Even though generic drug makers claim a recent Supreme Court decision gave them immunity from ALL lawsuits, some victims harmed by generic drugs may have a glimmer of hope. The First Circuit ruled some claims can go forward against the generic maker and upheld a jury award in a case called Bartlett v. Mutual Pharmaceutical Co. This decision comes after last year’s SCOTUS Pliva v. Mensing decision that granted generic drug makers immunity from most lawsuits.

Eighty percent of all prescriptions are filled with the generic, and that means 80% of all drug patients have few legal protections when they are injured by a generic drug. The Bartlett decision offers little hope to the hundreds of cases we that have already seen dismissed, as generic makers fight to avoid accountability.

Take Tammy Gilbert’s daughter, Kira Nicole. Kira was placed on the generic version of Darvocet for pain just a few days before surgery. She never woke up. However, Tammy can’t sue the maker of the drug that may have killed her daughter simply because she took the widely-used generic version and not the brand-name drug. Darvocet, the drug in question, has already been pulled from the market because of safety concerns, but that was too late for twenty-two year old who may have lost her life from this dangerous drug.

“I want the drug company to know what they have taken from us and from the world,” said Tammy Gilbert of her daughter. As hundreds of cases against the brand manufacturer of Darvocet continue to go forward, Tammy’s was dismissed, simply because her daughter took the generic form of Darvocet.

To protect patients like Kira who were injured by generic drugs, Seantors Harkin, Leahy, and Franken have written the FDA today to ask that they address the discrepancy in the law that allows brand drugs to update their warning lables, but lets generic makers off the hook for the same harmful effects.
The generic ruling in Pliva v. Mensing applies to any generic drug and we are seeing cases being dismissed in all types of drug cases, like Accutane, Reglan, and Phenergan lawsuits.

The Institute of Medicine (IOM) released a report earlier this month recommending that the U.S. Food and Drug Administration (FDA) review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues. The IOM also recommended that the FDA create a comprehensive, publicly available document that reflects risks as they crop up throughout the “lifecycle” of the drug. This report is further evidence that FDA approval does not mark a drug as safe. Vioxx, Accutane, and Reglan are just a few recent ensamples of drugs that were approved by the FDA and then found to have dangerous side effects.

This report is even more troubling because, the U.S. Supreme Court ruled last June that generic drug manufacturers only have the responsibility to carry the same warning label as the brand name drug, even when they know of new risks. As a result of that decision, many people injured by generic drugs have been unable to hold generic pharmaceutical companies accountable for their injuries. This is in direct contrast to the U.S. Supreme Court’s decision in 2009, which established that people injured by brand name drugs can pursue their claims in court.

Many long term side effects of prescription drugs are not known at the time of FDA approval. In fact, the IOM report noted that “it is impossible to know all of the risks and benefits of a drug before approval.” Without accountability in the courts or from the FDA, generic manufactures have no motivation to warn the public of new side effects, leaving consumers paying the price while the drug companies continue to profit.

AAJ has asked the FDA and Congress to act; support the “Patient Safety and Generic Drug Labeling Act” to keep patients safe.

For Immediate Release: April 18, 2012

Contact: Katie Gommel
American Association for Justice
202-965-3500 x8369
AAJ Press Room

Washington, DC—Today Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety and Generic Labeling Improvement Act of 2012” (S. 2295), amending U.S. Food and Drug Administration (FDA) regulations to allow manufacturers of generic drugs to initiate labeling updates. A companion bill, “Patient Safety and Drug Labeling Act,” (H.R. 4384) was introduced in the U.S. House of Representatives by Reps. Bruce Braley (D-IA) and Chris Van Hollen (D-MD).

This bill would allow generic manufacturers to initiate changes to their labels to reflect current health and safety information under the same circumstances that apply to manufacturers of branded drugs; ensuring brand and generic manufacturers have the same responsibility to adequately warn the public of their drugs’ risks.

The American Association for Justice (AAJ) has called for expanding generic drug manufacturers’ responsibility to warn since last June’s U.S. Supreme Court decision in Pliva v. Mensing.

“With the expanding generic drug market, it is essential all manufacturers—brand and generic—are held accountable for the safety of their drugs,” said AAJ president Gary M. Paul.

As a result of Mensing, hundreds of patients have had their cases dismissed because the court ruled that state law-based failure to warn claims conflicted with FDA labeling requirements.

As Gabriel N. Drapos wrote last week in his university’s newspaper, The Harvard Crimson, the Mensing decision has prevented him from having the facts of his case heard in court because he took the generic form of Accutane and not the brand name drug. He developed Ulcerative Colitis his freshmen year at Harvard University after taking a generic form of Accutane in high school. After months of pain, tests and surgeries doctors were forced to remove Gabriel’s entire large intestine greatly impacting his day-to-day actives.

“This legislation would restore the civil justice system for hundreds of Americans injured by defective generic drugs,” said Mr. Paul.

Over 75 percent of prescriptions are filled with generic drugs. Once a drug goes generic most brand name manufacturers leave the market resulting in inaccurate and old warning labels. Accountability is the only incentive generic drug companies have to monitor and adequately warn patients about the safety of their drugs.

For more information and a list of cases that have been dismissed as a result of the Mensing decision please visit www.justice.org/courts.

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As the world’s largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org/newsroom.

Contact: Michelle Widmann
American Association for Justice
202-965-3500 x8369
AAJ Press Room

Washington, DC— Florida Special Prosecutor Angela Corey announced yesterday that the State of Florida has taken the first step to achieving justice for Trayvon Martin and his family by filing criminal charges against George Zimmerman.

The Martin family’s fight for basic access to justice has been delayed and jeopardized by Florida’s “Stand Your Ground” immunity law that grants complete criminal and civil immunity, regardless of the facts, when individuals take the law into their own hands. The law was adopted and promoted in state legislatures across the country by the American Legislative Exchange Council (ALEC).

“ALEC’s ‘Stand Your Ground’ laws make our streets more dangerous by taking all accountability out of the equation,” said American Association for Justice (AAJ) President Gary M. Paul. “If no one is accountable, no one is safe.”

ALEC is a secretive organization composed of multi-national corporations and state legislators that together write and spread dangerous legislation to counter our constitutional rights. In addition to pushing “Stand Your Ground” laws, ALEC has been working behind the scenes for decades on behalf of its corporate donors to pass legislation that eliminates accountability by limiting Americans’ access to the political process and our nation’s courts. ALEC-sponsored legislation includes voter ID laws that disenfranchise whole groups of voters and laws that grant immunity to manufacturers of deadly products like asbestos and pharmaceuticals that harm and kill patients.

“All Americans benefit when justice and democracy are accessible,” said Mr. Paul. “If the courts and the voting booths are barred, accountability will be eliminated and Americans will be left voiceless with dangerous products, vulnerable civil rights and unsafe streets. Americans deserve to know exactly who or what corporations are behind these ALEC-sponsored laws.”

AAJ was one of the first organizations to shine a spotlight on the way ALEC’s corporate contributors pay to gain access to legislators and distribute their corporate-crafted legislation. In a May 2010 report, AAJ exposed ALEC as the ultimate smoke-filled backroom for introducing laws that protect corporate interests at the expense of consumers’ rights. For a full copy of the report, “ALEC: Ghostwriting the Law for Corporate America,” visit: http://www.justice.org/ALEC

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As the world’s largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org/newsroom.

April is National Distracted Driving Awareness Month. Distracted Driving occurs when drivers take their full attention away from the road and instead attempt to either multi-task or focus on texting, talking on a cell phone, grooming, adjusting a radio, or attempting other activities.

Distracted Driving is an all too common occurrence in our society today. And it is a dangerous issue that must be address immediately. In fact, studies indicate that each year Distracted Driving results in thousands of deaths and hundreds of thousands of injuries.

In an effort to draw attention to this epidemic and make our communities a safer place to live, many AAJ members across the country are joining forces with The Casey Feldman Memorial Foundation, 60 For Safety, and EndDD.org will provide End Distracted Driving campaign presentations at hundreds of schools, community groups, civic organizations and other gatherings.

This effort to reach more than 100,000 student drivers will kick-off an ongoing campaign that will continue throughout 2012 and beyond. These educational, informative and inspiring talks will present the sobering statistics of our current safety crisis, share true stories of the costs of Distracted Driving, and offer simple steps that drivers can use immediately to help themselves and others around them End Distracted Driving.

For more information about the program, click here.

If you want to take action to help end distracted driving, here are two ways you can get started:

Make a pledge—Make a commitment to do something to end distracted driving. Submit a written pledge, or share a video pledge.
Share the featured “Faces of Distracted Driving” video.

Over the weekend, the New York Times called on Congress and the U.S. Food and Drug Administration (FDA) to address the lack of accountability generic manufacturers have when it comes to monitoring the safety of their drugs. They stated:

“This outrageous denial of a patient’s right to recover fair damages makes it imperative that Congress or the Food and Drug Administration fashion a remedy.”

This editorial comes after last week’s article, also in the Times, “Generic Drugs Proving Resistant to Damage Suits,” which presented the stories of Debbie Schork and Diana Levine. Both women were given an anti-nausea drug which when it was injected caused gangrene in their hands and arms. As a result, both women had to have their hands amputated.

The only difference between the two cases was Ms. Levine was given the brand name drug, Phenergan, and Ms. Schork was given the generic version of the exact same drug. Because of that difference, when the women set out to hold the drug manufacturers accountable, Ms. Schork was denied her day in court, while Ms. Levine won her case after it was heard by the U.S. Supreme Court.

Ms. Schork’s case was dismissed following the Pliva v. Mensing decision, where the U.S. Supreme Court ruled generic drugs must carry warning labels identical to those of the brand name drug, even if there are known, new side-effects that warrant a change a to the label. This means that generic drug manufactures cannot be held accountable for failing to warn patients about problems with their drugs.

The Times, in their editorial, goes on to write:

“Same drug. Same devastating health consequences. Opposite results. This injustice will affect more people as generics, which already dominate the market, expand even more under the pressure to control health care costs.”

Ms. Schork is not the only injured patient whose rights have been eliminated following the Pliva v. Mensing decision—hundreds of cases have been dismissed. Additionally, many brand manufacturers get out of the market once a drug goes generic, this means there will be many instances where no one will be monitoring drugs for safety. The Times concluded:

“Generic drugs have rapidly expanded their reach, and, by one estimate, from one-third to one-half of all generic drugs no longer have a brand-name competitor. The regulatory system needs to hold generic companies, many of them large multinationals, accountable for labels on the products they sell.”

Congress and/or the FDA need to act to protect patients who have been injured by dangerous drugs and restore patients’ rights to hold generic manufacturers accountable, just like brand name manufacturers.

H.R. 5 is an extreme bill that limits the rights of not only patients injured by preventable medical errors, but those injured by dangerous drugs as well. This bill would eliminate accountability of manufacturers to monitor the safety of their drugs by creating immunity for pharmaceutical corporations from punitive damages when their products kill or injure Americans.

Proponents of H.R. 5 should remember that this is about real patients – like Elizabeth Rippee of Escondido, California, who died from a pulmonary embolism and deep vein thrombosis, attributed solely to her use of birth control, Yasmin.

Elizabeth was a veterinary assistant, enjoyed horseback riding and maintained an active lifestyle. She never smoked, had no previous history of blood clots and had taken another birth control pill for over a year before switching to Yasmin.

After taking Yasmin for about three months, on Christmas Eve, Elizabeth’s twin sister found Elizabeth on the floor in their bathroom. Elizabeth’s mother and paramedics performed CPR, but five hours later Elizabeth was pronounced dead.

Studies, including one in the British Medical Journal, show oral contraceptives containing drospirenone, like Yaz/Yasmin, are two to three times more likely to cause blood clots than other birth control pills, but, according to the FDA, makers of Yaz/Yasmin failed to adequately warn the public about these risks.

H.R. 5’s broad-based immunities completely undermine patient safety by eliminating the deterrent effect of punitive damages allowing big business to balance the costs of improving safety against the costs of killing or injuring patients.

Tell Congress not to eliminate the rights of patients injured by drugs by voting against H.R. 5.

This week marks National Patient Safety Awareness Week – a reminder of how we must work to prevent the hundreds of thousands of injuries and deaths that occur every year from medical errors, neglect and defective drugs and devices.

The American Association for Justice (AAJ) has long advocated for the rights of patients by ensuring they have full access to the civil justice system when they are injured by negligence or misconduct. Accountability serves as an important incentive to keeping patients safe. Efforts that aim to take away the legal rights of patients leave people at risk for more injures–whether it’s from negligent health care providers or device and drug companies.

These are four real life examples of that remind us of the importance of patient safety:

Richard Smith, an active retired PE teacher, was admitted to the ICU for shortness of breath after receiving routine kidney dialysis. The next day, Richard was alert and stable, but complained of an upset stomach and his doctor prescribed an antacid. Richard’s nurse, disregarding a number of protocols, instead gave him a paralytic drug, pancuronium, which was also inappropriately stored in the nursing area. This sent Richard into cardiac arrest and eventually into a vegetative state, dying a month later. 98,000 people die every year from preventable medical errors. Recent studies have confirmed the problem is only getting worse. The civil justice system not only provides patients with their constitutional right to seek justice; it also encourages patient safety improvements that help prevent negligence before it occurs.
John Donahue, while under the care of a nursing home, suffered an eye injury so severe that his eye had to be removed. The infection caused by his injury eventually led to his death. When his daughter Marlene Owens went to file a claim against the nursing home corporation, she was told that her father signed a forced clause without any family members present. The nursing home insisted that the case be taken to secret arbitration. Only after years of fighting this abusive forced arbitration clause was she allowed to have her father’s case heard by a jury. Inserted in the fine print of lengthy admission documents, mandatory binding arbitration clauses force patients and families to give up their rights to seek justice in court even if a resident is severely injured or killed in the care of a nursing home facility. More and more nursing home corporations are using forced arbitration clauses as a way to avoid accountability.
Gladys Mensing was prescribed Reglan in 2001 to treat stomach issues, diabetic gastroparesis. The pharmacist filled her prescription with the generic metoclopramide. Gladys took the drug for four years, causing her to develop tardive dyskinesia, a severe, irreversible neurological disorder. In 2009, the FDA ordered all manufacturers of Reglan and the generic to add a “Black Box” warning about the increased risk of tardive dyskinesia from long-term metoclopramide use. In 2010, the Supreme Court ruled Gladys was not entitled to be compensated for the injuries she suffered because the pharmacist gave her the generic drug and not the brand because the generic manufacturer only had to follow the brand drug’s label. Generic and brand manufacturers should be required to protect patients and adequately warn ALL prescription drug users of adverse risks.
Forrest Heaney was only 18 when he needed a hip replacement from a football injury. He thought he was getting the latest and greatest model, a DePuy ASR hip implant, a hip made of metal-on-metal. It wasn’t long after the implant when Forrest began experiencing extreme pain and had difficulty with simple daily living activities. It was then he learned his hip had been recalled. The latest and greatest hip was causing metallic ions to enter his bloodstream. Forrest was tested and found to have excessive levels of chromium and cobalt in his blood stream. As the FDA looks to revise its approval process of medical devices, patient safety should be at the forefront of the debate, not a push to rush untested medical devices to the market.

Myth: The number of lawsuits filed is skyrocketing.

The number of tort (personal injury) cases has been declining for years. According to the National Center for State Courts, tort cases accounted for just 4.4 percent of all civil cases filed in 2008, and declined by 25 percent between 1999 and 2008. Tort filings in state courts decreased by six percent between 2007 and 2008.

According to the Justice Department under President George W. Bush, the number of federal tort cases resolved in U.S. District Courts fell by 79 percent between 1985 and 2003. In 1985, 3,600 tort trials were decided by a judge or jury in U.S. District Courts. By 2003, that number had dropped to less than 800.1

Additionally, the most recent statistics from the Administration’s Bureau of Justice Statistics show the number of tort trials at the state level has decreased. These statistics were compiled as part of the Bureau’s survey of state civil justice systems in the nation’s largest 75 counties. Among these counties, the number of tort trials decreased 31.8 percent between 1992 and 2001. 2

Myth: Health care costs are rising and doctors are unable to practice due to litigation.

Health care costs are rising; however, medical malpractice litigation has nothing to do with it. According to the Congressional Budget Office, medical malpractice amounted to less than 2 percent of overall health care spending.3 The Government Accountability Office also found that malpractice cases have not widely affected access to health care. 4

According to the American Medical Association, the overall number of physicians is up more than 40 percent since 19905, while over the same time, the U.S. population increased by only 18 percent .6 The number of emergency physicians, neurosurgeons, and OB/GYNs has also increased significantly over the same time period.

Myth: Legal reform is needed because lawsuits hurt small businesses.

Wrong. Multiple surveys have shown that lawsuits are not a concern for small business owners. A survey from the National Association of Manufacturers suggests that “lawsuit abuse” ranks at the bottom of concerns for manufacturers.7 A 2008 survey from National Federation of Independent Business had similar results, with “costs and frequency of lawsuits / threatened suits” ranking 65th on a list of small business owners’ worries. 8

In reality, only big corporations and their front groups want to destroy the legal system so they can’t be held accountable for negligence and misconduct. Drug, oil, and insurance companies have tried to hide behind small business owners to accomplish this; however, these surveys reveal their true intentions.

Myth: Trial attorneys are trying to drive corporations out of business.

Absolutely not. Corporations, large and small, are all entitled to have profitable businesses. Most do so without being negligent or engaging in misconduct.

A strong civil justice system allows deserving individuals to get justice and hold wrongdoers accountable. Civil justice attorneys work to make sure all people have a fair chance through the legal system – even when it means taking on the most powerful corporations.

Myth: Lawsuits are out of control. Someone even sued because they spilled hot coffee on their lap!

Those looking to destroy the civil justice have continually mocked Stella Liebeck and the McDonald’s coffee case. Unfortunately, the actual facts of this case make it no laughing matter.

Ms. Liebeck’s injuries include third degree burns—the most severe—to her groin, inner thighs, and buttocks. She was hospitalized for eight days, during which time she underwent skin grafting and debridement treatments (the surgical removal of tissue).

Ms. Liebeck sought to settle her claim with McDonald’s for $20,000, but they refused. McDonald’s eventually produced documents showing more than 700 claims by people burned by its coffee between 1982 and 1993, some involving third degree burns similar to Ms. Liebeck. This history documented McDonald’s knowledge about the extent and nature of this hazard. McDonald’s own quality assurance manager testified that a burn hazard exists with any food served above 140 degrees; their coffee was kept warm at 185 degrees.

A jury awarded Ms. Liebeck $200,000 in compensatory damages, but reduced it to $160,000 because they found her 20 percent at fault for the spill. The jury also awarded her $2.7 million in punitive damages, equal to two days of McDonald’s coffee sales. This was eventually reduced to $480,000, even though the judge called McDonald’s conduct reckless, callous, and willful. Jurors expressed similar sentiments in interviews after the trial. Ms. Liebeck and McDonald’s eventually entered a post-verdict settlement.

Myth: Trial attorneys are charging outrageous hourly fees and leave victims with nothing if they win.

Civil justice attorneys do not charge by the hour like most other attorneys. Instead, their clients pay on what is called a “contingency fee basis.”

For over 200 years the contingency fee system has provided Americans who must go to court with a degree of access to justice that is unheard of in most other countries. Our system allows people who cannot afford to pay legal fees to obtain representation on a contingency fee basis. In personal injury and death cases, and in certain other types of litigation, the fee is based on a percentage of any money damages that are recovered.

Myth: My insurance rates are skyrocketing because of lawsuits.

Your insurance premiums may be going up, but it has nothing to do with lawsuits. Look no further than the insurance industry’s annual profit reporting. In 2007, insurance companies reported a near-record profit of $61.9 billion. In comparison, the insurance industry’s 2004 profit was $38.7 billion, which broke all previous records. Their profits continue to rise, and unfortunately, your premiums are following suit.

The insurance industry has also made the argument that awards and damages should be limited; however, have later admitted that caps will not lower premiums. For example, American Insurance Association spokesman Dennis Kelly told the Chicago Tribune in 2005 that, “We have not promised price reductions with tort reform.”

Myth: Lawsuits cost taxpayers X hundreds of dollars each year.

Several so-called “independent” think tanks or organizations have devised the notion that American families pay a yearly “tort tax,” or that the cost of litigation is passed on to taxpayers. These organizations, funded by oil, drug, tobacco, and insurance companies, produce studies that are a prime example of junk science. There is no methodology or academic basis for their results. Trying to pass off these organizations and their studies as legitimate is yet another scheme by corporations to avoid accountability in the courtroom and stack the deck against every day Americans.

Towers Perrin’s “tort cost” study has also been widely rejected. Read more »

Myth: Schools are cancelling recess because they are afraid of litigation.

Wrong. School districts across the country are almost universal in blaming the elimination of recess on the need to meet requirements for teaching and testing hours.9

Myth: People aren’t volunteering to help with Little League, Boy / Girl Scouts, etc., because they are afraid of lawsuits.

Wrong again. Similar to the previous myth, these lies are peddled by groups interested in destroying the civil justice system.

The Volunteer Protection Act of 1997 was passed to provide immunity for volunteers of nonprofits in the course of their charity work.

Sources:

1. “Federal Tort Trials and Verdicts, 2002-03”, Bureau of Justice Statistics, 8/17/05

2. “Civil Trial Cases and Verdicts in Large Counties, 2001”, Bureau of Justice Statistics, 4/04

3. “Congressional Budget Office, “Limiting Tort Liability for Medical Malpractice,” 1/08/04

4. “Medical Malpractice: Implications of Rising Premiums on Access to Health Care,” GAO, 9/29/03, www.gao.gov/cgi-bin/getrpt?GAO-03-836

5. “Physician Characteristics and Distribution in the U.S.,” American Medical Association, 2006 edition, p.312

6. U.S. Census Bureau data: http://factfinder.census.gov/servlet/SAFFPopulation?_submenuId=population_0&_sse=on; http://factfinder.census.gov/servlet/DTTable?_bm=y&-geo_id=01000US&-ds_name=PEP_2005_EST&-mt_name=PEP_2005_EST_G2005_T001

7. “National Manufacturing Week 2006 Annual Survey Results,” National Association of Manufacturers, http://www.nam.org/s_nam/doc1.asp?CID=6&DID=236617

8. “Small Business Problems and Priorities,” National Federation of Independent Business, http://www.nfib.com/object/2008problemspriorities.html

9. http://www.washingtonpost.com/wp-dyn/content/article/2006/05/31/AR2006053101949_pf.html;
http://seattlepi.nwsource.com/local/191407_recess18.html; http://online.wsj.com/public/article/SB116044203663787613-OWTfLOXAilkTcNPcqP3tS75OWcE_20061108.html?mod=tff_main_tff_top

For more information contact the lawyers of Raslont, Pope & Diehl, LLC.

A few days ago the U.S. Supreme Court ruled against plaintiff Gloria Kurns in Kurns v. Railroad Friction Products Crop. Gloria is the widow of retired railroad worker George Corson who died of mesothelioma after years of service for Railroad Friction Products as a welder, machinist and supervisor.

The Court held that the Locomotive Inspection Act trumps state laws requiring specific product warnings intended to protect workers and consumers. Manufacturers should be held responsible for knowingly exposing their workers and families to deadly asbestos, a product still legal in the U.S.

The Center for Constitutional Litigation wrote a brief on behalf of AAJ arguing:

“[the]right to legal remedy for wrongful injury is a fundamental right under the Constitution, courts may not preempt such a cause of action and leave injured persons without remedy unless Congress specifically intended…”

Asbestos exposure has been known to cause mesothelioma for over 60 years, but corporations continued to expose their workers without adequate protections.

Learn more about the case from AAJ’s amicus curiae brief filed in support of Gloria Kurns. visit http://www.americanbar.org/content/dam/aba/publishing/previewbriefs/Other_Brief_Updates/10-879_petitioner_amcu_aaj.authcheckdam.pdf for more information.