Archive for the 'Personal injury' Category

20
Nov
08

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 But when it was originally enacted by Congress back in 1938, all remedies available to consumers under state law were consistent with the FDCA, unlike today where there are numerous conflicts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.

16
Nov
08

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    




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