Zeno Swijtink
11-03-2008, 03:40 PM
Court Weights Amputee's Case, Limits on Drug Suits (https://www.iht.com/articles/ap/2008/11/03/america/NA-US-Supreme-Court-Drug-Suit.php)
International Herald-Tribune
WASHINGTON -- A musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term.
At issue is whether the federal government can limit lawsuits by consumers like Diana Levine who have been harmed by prescription medications.
The justices are hearing arguments in Levine's case Monday, shortly after the court announces whether it will accept other cases for argument sometime next year.
The issue of limiting lawsuits arises in the heart-rending story of Levine, a guitarist and pianist who lost her right arm after an injection of the anti-nausea drug Phenergan, made by Wyeth Pharmaceuticals.
A Vermont jury awarded Levine $6.7 million, agreeing that Wyeth should have been clearer in its warning label about the risks of improperly administering the drug.
Wyeth and the administration, however, are asking the court to rule that drug makers may not make changes to labels without the approval of the Food and Drug Administration and that people cannot sue under state law for harm caused by an FDA-approved drug.
In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption asserting the primacy of federal regulation over rules that might differ from state to state.
***
US court weighs amputee's case in drug suit
WASHINGTON: The U.S. Supreme Court appeared likely Monday to decide an amputee's lawsuit against a drug maker based on how much federal regulators knew about an anti-nausea drug's risks in the event of a botched injection.
Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals' anti-nausea drug Phenergan, and approved its warning label anyway, then Wyeth probably would prevail in its court fight against Diana Levine.
But there was considerable skepticism among the justices — and disagreement between the opposing lawyers — that the FDA had a clear picture of the disastrous consequences of improperly giving Phenergan by an intravenous method of injection known as IV push, the fastest way to bring relief to nauseated patients.
"How could the FDA have concluded that IV push was safe and effective," Justice Samuel Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration?
Justice Ruth Bader Ginsburg chimed in, "No matter what benefit there was, how could the benefit outweigh that substantial risk?"
Levine, a guitar- and piano-playing musician from Vermont, was in the courtroom for Monday's arguments in Wyeth's appeal of a $6.7 million verdict she won from a state jury.
The jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of IV push, which include that gangrene is likely if the injection accidentally hits an artery. That is precisely what happened to Levine.
The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets FDA approval, consumers cannot pursue state law claims that they were harmed.
In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.
The Supreme Court has largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.
The Levine case has drawn a lot of attention because the administration and Wyeth are contending that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.
But any sort of sweeping ruling seemed unlikely after Monday's arguments.
Chief Justice John Roberts and Justice Antonin Scalia seemed most receptive to Wyeth's arguments, suggesting that FDA approval should protect Wyeth.
The warning label indicates gangrene can result if the injection accidentally hits an artery and also makes clear that intramuscular injection is the preferred method of delivery. It also says that the next best method is to use an IV drip, in which a catheter is inserted into a vein, often in an arm, and fluids and drugs can be administered.
"The labeling plainly comprehended and warned about the specific risks of IV administration," Seth Waxman, representing Wyeth, told the justices.
But David Frederick, Levine's lawyer, said there is no evidence the FDA ever considered and rejected a stronger warning against the IV push method.
Frederick noted that Pfizer, Inc., stopped making IV push an acceptable method of injecting its anti-nausea drug after two amputations were reported.
A ruling probably will not come before early next year.
****
www.nytimes.com/2008/ 02/21/washington/21fda.html
February 21, 2008
NEWS ANALYSIS
Justices Add Legal Complications to Debate on F.D.A.’s Competence
By GARDINER HARRIS
WASHINGTON
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.
International Herald-Tribune
WASHINGTON -- A musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term.
At issue is whether the federal government can limit lawsuits by consumers like Diana Levine who have been harmed by prescription medications.
The justices are hearing arguments in Levine's case Monday, shortly after the court announces whether it will accept other cases for argument sometime next year.
The issue of limiting lawsuits arises in the heart-rending story of Levine, a guitarist and pianist who lost her right arm after an injection of the anti-nausea drug Phenergan, made by Wyeth Pharmaceuticals.
A Vermont jury awarded Levine $6.7 million, agreeing that Wyeth should have been clearer in its warning label about the risks of improperly administering the drug.
Wyeth and the administration, however, are asking the court to rule that drug makers may not make changes to labels without the approval of the Food and Drug Administration and that people cannot sue under state law for harm caused by an FDA-approved drug.
In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption asserting the primacy of federal regulation over rules that might differ from state to state.
***
US court weighs amputee's case in drug suit
WASHINGTON: The U.S. Supreme Court appeared likely Monday to decide an amputee's lawsuit against a drug maker based on how much federal regulators knew about an anti-nausea drug's risks in the event of a botched injection.
Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals' anti-nausea drug Phenergan, and approved its warning label anyway, then Wyeth probably would prevail in its court fight against Diana Levine.
But there was considerable skepticism among the justices — and disagreement between the opposing lawyers — that the FDA had a clear picture of the disastrous consequences of improperly giving Phenergan by an intravenous method of injection known as IV push, the fastest way to bring relief to nauseated patients.
"How could the FDA have concluded that IV push was safe and effective," Justice Samuel Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration?
Justice Ruth Bader Ginsburg chimed in, "No matter what benefit there was, how could the benefit outweigh that substantial risk?"
Levine, a guitar- and piano-playing musician from Vermont, was in the courtroom for Monday's arguments in Wyeth's appeal of a $6.7 million verdict she won from a state jury.
The jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of IV push, which include that gangrene is likely if the injection accidentally hits an artery. That is precisely what happened to Levine.
The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets FDA approval, consumers cannot pursue state law claims that they were harmed.
In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.
The Supreme Court has largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.
The Levine case has drawn a lot of attention because the administration and Wyeth are contending that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.
But any sort of sweeping ruling seemed unlikely after Monday's arguments.
Chief Justice John Roberts and Justice Antonin Scalia seemed most receptive to Wyeth's arguments, suggesting that FDA approval should protect Wyeth.
The warning label indicates gangrene can result if the injection accidentally hits an artery and also makes clear that intramuscular injection is the preferred method of delivery. It also says that the next best method is to use an IV drip, in which a catheter is inserted into a vein, often in an arm, and fluids and drugs can be administered.
"The labeling plainly comprehended and warned about the specific risks of IV administration," Seth Waxman, representing Wyeth, told the justices.
But David Frederick, Levine's lawyer, said there is no evidence the FDA ever considered and rejected a stronger warning against the IV push method.
Frederick noted that Pfizer, Inc., stopped making IV push an acceptable method of injecting its anti-nausea drug after two amputations were reported.
A ruling probably will not come before early next year.
****
www.nytimes.com/2008/ 02/21/washington/21fda.html
February 21, 2008
NEWS ANALYSIS
Justices Add Legal Complications to Debate on F.D.A.’s Competence
By GARDINER HARRIS
WASHINGTON
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.