The manufacturers are not entirely to blame. The federal oversight agency, the Food and Drug Administration (FDA), has created regulatory obstacles preventing manufacturers from adequately warning patients when the manufacturers become aware of potential hazards associated with their products that are not currently addressed on the generic drugs’ labeling. Second, and compounding this safety problem, patients harmed by generic drugs are barred from suing manufacturers of generic drugs. The result is a significant gap in generic drug safety and manufacturer accountability.

In August 2011, Public Citizen submitted a citizen petition (PDF) to the FDA urging it to address the problem. The petition asked the agency to amend its regulations so that manufacturers of generic drugs could revise their products’ labeling to add new information about risks and contraindications, through a revision process currently permitted only for brand-name drug manufacturers.
As experts have noted, all the risks associated with a particular medication are not identifiable until after the product has been on the market for several years. In addition, the majority of approved drugs with distinct ingredients, delivery routes, and strengths are available in generic form. In fact, many drugs are available solely in generic form. Because of their expanding market share, generic drug manufacturers likely receive substantial reports of safety incidents, and have the tools to be fully aware of information suggesting previously unknown risks or other inadequacies in the current labeling.

Unfortunately, the FDA’s failure to keep regulations in pace with the growth of the generic drug market creates a gap in drug safety. 

Adding fuel to the fire is a 2011 Supreme Court decision, Pliva v. Mensing, where the court held that the restrictions imposed by federal law on the ability of generic drug manufacturers to alter labeling preempts state common-law claims against a generic manufacturer based on failure to warn of product hazards. The decision bars patients from seeking compensation in court for injuries caused by generic drugs. Yet, just two years before, in Wyeth v. Levine, the Supreme Court had held that federal regulations did not preempt state-law failure-to-warn claims against brand-name prescription drug manufacturers.

The court’s explanation of the inequity turns on the FDA regulations that do not allow generic drug manufacturers from updating generic drug warning labels. The court in Pliva said that it was “impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”

Preemption of tort suits is harmful, not just for the injured individuals who cannot sue, but for all patients because it leaves responsibility for ensuring drug safety in the FDA’s hands, which cannot protect consumers on its own. Indeed, the Supreme Court noted the FDA’s limited resources to monitor the vast number of products – approximately 11,000 drugs – on the market.

Three years earlier, in holding that patients’ right to sue brand-name drug companies is not preempted, the Supreme Court observed that tort law benefits patients in several ways:

• uncovering unknown drug hazards;

• providing incentives for drug manufacturers to disclose safety risks promptly;

• serving a compensatory function that motivates injured patients to come forward with information.

On Thursday, a House subcommittee will hold a hearing to discuss an agreement between the generic drug industry and the FDA over user fees. User fees are paid by each manufacturer to help support the cost of reviewing generic drug applications. The hearing makes this a good time to remind the FDA and Congress about the generic drug safety gap.

As the generic drug market expands, manufacturers must be given responsibility to patients for the products they sell. Either the FDA must allow these manufacturers to revise labeling to warn of newly discovered risks, or Congress must pass a law giving manufacturers that ability.

Christine Hines is consumer and civil justice counsel at Public Citizen’s Congress Watch division.

Flickr photo via thewendyhouse.

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Aside: if you’ve read this far and the mere mention of that case makes you apoplectic, then RSVP right now for one of tomorrow night’s organizing parties geared at overturning it. Or sign up to host one! It’s definitely not too late; we’re at well over 200 gatherings and growing!

Flickr image by steakpinball

One thing that doesn’t get covered as much in that conversation, and which I’ll now briefly spotlight: how Citizens United has changed the playing field when it comes to judicial elections. It’s a trend that fuels the very corrosion of our democracy that the Supreme Court in Citizens United brushed aside, something that “We, the People” now must rectify.

The Brennan Center for Justice at NYU School of Law documented how this has played out in a report, The New Politics of Judicial Elections: 2009-2010. The report was published last month, in partnership with the Justice at Stake Campaign and the National Institute of Money in State Politics. Essentially, the report boils down to this: in states where the judiciary is subject to popular election or to “retention” votes, a flood of special-interest money has increasingly politicized what the Framers envisioned as our least political branch of government.

As the report details, judicial retention elections in places like Iowa, rarely the site of pitched battles in the past, have moved toward becoming high-dollar battlegrounds flush with outside special-interest money. More broadly, 2009-2010 became the highest-spending cycle in history, by far, on all judicial election campaigns.  The Brennan Center carefully and persuasively traces this all to a “coalescing national campaign that seeks to intimidate America’s state judges into becoming accountable to money and ideologies instead of the constitution and the law.”

In his keynote address at Public Citizen’s 40^th Anniversary Gala last month, journalist Bill Moyers quoted an eminent historian of the American Revolution, Gordon Wood, about how American democracy paved the way for others after it “by creating a prosperous free society belonging to obscure people with their workaday concerns and their pecuniary pursuits of happiness.” (Those words speak me in particular because I had the privilege of taking two of Professor Wood’s lecture courses when I was in college.)

Wood’s words also speak to me, as they did to Moyers, because they sum up the notion that “We the People” are the fundamental creators and beneficiaries of American democracy, with judges serving as the trusted mechanism for honestly interpreting our laws and Constitution. It’s that theme that animates the Brennan Center’s criticism of post-Citizens-United spending on judicial elections, and of just what that means for our democracy.

I’m currently reading Professor Wood’s latest book, a collection of essays and speeches titled The Idea of Liberty: Reflections on the Birth of the United States. In his essay on “The Making of American Democracy,” Wood notes that in our recent history “Many Americans became concerned with large and unequal campaign contributions precisely because they seemed to negate the effects of equal suffrage and violate the equality of participation in the political process.”

We can now add to that list of concern, sadly, the undermining of the very judiciary that so often serves as a critical backstop on behalf of the Constitution and the law. Judges are subject to the same troubling leverage as members of the other two branches of government under the post-Citizens-United regime. The threats of spending on their opponents, their non-retention in office, and even politically-motivated calls to impeach them—all of the above are documented in this latest report, and undermine the independent judiciary’s vital role.

It doesn’t have to be this way. Our democratic society, rooted in the people, remains despite this corrosion on elections and on the judiciary, and it has an essential mechanism by which to reassert itself: amending the Constitution to prevent corporate control of our elections.

So read the full report on judicial elections if you’ve got a few minutes. Reflect on what this means for the vote you may have just cast today. And then dry your eyes, and join a house party tomorrow.

Sean Siperstein is a Legal Fellow with the Democracy is For People campaign.

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“Prevent the lawsuits,” they essentially said, “and our health care problems will solve themselves.”

One of their chief exhibits was the state of Texas, which imposed some of the strictest liability caps in the country in 2003 and, in the critics’ imaginations, had experienced wondrous results. For instance, Rep. Michele Bachmann (R-Minn.) said, “the state of Texas did a wonderful job of lawsuit reform and actually saw medical costs come down.”

We decided to take a look at what really has happened in the Lone Star state since it imposed a $250,000 cap on doctors’ liability for non-economic damages and immunized emergency room doctors except in cases of “wanton” negligence.

What we found is that the reality is the opposite of the rhetoric.

First, as the tort reform crowd hoped, litigation did go way down. Payments for malpractice are down 65 percent since 2003 and nearly 75 percent if corrected for inflation and population growth.

But regular Texans have not received any of the benefits they were promised in exchange for giving up their legal rights.

Medicare spending in the state has increased faster than the national average on a per-enrollee basis, meaning the increases are not connected to Texas’s rising population.

The more discretionary types of Medicare spending, such as for diagnostic testing, have risen even faster compared to national norms. Viewed in conjunction with Texas’s plummeting litigation rates, this contradicts the “defensive medicine” argument, which holds that doctors order more tests and procedures to insulate themselves from litigation.

Health insurance costs in Texas have risen by more than 50 percent since 2003, slightly faster than the national average.

The percentage of uninsured in Texas has increased, solidifying the state’s distinction of having the highest percentage of uninsured people in the country.

The per capita population of primary care doctors has flat-lined and the prevalence of rural doctors practicing in the state has decreased slightly.

The term “Texas Miracle,” has become fashionable of late. But with miracles like these, who needs tragedies?

Taylor Lincoln is the research director for Public Citizen’s Congress Watch division.

For more on this topic, check out this post: The NPDB Shut Down: Even Worse Than Texas Malpractice Law? from the Center for Justice & Democracy’s Pop Tort blog.

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The House Judiciary Committee just approved the “Lawsuit Abuse Reduction Act,” H.R. 966 AKA “LARA.”

Unfortunately, for anyone who cares about justice or about wise uses of their taxpayer dollars, H.R. 966 is yet another example of bills to add to the long list of “Clear Skies” and other let’s-call-this-bill-the-exact-opposite-of-what-it-actually-is-bills.

If the title wasn’t bad enough, the bill by Rep. Lamar Smith and Senator Charles Grassley, who sponsored the Senate version, S. 533, is deceptively cloaked in technical terms. What better way for Congressional lawmakers to slip this past ordinary citizens (the ones who will be at an even greater disadvantage if LARA moves forward as feared).

Here is the scoop: HR 966 revises a procedural rule – commonly called Rule 11. The old Rule 11, which was implemented in the 1980s, was typically used as a tactic by corporate defendants to prolong and create sidebar litigation, distracting attention away from the real claims in lawsuits and increasing the costs of already-expensive litigation.

A judicial advisory committee reviewed several empirical studies and judicial surveys and found not only that the rule encouraged additional unnecessary litigation, but also that the incidence of motions for sanctions and court orders was higher in civil rights cases than in some other types of cases. It was also discovered that sanctions were sought more frequently against claimants than against defendants. In other words, the old Rule 11 as written made it easy for corporate lawyers to create expensive procedural hoops, which the claimants (ordinary citizens like you and me) would have to jump through. While corporations with teams of lawyers may have the time and resources to stay in court indefinitely, others do not.

After these and other problems came to light, Rule 11 was revised in 1993 to give judges more discretion to address the issues as they see fit, and the new revisions alleviated the burdens on the courts. In a recent survey on the newer rule, more than 80 percent of federal trial judges said that “the rule is needed and it is just right as it now stands.”

Fast-forward now to 2011 and I find myself sitting in a hearing on LARA where I cannot help but wonder why the House Judiciary Committee is so dead-set on removing federal judges’ ability to exercise their judgment in deciding whether to impose punishment for unnecessary court filings and on eliminating lawyers’ ability to correct or withdraw filings with the court if they are not well grounded in fact or law.

The judiciary as well as consumer, employment and civil rights groups oppose HR 966 because it will take us back to a place where we should not care to return. But it looks like some members in Congress are determined to live in the past.

Christine Hines is Public Citizen’s Consumer and Civil Justice Counsel
Follow her on Twitter @Chines_citizen
Join The Civil Justice Project on Facebook

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Most Americans have heard of Stella Liebeck. She was the 79-year-old woman who in 1992 sought and won compensation in court in a case against McDonald’s Corp. after suffering third-degree burns on her groin, inner thighs and buttocks when the company’s too-hot coffee which was heated at dangerously high temperatures spilled onto her lap. Due to the distortions and false rumors that soon became conventional wisdom – no, she was not racing down a highway while trying to sip her coffee – Liebeck’s case became a symbol for so-called “tort reform,” or corporate efforts to give big businesses near-immunity from liability.

Stella Liebeck’s tale portrayed in “Hot Coffee,” was frank and compelling truth-telling, but it was the lesser known story of Jamie Leigh Jones and the knowledge that forced arbitration clauses are inserted within everyday consumer and employment contracts which seemed to stir indignation in some writers who reviewed the film.

Jamie Leigh Jones’ case was the “most infuriating example of legal injustice,” wrote Peter Debruge in his review of the film for Variety, the entertainment industry magazine.

Jamie Leigh Jones was a 19-year-old employee of defense contractor and Halliburton subsidiary KBR who was gang-raped in Iraq by her co-workers and wrongfully imprisoned by her employer after she reported the crime. She attempted to sue her employer in civil court, but the provision in her employment contract barred her from court and required her to go to arbitration, a secretive system where corporations typically have enormous influence over the process and outcome of disputes. As Debruge recounted Jones’ story in the film right up to Senator Al Franken’s effort to assist Jamie Leigh and similar victims, it became crystal clear that “as consumers and employees, virtually everyone watching the film has similarly waived their rights.”

Hank Stuever of the Washington Post also found the immediate impact of this type of tort “reform” on our everyday lives significant enough to mention in his glowing review of the film. “As Saladoff shows,” Stuever wrote, “each of us at present relinquishes our right to sue in all sorts of everyday consumer transactions — while using credit cards, cellphones and a host of other products.”

Forced arbitration is mentioned and described in other reviews of the film including in The New York Times, The Daily Beast, CNN and Reuters, to name a few. Saladoff’s “Hot Coffee” and by consequence the movie reviewers have brought more attention to the injustice of forced arbitration than tireless public interest advocates could even dream of providing it. With any luck, viewers of the film will be spurred into action so we can all work together to effect change in the system.

“Hot Coffee,” premiered last night  on HBO at 9 p.m. Get info about the movie and other viewing opportunities at hotcoffeethemovie.com and be sure to join Public Citizen’s Civil Justice Project on Facebook and visit our page devoted just to these issues at www.fairarbitrationnow.org to stay informed of issues like forced arbitration and urge your representatives to support the Fair Arbitration Now Act.

Christine Hines is consumer and civil justice counsel for Public Citizen. Follow her on Twitter @chines_citizen

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If that sounds alarmist, it’s because the numbers are truly alarming: A recent study of Medicare participants found that, in a single month, one of every 17 hospital patients was injured or killed by a preventable medical error. Many more Americans are hurt by unsafe drugs and medical devices.

Given the staggering injury and death rate, it’s shocking that some members of Congress want to shield from accountability those in the medical field who are responsible for harm.

They’re pushing H.R. 5, and overreaching bill that would immunize practically the entire medical industry from responsibility when their defective products or services hurt people. If it passes, the costs of medical mistakes would shift from the negligent actors to injured patients, their families, and taxpayer-funded health and disability programs.

Only an extremely small number of doctors are responsible for most medical errors. Just 5 percent are responsible for more than half of all medical errors. Those doctors should be held responsible for their actions – not given a free pass. The same goes for drug companies and medical device manufacturers.

Instead of attacking patients’ rights, Congress should focus on improving patient safety and reducing deaths and injuries. H.R. 5 does neither. But Public Citizen’s research has shown that 10 basic safety measures would save, conservatively, $35 billion and 85,000 lives a year.

Urge your representative to oppose H.R. 5.

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The only result practically ensured from their bill, ironically called the HEALTH Act, is the further devastation of patients who suffer debilitating injuries from medical errors. The bill aims to give a free pass to practically every player in the health industry (physicians, hospitals, pharmaceutical companies, and nursing homes, to name a few), releasing them of their duty to treat patients with adequate care and respect. Meanwhile, injured patients will lose their ability to hold these powerful groups accountable.

And on top of it all, this bill won’t even lower health care costs. All it would do is shift the burden of paying for medical providers’ bad behavior from the wrongdoers themselves to the patients, their families and taxpayers.

The bill specifically restricts individuals’ rights by:

• presenting an arbitrary and cruel $250,000 cap on noneconomic damages that directly impacts patients with the most serious injuries such as deafness, blindness, loss of limb or organ, paraplegia or severe brain damage;

• allowing providers and insurance companies to control payout for future damages, delaying the compensation that patients need right away;

• capping attorney fees, which will reduce the supply of representation for victims;

• shortening the time that patients can sue, which will extinguish many valid claims against negligent medical providers; and

• imposing a federal one-size-fits-all scheme on all 50 states, trumping hundreds of years of state law and intruding upon states’ rights to manage their own legal systems.

Hopefully, this bill, introduced by Reps. Phil Gingrey (R-Ga.), Lamar Smith (R-Texas) and David Scott (D-Ga.), won’t proceed any further. But if it comes up for a vote, Congress must reject it.

Christine Hines is consumer and civil justice counsel for Public Citizen. Find Christine on Twitter @chines_citizen.

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Patients’ legal rights continue to be a scapegoat in the public debate on solutions to the country’s skyrocketing health care costs.  However, the proof is in the pudding. When Public Citizen examined Texas’ experience with strict liability limits (PDF) since their adoption in 2003, we found that injured patients in Texas lost their access to the courts but the restrictions did not translate into health or cost benefits. Instead, the opposite has occurred. In Texas: the uninsured rate has increased, remaining the highest in the country; health insurance cost has more than doubled; spending increases for diagnostic testing (measured by per-patient Medicare reimbursements) have far exceeded the national average; and the cost of diagnostic testing in Texas (measured by per-patient Medicare reimbursements) has grown 50 percent faster than the national average.

Clearly, tort reform will not cut the fat.

To blame high costs on medical malpractice litigation is to ignore the facts. In 2008, the cost of medical malpractice liability fell to less than 0.6 percent of the $2.1 trillion in total nation health care costs as measured in 2006. In fact, there are nearly 10 times as many injuries caused by medical negligence (PDF) as there are malpractice claims.

If the debt commission really wants to slice the deficit, they will reject this recommendation by the co-chairs and follow the money.

Medical errors are the real crisis for health care costs. The Institute of Medicine estimated in 1999 that medical errors cost an estimated $17 billion to $29 billion annually for lost income, lost household production, disability and health care costs. Adjusted for inflation, these numbers are $22.1 billion to $37.7 billion today.

The recommendations of the co-chairs are just that, recommendations. Therefore, we urge the members of the commission to cut the fat where it counts, by removing this dangerous recommendation and inserting the solution that will save lives and costs: reducing the malpractice.

Christine Hines is the consumer and civil justice counsel for Public Citizen.

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As Hathaway noted, the new Consumer Financial Protection Bureau created by the recently passed financial reform law will be authorized to ban or restrict forced arbitration. So will the Securities and Exchange Commission. But here’s what Hathaway leaves out: millions of other consumer contracts exist that fall outside of these agencies’ jurisdictions. The CFPB and SEC can restrict investor-broker contracts and contracts for other financial products as designated under the new law. But they have no authority to restrict or ban forced arbitration in numerous consumer contracts, such as those for employment, nursing homes, cell phones, and home building.

Hathaway guesses that the days of forced arbitration “could be numbered.” His optimism is refreshing. But even with SEC and CFPB’s new authority, we still need Congress to pass the Arbitration Fairness Act to eliminate pre-dispute forced arbitration from all consumer contracts for good.

Christine Hines is the consumer and civil justice counsel for Public Citizen.

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First, he told me that the agreement was not a contract. I quickly corrected him and explained that they were one and the same. Then I started flipping through the three-page document. Lo and behold, there it was, in bold: an arbitration clause AND a statement claiming that there is no agreement to enter into any class action arbitration.

I explained to him in my excitable way that I wouldn’t sign the document, explained to him what the arbitration clause meant and its impact on consumers. He was shocked. In a very brief moment he removed the professional mask and showed that he was appalled by the provision’s meaning. I told him about the need to support the Arbitration Fairness Act in Congress. He asked if it would eliminate arbitration. I explained that it wouldn’t – but it would make it voluntary, rather than forced.

He said it was the first time he’d ever heard anyone complain of it. He said that another lawyer-client had crossed out a phrase (not arbitration-related) in a type of insurance contract and the company accepted it. He thought maybe they would do the same for me in this case — cross out the arbitration clause. Then after talking about the issue some more, we both agreed that it was highly unlikely that the company would do so, but that he would try.

I further depressed the poor guy when we were finishing up the meeting by bringing up his employment agreement. He said he signed an employment agreement, and I said that an arbitration clause is likely in the contract. He said, “What should I do, not take the job?” And I said that’s exactly the point. We don’t have a choice when it comes to these provisions. Afterwards, he practically pushed me into the elevator, happy to see me leave.

He really was a nice and very helpful guy – hopefully he doesn’t have an arbitration clause in his employment agreement. Now we’ll see if he can get the clause removed from my contract!

Christine Hines is the consumer and civil justice counsel for Public Citizen.

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