Our Rights, Our Future

Prescription Drug Companies Must Warn Consumers of Drug Side Effects

By Paula Z. Segal

Gladys Mensing had diabetic gastroparesis, a chronic condition caused by nerve damage. For a person suffering from this illness, the stomach takes too long to empty its contents. Symptoms include heartburn, nausea, vomiting undigested food, and weight loss. In 2001, Mensing’s doctor prescribed Reglan to treat her symptoms, and her pharmacist filled the prescription with a generic version of the drug. Ms. Mensing took the generic for four years,  and in the process developed tardive dyskinesia, a severe neurological movement disorder characterized by involuntary movements, especially of the lower face. Tardive means "delayed" and dyskinesia means "abnormal movement” -- symptoms include facial grimacing, jaw swinging, repetitive chewing, and tongue thrusting. While Ms. Mensing stopped taking the drug in 2005, the disorder is often irreversible and there are no known treatments.

Ms. Mensing sued the manufacturers of the drug she took (Pliva, Inc., Teva Pharmaceuticals USA, Inc., UDL Laboratories, Inc. and Actavis Elizabeth, LLC.) for failing to warn her and other consumers of the side effects of their drug and misrepresenting its safety. Doctors and consumers use the labels on prescription drugs to decide what drugs are safe enough to take and prescribe. Neither the label on Reglan or the label of the generic Ms. Mensing took warned of the actual quantity of risk of this severe disorder when taking the drug over a long period of time. The label said that the risk of any neurological disorder from taking the drug for at least three months was 1 in 500. It did not warn that certain groups of patients are more likely to develop the condition. The Food and Drug Administration (FDA) says that the risk for tardive dyskinesia alone is 20%  - one in five patients can develop the debilitating condition after taking the drug for just three months.  The FDA has also found that the elderly, especially elderly women like Ms. Mensing, are more likely to develop the condition. Yet Reglan had not updated its labels since 1985, just five years after Reglan was first approved by the FDA. Had Ms. Mensing and her doctor known about these risks, they would not have decided on long-term treatment with Reglan or its generic version.

Ms. Mensing sued the drug manufacturers in federal court. The generic manufacturer had a clever answer: It claimed that it could not put anything on its label that the name brand did not have on its label. So when Reglan left out its long term side effects, the generic manufacturer claimed that the law said they had to leave them out too -- even if Reglan was mistaken or lying to its customers. The generic manufacturer argued that federal law forbid them from taking steps to warn their consumers of hazards they knew about if the name brand manufacturer didn’t warn against those hazards. The Minnesota federal district court agreed with the drug company and dismissed Ms. Mensing’s lawsuit. She refused to give up and appealed to the Eighth Circuit Court.

In the end, Ms. Mensing’s perseverance paid off. A week after she filed her appeal, on February 26, 2009, the Food and Drug Administration (FDA) ordered Reglan to update its labels to reflect the known risks. In April 2009, the United States Department of Justice, who had filed a ‘friend of the court’ brief on behalf of the drug companies during the first trial, withdrew its support for the drug companies. On November 27, 2009, the Eighth Circuit Court of Appeals held the generic drug manufacturers accountable for labeling the drugs they manufacture. This is extremely important for drug safety. Over 70% of prescriptions for drugs in the US are filled by generic versions of name brand drugs. The court has refused to give the manufacturers of generic drugs a pass when it comes to labeling.

District courts in Vermont and Illinois have made similar rulings. The courts are holding generic drug manufacturers accountable for the side effects of the drugs that they manufacture, no matter what the name brands put on their labels. Such instances continue to remind us that the courts are indeed powerful tools, primarily intended to protect the American public, not American commerce.

Paula Z. Segal is a second year student at City University of New York School of Law and a Haywood Burns Fellow in Civil and Human Rights. Before law school, she taught English to Speakers of Other Languages and continues to develop materials for ESOL instructors to connect language and life skills. She is also working with the New York Civil Liberties Union to reduce the school to prison pipeline and coordinates the CUNY Street Law Team, which brings the law to New York City high school students and community groups. For more on the school to prison pipeline, go to http://www.nyclu.org/issues/youth-and-student-rights.

(Photo by Pink Sherbet Photography.)

EPA Answers a Supreme Court Challenge, Declares Greenhouse Gases a Threat

In a surprising announcement on Monday, the Environmental Protection Agency (EPA) declared that greenhouse gases threaten public health and the environment. The decision came as advocates and world leaders gathered in Copenhagen this week to redefine international policy on climate change. 

EPA Administrator Lisa P. Jackson stated:

“These long-overdue findings cement 2009’s place in history as the year when the United States Government began addressing the challenge of greenhouse-gas pollution and seizing the opportunity of clean-energy reform…business leaders, security experts, government officials, concerned citizens and the United States Supreme Court have called for enduring, pragmatic solutions to reduce the greenhouse gas pollution that is causing climate change. This continues our work towards clean energy reform that will cut GHGs and reduce the dependence on foreign oil that threatens our national security and our economy.”

To what do we owe this shift in environmental policy? In large part, we can thank the courts. In Massachusetts v. EPA (2007), the Supreme Court questioned the Bush Administration’s stance that the EPA did not have the right to regulate carbon dioxide and other greenhouse gas emissions under the Clean Air Act. The Court ruled 5-4 that given the requirements of the Clean Air Act, the only way the EPA could refuse to regulate greenhouse gas emissions was “if it determines that greenhouse gases do not contribute to climate change” or if it could provide a good explanation for why it could or would not do so. 

Happily, the EPA appears to be taking the Court up on its challenge. We hope to see the agency fulfill the mission for which it was created.

Celebrating a Civil Rights Game Changer

Today marks the 54th Anniversary of Rosa Parks’ historic refusal to give up her seat to a white passenger on a bus in Montgomery, Alabama. While Ms. Parks’ act of civil disobedience and her subsequent arrest were not the first time anyone had dared to challenge racial segregation on buses, it was this incident that sparked a 381-day-long boycott of the Montgomery bus system, resulting in the Supreme Court’s affirming once and for all that separating people by race on public transportation was unconstitutional.

Half a century later, we find ourselves at a time in which many of the rights we’ve fought for in years past are slowly and quietly being eroded. While the court system has both the capacity and the duty to step in and demand equal protection for all, it has turned its back on many in need, from people with disabilities to low-income communities of color shouldering an unfair burden of toxic waste.

As part of its mission to ensure that the courts protect and preserve fairness and justice for all, the National Campaign to Restore Civil Rights (NCRCR) invites you to check out two exciting new projects in the works. NCRCR has started an Audio Interview Series and ‘Real People, Real Stories’, a multimedia project. Both seek to present the perspective of those fighting present-day courtroom battles, putting human faces on the legal issues that affect our lives.

Honor Rosa Parks’ legacy -- learn more about today’s civil rights movement.

The National Campaign to Restore Civil Rights is a collection of more than one hundred civil rights organizations and numerous individuals who came together to ensure that the courts protect and preserve justice, fairness, and opportunity for everyone. The Campaign focuses on public education and outreach, finding ways to get the message out about the impact of court rulings on our communities, our opportunities and our rights.

(Photo by mattlemmon.)

Connecticut v. American Electric Power

Tricia Perry of the National Campaign to Restore Civil Rights spoke with Bruce Myers, Senior Attorney at the Environmental Law Institute, about the recent decision in the Connecticut v. American Electric Power case. Listen in as Myers talks about how the court system is weighing in on issues of global warming.

Despite the Fine Print, the Courts in Washington State Are Open!

By Paula Z. Segal

When you buy a computer or any other complicated piece of consumer electronics, you also receive a bundle of infinitesimally small print type, that many of us all too often skip reading. Some of that small print is written specifically to protect the companies from you: a future, frustrated version of you, who might decide to sue the company for selling a defective product.

Kristin Cariedo bought a new Dell laptop for $1300. Catherine Candler paid $1700 for hers. Neither computer worked the way it was supposed to. Ms. Cariedo and Ms. Candler wanted to sue Dell to get their money back but the fine print that accompanied their laptops said that by simply buying and keeping the computers, Ms. Cariedo and Ms. Candler and all other consumers buying Dells laptops waived their right to ever sue Dell. Dell had written an “agreement” that said that any disputes between consumers and Dell were to be settled through arbitration by a private arbitrator that Dell had selected (the National Arbitration Forum); Dell also said that no class actions were permitted, meaning that consumers could not get together to bring Dell to court for selling defective products. The “agreement” that Ms. Cariedo and Ms. Candler had entered into with Dell when they bought their computers was designed to keep them out of court.

The National Arbitration Forum (NAF), the arbitrator that Dell chose, turned out to not be a neutral arbitrator; rather, it turned out to be intimately tied to the country’s largest debt collection firms, which profit directly from deciding cases against consumers. A House of Representatives investigation report on NAF documented its abuses, and lawsuits have been filed against NAF nationwide. The Center for Responsible Lending issued a report calling NAF’s neutrality into question in May 2009, and finding that NAF decisions tend to favor companies – like Dell – that give them business. In the midst of all this controversy, NAF stopped accepting consumer arbitrations in July 2009.

On October 26, 2009, the highest court in Washington State, where Ms. Cariedo and Ms. Candler brought their case against Dell, ruled that the mandatory arbitration agreement written into the fine print of their computer purchase agreements could not be enforced because NAF, the arbitrator, was not available. The court refused to appoint a different arbitrator.

The Washington court also said that the provision prohibiting class action lawsuits could not be enforced. Class actions are important because they allow individual consumers to use their collective resources to hire experts to testify at trial. In consumer cases, where the amount at stake is usually the price of the purchased item, the expense added by hiring an expert makes the lawsuit unreasonable to fund. When the expense is shared by many consumers of similarly defective products, the lawsuit becomes possible.

Now Ms. Cariedo, Ms. Candler and everyone else who purchased defective computers from Dell can go to court to ask for their money back (at least in Washington State). They can come together in a class action to bring the best case possible against Dell and other corporations selling defective products. This ruling, opening the courts to consumers despite the fine print designed by companies to keep them out, recognizes that consumers’ ability to sue is crucial to preventing widespread misconduct by corporations.

Paula Z. Segal is a second year student at City University of New York School of Law and a Haywood Burns Fellow in Civil and Human Rights. Before law school, she taught English to Speakers of Other Languages and continues to develop materials for ESOL instructors to connect language and life skills. She is also working with the New York Civil Liberties Union to reduce the school to prison pipeline and coordinates the CUNY Street Law Team, which brings the law to New York City high school students and community groups. For more on the school to prison pipeline, go to http://www.nyclu.org/issues/youth-and-student-rights.