AP (2/21, Marchione) reports that “[s]trokes have tripled in recent years among middle-aged women in the U.S.,” and physicians attribute this “alarming trend” to “the obesity epidemic,” according to a study presented at the International Stroke Conference in New Orleans.

Lead author Amytis Towfighi, M.D., a neurology specialist at the University of Southern California-Los Angeles, and colleagues, “used the National Health and Nutrition Surveys, a federally funded project that gives periodic health checkups and questionnaires to a wide sample of Americans.” The subjects were “asked whether a doctor had ever told them they had had a stroke, and about 5,000 middle-aged people answered that question in each survey.”

After analyzing the data, the authors found that “women aged 35 to 54 experienced an increase in the possibility of experiencing stroke,” AHN (2/21, Duerme) adds. From 1988 through 1994, “a woman’s chance was 0.6 percent.” But, “between 1999 and 2004, a woman’s chance grew to 1.8 percent.”

MedScape, January 2008:

Authors: Michael O’Riordan, Laurie Barclay, MD
Results from a new study have confirmed what many have long suspected, that a Western diet, one rich in meat, refined grains, and fried foods, increases the risk of developing the metabolic syndrome [1]. Dairy consumption, on the other hand, appears to offer some protection against this cluster of cardiovascular risk-factor abnormalities.

“There have been a couple of prospective studies looking at different components of diet and the effect on metabolic syndrome, but this study extends things further as we looked at whole dietary patterns,” lead investigator Dr Lyn Steffen (University of Minneapolis, MN) told heartwire. “Nobody eats just one food. With the Western diet pattern as a whole, a diet characterized by red and processed meat, fried food, and refined grains, as well low intakes of fruit and vegetables, fish, and whole grains, we were able to observe an increased risk of developing metabolic syndrome.”

The results of the study are published online January 22, 2008 in Circulation.

Fried foods also a major culprit

Speaking with heartwire, Steffen said that while dietary intake has been linked to various components of the metabolic syndrome, a cluster of risk factors defined by elevated measurements of waist circumference, blood pressure, fasting glucose levels, triglycerides, and low high-density lipoprotein (HDL) cholesterol, the role of diet in the development of the syndrome as a whole is still undefined.

To look at the relationship between dietary intake and the metabolic syndrome, the investigators obtained data from 9514 participants in the Atherosclerosis Risk in Communities (ARIC) study, excluding individuals with metabolic syndrome or cardiovascular disease at baseline. The group assessed food intake using a 66-item food frequency questionnaire and used this information to categorize dietary preferences as a “Western diet” or “prudent diet.” The Western diet was heavy on refined grains, processed meat, fried food, eggs, red meat, and soda, but skimpy on fish, whole grains, and fruits and vegetables. Those categorized as adhering to a prudent diet ate plenty of vegetables, including cabbage, radish, broccoli, carrots, pumpkin, red peppers, and spinach, as well as fruit, fish, seafood, poultry, whole grains, and low-fat dairy products.

After nine years of follow-up, nearly 40% of the ARIC participants studied developed metabolic syndrome. After adjusting for various demographic factors, smoking, physical activity, and energy intake, the consumption of a Westernized diet was associated with an 18% increased risk of developing the metabolic syndrome, whereas Steffen said the prudent dietary pattern had a neutral effect on metabolic-syndrome development.

Further adjusting for the consumption of meat, dairy, fruits and vegetables, refined grains, and whole grains, the analysis showed that meat, fried foods, and diet soda were all individually associated with a risk of developing metabolic syndrome. Dairy consumption, on the other hand, appears to confer protection against developing the disorder.

Nine-year multivariable-adjusted hazard ratios (95% CI) for 3782 cases of metabolic syndrome

Speaking with heartwire, Steffen said the increased risk of the metabolic syndrome associated with the Western diet is likely driven by the risk associated with increased red and processed meat consumption. For example, the consumption of red meat twice daily, those in the highest quintile of consumption, was associated with a 26% increase in risk of the metabolic syndrome compared with those who ate meat just twice per week, or those in the lowest quintile. Another study highlight was the finding that the consumption of fried foods was associated with a 25% increase in risk in developing the metabolic syndrome.

The investigators also showed, much like a study published last year in Circulation and reported by heartwire at that time [2], that diet soda consumption was associated with an increased risk of developing metabolic syndrome, despite the zero calories and zero sugar.

“We’re not exactly sure what is going on with diet pop,” said Steffen. “It could be that there is some sort of chemical in it that is promoting insulin resistance, or it could be related to behavior, something people are doing to increase their risk. There’s no calories in diet pop so maybe people feel less guilty about eating an extra cookie or slice or cake.”

Steffen said that the obesity epidemic, and the increasing prevalence of the metabolic syndrome, makes it important to identify whole dietary strategies, and not just specific foods or nutrients, to reduce the risk of developing the multicomponent syndrome. She said individuals would be served well by following the American Heart Association dietary guidelines, which recommend five to nine servings of fruits and vegetables daily, but very few individuals are doing just that. In addition to the fruits and vegetables, two servings of low-fat dairy and three servings of whole grains are recommended each day.

Sources

1. Lutsey PL, Steffen LM, Stevens J. Dietary intake and the development of the metabolic syndrome. Circulation. 2008;DOI:10.1161/circulationaha.107.716159. Available at: http://circ.ahajournals.org.
2. Dhingra R, Sullivan L, Jacques PF, et al. Soft drink consumption and risk of developing cardiometabolic risk factors and the metabolic syndrome in middle-aged adults in the community. Circulation. 2007;116:480-488.

Wall St. Journal (2/21, D6, Dooren) reports that a Food and Drug Administration (FDA) panel has “recommended the approval of Rotarix, a GlaxoSmithKline PLC vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus.”  Citing “11 clinical studies, involving more than 75,000 children,” the panel concluded that the vaccine does not increase the “risk of intussusception,” a “rare bowel problem.”  But according to an FDA medical officer, “there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies.”  Yet, the “overall death rate from any cause…was similar between infants given the vaccine and those in placebo groups.”  Clare Kahn, of GSK, said, “The risk-benefit ratio is favorable for the intended population.”

        The federal “government and several medical societies already recommend infants receive vaccination for rotavirus at two, four, and six months,” adds the AP (2/21).  According to GSK, “Rotarix is already available in more than 90 countries worldwide.”

Wall St. Journal (2/21, B1, Tesoriero) reports that according to Delta Marketing Dynamics Inc., a healthcare marketing research company, “Pharmaceutical companies increased wholesale prices for the 50 top-selling branded drugs by an average of 7.82 percent in 2007, after increases of 6.73 percent and 6.22 percent in the previous two years.” Some medications “had double-digit price increases over three years.”

Pfizer’s Lipitor (atorvastatin), for instance, “rose 16 percent.” The companies are attempting to “keep revenues afloat by raising prices ahead of many drug-patent expirations and the possibility of changing government regulations, part of the presidential candidates’ agendas.” However, “aggressive price increases could backfire politically, pushing policies toward greater government power over price negotiations.” Moreover, some “drugmakers are raising prices on medications that are due to lose patent protection so that customers will switch to — and continue to buy — similar, newer products that enjoy market exclusivity” for years to come.

MedPage Today (2/20, Smith) reported, “Women who report that they were abused as children have higher healthcare costs later in life,” according to a survey published in the Journal of General Internal Medicine. Amy Bonomi, Ph.D., of Ohio State University, and colleagues found that, “[c]ompared to those with no history of abuse, annual healthcare costs were 36 percent higher for women who reported childhood sexual and physical abuse.” The researchers also found that “[c]osts were 22 percent higher for women who reported physical abuse only and 16 percent higher for those who reported just sexual abuse.” According to the researchers, “women who suffered both types of abuse were significantly more likely to use mental health services, emergency departments, hospital outpatient departments, pharmacy services, primary care services, and specialty care than were women with no history of abuse.” bad credit asheville loans in northcarolinabad money credit loan tobaldwin officer california loan parkbangor bank savings rates home loanhome loan bank rateloan information bank operationsloans capital california bankof loans amercia acorn bank Map

 NBC Nightly News (2/20, story 7, 2:10, Williams) reported on the alleged dangers of the anti-bleeding drug Trasylol (aprotinin).

        The AP (2/21, Stobbe) adds that patients undergoing heart surgery “were more likely to die if given…Trasylol, two more U.S. studies have found, renewing the claims that the drug is dangerous.” Last year, “Bayer AG stopped selling” Trasylol “after a…study was halted because of deaths among patients taking” the drug. The drugmaker “funded one of the two new studies, and had the preliminary results before a September 2006 federal hearing on the drug’s safety — but did not present them.” In one study, Dr. Andrew Shaw, of Duke University Medical Center, and colleagues “looked at more than 10,000 patients who had bypass surgeries.” The researchers “found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2.5 times higher than patients who got another drug or who received no treatment for excessive bleeding.” Furthermore, “[a]t one year after surgery,” nearly “16 percent of Trasylol patients had died,” which is also approximately “2.5 times higher than the other two patient groups.”

        In the second study, which was “led by physicians at Harvard Medical School and Brigham and Women’s Hospital,” the researchers looked at “data on more than 78,000 coronary bypass surgery cases, comparing results when either Trasylol or aminocaproic acid was used,” according to HealthDay (2/20, Edelson). The researchers “looked at the risk of death over the short term, with average follow-up of about a week after surgery.” Nearly 45,000 patients received aminocaproic acid, while “[m]ore than 33,500 patients…received Trasylol.” The researchers, “[a]fter adjusting for a number of factors,” found that “the risk of death was 64 percent higher in the Trasylol group compared to those who got aminocaproic acid.” Furthermore, the researchers found “an increased need for dialysis…among those who got the drug.” Both studies were published in the Feb. 21 issue of the New England Journal of Medicine.

Modern HealthCare (2/20, Becker) reported, “Prices for hospital services rose 1.1 percent in January,” compared to “a 0.6 percent increase in December and the highest jump since April 2002 when it increased 1.2 percent,” according to data from the U.S. Bureau of Labor Statistics’ seasonally adjusted Consumer Price Index (CPI).

Additionally, during the “12 months ended in January, the hospital CPI was up 8.8 percent, compared with a 6.4 percent rise in the year-ago period.” Furthermore, “physician CPI rose 3.5 percent, compared with a 3.2 percent increase in the year-ago period.” However, during the month of January, physician CPI rose 0.2 percent,…down from the 0.3 percent rise in December.”

MedPage Today (2/20, Peck) reported that the “[l]oss of consciousness or sudden onset of confusion and weakness are stroke symptoms that are about 60 percent more likely to trigger 911 calls than is numbness as a first sign of an event,” according to research discussed at an American Stroke Association press briefing.

Dawn Kleindorfer, M.D., of the University of Cincinnati, said that the “finding emerged from an analysis of data from 2,056 stroke and transient ischemic attack patients treated during 1999 at Cincinnati-area hospitals.” Dr. Kleindorfer said that “[n]umbness was associated with a decreased likelihood of using emergency medical services.” However, “patients who have decreasing consciousness or ‘falls to the ground’ were 1.6 times more likely to call 911…and those with sudden weakness were 1.5 times more likely to call 911,” according to Dr. Kleindorfer.

NY Times, 2/21/08:  Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.

One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.

By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.

“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ ” Mrs. Hirst said in an interview.

“I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ ” — in other words, for all her cancer treatment, far more than she could afford.

Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.

Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,” the health secretary, Alan Johnson, told Parliament.

“That way lies the end of the founding principles of the N.H.S.,” Mr. Johnson said.

But Mrs. Hirst, 57, whose cancer was diagnosed in 1999, went to the news media, and so did other patients in similar situations. And it became clear that theirs were not isolated cases.

In fact, patients, doctors and officials across the health care system widely acknowledge that patients suffering from every imaginable complaint regularly pay for some parts of their treatment while receiving the rest free.

“Of course it’s going on in the N.H.S. all the time, but a lot of it is hidden — it’s not explicit,” said Dr. Paul Charlson, a general practitioner in Yorkshire and a member of Doctors for Reform, a group that is highly critical of the health service. Last year, he was a co-author of a paper laying out examples of how patients with the initiative and the money dip in and out of the system, in effect buying upgrades to their basic free medical care.

“People swap from public to private sector all the time, and they’re topping up for virtually everything,” Dr. Charlson said in an interview. For instance, he said, a patient put on a five-month waiting list to see an orthopedic surgeon may pay $250 for a private consultation, and then switch back to the health service for the actual operation from the same doctor.

“Or they’ll buy an M.R.I. scan because the wait is so long, and then take the results back to the N.H.S.,” Dr. Charlson said.

In his paper, he also wrote about a 46-year-old woman with breast cancer who paid $250 for a second opinion when the health service refused to provide her with one; an elderly man who spent thousands of dollars on a new hearing aid instead of enduring a yearlong wait on the health service; and a 29-year-old woman who, with her doctor’s blessing, bought a three-month supply of Tarceva, a drug to treat pancreatic cancer, for more than $6,000 on the Internet because she could not get it through the N.H.S.

Asked why these were different from cases like Mrs. Hirst’s, a spokeswoman for the health service said no officials were available to comment.

In any case, the rules about private co-payments, as they are called, in cancer care are contradictory and hard to understand, said Nigel Edwards, the director of policy for the N.H.S. Confederation, which represents hospitals and other health care providers. “I’ve had conflicting advice from different lawyers,” he said, “but it does seem like a violation of natural justice to say that either you don’t get the drug you want, or you have to pay for all your treatment.”

Karol Sikora, a professor of cancer medicine at the Imperial College School of Medicine and one of Dr. Charlson’s co-authors, said that co-payments were particularly prevalent in cancer care. Armed with information from the Internet and patients’ networks, cancer patients are increasingly likely to demand, and pay for, cutting-edge drugs that the health service considers too expensive to be cost-effective.

“You have a population that is informed and consumerist about how it behaves about health care information, and an N.H.S. that can no longer afford to pay for everything for everybody,” he said.

Professor Sikora said oncologists were adept at circumventing the system by, for example, referring patients to other doctors who can provide the private medication separately. As wrenching as it can be to administer more sophisticated drugs to some patients than to others, he said, “if you’re a doctor working in the system, you should let your patients have the treatment they want, if they can afford to pay for it.”

In any case, he said, the health service is riddled with inequities. Some drugs are available in some parts of the country but not in others. Waiting lists for treatment vary wildly from place to place. Some regions spend $280 per capita on cancer care, Professor Sikora said, while others spend just $90.

In Mrs. Hirst’s case, the confusion was compounded by the fact that three other patients at her hospital were already doing what she had been forbidden to do — buying extra drugs to supplement their cancer care. The arrangements had “evolved without anyone questioning whether it was right or wrong,” said Laura Mason, a hospital spokeswoman. Because their treatment began before the Health Department explicitly condemned the practice, they have been allowed to continue.

The rules are confusing. “It’s quite a fine line,” Ms. Mason said. “You can’t have a course of N.H.S. and private treatment at the same time on the same appointment — for instance, if a particular drug has to be administered alongside another drug which is N.H.S.-funded.” But, she said, the health service rules seem to allow patients to receive the drugs during separate hospital visits — the N.H.S. drugs during an N.H.S. appointment, the extra drugs during a private appointment.

One of Mrs. Hirst’s troubles came, it seems, because the Avastin she proposed to pay for would have had to be administered at the same time as the drug Taxol, which she was receiving free on the health service. Because of that, she could not schedule separate appointments.

But in a final irony, Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.

Mrs. Hirst is pleased, but up to a point. Avastin is not a cure, but a way to extend her life, perhaps only by several months, and she has missed valuable time. “It may be too bloody late,” she said.

“I’m a person who left school at 15 and I’ve worked all my life and I’ve paid into the system, and I’m not going to live long enough to get my old-age pension from this government,” she added.

She also knows that the drug can have grave side effects. “I have campaigned for this drug, and if it goes wrong and kills me, c’est la vie,” she said. But, she said, speaking of the government, “If the drug doesn’t have a fair chance because the cancer has advanced so much, then they should be raked over the coals for it.”

NY Times News Analysis, 2/21/08: THE Supreme Court’s ruling on Wednesday limiting lawsuits by patients over medical devices comes just as independent groups have raised questions about the Food and Drug Administration’s ability to ensure the safety of these products.

The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own science board have all issued reports concluding that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food.

A result, said David Vladeck, a professor at Georgetown University Law Center, is that the public is facing the worst of both worlds: a government health agency that cannot protect them and rules that block them from winning compensation when injured.

Randall Lutter, the F.D.A.’s deputy commissioner for policy, said that the agency was responding to reports of its deficiencies and improving. And advocates for the administration’s position say that regardless of the recent reports, the F.D.A. is a far better judge of product safety than the courts.

“Anyone who is in favor of a strong F.D.A. cannot also be in favor of unlearned, unscientific state juries second-guessing F.D.A.’s science-based decisions,” said Daniel Troy, a former F.D.A. general counsel who helped push the new policy.

Before President Bush took office, F.D.A. officials said that courts provided patients additional protection. In a 1997 brief, the agency’s chief lawyer wrote that “even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems.”

But the administration argues that the courts interfere with rather than bolster agency oversight and it has undertaken a concerted effort to protect drug and device makers from lawsuits by filing briefs in the Supreme Court and other courts and changing rules to limit companies’ liability.

With Wednesday’s ruling, those efforts proved successful for device makers. Two more cases, one to be argued Monday and the other in October, will determine whether drug makers will benefit as well. In his majority opinion, Justice Antonin Scalia wrote that the F.D.A.’s interpretation of its rules deserves “substantial deference.” Since the administration now interprets those rules to provide similar liability protection to drug makers, Justice Scalia’s opinion suggests that the court may soon provide a liability shield to pharmaceutical companies, too.

The politics of these cases are bewildering, said Susan P. Frederick, federal affairs counsel for the National Conference of State Legislatures. Republican administrations generally advocate limited regulation and deference to state oversight, Ms. Frederick said. But in what she said was its push to reduce court damage awards, the administration has written a blizzard of rules that do just the opposite.

“This is shocking to us because usually Republicans align quite nicely with our federalism policy,” she said.

The administration has undertaken similar efforts in other regulatory areas, including highway and consumer safety, contending that strengthened federal regulations trump, or pre-empt, the decisions of state courts.

Diana Levine’s suit, which will be argued in October, illustrates the debate.

In April 2000, Ms. Levine, a professional guitarist in Vermont, suffered a disabling migraine and went to a health clinic for a shot of Phenergan, an anti-nausea medicine. The drug was inadvertently injected into her artery, where it caused an arterial spasm that led to gangrene. After slowly turning black, Ms. Levine’s hand and forearm were amputated.

Ms. Levine sued Wyeth, arguing that the drug’s label should have forcefully warned of this known risk. She won a $6.8 million judgment. Wyeth appealed, contending that federal drug regulators did not call for such a forceful warning and instead approved a label that simply stated a preference for a less risky method of administering the drug.

The question is who controlled the drug’s label, the lengthy listing of the drug’s uses, dosages and risks.

F.D.A. rules had long allowed companies, which know their products better than the government and usually learn of new or worsening risks first, to change labels without federal approval. Indeed, the labels initially approved by regulators were seen as setting minimum safety standards that companies could then bolster.

But in January, the agency issued a proposed rule to limit when companies can list new warnings without federal approval, which Mr. Lutter said “improves and strengthens our control of the label.”

The administration argues that a product’s approved label represents not only the least but the most that the drug agency allows in warnings, “both a floor and a ceiling for labeling,” its brief in the Levine case states.

“If you put too much junk in the label, people don’t understand it in the right way,” Mr. Lutter said. “There is a risk of overreaction and ignoring it.”

For the administration, an unstated warning is a deliberate decision by the F.D.A. to protect against undue alarm, and companies cannot be held liable for such nonwarnings. Citing this argument, Wyeth contends that Ms. Levine’s suit punishes the company for failing to issue a warning that the F.D.A. implicitly rejected.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said that the F.D.A. oversees drug safety and labeling because its “expert staff is the most qualified to make such highly scientific and technical judgments.”

Andy Vickery, a plaintiffs’ lawyer in Houston, said that without the threat of litigation, companies would be less careful and patients would suffer.

“Many of the problems with drugs have been found out only because of vigorous litigation,” Mr. Vickery said. Phenergan’s label now includes a lengthy warning about the dangers of intravenous injections.

NY Times, 2/21/08:  Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.

The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.

The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.

The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of “grandfathered” devices.

Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky.

Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.

It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.

The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.

Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin.

Writing for the majority in Wednesday’s case, Riegel v. Medtronic Inc., No. 06-179, Justice Antonin Scalia said that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the F.D.A. has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use.

A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”

The decision affirmed the dismissal of a lawsuit by a patient who was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna.

The medical device statute contains a pre-emption clause that bars states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by “any requirement.”

Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.

That was all that Congress had in mind, Justice Ginsburg said, not “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” She said that Congress had passed the 1976 law “to protect consumer safety,” not to oust the states from “a domain historically occupied by state law.” The decision was at odds with the “central purpose” of the 1976 law, Justice Ginsburg added.

Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, Education, Labor and Pensions Committee and was the sole Senate sponsor of the 1976 legislation in question.

“In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” Mr. Kennedy said in a statement. He added: “Congress obviously needs to correct the court’s decision.”

Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Mr. Waxman said. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute.

The Supreme Court’s interest in pre-emption is not limited to the medical arena. In a similar case decided on Wednesday, this one unanimously, the court ruled that the federal law that deregulated the trucking industry in 1980 pre-empted two recent laws adopted by the State of Maine to regulate the shipment of tobacco products into the state.

The state laws were intended to prevent children who were not of legal age to buy cigarettes from ordering them over the Internet. The laws placed responsibility on shippers and delivery companies to verify the recipient’s identity and age.

Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New Hampshire Motor Transport Association, No. 06-457, said the state law “produces the very effect that the federal law sought to avoid, namely, a state’s direct substitution of its own governmental commands for competitive market forces” in a deregulated environment.