“From The Roberts Fab Five”: With No Accountability Or Liability, Generic Drug Companies Get Even More Immunity
Monday’s U.S. Supreme Court ruling immunizing drug companies from lawsuit for egregious injuries wasn’t terribly surprising for those who have been following along. Two years ago, in a case called PLIVA v. Mensing, the U.S. Supreme Court held that generic drug companies were largely immune from lawsuits alleging their failure to warn of harmful consequences. On Monday, in a 5-4 ruling along ideological lines, the court extended this holding to apply to other types of claims against generic drug manufacturers, and held that a federal statute precluded suit by a woman who incurred burns on 60 percent of her body and was rendered legally blind by an alleged drug defect.
This ruling was a predictable addition to the line of cases immunizing big business from liability, but it was not an inevitable follow-up to PLIVA. In conjunction with two other rulings Monday that stomped on workplace protections for minorities and women, this decision brings the top corporate lobby’s win rate before the U.S. Supreme Court term to 13-3. With one case remaining in which the Chamber of Commerce weighed in, it is clear that however that final case is decided, big business won very big at the expense of the little guy.
As has been a frequent practice by the Roberts Court, the five-justice majority found that federal law trumped state law protecting patients, over protestations from the four dissenting justices that both federal and state law could co-exist. Interpreting a federal law requirement that generic drug companies simply follow the warnings and design of the brand name drug, the court held that generic companies cannot be held liable for its flaws. This means that a generic company that distributes a dangerous product has no obligation to simply stop selling that drug, and can go on dispensing the potentially dangerous substance with immunity. As Justice Sonia Sotomayor wrote in dissent, the court justified its holding through “an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability.”
The majority holding in this case overturned a $21 million verdict — upheld by the appeals court — for the plaintiff’s alleged injuries. Now, the company owes nothing. With 80 percent of U.S. prescriptions filled by generics, this ruling not only wipes away generic manufacturers’ responsibility to halt the sale of dangerous products; it also impacts safety for the great majority of consumers.
According to a Public Citizen report released Monday, much of the safety information about a drug emerges after FDA approval, once the drug enters the market. And it is often not the case that the FDA revisits approval. As Justice Stephen Breyer explains in his dissent, it is “far more common for a manufacturer to stop selling its product voluntarily after the FDA advises the manufacturer that the drug is unsafe and that its risk-benefit profile cannot be adequately addressed through labeling changes or other measures” than for the FDA to formally withdraw approval based on new information.
In the wake of the PLIVA decision, members of Congress had asked FDA to revise its regulations in ways that will now be doubly essential to consumer safety. In the absence of clarity from Congress or the FDA, today’s decision paves the way for a whole lot of malfeasance.
By: Nicole Flatow, Think Progress, June 24, 2013
“In Need Of A Constitutional Rationale”: Supreme Court Judicial Activism At Its Worst, Because They Felt Like It
There’s something about the Supreme Court’s ruling in Shelby that’s bothered me all day. It’s probably unimportant — Jonathan Adler, feel free to jump in and set me straight — but as I read the ruling (pdf) this morning, I was looking for something specific: why the court majority considers Sec. 4 of the Voting Rights Act unconstitutional.
I’m not an attorney, so I’ll concede my background is limited, but in the rulings I’ve read striking down federal laws, there’s some kind of explanation as to the part of the Constitution the law ostensibly contradicts. A statute violates the First Amendment, or the Commerce Clause, or the Due Process clause, etc., and is therefore unlawful.
So on what grounds, exactly, did the court find Sec. 4 of the VRA unconstitutional? I have no idea.
Assuming I’d missed something important, I asked the Constitutional Accountability Center’s David Gans to help me out. He told me:
“Your question highlights a fundamental flaw in Chief Justice Roberts’ majority opinion in Shelby County v. Holder. The Court strikes down a core provision of the Voting Rights Act as unconstitutional without ever explaining what provision of the Constitution commands this result. Chief Justice Roberts’ opinion for the conservative majority argued that the Voting Rights Act provision was inconsistent with the ‘letter and spirit of the Constitution,’ but he never really explained why.
“His majority opinion emphasized that the Voting Rights Act diminished the sovereignty of states, ignoring that Fifteenth Amendment expressly gives to Congress broad power to prevent all forms of racial discrimination in voting by the states. As Justice Ginsburg’s powerful dissent demonstrates, the Court’s opinion cannot be squared with the text, history, and meaning of the Fifteenth Amendment.”
Judicial restraint is often a rather amorphous concept, which sometimes means different things to different people. But in this case we have a piece of civil-rights legislation that was approved by the people’s representatives, and then re-approved with large majorities several times. It was signed into law by an elected president, and then reauthorized to great fanfare by subsequent presidents of both parties. It’s been subjected to judicial scrutiny over the course of several decades, and a judicial precedent has been set: the Voting Rights Act is legal.
Or put another way, when federal law is endorsed by the House, the Senate, the president, and the public, and it’s consistent with decades of Supreme Court precedent, a court majority probably ought to have a very good reason for tossing all of that aside.
But in Shelby, five conservative justices gutted the Voting Rights Act anyway, deeming it inconsistent with the Constitution because, well, they said so. These jurists said the same law used to be perfectly constitutional, but somehow morphed into being unconstitutional without anyone noticing, and without violating anything specific in the Constitution itself.
I’d argue this is the opposite of restraint; it’s activism. The justices decided to substitute their judgment for the people’s and their elected lawmakers, because they felt like it.
By: Steve Benen, The Maddow Blog, June 25, 2013
“Protection Of Minority Voting Rights Is A Thing Of The Past”: SCOTUS Voting Rights Decision Hurls Nation Back To Its Tragic Past
In a 5-4 decision along the ideological lines one might expect, the Supreme Court today cut out the heart and soul of the Voting Rights Act of 1965.
While preserving the purpose and the intent of the momentous civil rights law—as set forth in Section 2 of the Voting Rights Act (“VRA”) which proclaims that no American can be denied the right to vote based on their race or gender—the Court struck down the sole method of enforcing the intent of the law. They accomplished this by declaring Section 4 of the Act, which sets forth the formula for determining which state and local governments must seek federal approval of any and all changes to their voting laws before placing the same into effect, to be unconstitutional.
Writing for the majority, Chief Justice Roberts stated,
“In 1965, the states could be divided into two groups: those with a recent history of voting tests and low voter registration and turnout, and those without those characteristics,” Chief Justice John G. Roberts Jr. wrote for the majority. “Congress based its coverage formula on that distinction. Today the nation is no longer divided along those lines, yet the Voting Rights Act continues to treat it as if it were.”
In other words, it is the opinion of the Court’s majority that the enforcement provisions of the Voting Rights Act worked so well that to continue enforcement under the existing scheme is unconstitutional.
The logic of the majority represents a tragic irony given that the ruling comes at a time when minority voting rights are, once again, under severe attack as state governments under GOP control seek to rig the game in an effort to overcome the demographic and racial shifts in the electorate. These changes dramatically improve the opportunities for Democrats to gain elected office—particularly when it comes to the presidency.
Indeed, it was the Voting Rights Act that was at the heart of successful efforts to stop states attempting to cut back on early voting hours and instituting voter identification laws that would have dramatically affected minority voter turnout during the 2012 election. Now, the opportunity to rely on the law to stop future efforts to curtail minority voting will have vanished in a 5-4 decision.
Not all that many years ago, I might have seen the logic in the majority’s opinion.
A review of registration and voting data in the state and local governments that have been—up until today—required to gain federal approval of their voting and registration laws before placing them into effect, revealed that major steps forward had taken place as a result of the 1965 law. Still, Congress saw fit to continue the formula set forth in Section 4 of the VRA when they renewed the law in 2006 without making changes to which states and local governments are affected—a Congressional decision that rests at the very heart of the Supreme Court majority’s displeasure.
The Court had previously warned Congress of what might come if they failed to make adjustments to the law based on recognizing the advancements made in states still subject to federal oversight. In 2009, the Supreme Court considered the constitutionality of the 2006 extension of the Voting Rights Act in Northwest Austin Municipal Utility District Number One v. Holder. In that case, the Court avoiding ruling on the central issue—the constitutionality of all or part of the VRA. However, the majority went out of their way to highlight their concern that Congress was relying on old data collected in 1974 when calculating which state and local governments would continue to be subject to federal approval of local voter laws.
Congress never got around to reviewing the law, based on the Supreme Court’s admonition, leading to today’s regressive decision.
At the time of the Municipal Utility decision, I saw some value in the Court’s approach. While it remained—and remains—essential that the VRA continue in full force and effect to protect the voting rights of all Americans, it made sense that data constantly be reviewed by Congress so as to grant more sovereign authority to states and local governments who may now adequately protect voting rights. But it remains equally as important that the federal government hold onto the opportunity to clamp down on these governmental units should they return to old habits.
But then came the efforts over the past few election cycles to suppress the vote of minorities in various states throughout the nation. In each instance, the drive to limit access to the polls came in states where the government was fully under the control of Republicans looking to improve the chances of electoral victory in the 2012 presidential election.
We all recall what happened in states like Florida, Pennsylvania and Ohio where difficult and unreasonable voter ID laws, or dramatically shortened early voting hours and other voting opportunities were suddenly legislated into existence.
The State of Texas—a state subject to the requirements of Section 4 of the Voting Rights Act—has now produced the most restrictive voter ID law in the country but has been unable to implement the law as the Feds have yet to approve it. The same is the case in Virginia where an onerous voter ID law has been signed by the Governor but held up pending federal approval as they too are subject to the enforcement provisions of the VRA.
Federal protections of minorities in these states are now a thing of the past. Indeed, the state of Texas has already announced that, based on today’s Supreme Court ruling, they no longer have to wait for federal approval of their voter ID law and that the law will go into effect immediately.
Seeing this happen makes it all too clear that many of these states have not changed their ways since the day President Lyndon Johnson signed the Voting Rights Act into law and that the only thing that has protected minorities in these states during the years following 1965 has been the very part of the Voting Rights Act that has now been invalidated.
The Supreme Court got it wrong. By not recognizing that the success of the Voting Rights Act enforcement provisions was based on the existence of the enforcement provisions, the Court has condemned the nation to relive some of the worst days and inequities in our history.
While today’s decision does leave the door open for Congress to take on the issue and re-craft Section 4 with an eye to current data, does anyone actually believe that this will happen with the GOP in control of the House of Representatives?
Not likely—or at least not likely until we have a federal government fully back in the hands of the Democratic Party.
For anyone out there who believes that midterm elections are not particularly exciting or worth your time, the stakes of the 2014 midterms just increased dramatically. The nation took a giant step backwards today—a misstep that can only be corrected by the return of the House of Representatives to Democratic control and retaining the Democratic majority in the Senate. As a result, while today’s Supreme Court decision makes this a very sad day in the advancement of the nation, it may be just the kick in the pants Americans require to get out of the house and down to the voting booth in November, 2014.
Let’s hope so.
A lot of Americans suffered a great deal—some making the ultimate sacrifice—to make the Voting Rights Act of 1965 a reality.
We should not let them down now.
By: Rick Ungar, Op-Ed Contributor, Forbes, June 25, 2013
“The Status Quo Is Unacceptable”: It’s Time To End The Imposed Ignorance Of Guns And The Harm They Do
A revealing thing happened in the grief-filled days that followed the massacre of helpless children and their teachers at Sandy Hook Elementary School in Newtown, CT.
Virtually every conversation about gun control, about any possible remedy for gun violence, hit a roadblock. We just didn’t know a lot about the guns circulating in America.
How many guns are in the U.S.? We don’t have reliable figures.
Is there a connection between gun violence and the depictions of violence in video games and movies? Studies on that issue are few and inconclusive.
Just how do guns wind up in the hands of the mentally ill or the criminally minded? To answer that, we’d have to do a better job of tracking guns used in crimes.
This national ignorance is the cover under which the gun lobby hides. Its denialism and simplistic wishful thinking — the solution to mass shootings is more “good guys with a gun” — thrives and holds sway because we have failed to study the problem and base our policy decisions on a sound basis: evidence.
Things may be about to change. A new report pushes us one step closer to treating gun violence as a public health issue. If allowed to gain traction, this change in attitude will have huge consequences.
The report was issued by a panel of experts called together under executive order by President Obama after Newtown killings. The Institute of Medicine and National Research Council assembled the panel and has set priorities to focus research.
Obama is asking for $10 million in the 2014 budget to fund research. Time will tell if Congress has the backbone to follow through. It has folded before.
Money for such research was halted in the mid-1990s under pressure by the National Rifle Association. Ever since, we’ve been stumbling along as a nation, racking up more than a quarter-million deaths by gunfire in the last decade alone.
Because we haven’t gathered a great deal of data on how guns are used in America — for self-defense, in crime, in suicides — we have permitted all sorts of magical thinking.
Hence, some have argued that the solution to mass shootings is to get rid of “gun-free zones,” which (they reason) create easy targets for killers to seek. Then there’s the argument that simply giving children more education about gun safety will lessen their chances of playing with a weapon. What does the evidence say? Well, studies conflict. More and better research would help assess policy proposals.
The president’s panel has selected five areas for focus: the characteristics of gun violence, risk and protective factors, prevention and other interventions, gun safety technology, and the influence of video games and other media.
The aim is not to take guns away from people. It’s about making gun ownership and use safer. It’s about respecting the lethal nature of the weapons enough to reduce accidents, suicides and gun use by the untrained and criminals.
The report took pains to address the fear of creating any sort of national database for gun ownership, a favorite bugbear of gun-control critics. It notes that “anonymized data should be used to protect civil liberties.”
In fact, more and better information could decrease the gulf between those who see gun ownership as an absolute and integral American right and those who regard guns as a serious public health problem. The two points of view need not be mutually exclusive.
Think about the great benefits to American society that have come from efforts to change attitudes about road safety, as well as improvements to roadway design. Countless lives have been saved by a process that began after the federal government began thoroughly studying car wrecks.
By understanding better how people were being injured, both government and industry could make sensible changes. Some key changes were instituted by law, such as speed limits and seat belt usage. Some were safety design changes initiated by manufacturers. After all, protecting the car’s “precious cargo” is a great selling proposition.
Wouldn’t the same argument appeal to a responsible gun owner? This model is less likely to be used by a child or stolen and used by a criminal due to biometrics.
We didn’t confiscate people’s cars. We simply mitigated the injury and loss of life they caused.
As the debate about funding research into firearms goes forward, note which organizations and politicians fight mightily against it. It will speak volumes.
The status quo is unacceptable. And those who fight research and understanding will be telling us that they are satisfied with the way things stand.
By: Mary Sanchez, The National Memo, June 24, 2013
“Edward Snowden Blows It Big Time”: Crossing A Major Line To Further His Own Self-Aggrandizement
While it was inevitable that there would be those who support and those who condemn the initial disclosures of Edward Snowden—the 29 year-old former NSA contractor who disclosed the agency’s telephone and electronic communications surveillance programs—the tide of public opinion may be rapidly turning against Snowden…and with very good reason.
Spilling the beans to his fellow Americans over the depth of surveillance being carried out by the National Security Agency within the borders of the United States is one thing—disclosing the nation’s covert activities involving spying on other nations is something else entirely.
Last week, Snowden turned over documents to the South China Morning Post revealing that the United States has been hacking into Chinese computers—a revelation that came at a particularly embarrassing moment for the U.S. President who was busy castigating his Chinese counterpart for China’s constant intrusions into our own computer banks for various purposes, including the theft of American intellectual property. If that wasn’t enough, the Guardian newspaper followed up with a report provided by Snowden revealing that the Americans and British spied on various delegates attending the G20 conference in 2009, choosing to disclose this bit of information right before the start of this year’s G8 conference held in the U.K.
Anyone think much got accomplished at the G8 after that little gem was brought into the light?
Even more disturbing is what appears to have motivated Snowden to expand his leaking beyond the borders of the United States and into the world of foreign espionage.
Despite making a pretty good living for quite a few years through his employment as a small cog in the gears of government surveillance activities, Snowden declared, during a live chat with the Guardian on Monday, that he believes that “all spying is wrong.” And because it is Snowden’s personal judgment that all spying is wrong, he also believes it appropriate that he reveal our covert activities to affected foreign governments without a shed of concern for what the rest of his fellow Americans might think about this.
I don’t recall there being an election where I voted to assign my proxy to Edward Snowden so that this 29 year-old guy—who I never heard of before two weeks ago—could determine, on my behalf, what this country should or should not be doing when it comes to its covert, overseas spying program.
So, how is it that Mr. Snowden has decided that it is appropriate to appoint himself the arbiter of judgment and morality when it comes to such issues? How is it that Snowden has determined that he is providing me with some patriotic service when I neither asked him to do so nor agree that disclosing information on foreign spying is, in any way, a service to his nation or to me personally?
With his decision to move beyond informing his countrymen of surveillance activities that allow the government to track our telephone calls and emails, Edward Snowden not only crossed a major line but gave us all reason to feel considerable concern about his motives and purposes.
In discussing the rationale for his disclosures on foreign spying, Snowden said:
“When NSA makes a technical mistake during an exploitation operation, critical systems crash. Congress hasn’t declared war on the countries — the majority of them are our allies — but without asking for public permission, NSA is running network operations against them that affect millions of innocent people. And for what? So we can have secret access to a computer in a country we’re not even fighting? So we can potentially reveal a potential terrorist with the potential to kill fewer Americans than our own Police? No, the public needs to know the kinds of things a government does in its name, or the ‘consent of the governed’ is meaningless.”
There appears to be no shortage of logic fails in Snowden’s remarks.
If the public knows the details of what our government is doing when it comes to spying on foreign governments—as Snowden suggests is necessary—then it wouldn’t be covert spying activity, now would it? Spying is not particularly effective when everyone knows the target and nature of such a program.
And while Ed Snowden may have decided that all spying is wrong, I strongly suspect that the overwhelming majority of Americans would very much disagree with his assessment and might appreciate his not complicating our lives in furtherance of his own self-aggrandizement and the soothing of whatever crisis of conscience he may be experiencing.
What should further concern us all is not just that Edward Snowden has decided that we must now live with his judgments and moral determinations when it comes to how we conduct foreign policy, but that those judgments are based on a shocking degree of naiveté as Snowden doesn’t seem capable of grasping that in the world in which we live, our allies are not always our friends.
Snowden also appears to have missed civics class on the day when it was explained that the United States is a Republic where we elect people to make decisions on these matters and then judge the effectiveness of those decisions by deciding who we will keep in office and who we will turn away.
The bottom line here is that I really don’t care if Ed Snowden thinks all spying is wrong and neither do most Americans. This being the case, I have considerable difficulty with his decision to disclose the nation’s secrets to foreign governments just because he could.
I do care what the President thinks about our foreign spying operations just as I care about what Congress and the Judiciary think. It is their opinions and practices that I can either support or reject when I show up to vote. And while I may appreciate Mr. Snowden’s decision to inform his countrymen of surveillance programs involving spying on Americans, there is no claim nor evidence that spying on foreign entities crosses any legal lines and, therefore, it is incredibly wrong for Snowden to reveal data involving our spying programs outside the country .
Until I cast a vote for Edward Snowden to make such determinations for me, I would very much appreciate it if he would shut up and get over whatever psychological complexes are driving him to make these decisions on my behalf. He is doing neither me nor the country any favors.
By: Rick Ungar, Op-Ed Contributor, Forbes, June 20, 2013
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