Supreme Court rules against Wyeth in pre-emption case.
ABC World News (3/4, story 9, 0:30, Gibson) reported, "The Supreme Court today [Wednesday] down a ruling in an important business case, saying drug companies are not shielded from injury claims simply because their products and labels have government approval. The court ruled against pharmaceutical giant Wyeth, upholding a $7 million jury award to a woman who lost her arm because of a botched injection. The decision was 6-3, with the justices saying the manufacturer bears responsibility for the content of its label at all times." CBS Evening News (3/4, story 4, 2:00, Couric) and NBC Nightly News (3/4, story 5, 2:05, Williams) also included the story in their broadcasts.
In a front-page story, the New York Times (3/5, A1, Liptak) reports, "In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators." The decision "could have significant implications beyond drug manufacturing" as "many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation."
The Washington Post (3/5, A2, Barnes) reports, "The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them."
The AP (3/5) adds that the Supreme Court upheld "a $6.7 million jury award to a musician who lost her arm to gangrene following an injection." The plaintiff, "Diana Levine of Vermont once played the guitar and piano professionally" and "her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered." Many other outlets covered the Wyeth ruling, including, BusinessWeek (3/5, Johnson), CBS News (3/5, Cohen), the San Francisco Chronicle (3/5, Egelko), the Wall Street Journal (3/5, A1, Bravin), the Legal Times (3/5, Mauro), the Los Angeles Times (3/5, Savage), USA Today (3/5, Biskupic, Appleby), and UPI (3/4).
Drug industry may face more litigation after ruling. The Financial Times (3/5, Jack) reports, "Pharmaceutical companies face substantial extra litigation after the US Supreme Court ruled [Wednesday] that safety warnings on their drugs approved by federal regulators did not protect them from lawsuits in individual states." The ruling "marks the failure of efforts by the industry to fight legal settlements by imposing federal pre-emption, an argument that had been supported by George W. Bush's administration."
Bloomberg News (3/4, Stohr) reported that now drugmakers can be sued "for failing to provide adequate safety warnings." Justice John Paul Stevens wrote in the opinion, "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." The ruling "might help former users of Wyeth's Prempro (conjugated estrogens) and Premarin (conjugated estrogens) menopause drugs and consumers of AstraZeneca PLC's antipsychotic drug Seroquel (quetiapine fumarate)." However, "the impact isn't clear for allegations that Pfizer Inc. and GlaxoSmithKline PLC should have done more to warn that their antidepressants might cause suicidal tendencies."
The Philadelphia Inquirer (3/5, Hill) reports that Sol Weiss, a Philadelphia plaintiffs' lawyer, said, "This doesn't mean you're going to win, but you get your day in court." He is "not involved in this case" but "he is hoping that the decision will revive his cases involving Pfizer Inc.'s antidepressant Zoloft (sertraline) and GlaxoSmithKline PLC's antianxiety agent Paxil (paroxetine hydrochloride)." The Wall Street Journal (3/5, A2, Johnson, et al.) also considers the implications of the decision.
Ruling may make drugmakers more cautious, halt development. The AP (3/5) reports that the ruling "could make drugmakers more cautious about safety issues and may lead them to halt development of some medicines and even pull others off the market." Erik Gordon, an analyst and professor at University of Michigan's Ross School of Business, said, "'They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug."
Ruling seen as contradictory to medical device case. On the front of its Business Day section, the New York Times (3/5, B1, Meier, Singer) reports that the "result of a decision Wednesday by the Supreme Court" was that "federal law does not protect drug companies from product liability suits in state courts." However, "in contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices." David C. Vladeck, a professor at Georgetown University Law Center, said, "I think this is going to force Congress to revisit the issue of why medical devices should be insulated from lawsuits."
Wyeth loss seen as possible victory in disguise. Forbes (3/5, Fisher) reports, "Wyeth's loss dashes the hopes of those who support pre-emption as a tactic for cutting back on excessive jury awards in product-liability cases, which the court affirmed last year in Riegel v. Medtronic." However, "Wyeth v. Levine may be a victory in disguise. By stepping back from the brink and refusing to give drug companies federal immunity from suits under state laws, the court has likely prevented an even more toxic response from the Democrat-controlled Congress."
WSJournal, NYTimes editorials split on Wyeth ruling. The Wall Street Journal (3/5) editorializes, "The decision is a huge victory for plaintiffs lawyers, but it's a much bigger defeat for drug innovation and public health." The Journal adds that the "ruling will expose drug companies to a kind of double innovation jeopardy." Concluding, now drug companies " will have to contemplate paying up front -- and paying later, even if the tragic mistake in applying the drug is someone else's. Wyeth is a dream come true for the plaintiffs bar."
In contrast, the New York Times (3/5) editorializes, "The Supreme Court made a wise and surprising decision on Wednesday when it rejected a drug company's claim that it cannot be sued for damages in state courts if a product and its label have been approved by the Food and Drug Administration." The ruling "demolished the notion that federal regulatory rulings automatically pre-empt the states from enforcing even tougher standards on drugs" and "also exposed as a sham the Bush administration's strenuous efforts to protect its allies in industry with phony pre-emption claims." The Times concludes, "We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well."
Federal Agency News
House committee approves measure that may enable FDA regulation of tobacco, marketing practices.
As a follow-up up to its article published two days ago, the AP (3/5) reports that a "House committee has approved legislation that would place cigarettes under government regulation for the first time." Although the measure "would not let the Food and Drug Administration (FDA) outlaw tobacco or nicotine, the agency could reduce or eliminate cancer-causing chemicals in cigarette smoke." The legislation would also require that companies divulge ingredient lists and enlarge the warning labels on all packages. Furthermore, the bill "would prohibit candy-flavored cigars and cigarettes and give the FDA authority to ban menthol."
It also "restricts tobacco marketing to young people," Bloomberg News (3/4) added. The legislation has "broad support," including industry leader Altria Group Inc. and President Barack Obama, and that "may speed approval this year." The House Committee on Energy and Commerce has already "passed the legislation, the Family Smoking Prevention and Tobacco Control Act, in a 39-13 vote" on Wednesday. "All of the Democrats at the panel's meeting voted in favor of the legislation, and they were joined by six Republicans." The measure might eventually move "to the full House" after other committees weigh in.
But not everyone views the bill in a favorable light, according to Dow Jones Newswires (3/4, Favole). "Several Republican members of the Energy and Commerce Committee voted against the bill, saying the bill would give people the perception that FDA approves the use of tobacco products." Other opponents maintain that the FDA's "handling of recent drug scandals and food outbreaks involving the bacteria salmonella show the agency doesn't have the resources and can't handle the responsibility of overseeing another area of the public's health."
In addition, a number of "smaller tobacco makers oppose regulation, in part because they believe new restrictions on the marketing of tobacco would essentially lock in Philip Morris' market share," CQ (3/4, Armstrong, Wayne) pointed out. Moreover, "critics of the industry say...that most Republicans are simply looking out for their friends, since the tobacco industry gave $743,000 more to congressional Republicans in the 2008 election cycle than it did to Democrats."
In light of these and other criticisms, one lawmaker offered an alternative to HR 1256, brought forth by Henry A. Waxman (D-CA), the Winston-Salem (NC) Journal (3/4, Craver) reported. But the House panel rejected Rep. Steve Buyer's (R-IN) amendment, which "would have created a new tobacco harm reduction center within the Department of Health and Human Services (HHS)." Specifically, the HHS center "would combine smoking cessation programs with industry strategies to reduce the harm from tobacco products." Those that supported the amendment argue that the "potential FDA tobacco regulation bill does not carve out a niche for harm-reduction tobacco products." Instead, the "Waxman bill simply keeps the same playing field," while ensuring that "Philip Morris and Marlboro [remain] dominant." And, according to some analysts, "Philip Morris USA helped write the language in the proposed FDA tobacco-regulation bill."
Healthcare Policy/Legislation
Obama budget proposes "deep cuts" to Medicare Advantage plans.
Roll Call (3/5, Murray) reports, "Attempting to make good on campaign promises to curb wasteful spending, President Barack Obama recently ordered deep cuts to a Medicare program favored by the insurance companies, whose criticism of the proposal may be situating the powerful industry for a prime seat at the table when deliberations begin later this week." As part of his new budget, "the President proposed saving $176.6 billion during the next decade by establishing 'competitive bidding' for Medicare Advantage, a taxpayer-financed healthcare program administered by private insurance carriers that is popular with seniors living in rural areas." America's Health Insurance Plans spokesman Robert Zirkelbach maintains that "this budget would ask seniors and Medicare Advantage to fund a disproportionate share of the costs to reform the healthcare system." But, AARP spokesman Jim Dau says that the cuts "would not only help level the playing field for MA and traditional Medicare -- a goal which AARP supports -- but also save Medicare billions of dollars that could be used to improve Medicare and our entire healthcare system."
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Proposed legislation may allow imports of cheaper prescriptions.
Bloomberg News (3/5, Randall) reports, "Americans may soon be able to buy cheap drugs imported from other countries without fear of breaking the law, now that a five-year push in Congress for new rules has gained support in President Barack Obama's budget." On Wednesday, Sen. John McCain (R-AZ) and other lawmakers introduced "a proposal to allow drug imports. ... Obama called for the changes in his budget last week, and views the measure as one way to reduce healthcare costs so that medical coverage for the uninsured can be expanded." Data show that "brand-name drugs in other countries cost as much as 70 percent less than in the U.S." Therefore, "allowing imports would save Americans $50 billion over the next decade, including $10 billion for the U.S. government, the lawmakers said." Notably, the "Pharmaceutical Research and Manufacturers of America...opposes the legislation. The group has argued that allowing imports would open the door to unsafe, counterfeit medicines." Meanwhile, "AARP, the largest advocacy group for older Americans, supported" the measure even when it was first introduced on former President George W. Bush.
CongressDaily (3/5) notes that the lawmakers "expect this to pass," particularly since "Obama announced in his budget a strong interest in implementing this policy."
Sen. Baucus believes a bipartisan healthcare reform bill will be ready to go by June, July.
MedPage Today (3/4, Walker) reported, "Sen. Max Baucus (D-MT) laid out an 'ambitious' plan to have a bipartisan healthcare reform bill ready to go by June or July, while acknowledging the massive task ahead of him. ... But despite the complexity of healthcare reform and the difficulty of gaining bipartisan support for the movement, Baucus said he's been encouraged by what he characterized as growing Republican support for a major healthcare bill this year." Sen. "Baucus said Republicans are likely to come around and support changing the healthcare landscape." However, "vote tallies on two recent healthcare bills gave no indication the GOP is warming to Democrat-sponsored legislation. In February, just nine Senate Republicans voted to expand the State Children's Health Insurance Program." And, "the economic stimulus bill, which contained $19 billion for healthcare, garnered just three votes from the GOP." Nevertheless, the Montana senator "said that he thought Republicans were opening up to the idea of broader legislation after a fiscal summit at the White House last week."
Louisiana could reduce Medicaid reimbursement due to budget shortfall.
The AP (3/5, Deslatte) reports, "Louisiana likely will have to reduce how much Medicaid pays for services by doctors, hospitals, and other healthcare providers as it works to balance the budget next year," Alan Levine, "the state's health secretary, said Wednesday." Levine also "told lawmakers that he will look at reducing payment rates rather than eliminating any Medicaid services for the poor, elderly, or disabled as a way to cut costs." Yet, "Levine declined to give specifics to the Senate Finance Committee, saying his proposals would be outlined next week when the Jindal administration delivers its budget recommendations to the joint House and Senate budget committee." The lawmakers expressed concern that "cutting the dollars paid to healthcare providers could mean fewer services to Medicaid patients." The AP notes that "about 1.1 million Louisiana residents -- a quarter of the state's population -- receive care" from Medicaid.
Health Information Technology
Hospitals curbing some IT spending due to recession, survey finds.
Healthcare IT News (3/4, Enrado) reported that, according to a survey by Health Industry Insights, many "independent hospitals, ambulatory care facilities, and hospitals in a health system are still pursuing their [Computerized Physician Order Entry (CPOE)] and electronic medical record projects," though "IT projects overall have slowed down." The survey included 44 respondents, "equally represented in all regions of the country and ranged in size from 1,500 beds to under 200 beds." Overall, "75 percent of the respondents reported the recession has negatively impacted their capital and/or operating budgets," while "85 percent saw a decrease in their capital budget in the first quarter." Moreover, "64 percent reported the economic crisis has forced them to cancel, suspend, delay, or curtail their major IT initiatives." Also, 55 percent of respondents reported that "operating and capital budget reductions have resulted in IT staff hiring freezes." According to Marc Holland, program director for Health Industry Insights' Health Provider Research, the results are "as good as can be expected. ... Healthcare will ride out this downturn certainly impacted but a little more intact compared to other industries."
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Many hospitals said to be unprepared to receive health IT incentives.
Healthcare IT News (3/4, Manos) reported that the recently passed "economic stimulus package has allotted $17.2 billion to reward Medicare and Medicaid providers who can prove they are using certified healthcare IT 'in a meaningful way.'" And while the "incentives are scheduled to take effect starting Oct. 1, 2011, experts say providers should not waste time getting prepared because there is a shortage of change management experts available to help." According to one estimate, "94 percent of hospitals currently don't have enough healthcare IT in place to meet the stipulations required to receive bonuses." To qualify, "providers must have certified electronic health record technology capable of providing clinical decision support to physician order entry and capturing query information relevant to healthcare quality." But experts say it is "not as simple as hiring a software technician to make the transition. There is a need for qualified people who know how to help with workflow adaptation and how to implement software packages so they work for the organization."
Physician explains drawbacks to widespread EMR implementation.
In Time (3/5), Scot Haig, MD, writes that those arguing for the implementation of healthcare IT argue that "computerized medical records will save us all: save jobs, save money, reduce errors, and transform healthcare as we know it." But Dr. Haig examines the downsides of electronic medical records (EMR), noting, "we must keep in mind there will be a cost to this -- far beyond the billions to be spent setting it up." But many "in medicine are concerned that the greatest cost will be in the quality of medicine that we practice." Many clinicians, in fact, "have found that [Computerized Physician Order Entry (CPOE)] is...in too many ways is just not as good" than writing orders on paper. Haig notes that the managerial obstacles are daunting, but "really hard is going to be getting this multi-billion dollar juggernaut to actually save us money." Dr. Haig describes ways in which administrators may use EMRs to bill for more expensive diagnoses, and how insurance companies may thwart a clinician's opinion by denying payment for tests that they deem unnecessary. He concludes, "With pen and paper, personal commitment to each patient and judgment born of practical experience. None of which I have found in a machine."
Hospitals and Health Systems
Hospital fined by state for allowing woman to die.
The San Diego Union-Tribune (3/5) reports, "State health officials yesterday fined Scripps Mercy Hospital $25,000 – the maximum allowed – for the preventable death of a patient about a year ago at its Chula Vista campus." The woman, who was terminally ill, "died after hospital staff failed to administer saline solution that had been ordered more than four hours earlier." The incident was first made public last summer when "federal regulators said they were considering withholding Medicare and Medi-Cal payments because of the death."
Insurance and Managed Care
Analysis indicates 86.7 million Americans had no health insurance at some point in 2007, 2008.
UPI (3/5) reports, "Some 86.7 million people -- one out of every three U.S. residents under the age of 65 -- had no health insurance at some point in 2007 and 2008," according to "the progressive healthcare reform nonprofit group Families USA." They found that, "of the 86.7 million uninsured individuals, 60.2 percent were uninsured for nine months or more, while nearly 74.5 percent were uninsured for six months or more, the group said. It also found 52 percent of individuals in families with incomes between $21,200 and $42,400 per year went without health insurance at some point in 2007-08."
Patient Rights/Quality of Care
Americans spending more income on medical costs.
The Wall Street Journal (3/5, Fuhrmans) reports, "The slumping economy is pulling down fragile networks of support that in better times could keep families with insurance but big bills from falling into a financial hole." According to an estimate by the Commonwealth Fund, "as of 2007, 25 million Americans had to spend at least 10 percent of their income -- five percent for low-income families -- on out-of-pocket medical costs. That's a 60 percent increase from 2003." While "families typically have been able to make due as long as they remained employed and on a company health plan," many "companies have steadily raised employees' premiums, deductibles and co-payments to curb their own soaring healthcare spending," which has "left Americans with costly illnesses exposed to a much broader set of economic strains."
Legislation/Regulation
Washington state assisted-suicide law goes into effect.
The New York Times (3/5, A16, Yardley) reports, "Assisted suicide becomes legal in Washington on Thursday, but dozens of hospitals are not expected to participate, and even supporters of the law say they do not foresee a rush of requests for lethal drugs." The law "allows terminally ill patients who are 18 or older, and who have been found mentally competent, to self-administer lethal drugs under the prescription of a doctor," although an "opt-out provision for hospitals was included, partly for the sake of healthcare providers affiliated with religious groups like the Roman Catholic Church, though many nonreligious hospitals have also invoked it." Cassie Sauer, a spokeswoman for the Washington State Hospital Association, "speculated that as many as two-thirds of hospitals might opt out completely or partly."
Legal Practice and Procedure
Some seek end to peremptory strikes due to potential for discrimination.
The Wall Street Journal (3/5, Koppel) reports, "In the interest of fair trials, attorneys can dismiss people from jury pools for dressing strangely, for being fat, even for just looking at them funny" but are not allowed to dismiss on the basis of race, ethnicity or gender. In an effort to end "discrimination in the jury room critics have called for a radical solution: Get rid of peremptory strikes, which typically allow lawyers to dismiss a limited number of jurors, no questions asked." However, some experts say that a "more realistic reform...would be to cut back significantly on the number of potential jurors each side can boot without explanation."
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