for violations of federal  health and safety standards. Further, in a report released by the federal agency’s inspector general found that for-profit nursing homes were in fact more likely to have problems compared to other types of facilities.

Some of the problems frequently cited include infected bedsores, medication mix-ups, poor nutrition, as well as abuse and neglect of patients. And adding insult to injury, the article notes that in some cases, nursing homes went so far as to billed Medicare and Medicaid for services that “were not provided, or were so wholly deficient that they amounted to no care at all.”

A spokesperson for the nursing home industry argues that the federal inspection program itself is in fact “broken” and that it does not reliably measure quality nor create positive incentives.


Report: Medicare Will No Longer Pay for “Preventable” Hospital Errors

The New York Times reports on a recently announced change in Medicare’s policy that is likely to have far-reaching implications for practice of medical malpractice law. The largest insurer in the US will no longer pay bills resulting from what it deems “preventable” medical errors made by hospital employees on patients under their care. By forcing the hospitals to internalize any additional costs they might incur due to negligence, it is reasoned that health care providers will have an even stronger incentive to prevent their patients from being injured as a result of bed sores, injuries from falls or urinary tract infections, for example.

According to the Times’ report, Medicare has created a list of ten conditions it argues are in fact “reasonably preventable.”

The new Medicare policy is still less stringent than the standard advocated by some health policy experts. As the article notes: “In 2002, the National Quality Forum, a standard-setting consortium for the health care industry, compiled a list of 27 largely preventable adverse events, a list that grew to 28 in 2006.”

An executive for the American Hospital Association points out toward the end of the article that it remains unclear which mistakes will be categorized by different insurers as being preventable and which ones would not.

And it is noted that similar policies are already in place:

Over the last year, four state Medicaid programs, including New York’s, have announced that they will not pay for as many as 28 “never events” (so called because they are never supposed to happen). So have some of the country’s largest commercial insurers, including WellPoint, Aetna, Cigna and Blue Cross Blue Shield plans in seven states.

It is argued that many commercial insurers will follow the lead of Medicare and Medicaid and change their criteria as well – leading to a multiplier effect. But while the change in policy makes may end up succeeding in forcing hospitals to be more vigilant in avoiding injuries that shouldn’t happen in the first place, according to the article the cost savings are projected to be relatively small compared with the overall amount of money spent annually for inpatient care.

A much more significant source of savings, according to health economists, would be achieved by  hospitals providing its patients with more preventative healthcare, chronic disease management and by cutting back on unnecessary procedures.

For more background and analysis, see this post from the Healthcare Blog last August.

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