Entries in Supreme Court (10)


Woman Disfigured by Generic Drug Loses $21 Million Award

iStockphoto/Thinkstock(WASHINGTON) -- Eight years after she was burned and blinded by a prescription drug, Karen Bartlett feels numb.

On Monday the Supreme Court ruled that Mutual Pharmaceutical Co., the maker of the drug Bartlett took for shoulder pain, should not be held responsible for her injuries because the company had copied the brand drug's formula and warning label.

"I was numb," Bartlett said of the moment her lawyer delivered the news. "I don't even have words to describe it because I can't believe that they would do that."

In a five-four decision, the court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they're required by federal law to copy their brand-name counterparts. The ruling overturns the verdict from Bartlett's 2010 New Hampshire Superior Court trial in which a jury awarded her $21 million in damages, as well as the decision by an appeals court to uphold the verdict.

"I can't believe the Supreme Court can just say, 'I'm sorry, you guys are wrong,'" said Bartlett, whose body is scarred from the fierce reaction to sulindac, a generic version of the nonsteroidal anti-inflammatory drug Clinoril. "It boggles my mind. I just don't get it."

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004, "wrapped up like a mummy" as the skin eroded two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including NSAIDS like Clinoril and sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing.

"I have no independence," said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. "This ruined my life, basically."

In a lawsuit against Mutual Pharmaceutical Co., Bartlett's lawyer argued that the company "failed to adequately warn users" about Stevens-Johnson syndrome, one of sulindac's more serious, albeit very rare side effects. A jury in New Hampshire Superior Court agreed, awarding Bartlett the $21 million payout to cover medical and legal costs, and compensate her for "physical and mental pain and suffering" as well as "loss of enjoyment of life," according to the complaint.

At the time of Bartlett's reaction, sulindac's label did not specifically warn about Stevens-Johnson Syndrome, the Supreme Court acknowledged, though it did warn that the drug could cause "severe skin reactions" and "fatalities." But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

"Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design," Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

In 2005, one year after Bartlett's reaction, the Food and Drug Administration recommended changes to the labeling of all NSAIDs, including Clinoril and sulindac, to more explicitly warn about Stevens-Johnson syndrome.

Alito noted that Bartlett's case "arises out of tragic circumstances" and "evokes deep sympathy.
"But sympathy for [Bartlett] does not relieve us of the responsibility of following the law," he wrote.

Jay P. Lefkowitz, the lawyer who represented Mutual Pharmaceutical Co., said the ruling "vindicates the authority" of the FDA, the federal agency charged with assessing drug safety.

"The FDA has the scientific and medical expertise to make decisions about the safety and efficacy of drugs based on all of the data," said Lefkowitz, whose office is based in New York City. "State court juries that are only looking at one example of a tragic side effect don't have the ability to make an assessment about the safety and efficacy of a drug that millions of people use with good results."

Lefkowitz said his "heart was filled with sympathy" for Bartlett.

"Every one of us takes prescription drugs. We give them to our kids, and this can happen to anyone," he said. "But I think the court got it right, even though it's obviously a tragic set of circumstances."

Bartlett said, "I walk away with nothing except disability checks. They don't seem to care that this has affected me for rest of life."

Copyright 2013 ABC News Radio


'Obamacare' Ruling Puts New Emphasis on State Governments

(WASHINGTON) -- There are very few certainties in politics, but the Supreme Court's ruling on the Affordable Care Act, the controversial health care law colloquially referred to as "Obamacare," resulted in one of those rare sure things: It assured that the debate surrounding the law will rage on for the foreseeable future.

Almost immediately after the Supreme Court announced its ruling, Mitt Romney vowed to repeal the law if elected in the fall. Republicans in the House and Senate got a new talking point -- Republican control of both chambers will greatly improve their ability to facilitate this repeal.

And several Republican governors, including Bobby Jindal of Louisiana and Scott Walker of Wisconsin, said that they would wait until November to take any sort of action to begin actually to implement the law.

Democrats need to maintain control in only one of the following three places -- the White House, the Senate, or the House of Representatives -- to, at the very least, seriously hinder Republicans' ability to repeal the law entirely. If Romney is elected president, there are a handful of legal options he can take unilaterally, without the help of Congress, to go after the law, but he'll be greatly limited. And Republicans will face a time crunch, given that the law will take full effect in 2014.

If the Affordable Care Act continues to be the law of the land, however, state governors will have the job of implementing several requirements outlined by the reform. For example, under the law, each state is required to set up state exchanges where residents can, if they choose, select a healthcare plan (residents can also go through employer if that is an option for them). The exchanges do not need to be up and running until 2014, but states are required to demonstrate by Jan. 1, 2013, that their exchanges are in progress, and will be operational by the 2014 deadline. If they fall behind, the Department of Health and Human Services would then come in and set up the exchanges.

"If the state decides not to establish an exchange, then the federal government establishes the exchange for them. So it's kind of a pick-your-poison scenario, if you will," said Renee M. Landers, a professor of law at Suffolk University Law School in Boston. Presumably, governors who are resistant to setting up exchanges would be more resistant to the federal government establishing the exchanges for them.

Under the law, as it was written, governors would also oversee an expansion of Medicaid within their states. However, the Supreme Court ruled that states could opt out of this expansion. The legal procedure for deciding whether to go forward with the expansion will differ by state. It would be paid for entirely by the federal government for the first several years, and afterward states would only be required to chip in 10 percent of the cost.

The governors might not be acting alone.

"States might need to have legislation to be able to take advantage of the expansion," said Landers. "It's really impossible to generalize accurately because each state situation is so different. A governor can possibly make some kind of administrative changes, but certainly if it's going to take more money than they would need to go through the legislature."

It's not known what the governors in these states might do about the expansion of Medicaid, but many states that joined the suit against the law have Republican-controlled legislatures, and that's unlikely to change.

In Louisiana, for example, members in both the state house and senate have four-year terms, and are currently serving out their 2012-2016 term. In Michigan, no state senators are up for re-election this year, and house Republicans have a 16-seat majority.

In Virginia, the state senate has 20 Republicans and 20 Democrats, but the state's Republican lieutenant governor serves as the tie-breaking vote. The Virginia state legislature won't hold elections again until fall 2013, when there will also be a gubernatorial race in the state.

Several states could end up opting out of the Medicaid expansion -- and in that case, Landers says, the ACA would not meet all of its goals.

"It will mean that the Affordable Care Act will fall short of achieving some of its goals, because the Medicaid expansion was supposed to address low income people," Landers said.

Low-income residents of a state that opts out of the expansion will likely not be required to pay the fee for not having insurance.

"Their incomes will be too low to pay the tax. Unless a person has an income that meets the federal threshold for filing a tax return, they don't have to meet the individual mandate requirements" said Landers. "And even if you have the income that's above that level, if there are hardship requirements or you can show that there is no affordable product on the market for you to pay that's not less than 8 percent of your income, also can get an exemption."

The federal threshold for filing a tax return is an income of at least $9,350 annually for a single filer, $18,700 for a married couple with no dependents, and $22,350 for a couple with one dependent. After that it increases by an amount of $3,650 per dependent.

The National Journal estimates that the 26 states that opposed the health care law represent a majority -- 55 percent -- of Americans who have no medical insurance.

Copyright 2012 ABC News Radio


Medical Organizations Applaud Health Care Ruling

Mark Wilson/Getty Images(NEW YORK) -- The U.S. Supreme Court's ruling on Thursday that the Affordable Care Act, with its individual mandate, is constitutional has elicited a wide range of opinions from across the medical community.

Most major national medical organizations -- including the American Medical Association, the National Physicians Alliance, the American Academy of Pediatrics, and the Association of American Medical Colleges -- hail the ruling as a victory.  Many of these organizations have been strong supporters of the ACA since Congress passed it in 2010.

"The American Medical Association has long supported health insurance coverage for all, and we are pleased that this decision means millions of Americans can look forward to the coverage they need to get healthy and stay healthy," said Dr. Jeremy Lazarus, president of the American Medical Association.

"At last, the country is moving in a healthy direction on health care," said Dr. Valier Arkoosh, president of the National Physicians Alliance.

However, a handful of medical organizations are not as enthusiastic.

"We cannot overlook provisions like the Independent Payment Advisory Board that threaten the doctor-patient relationship and the administrative burdens within the law that could greatly hinder providers' ability to deliver quality care by infringing upon exam room time," said Dr. John Tongue, president of the American Association of Orthopaedic Surgeons.

"We are concerned that there are key aspects to this law that will, ultimately, hurt this nation's ability to provide widespread are for its citizens," the American Urological Association, the American Association of Clinical Urologists, and the Large Urology Group Practice Association said in a joint statement.

The U.S. Supreme Court has upheld the individual mandate, which states that all Americans must have health insurance or else pay a fine.  The Court stated that the fine is essentially a tax, giving the government the right to impose it.  However, the Court limited the law's ability to expand Medicaid, deciding that the U.S. government cannot withhold a state's Medicaid money if the state doesn't want to participate in the expansion.

The ACA, initially passed through Congress in 2010, could potentially cover more than 30 million people who are currently uninsured in the United States.

The law also has support from a wide range of patient advocacy groups, including the American Cancer Society, the National Organization for Rare Diseases, the American Heart Association, Consumer Reports, and the March of Dimes.

The parts of the law that have already been implemented will not be changed. Thus, children can stay on their parents' health insurance until they turn 26, and patients will not have to provide co-payments for preventive care.  However, the key piece of the law -- the individual mandate -- will not commence until 2014.

Copyright 2012 ABC News Radio


Supreme Court Curbs Health Reform Expansion of Medicaid

iStockphoto/Thinkstock(WASHINGTON) -- While the Supreme Court narrowly ruled the Affordable Care Act constitutional, it did place some important restrictions on a Medicaid expansion that is a backbone of the law’s efforts to insure more Americans.

In addition to requiring citizens to buy health insurance, the law also expanded Medicaid and tied federal funding to that expansion of state programs. In order to provide insurance to more poor people, the law said that states who did not accept the Medicaid expansion would risk losing existing Medicaid funds.

Today the Court said that as long as states who chose not to participate in the law’s expansion of Medicaid do not lose existing funds, the Medicaid the expansion is constitutional. The vote was 5-4 with Chief Justice John Roberts joining the liberal bloc.

The end result could be that more states opt out of the Medicaid expansion, which won’t be enacted until 2014, and the law could end up insuring fewer currently uninsured Americans.

The bottom line from Roberts: “The Court today limits the financial pressure the Secretary may apply to induce States to accept the terms of the Medicaid expansion.As a practical matter, states may now choose to reject expansion; that is the whole point.”

But what is interesting is that liberal justices like Elena Kagan and Stephen Breyer joined the five conservatives to insist that the states couldn’t be threatened with a loss of funding.

“Although many will be surprised that Chief Justice Roberts joined the Court’s progressive bloc to uphold the mandate, the far bigger surprise is that two members of that bloc-Justices Breyer and Kagan-joined the conservatives in holding that the Medicaid expansion exceeded Congress’s power,” says Stephen Vladeck, of American University Washington College of Law.” As a matter of precedent rather than politics, the Breyer and Kagan votes on Medicaid are likely to be far more significant going forward than the Roberts vote on the mandate,” he said.

Paul Clement, an attorney for the states called this part of the ruling a “significant victory." He said, “The states will have a chance to make the choice. They will no longer have the gun to their head.”

Renee M. Landers of Suffolk University Law school says the impact of today’s ruling, “could reduce the number of people who will be eligible for Medicaid because it is easier for the states to opt out.”

Copyright 2012 ABC News Radio


Supreme Court Health Care Ruling: What It Means For You

Creatas Images/Thinkstock(WASHINGTON) -- The Supreme Court ruled five to four Thursday morning that President Obama’s health-care law, his top domestic policy achievement, is constitutional because the “individual mandate” -- the penalty individuals must pay for not buying health insurance -- can be considered a tax.

Here is what the decision means for you:

  • You have to buy health insurance or be subject to a tax.
  • If you are under 26, you can get health insurance from the plan your parents use.
  • If you’re on Medicare, you can get free mammograms.
  • If you have what’s called a pre-existing condition, you can get health insurance.
  • Insurance companies can’t deny you coverage even if you get sick and make a mistake on your health insurance application.

Copyright 2012 ABC News Radio


President Clinton Cites Cases He Would Have Used in Health Care Law Case

Creatas Images/Thinkstock(WASHINGTON) -- Former President Bill Clinton, who used to teach constitutional law, has a list of cases he seems surprised the Obama administration didn’t cite in its arguments defending the health care law before the U.S. Supreme Court last week.

“It seemed to me that the conservative justices were just accepting as a matter of course that there was a serious constitutional question here,” the former president said, “and that they didn’t make the plaintiffs, the people that want to strike the law down, prove their case.”

“Nobody asked, for example, do they want to overturn a case called Wickard v. Filburn in 1942,” Clinton said. “Where in the beginning of World War II, where we were still coming out of the Depression, a farmer was told and the Supreme Court upheld the ability of the federal government to limit his ability to grow food on his own farm for personal consumption. Because they said it affected the aggregate amount of food consumed in interstate commerce and the price of food.”

Said Clinton, of the case, “that goes far further than the individual mandate. No one can question that the accumulated decisions by American individuals not to buy health care adds $1,000 a year to your health care premium.”

President Clinton noted, smiling, that “Justice (Antonin) Scalia loves the framers, right? We’re somehow supposed to follow the intent of the framers. I believe George Washington signed a bill to require shipping companies to insure their employees. I believe George Washington– I could be wrong about this. I believe he signed a bill to require able-bodied male citizens to have a rifle in their home. In case the British came back. Now, that’s not the right to keep and bear arms. You don’t have a right not to bear one. All the Quakers were supposed to buy rifles.” He added that President “John Adams, another framer, signed a bill to require individual seamen to buy hospitalization insurance.”

“So if those facts are right, what is this case about, anyway? Unless it’s politics,” Clinton said.

The president made his comments in an exclusive interview with ABC News focused on his work with Clinton Global Initiative University.

Asked if he thinks the Supreme Court is too political, the president said, “only occasionally.” This court, he said, is “genuinely more conservative. And I think that conservatives in general believe that every branch of government should advance their philosophy. Prosecutors, judges, no different than members of Congress. That’s a different view than we’ve had in the past. But you saw that in the Bush V. Gore decision.”

The former president began recalling that 2000 case in detail, calling it “a pretty political decision. It was the most amazing thing I’d ever seen.”

How would that case impact this one?

“I think it will make them either more willing to do it again, or maybe they say, ‘You know, we probably shouldn’t do that again,’” Clinton said.

The president reiterated that he found it “interesting that– that there was apparently no discussion of those previous examples of individual mandates.”

Copyright 2012 ABC News Radio


Supreme Court to Hold Three-Day Hearing on Health Reform Law

iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Supreme Court has set aside an unprecedented amount of time for lawyers arguments on the health reform law.

For three days in March, three sets of lawyers will present three arguments before the court, trying to determine whether it is too soon for a constitutional challenge to the health reform law.  As of yet, no one has been fined for failing to buy health insurance.

On March 26, the court will hear augments on whether it is too early to challenge the law, because the requirement to buy health insurance has not gone into effect yet.  March 27, the subject will be whether Congress has overstepped its authority.  The final day of arguments, March 28, will focus on the ability for the rest of the law to stand in the case that the requirement to purchase insurance is ruled unconstitutional.

Copyright 2011 ABC News Radio


Psych Experts: Violent Video Games Distort Kids' Health, Perceptions

Comstock/Thinkstock(NEW YORK) -- Studies have persuasively demonstrated that depictions of extreme violence in video games like Mortal Kombat and Grand Theft Auto: Vice City harm youngsters' mental health, according to pediatricians who disagreed with part of a U.S. Supreme Court decision striking down a California ban on video game sales to children.

However, the mental health experts agreed with the justices that ultimately, parents have a responsibility to vet and control what their children watch and play.

"The studies are actually very strong," said Dr. Laura Davies, a child and adolescent psychiatrist at California Pacific Medical Center in San Francisco. She had just read a paper published this past weekend in the journal Pediatrics that found violent videos disrupted preschoolers' sleep.

"Every one of us -- child psychiatrists, behavioral pediatricians and regular pediatricians, see in our practices every day that when children (younger than 7) are exposed to violence and to trauma, they act biting, hitting, kicking, name-calling, wetting themselves, poor sleep, poor eating," Davies said.  "Older kids act out by fighting, with academic problems, social problems, bullying, anxiety, fearfulness, withdrawal from friends."

Writing for the high court's 7-2 majority, Justice Antonin Scalia agreed with a lower court that the state of California failed to prove that depictions of "killing, maiming, dismembering or sexually assaulting an image of a human being" were sufficiently harmful to young minds to justify carving out a free speech exception solely for children.

For centuries, young children have been exposed to "no shortage of gore" in Grimm's Fairy Tales, he wrote. "Cinderella's evil stepsisters have their eyes pecked out by doves.  And Hansel and Gretel (children!) kill their captor by baking her in an oven."

Davies, however, said the impact of reading Grimm's Fairy Tales on the page cannot be compared with the visual and aural assault of a violent video: "It's much more vivid and much more traumatic," she said.  On another level, though, repeatedly playing these fictional, interactive video games distorts children's concept of death, she said.

Copyright 2011 ABC News Radio


Supreme Court Takes No Action Regarding Health Care Challenge

Comstock/Thinkstock(WASHINGTON) -- The Supreme Court has taken no action regarding a request from Virginia’s attorney general, Ken Cuccinelli, to step in early and hear a challenge to the Obama administration’s health care law. The Justices discussed the issue at their closed-door conference last Friday.
While there could be a number of explanations for the court’s action, it would be very unlikely for the Court to step in at this juncture. The justices like to hear from appellate court judges on issues of national importance. Furthermore, appellate courts have already expedited the cases and will hear arguments this spring.

In court papers, Cuccinelli argued that “given the importance of the issues at stake to the States and to the economy as a whole, this Court should grant certiorari to resolve a matter of imperative public importance.”

Under normal circumstances, the Court taking no action after Friday's meeting means the issue will come up again at their next conference, set for April 22.

We can expect to learn either at the end of this week or early next week if the Court will grant Cuccinelli’s request to take up the issue before it goes to the appellate court.

Copyright 2011 ABC News Radio 


Supreme Court Case Could Make Vaccine Makers More Liable

Photo Courtesy - Getty Images(WASHINGTON) -- For the past 24 years, the National Childhood Vaccine Injury Act has protected vaccine manufacturers from being sued for most injuries caused by their products, but a Supreme Court case brought Tuesday by parents of allegedly vaccine-injured Hannah Bruesewitz may challenge this liability safeguard.

Robie and Russell Bruesewitz are suing vaccine manufacturer Wyeth, which is now part of Pfizer, for using an allegedly outdated and flawed vaccine design for the DPT vaccine their daughter received in 1992 -- a vaccine they claim is responsible for Hannah's residual seizure disorder, according to court documents.

Cases concerning vaccine safety design are normally handled by the federal "vaccine court," a no-fault compensation program set up by the 1986 Vaccine Injury Act to shield manufacturers from liability for injuries or death "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

When the vaccine court rejected their case in 2002, on the grounds her particular disorder was no longer a presumed vaccine-related injury, the Bruesewitzes sued Wyeth anyway and have appealed continued rejection of their claim all the way to the Supreme Court.

Now the Supreme Court must decide whether suits over flaws in design of a vaccine bypass the vaccine courts set up in 1986. If so, manufacturers will be opened up to an increased liability that some doctors fear might scare companies away from producing much-needed vaccines, as was the case before the 1986 Vaccine Injury Act.

Seven out of the eight vaccine manufacturers had stopped making vaccines before the act was put in place in the 1980s says Dr. Paul Offit, chief of the Division of Infectious Diseases at the Children's Hospital of Philadelphia . With the help of vaccine court, there have been "two decades of new vaccine research and development" and it would be "a disaster" if the court were done away with, he says.

Copyright 2010 ABC News Radio

ABC News Radio