HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, December 12, 2007

Good News for Attorneys: Hospitals Need You

Law.com has an article discussing a disturbing trend among hospitals - filing for bankruptcy.

When Culver City, Calif.'s Brotman Medical Center filed for Chapter 11 bankruptcy in late October, attorneys paid attention.  Its financial struggles are likely to be a harbinger of hospital woes to come as the number of uninsured patients grows and hospital revenues decrease.  "All of those factors are forming a real storm for hospitals," said Stephen Warren, a partner in O'Melveny & Myers' L.A. office. "And this wave is going to involve sophisticated counsel."

Of course, law.com's take is that this is an interesting opportunity for attorneys, however, it sounds terrible for patients and hospitals.  Law.com focuses on California but that state doesn't sound too different from many others.  It reports:

Many California lawyers are especially interested in the hospital woes, since the state's high cost of compliance and higher costs of operating magnify the problems. The state's retrofitting requirements add an additional layer of expense to some already beleaguered hospitals. That's coupled with overarching stresses such as the proliferation of urgent-care centers as an alternative to hospital care. "I think there has to be a shakeout," Buchalter Nemer's Seigel said. "The hospital industry is going through a revolution." While more established hospitals like L.A.'s Cedars-Sinai will likely weather the storm, smaller community hospitals such as Brotman will be the hardest hit, he said.

The trend isn't going unnoticed. Just recently, members of Southern California's Turnaround Management Association, a group of professionals who work with distressed businesses, organized a presentation titled "Hospitals in Need of Care: The financial crisis looming in southern California's hospital system." "California's hospital system may be the 'canary in the mine' -- demonstrating weaknesses that are extant throughout the United States but have yet to become obvious elsewhere," the presentation stated. . . .

December 12, 2007 | Permalink | Comments (0) | TrackBack (0)

Slow down in Pharmaceutical Innovation

Ezra Klein notes a recent article by the Wall Street Journal discussing a decline in research successes at pharmaceutical companies.  The Journal article states,

In January, Pfizer Inc. announced it was closing its storied research laboratories here, laying off 2,100 people. Among the casualties: Bob Sliskovic, a 23-year lab veteran who helped create the world's most successful drug.

The closure and Dr. Sliskovic's abrupt change of circumstances are emblematic of the pharmaceutical industry's declining fortunes. It was at the Ann Arbor facility in the late 1980s that Dr. Sliskovic first assembled the chemicals that make up Lipitor, the cholesterol-lowering drug that has generated about $80 billion in sales since its launch and ranks as the bestselling pharmaceutical product ever. Today, Lipitor is nearing the end of its patent life, and Pfizer hasn't been able to come up with enough promising new drugs to replace it.

Following that initial breakthrough some 20 years ago, Dr. Sliskovic worked on several other research projects, but none panned out. His losing streak mirrors the industry's. A byproduct of the late-19th-century chemical business, pharmaceutical research thrived for more than a century by finding chemical combinations to treat diseases. But after contributing substantially both to human health and drug-industry profits, it has failed to produce significant innovations in recent years. . . .

Ezra Klein also points to other issues facing the drug industry, including many problematic patent law issues. 

December 12, 2007 | Permalink | Comments (0) | TrackBack (0)

Delays in Social Security Disability Claims

Frank Pasquale at Concurring Opinions writes about the recent New York Times article concerning the delays in processing of social security disability claims.  He states,

Timely justice in these cases would require more staff to deal with appeals. Instead, continuing budget battles mean that SSA "will probably operate on the basis of continuing resolutions, which will keep agency spending at last year’s level and doom the plan to add judges."

The parsimonious and inaccurate bureaucracy excels at a few things, though. It generates lots of work for those who represent the claimants. And it displays a Kafkaesque willingness to help once it's too late:

In the past, said Walter Patterson, a disability lawyer in Charlotte, N.C., clients who received a foreclosure warning were pushed up the waiting list for quicker hearings. But as the hearing offices have become overwhelmed, he said, they now expedite cases only after seeing an actual eviction notice — usually too late to help.

Like the costly ER interventions that could be avoided if only we provided preventive medical care for the poor, the dilatory aid offered by a torpid SSA should provoke a rethink of bureaucratic justice here. Though the agency is under stress, it should no longer hide behind Mathews v. Eldridge to justify a deeply flawed and unfair system.

December 12, 2007 | Permalink | Comments (1) | TrackBack (0)

Huber: Disability Law Case Granted Cert.

Last week, the Supreme Court granted cert. in the Huber v. Wal-Mart case concerning disabled employee rights to reassignment to vacant positions. Scotusblog provides a brief overview: 

In the Huber case, the Court limited its grant of review to the first question raised, and Justice Stephen G. Breyer recused. The issue to be decided is whether an individual who is disabled and cannot perform her present job must be reassigned to a vacant, equivalent position without having to compete with other workers for that slot. The case involves Pat Huber, a Wal-Mart employee in Clarksville, Ark. After she became disabled by an injury, she sought an open job, but a non-disabled worker gained the position. Wal-Mart said the other worker was better qualified, and that it followed a policy of basing such assignments on qualifications. The appeal says that the U.S. Equal Employment Opportunity Commission has issued regulations providing that a disabled worker need not be the best qualified for an open position to obtain it in a reassignment. The Americans with Disabilities Act requires employers to make “reasonable accommodations” for their disabled employees.  The Circuit Courts are split on the issue at stake.

Scotusblog also posts the following:

Docket: 07-480
Case name: Huber v. Wal-Mart
Issue: Whether, under the Americans with Disabilities Act, disabled employees must be reassigned to a vacant position for which they are qualified or merely be permitted to apply for such a position.

The Laborprofblog has some thoughts on the case and is not optimistic about the plaintiff's chances.

December 12, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, December 5, 2007

Some Controversy Over Democratic Health Care Plans

In Iowa, both Democratic candidates Clinton and Obama have been arguing over their health care plans recently.  Ezra Klein, as usual, does an excellent job describing both plans and the controversy here and here, and the Wall Street Journal discusses the recent uproar over the topic of who will cover more Americans and whether a mandate will provide an answer to some of our health care problems.   The Journal states,


Clinton says Obama’s health care plan, which doesn’t require everyone to get coverage, would leave out 15 million people. Clinton’s own plan requires everybody to get coverage. But Obama says there’s not enough money in Clinton’s plan to pay for everybody to do so.

Both candidates are probably right, more or less, and which plan would cover more people is anyone’s guess, according to stories this morning in the WSJ and the New York Times. . . .

The WSJ notes that both candidates say they’d spend roughly the same amount of money — about $110 billion a year — on their plans, which share many similarities. The NYT points out that just because you have a mandate, it doesn’t mean everybody will follow it, citing the fact that an estimated 15% of the nation’s drivers flout the mandate for auto insurance.

December 5, 2007 | Permalink | Comments (0) | TrackBack (0)

Supreme Court Considers Medical Device Case

The New York Times' Linda Greenhouse reports on Riegel v. Medtronic Inc., argued yesterday in front of the Supreme Court.  The case considers, "whether the manufacturer of a medical device approved for sale by the Food and Drug Administration can be sued for damages under state law if the device injures a patient."  She writes,

The device at issue was a balloon catheter that burst during an angioplasty, causing serious injury to the patient, Charles R. Riegel. He and his wife, Donna, sued the manufacturer, Medtronic, which had received approval to market the device in 1994, two years before the incident. Two lower federal courts in New York dismissed the suit on the ground that the F.D.A.’s “premarket approval” precluded the imposition of liability under state law.

The Supreme Court last looked at a medical device case in 1996, when it ruled that devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At that time, the federal government itself argued against pre-emption.  But in 2004, the Bush administration reversed the government’s position and began to take the manufacturers’ side, as it did before the justices on Tuesday in an argument by a deputy solicitor general, Edwin S. Kneedler. Explaining the change in policy, Mr. Kneedler said that in 2004, the F.D.A. “recognized that there would be a serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits if a state jury could reweigh those.”

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is whether the court will give the government’s position the usual deference it accords an agency’s interpretation of its basic statute.

The federal law at issue is the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is ifferent from, or in addition to, any requirement applicable under this chapter.”  Beginning with a case in 1992 about warning labels on cigarette cartons, the Supreme Court has treated the word “requirement” as including not only obligations directly imposed by state laws and regulations, but also the award of damages by state tort systems. 

For a jury to say, “Well, gee, it should have been done differently in this particular situation” is the equivalent of imposing a requirement in addition to federal approval, Theodore B. Olson, the lawyer representing Medtronic, told the justices.  “The F.D.A. is the right place for these decisions to be made and this balancing process to occur,” Mr. Olson said, adding that while “nothing is perfectly safe,” it would harm consumers to “discourage the marketing of products that might save our lives.” Medtronic no longer makes the balloon catheter, called Evergreen, involved in the case.

While Mr. Olson’s argument clearly found traction with some justices, most notably Justice Antonin Scalia, the lawyer for the plaintiffs, Allison M. Zieve, was also effective in sowing doubts that “premarket approval” by the agency was rigorous enough to justify shielding the manufacturer from state liability.  Ms. Zieve, a lawyer with the Public Citizen Litigation Group, conceded that the law would prevent a state from imposing its own premarket approval process that differs from the federal one. But she said that premarket approval was a preliminary judgment of safety and effectiveness that did not relieve a manufacturer of an obligation to make a device better and safer.  Premarket approval was not “irrelevant to the tort suit” but was not by itself adequate to invoke pre-emption, Ms. Zieve said. . . .

December 5, 2007 | Permalink | Comments (0) | TrackBack (0)

Saturday, December 1, 2007

Giant Microbes

Looking for a unique holiday present for a loved one - well - your search is over - Giant Microbes are cute and fuzzy and quite educational.   You can read more about them here.

December 1, 2007 | Permalink | Comments (0) | TrackBack (0)

World AIDS Day

Thinkprogress reports some depressing numbers on this World AIDs Day.  It states,

There are 33.2 million people in the world currently infected with HIV, and 2007 saw 2.5 million new infections. But as Matt Foreman, Executive Director, National Gay and Lesbian Task Force, notes: “Here in the United States, the attitude of so many within our own community is that there’s not a lot more to be done.”

House Speaker Nancy Pelosi (D-CA) states, “Recently reported increases in both new HIV infections and new AIDS cases in the United States call out for stronger leadership domestically as well.” Right outside the U.S. Capitol, a “modern epidemic” is raging.

The cite also has a helpful map to illustrate the spread of this disease.

December 1, 2007 | Permalink | Comments (0) | TrackBack (0)