It seems that in every political election, one candidate talks about the need for “Tort Reform.” Sometimes, it is framed as a “us” against “them” issue. Others seek to blame the lawyers, blame the insurance companies, blame careless doctors or blame greedy and irresponsible corporations. However, the concept itself is rarely and never fully, explained.

This leaves us with the question: What is this talk of “Tort Reform” all about?

The best way to explain the concept is to break the phrase down into its respective parts.

What is a tort? Formally, a tort is a civil wrong which can be redressed by awarding damages. Torts are non-criminal, civil cases where an act, intentionally or otherwise caused an injury. This injury can be physical, mental and/or monetary. When this tort is committed, the injured party has the right to sue the wrongdoer for damages. Examples include medical malpractice, assault, negligence, workers compensation, and product liability.

Since torts cover varying types of civil actions, tort reform can be focused on one particular area of wrongdoing, or across-the-board attempts to limit the ability of people who are harmed to obtain full redress in the Courts. The tools that advocates of tort reform use include procedural limits on the ability to file claims and caps (or limits) on the damages that a plaintiff can recover in court.

For example, Florida places a cap on the amount of non-economic damages claimants may recover. Non-economic damages include things like pain & suffering, mental anguish, and, in general, anything you do not have a fixed bill for.

“If the negligence resulted in a permanent vegetative state or death, the total non-economic damages recoverable from all practitioners, regardless of the number of claimants, under this paragraph shall not exceed $1 million."

While this cap exists, the Florida Supreme Court in March 2014 struck down this legislative cap in wrongful death cases, even though they had previously held it did not violate the Equal Protection Clause of the United States Constitution. Justice Pariente stated there was no “rational relationship” between the cap and any benefit to physicians or patients, and ultimately, “only the insurance companies benefit in the form of an increase in profits.”

Not all states have caps on damages in medical malpractice cases. States that do not are Alabama, Arizona, Arkansas, Connecticut, Delaware, District of Columbia, Iowa, Kentucky, Minnesota, New Hampshire, New York, Pennsylvania (however, punitive damages are capped), Rhode Island, Vermont, Washington, and Wyoming.

Proponents of tort reform claim that through tort reform, frivolous lawsuits will be reduced and consequently lead to reduction in insurance and healthcare costs. They claim that medical malpractice lawsuits are making it difficult for doctors to make a good living.

Opponents of tort reform claim that the “fear tactics” of the tort reform movement are not supported by the facts. In 2012, the Institute of Medicine of the National Academies reported that one-third of hospitalized patients are harmed during their stay. In the Institute’s landmark study on hospital patient safety, To Err is Human found that nationwide up to 98,000 patients die from medical errors per year.

According to the National Association of Insurance Commissioners, the total amount spent defending medical malpractice claims and compensating victims is $7.1 billion annually – just 0.3 percent of America’s $2.2 trillion in overall healthcare spending. Meanwhile, the real driver of healthcare costs are preventable medical errors, which are responsible for an additional – and unnecessary – cost of $29 billion annually. So, is this a battle of facts or just a powerplay by the medical community to reduce their financial responsibility for the malpractice caused by careless doctors? It is clear that this is a complicated issue; otherwise it would have been resolved long ago. Ultimately, your viewpoint on tort reform is likely to be shaped by whether or not you and/or someone you know have been affected by a serious medical error which resulted in a life altering condition or death. It seems that many people are for tort reform – until they are the victim of negligence.

It is important to stay educated and aware of “tort reform”, so you can better understand the ways it may affect you now and in the future.

At Jacoby & Meyers, we hope you never find yourself the victim of medical negligence, a car accident or any other preventable injury. However, if you are the victim of such negligence, please contact an experienced personal injury attorney affiliated with Jacoby & Meyers for a free case evaluation.

Alexandra Bhatti, student intern Jacoby & Meyers.

The recent outbreak of measles has brought the question of responsibility to vaccinate to the forefront of the issue. When parents choose not to vaccinate their child, should they be held liable if their child gets a preventable disease and passes it to others who get infected? There has been a strong response by leaders in the legal community who believe such liability is fair and makes sense.

Currently, all 50 states and U.S. territories, as well as the District of Columbia, have requirements for the MMR vaccination. Some states allow exemption for personal or religious beliefs. There are a large and growing number of individuals that adhere to a non-vaccination belief based on a multitude of reasons. The responses from this group to the possibility of liability for harm caused by non-vaccination have included, “if your child is vaccinated, why would my non-vaccinated child present a danger?” The answer to that question is “More than 95% of the people who receive a single dose of MMR will develop immunity to all 3 viruses. A second vaccine dose gives immunity to almost all of those who did not respond to the first dose.” That is not 100%.

The legal argument for criminal or civil liability is an interesting one and, of course, has two sides. In 2013, Arthur L. Caplan, et al., published an article in the Journal of Law, Medicine & Ethics proposing the basis for a claim of negligence for non-vaccination. The article reviews the necessary elements needed to establish a case for civil negligence. The elements include the need to establish that the person who caused the harm were required to conduct themselves in a manner that would not put others at risk (Have their child vaccinated). The person did not conform to the requirement (they did not have their child vaccinated). The non-conformity directly caused the harm (another child acquired the disease from their exposure to the non-vaccinated child). The non-conformity “proximately” caused the injury (the parent knew or should have known they were putting others at risk). The complaining party was harmed (cost of medical care, long-term disability or death).

On the other side of this legal debate, the non-vaccinating community believe that they should be immune from liability because of the various waivers that allow them to enroll their children in school or acquire an exemption from state vaccination requirements. Ultimately, this is an issue that the Court or State Legislatures will have to decide.

For example, the United States District Court For the Northern District of Ohio ruled in 2012 “that a parent’s refusal to vaccinate her children against diseases is not a “free exercise” of religion, and is tantamount to neglect.” The court went on to hold that, “although some states have chosen to provide a religious exemption from compulsory immunization, a state need not do so.” In Sherr v. Northport–East Northport Union Free Sch. Dist. (1987), a New York court stated that (“[I]t has been settled law for many years that claims of religious freedom must give way [to] the compelling interest of society in fighting … contagious diseases through mandatory inoculation programs.”).

This debate is not new, and the recent measles outbreak may see victims seeking recovery for harm caused by non-vaccinators. It is yet to be seen how the Courts will rule in this constantly evolving and emotionally charged issue.

Toni Zeller Kohlbeck, student intern-Jacoby & Meyers.

Electronic Cigarettes (E-cigarettes) are battery-powered devices that turn liquid nicotine into a vapor that you inhale; many of these look like real cigarettes. For some smokers, electronic cigarettes may satisfy nicotine cravings. They can be used in nonsmoking areas and they may have less of the harmful chemicals that are in cigarette smoke. But they do contain small amounts of harmful chemicals.

There was a study published by British researchers indicated that the use of e-cigarettes could assist in smoking cessation. For those wishing to quit the harmful habit this was brilliant news. The study found that those who wanted to quit smoking were 60% more likely to succeed if they used an e-cigarette as opposed to the patch or gum. But is this traditional cigarette alternative actually being well received in the community? Is it actually lowering the number of people who smoke traditional cigarettes?

Research indicates that while this was thought to be a way to reduce smoking, it has had no significant effect on decreasing smoking rates. Additionally there are growing concerns on the safety of e-cigarettes as well as the possibility that the e-cigarette is actually a gateway to introduce nonsmokers to smoking.

For these reasons the organizations and groups such as American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects.

In April 2014, the FDA (Food and Drug Administration) proposed a “deeming rule”, which was basically a blueprint for a regulatory framework for e-cigarettes. This proposal includes provisions such as a ban on sale to minors and a requirement to disclose ingredients.

The FDA said it expects to publish a final rule in June 2015. The FDA said in a statement it needed “ample time to fully review and analyze these issues.” It said the subject involved “complicated rulemaking.” Meanwhile, U.S. e-cigarette sales topped $2.5 billion at retail last year and are expected to surpass $3.5 billion this year.

States have begun to propose regulations regarding e-cigarettes. Over 60 bills designed to rein in the “vape” industry are being considered in 21 state legislatures from Oregon to Virginia. Wednesday, January 28, 2015, California declared e-cigarettes a health threat and issued a 21-page report warning young people could become nicotine addicts if lawmakers don’t step in to regulate the fast-growing industry soon.

Ultimately, we must wait until June to see what the FDA decides but it is clear that while there are benefits to the use of e-cigarettes to assist in smoking cessation, there are growing concerns on whether the benefits outweigh the known and unknown risks of its use. The Centers for Disease Control and Prevention last year, reported that more than 250,000 youths who had never smoked a cigarette used e-cigarettes in 2013. This number reflects a three-fold increase, from about 79,000 in 2011, to more than 263,000 in 2013.

Alexandra Bhatti, student intern Jacoby & Meyers.

Older adults who use Xanax or other benzodiazepines may be increasing their risk of developing Alzheimer’s, according to a recent study published in the British Medical Journal (BMJ). Alzheimer’s is a chronic neurodegenerative disease that is reportedly the most common cause of dementia. Taking into account the broad impact of dementia as “the main cause of dependency in older people and a major public health concern,” as well as the prevalence of use among elderly populations ranging “from 7% to 43%” in developed countries, the study explored the possible link between the use of benzodiazepines and developing Alzheimers. The findings of the study fall in line with a 2012 report by the same researchers which suggested a link between taking anti-anxiety medications from the same class of drugs and developing dementia.

Xanax (alprazolam) is a medication prescribed to treat anxiety disorders, panic disorders, and insomnia. It is a member of the benzodiazepines class of drugs which also includes Valium.

The study, which included 8,980 elderly people over the age of 66, focused on 1,796 people already diagnosed with Alzheimer’s over a six year period and compared them with 7,184 control subjects. The participants were selected randomly among older people living in Quebec, Canada who were also members of the public drug plan from January 1, 2000 to December 31, 2009. Data was collected from an administrative claims database for prescription and medical services records.

The study found that among those patients who had used benzodiazepines in the past, the risk of Alzheimer’s was increased by 43-51%. In addition, the findings suggested that the greater the use and also the use of more “long acting” benzodiazepines further increased the risk.

While the study does not conclusively rule out other possible contributing factors in developing Alzheimer’s, it does show a “dose-effect” relation between using drugs like Xanax and an increased risk in Alzheimer’s disease in older patients whose treatment last for more than three months. Based on the findings of the study the researchers conclude that in accord with already established guidelines, use of these drugs should not last more than three months. Nevertheless, as the study notes, these findings should raise public health concerns especially for older patients who use drugs like Xanax chronically or in large doses.

Zachary Mayberry, student intern Jacoby and Meyers.

The daughter of a Tennessee woman who bled to death after using Xarelto, has filed a lawsuit on her mother’s behalf against JANSEN RESEARCH AND DEVELOPMENT LLC, the makers of the drug in the United States. The lawsuit asserts that Jansen failed to adequately warn of the dangerous bleeding that could occur as a result of using Xarelto. According to court documents, the decedent started using Xarelto in October 2013 and suffered two “life threatening bleedings” between November and December 2013 which “eventually led to her death” in March 2014.

Xarelto (Rivaroxaban) is an anticoagulant (blood thinner) that is prescribed to prevent and treat blood clots. It is typically used to treat a type of blood clot known as deep vein thrombosis (DVT) which can occur after certain types of surgery, including knee and hip replacements. Xarelto is also prescribed to lower the risk of stroke for people with atrial fibrillation, “an irregular (and often) rapid heart rate” that causes poor blood circulation. One of the most dangerous side effects associated with Xarelto is a risk of bleeding. People who take the drug are likely to bruise more easily and it may take longer for bleeding to stop. Taking Xarelto with other medications such as aspirin may increase the risk even more.

According to the lawsuit Xarelto’s boxed warning did not adequately address the increased risk of bleeding especially when taken in light of the findings of a clinical trial sponsored by the drug’s manufacturer that noted that in comparison to warfarin, a similar drug, “patients taking Xarelto have more gastrointestinal bleeds and need more transfusions.” In addition the complaint, citing a report by the Institute for Safe Medication Practices, asserts that the most “adverse event” related to using the drug was not the risk of bleeding but pulmonary embolism, a condition where a blood clot generally travels from the legs and causes a blockage in the arteries of the lungs. Ironically, this is a condition that Xarelto is intended to prevent.

The lawsuit also asserts that in spite of this knowledge, Jansen continues to market Xarelto without adequate warning. At present Xarelto does not include a FDA black box warning (the strongest warning required by the FDA) describing the irreversible bleeding related to using the drug, which effectively deprives doctors of critical information in prescribing the drug when could have deadly implications for consumers.
According to the complaint, Jansen’s failure to warn of the severity of the most dangerous side effects of using Xarelto resulted in the death of Emily Pigg, the mother of the plaintiff bringing the lawsuit. Ms. Pigg’s physician prescribed the drug for atrial fibrillation and after using it “suffered a hemorrhagic stroke and internal bleedings in November 2013 and in December 2013.” The complaint further alleges that she was not able to recover and as a result she succumbed to her injuries in March 2014.

If you use or have used Xarelto and have suffered any of the serious side effects discussed here, you may be entitled to compensation for your injuries. The attorneys at Jacoby & Meyers are qualified to assist you in evaluating your case. An attorney experienced in Xarelto litigation can help you file your lawsuit and protect your rights within the statute of limitations allowed by the law.

Please contact our defective drug lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.

The Center for Disease Control (CDC) reports elevated flu activity for the 2014- 2015 flu season.

The three strains of flu, that are common are:

• Influenza A (H1N1) viruses
• Influenza A (H3N2) viruses
• Influenza B viruses

Influenza A (H3N2) virus is the predominant strain reported this year and is associated with higher mortality rates than Influenza B (H1N1). Death rates from influenza are higher in young children and adults over 65 years of age. Reports indicate that half the country is experiencing elevated flu activity. “Flu season” varies year to year but most typically begins in December, with some periods reported as commencing as early as October. The current flu season is considered to have begun in December.

Typically an annual pattern for flu shows Influenza Like Illness (ILI) increasing first, with increased hospitalization and increased death rates following in order. This year’s statistics follow that pattern. Flu caused death statistics collected by the Center for Health Statistics are considered incomplete and depressed. Several factors contribute to this including the significant numbers of deaths, deaths listed under a different cause because no flu testing was completed, and deaths that occurred due to secondary conditions that are complicated by flu.

Flu viruses change which cause vaccinations to be less effective against a new strain. The 2014-2015 vaccination, called a trivalent vaccine, was developed to prevent 3 strains of influenza:

• A/California/7/2009 (H1N1)pdm09-like virus
• A/Texas/50/2012 (H3N2)-like virus
• B/Massachusetts/2/2012-like virus

Some of the vaccinations developed for this season also protect against an additional B virus (B/Brisbane/60/2008-like virus); this is called a quadrivalent vaccine. Vaccination does not always prevent the flu.

Many factors contribute to the effectiveness or lack thereof, of vaccinations including age, pre-existing health conditions, changes to the virus, and timing of immunization, to name a few. There are indicators that this year’s vaccine is not highly effective against the predominant strains in circulation this year.

It is possible for children 6 months to 8 years of age to need two doses of vaccination administered four months apart. “Starting in 2014-2015, CDC recommends use of the nasal spray vaccine (LAIV) for healthy children 2 through 8 years of age, when it is immediately available and if the child has no contraindications or precautions to that vaccine. Recent studies suggest that the nasal spray flu vaccine may work better than the flu shot in younger children. However, if the nasal spray vaccine is not immediately available and the flu shot is, children 2 years through 8 years old should get the flu shot.”

There are treatments for the flu, including the new FDA approved drug Rapivab. Antiviral drugs are used to treat flu and prevent serious complications from the flu. The CDC recommends that annual vaccination be combined with daily preventative measures such as washing hands and avoiding contact with others that are sick. Though it is recommended that vaccination be sought as early as October, it is not too late in the season to be vaccinated and protected against acquiring the flu. A flu season can last until May.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.

Viagra (Sildenafil), the popular drug prescribed to treat erectile dysfunction in men, has been associated with an increased risk of skin cancer according to a Harvard School of Public Health study published in JAMA Internal Medicine in April 2014. The study, which began in 2000, involved 25,848 health professionals who used Viagra and excluded participants who reported having cancer at the start of the study. The study found that men who use Viagra are 84% more likely to develop melanoma, the most deadly form of skin cancer. While the study was only preliminary and not sufficient “to alter clinical recommendations,” the findings support a concern that users of Viagra are more susceptible to developing the disease.

Melanoma is caused when the DNA of skin cells (melanocytes) is damaged and unrepaired as the result of intense or occasional ultraviolet exposure (usually from the sun or overexposure in tanning beds) occurring especially in demographics of the population genetically predisposed to this exposure. Signs of melanoma usually appear in the form of an unusual growth on the skin or a change in an existing mole such as discoloration. Melanoma can even appear in areas of the skin that are not normally prone to UV exposure. Traditional risk factors for developing melanoma include UV exposure, fair skin, freckling, light hair, family history of melanoma, age, and gender. Men over 40 have a higher rate of melanoma, while women under 40 have a higher rate of melanoma occurrence.

In December 2014, Edward Corboy Jr. of Illinois filed a lawsuit against Pfizer, the makers of Viagra, claiming that the drug company failed to adequately warn that using Viagra substantially increases the risk of developing skin cancer. Corboy asserts that he was prescribed and began using Viagra in 2008 to treat erectile dysfunction. In December 2012, the plaintiff saw a doctor who noticed a mole on his neck. A subsequent biopsy determined that the mole was a melanoma. The complaint asserts that Pfizer knew or should have known of the increased risk of developing melanoma when using the drug and failed to warn “doctors who prescribed or patients who were prescribed” the drug of this risk. Citing the April 2014 JAMA study, Corboy states that he did not discover the connection between his use of Viagra and subsequent development of melanoma until the study was published. Given that the authors of the study admitted that the findings were not conclusive and more research is necessary, Corboy will likely need more information in order to demonstrate a causal connection between the use of Viagra and the increased risk of skin cancer. In addition to negligence claims, the complaint also includes claims of strict liability, fraudulent concealment, and unjust enrichment.

If you have used Viagra and subsequently developed melanoma you may be entitled to compensation for your injuries. Call 800-977-5614 to speak to a Jacoby & Meyers attorney today.

Zachary Mayberry, student intern Jacoby & Meyers.

Effexor (venlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) manufactured by Wyeth that is prescribed to treat long and short-term depression and anxiety. Effexor was brought into the market in 1993. Pfizer acquired Wyeth in 2009.

There are several side-effects associated with the use of Effexor. One side effect that is the subject of a multidistrict ligation is regarding its effect if taken during pregnancy. Effexor is shown to cause serious birth defects if taken while a mother is pregnant.

In August 2013, the United States Judicial Panel on Multidistrict Litigation grouped nine class actions in Pennsylvania. U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania, is presiding over the cases. The panel believed she is best suited to hear the case since she is already hearing multidistrict litigation (MDL) with parallel claims involving Wyeth and Pfizer over Zoloft’s alleged links to birth defects.

Plaintiffs allege that before Wyeth and Pfizer began selling Effexor on the market, they knew its use during pregnancy increased risk that children exposed to the drug in utero would be born with serious birth defects. Furthermore, they allege that the defendants did not warn mothers or the medical community of the known risks and actively misrepresented the safety of Effexor.

On September 29, 2014, Judge Rufe issued a case management order which would allow any plaintiff whose case would be subject to transfer to the MDL proceedings the ability to file his or her case directly to the United States Court in the Eastern District of Pennsylvania. This was done to eliminate any delays associated with the transfer to the District Court. In order to qualify for direct filing, the lawsuit must be a “single-plaintiff complaint”, involving only one child injured by exposure to Effexor.

There are currently nearly 70 Effexor cases pending in the MDL. November 18, 2014 Judge Rufe directed that 14 bellwether cases undergo discover and the process of setting the cases for trial. The plaintiffs’ bellwether selections were to have be made before Christmas and Pfizer’s due late January 2015. Of the 14 selections, only 12 will ultimately proceed to trial first since each side will be allowed to strike one case from the other’s bellwether list. Trial is expected to begin by winter 2015.

Have you or a loved one used Effexor during pregnancy and delivered a child with birth defects? If so, contact experienced Jacoby & Meyers to speak with an experience dangerous drug attorney who are dedicated to recovering compensation for affected families. For more information, contact us today.

Alexandra Bhatti, student intern Jacoby & Meyers.

The Decisions

In 2011, the Supreme Court’s decision in Pliva Inc. v. Mensing held that in state courts, generic-drug manufacturers could not be held liable for failing to inform the Federal Drug Administration (FDA) when its label inadequately warns consumers of health risks. Pliva claimed that it was impossible for generic drug manufacturers to simultaneously adhere to state and federal law because federal law requires generic labels to be identical to labels approved for the name brand. As a result, Pliva stated that unilaterally strengthening the warning on the generic label to avoid state law liability would violate federal law requiring identical labels. This decision renders states unable to make generic drug makers responsible for the harm their products inflict on those that use them. This ruling impacts millions of individuals in the U.S., because generic drugs make up 75% of the prescription drug market.

In the recent Supreme Court of Alabama decision Wyeth v. Weeks, the Alabama court held that the plaintiffs can seek damages against the brand name manufacturers of the same generic drug that caused their harm, based on a theory of civil liability known as “innovator liability.”

The History

In an attempt to decrease the cost of prescription drugs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984. This act enables generic drug manufacturers to produce drugs without the cost of development, research, and trials required of the brand name manufacturers before approval by the FDA. This act afforded the generic manufacturers to sell their product at a lower cost making prescription drugs more affordable to the general public. The law required that the drug be an exact duplicate of the brand name drugs and that their labels, including their warnings, replicate those of the brand name drug being copied. The restrictions placed on the generic drug manufacturers included the inability to alter their warning labels unless the brand name manufacturer changed its label.

The Cases

In Pliva, each plaintiff filed the equivalent of a failure to warn case against the generic drug manufacturers, Pliva, Inc. and Activus, Inc., in the Minnesota and Louisiana state courts. The plaintiffs won their cases at the state level under state law.

The manufacturers appealed to the Supreme Court. The manufacturers argued federal law does not allow the generic labels to be altered unless the brand name label does so first. The state law requires the generic labels to warn of side effects of the drugs that they knew or should have known could cause harm. The Court ruled in favor of the manufacturers on their “impossibility” defense. Simply put, they could not follow the state law without breaking the federal law. In its decision, the Court cited the Supremacy Clause, which declares that any state law that is in opposition to a federal law is rendered ineffective.

In Wyeth v. Weeks, the Alabama Supreme Court held that brand name drug manufacturers may be held liable for the generic manufacturer’s failure to warn. Wyeth argued that since they had no actual “dealings” with the Weeks, they were not responsible to them for the harm caused by the generic prescription that harmed them.

The court decision used the element of tort law that requires liability for injury if the defendant could reasonably foresee that their negligent behavior may harm a third party. Wyeth should have expected physicians would rely on its label when making decisions to prescribe the drug.

The decision in Weeks cited Conte v. Wyeth, Inc. In this decision, a California court ruled Wyeth, the brand name manufacturer of Reglan, could be held liable for injuries which were reasonably foreseeable due to intentional misrepresentation by the brand name manufacturer of the drug. Also cited in the Weeks decision was a Vermont case, Kellogg v. Wyeth, which also found Wyeth liable for harm to the plaintiff in that case even though the plaintiff had only used the generic form of the drug Reglan or metoclopramide.

The Future

The FDA confirms the “sameness” requirement of generic labels to their brand name counterparts. The agency also clarified that it prohibits changes to generic labels unless the brand name label is changed first. Though generic drug manufacturers have eluded liability under the impossibility defense of tort law, it may be that some state courts are opening the door for compensation of harm to consumers. The courts have possibly created a new avenue for those injured by drug manufacturers negligence to have their day in court by allowing third party liability cases against name brand manufacturers.

Experienced Dangerous Drug Representation

If you or a loved one has suffered an injury due to taking a dangerous prescription drug, the attorneys at Jacoby & Meyers can help you receive compensation for your damages. We have the resources of a national law firm, and we have the skills and experience needed to battle the high powered legal teams of large pharmaceutical companies. Our lawyers can review the facts of your case to determine whether you have a valid defective drug claim.

Please contact our defective drug lawyers today to schedule your free initial consultation.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.

Several plaintiffs have joined together in a lawsuit filed against Eli Lilly, manufacturer of the popular anti-depressant Cymbalta (duloxetine). The complaint alleges plaintiffs suffered damages as a result of Eli Lilly’s failure to warn of symptoms experienced from Cymbalta withdrawal.

Cymbalta is a drug prescribed to treat depression, anxiety and other mood disorders. It is also used to treat nerve pain stemming from peripheral neuropathy in people with diabetes, and pain associated with conditions such as arthritis. It belongs to a sub class of anti-depressants known as serotonin-norepinephrine reuptake inhibitors. Cymbalta helps to increase naturally occurring substances in the brain such as serotonin, a neurotransmitter associated with happiness and well-being, and norepinephrine, associated with sustained concentration.

Approved by the FDA in 2004, the complaints assert that Eli Lilly “aggressively marketed” the drug to the general public and medical community, but failed to include adequate warnings describing the “frequency, severity, and/or duration of Cymbalta withdrawal.”

Assertions that Eli Lilly defectively designed Cymbalta pills by making them only available in delayed released capsules, with “beads” available only in 20, 30, and 60 mg doses. Accompanying instructions on Cymbalta packages advise users to only use the drug in the whole capsule form without providing any alternative dosages and prevented users from gradually tapering off of Cymbalta, as the instructions also advised.

The withdrawal symptoms associated with Cymbalta are not related to a patients pre-existing conditions, but rather the drug’s half-life. The effect of Cymbalta’s short half-life is a higher risk of withdrawal of symptoms. This condition is known as Cymbalta Discontinuation Syndrome. Lawsuit complaints assert that although Eli Lilly knew of the condition citing “a January 2005 article in the Journal of Affective Disorders,” which noted “that 44.3% and 50% of Cymbalta patients suffered from” these withdrawal effects, Lilly omitted this information instead marketing the occurrence as rare “stating that certain symptoms are experienced at a rate of 1% /2% or greater.

Rachel Anne Ben, a woman from Sacramento, California, alleges that she experienced dangerous withdrawal symptoms including “extreme mood swings, agitation and irritability, electric shock-like sensations in her head, nightmares, sleep disturbance, vertigo, dizziness and suicidal thoughts” upon trying to discontinue her use of Cymbalta. The complaint asserts that if Eli Lilly had “adequately and properly warned” of the symptoms associated with Cymbalta withdrawal, her physicians would not have prescribed the drug to her, and the injuries she sustained could have undoubtedly been prevented.

This lawsuit is only one of many lawsuits filed against Eli Lilly due to Cymbalta Discontinuation Syndrome.

Whether you were harmed by Cymbalta or any dangerous drug, you can rely on the skills and experience of Jacoby & Meyers lawyers for effective representation. To learn more about how we may be of service to you, please contact us today to arrange a free consultation and case evaluation.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.