Increased Attention to “Death with Dignity” after Brittany Maynard’s Death

In light of the recent death of Brittany Maynard, much attention has been directed toward Death with Dignity laws. Brittany Maynard was diagnosed in January with an aggressive terminal brain cancer, and doctors give her six more months to live. She was living in California at the time and decided to move to Oregon take advantage of the state’s Death with Dignity Act. She then became a vocal advocate for Death with Dignity laws and utilized social media to share her story with the world.

More than 20 years ago, Oregon voters passed the first Death with Dignity policy reform proposal. The act permits capable Oregon adult residents to make a written request for medication for the purpose of ending his or her life in a humane and dignified manner. The statute requires that an attending physician and consulting physician determine that the adult is suffering from a terminal disease and that the adult had voluntarily expressed his or her wish to die. In reviewing 15 years of data from Oregon, about 44 people each year have taken advantage of the Death with Dignity law.

Since then, Washington and Vermont have also developed Death with Dignity laws that allow mentally competent, terminally-ill adult state residents to voluntarily request and receive prescription medication to hasten their death.

The Death with Dignity Laws remain controversial, with the “battles” taking place in the courts and the State Legislatures. For in December 2009, the Montana Supreme Court ruled end-of-life care is not prohibited by state law. Four years later, a bill was introduced to Montana legislature regarding Death with Dignity, but it got stalled in the Senate Judiciary Committee, which tabled the bill.

Those who support Death with Dignity laws believe that a competent, terminally ill adult, with a prognosis of six months or less to live should be allowed to die with “dignity”and avoid a painful and difficult death. There have been two notable polls that suggest that the majority of adults in the United States support Death with Dignity for terminally ill patients. In 2011, a Harris poll that surveyed over 25,000 adults revealed that 70% of those in the survey agreed that people who are terminally ill, in great pain, and who have no chance of recovery should have the right to choose to end their lives. Likewise, in 2014, a Gallup poll revealed interesting results depending on how the question was posed. 58% of Americans support “physician-assisted suicide” while 69% of Americans believe “doctors should be allowed by law to end the patient’s life by some painless means.”

While polls suggest that 70% of Americans support the concept of Death with Dignity laws, the majority of states have not enacted such laws because of legal complexities and religious, ethical and moral objections. The Catholic Church in particular has expressly stated its opposition to physician-assisted suicide. Furthermore, there are fears of loopholes within the Death with Dignity laws that fail to protect the patient from coercion and abuse by others.

A disability rights organization called Not Dead Yet views assisted suicide and euthanasia as deadly forms of discrimination against old, ill and disabled people. Not Dead Yet also raises concerns that at the time of the patient’s death, the law does not require an independent witness to be present to verify that the patient is administering the drugs as opposed to being pressured into using them. Furthermore, Marilyn Golden , senior policy analyst at the Disability Rights Education and Defense Fund, points out that among other potential problems that may stem from legalization of assisted suicide, not every terminal prognosis is correct.

Ultimately, 21 years after the first policy reforms were proposed, support of and opposition to Death with Dignity laws continue to be debated. The recent death of Brittany Maynard has brought new attention nationally to this topic and has ignited more discussions. It is unclear whether more states will pass some sort of Death with Dignity law; however, it is apparent that while 70% of Americans may support it, there remains reluctance in the majority to legalize it at the moment.

Alexandra Bhatti, student intern Jacoby & Meyers.

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Increasing Testosterone Therapy Litigation

Use of testosterone therapy has increased fivefold from 2000-2011. More than 5 million men were prescribed testosterone therapy in 2011. Those who have experienced injuries have filed lawsuits against multiple manufacturers of testosterone drugs as Androgel, Testim and Axiron. Those injured claim that they were not properly warned of the potential risks associated with testosterone therapy.

Thousands of men have experienced undisclosed side effects resulting from their use of testosterone that was prescribed to them. Two studies that investigated the effects of testosterone therapy indicated an increased risk of myocardial infarction (heart attack) associated with testosterone therapy in men. Other studies showed that testosterone therapy was related to adverse heart conditions such as ischemic stroke, heart attacks, and even death.

As a result of these studies, on January 31, 2014, the U.S. Food and Drug Administration issued a safety announcement surrounding potential risks associated with testosterone therapy. They announced that further investigation would follow.

On June 20, 2014, the FDA issued a post-market update of the approved uses of testosterone therapy drugs. This update approved testosterone therapy drugs for men who suffer from specific medical conditions which limit the amount of testosterone produced naturally These conditions include failure of testicles to produce testosterone due to genetic problems or chemotherapy, and hypothalamus and pituitary issue that control the production of testosterone by the testicles. The FDA explicitly rejected the use of testosterone for all other low testosterone related conditions.

The plaintiffs in the recently filed action allege that the manufacturers understated the risks associated with testosterone use; and used misleading marketing tactics. On February 4, 2014, the first testosterone therapy lawsuit was filed in the US District Court for the Northern District of Illinois Eastern Division. By June 2014 the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation for testosterone litigation which affected at least 45 current lawsuits. Any subsequent cases involving testosterone therapy, not manufacturer specific, will be transferred to the multidistrict litigation.

Coordinated pretrial hearings have begun in the Northern District of Illinois with Judge Matthew F. Kennelly presiding. Discovery has begun and any documents that could reveal trade secrets will be sealed to protect the manufacturers. While there are currently over 200 cases that are part of the MDL, it is speculated that considerably more testosterone lawsuits will arise.

Parties on both sides are proposing strikingly different timelines for the trials. Those representing the plaintiffs have proposed June 2016. In the interest of judicial efficiency, expenses, and time, plaintiffs are encouraging Judge Kennelly to defer to their less length timeline so that unnecessary delays and burdens are not experienced.

Attorneys for the drug manufacturers would like to delay the prosecution of these cases until late 2017. They suggest that there is insufficient scientific evidence that can causally link testosterone and adverse heart complications. Because of this, they are requesting that Judge Kennelly address this causation issue first.

There will likely be a group of cases selected for a bellwether trial to assess how juries may respond to certain evidence and what testimony is likely to be offered. These outcomes are not binding on the other cases, but they may assist in future settlements. Discovery for the bellwether cases is expected to begin in April 2015.

Alexandra Bhatti, student intern Jacoby & Meyers, LLC.

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Woman Says She Developed Diabetes While Using Lipitor

A Stanford Washington woman has filed a lawsuit against the pharmaceutical company Pfizer after using the drug Lipitor that was prescribed to her in 1998.

The lawsuit alleges that Pfizer marketed and promoted Lipitor as “safe and effective for people like the plaintiff,” despite data indicating the drug was causally related to blood glucose levels associated with Type 2 Diabetes. Lipitor is prescribed by doctors to lower cholesterol and other fatty substances in the blood, works to prevent heart disease and lower the risk of strokes. Pfizer failed to adequately warn physicians and consumers of the risk of developing diabetes from using Lipitor.

In August 2011, the FDA’s Division of Metabolism and Endocrinology Products advised changes to the labels of Lipitor. These changes were based on an FDA review that included clinical trial data showing a connection between the use of Lipitor and rising blood glucose. The complaint further alleges that in 2012, at the urging of the FDA, Pfizer added additional language to its Warnings and Precautions Section regarding increases in serum glucose levels while using statins, but that the label changes made were inadequate in warning of Lipitor’s causal relationship with Type 2 Diabetes.

In 2003, the plaintiff was diagnosed with Type 2 Diabetes and is now is required to maintain a restrictive diabetic diet, and take medication to control her diabetes. Ironically, while the plaintiff was prescribed Lipitor to decrease her risk for heart disease, she now has a higher risk of heart disease due to her development of diabetes while using the drug.

This lawsuit is part of a surge in Lipitor lawsuits that have been filed since February 2012. In February 2014, a panel approved consolidation and transfer of Lipitor diabetes lawsuits to the District of South Carolina with the initial trial set to begin in October 2015.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.

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Extendicare Whistleblower Receives 2.79 million in Medicare Fraud Settlement

In October, Tracy Lovvorn, a former employee of Extendicare, Inc., received a $1.8 million payment for information provided regarding Extendicare’s inappropriate Medicare billing and services to the elderly in their care. This was in her capacity as ‘”Relator” in a qui tam claim brought on behalf of the government under the False Claims Act.

Under federal law, if a “Relator” (also known as a “whistleblower”) brings evidence of fraud or wrongful acts that resulted in the federal government overpaying for product, services or a contract under false pretenses, the Relator can receive a portion of the monies recovered. The False Claim Act was instituted to encourage individuals to come forward with information regarding the inappropriate and false collection of fees from the federal government. The process is that the individual puts together a claim for review by the federal government (usually to the United States Attorney), who then investigates and decides whether the join in the action and prosecute the claims. Approximately $27 billion has been recovered for the government in qui tam actions. Under the False Claims Act, a Relator can get between 15-25% of the amounts recovered by the government in their case. Relators are typically represented by attorneys who specialize in qui tam actions.

Lovvorn, a physical therapist who worked for Extendicare between 2008- 2009, was hired by Progressive Step, a subsidiary of Extendicare as director of rehabilitation for the company’s eastern region. When she complained about the billing practices of the company, specifically in Pennsylvania and Delaware, the company began a campaign of harassment and retaliation against her.

In the qui tam action, Lovvorn claimed that Extendicare put pressure on rehabilitation staff to provide increased services to residents during an assessment period when the Medicare reimbursement was higher. They were then told to decrease services when the assessment period was over. The claim went further to explain how Extendicare management applied pressure to therapy providers to deliver inappropriate therapies to residents that, in two documented cases, could not tolerate the services that were provided. This maximized profits for Extendicare, but cost the government millions of dollars in false claims

Extendicare management scheduled excessive physical and occupational therapy for one terminally ill resident, again resulting in unnecessary payments by the government. Another resident, who suffered from seizures which rendered her unable to tolerate excessive therapies, was labeled by an Extendicare manager as a “missed opportunity.” The manager wrote of the resident in an email, “Financial loss of 2300 bucks!!!!” and stated “We have to step up and make sure that this doesn’t happen again!!!!”. Additional claims included allegations of lesser standards of care in the medical treatment of its residents.

Extendicare, Inc., a Canadian company incorporated in Delaware and whose headquarters are in Milwaukee, Wisconsin, owns 150 nursing homes in 11 states and is the 7th largest nursing home operator in the U.S. based on the combined number of beds across all its facilities.

Extendicare, Inc. claims no wrongdoing in the settlement of Lovvorn’s case, but will pay a total of $10 million, which includes the $2.76 million to Lovvorn and $206,000.00 to another claimant. The remainder will be paid to the government for reimbursement on fraudulent Medicare claims. The company released a statement citing the wish to avoid expensive litigation rather than any wrong doing as the instigation for the settlement.

Acting Associate Attorney General Stuart F. Delery said in a prepared statement, ”As part of this historic resolution, Extendicare will also enter into a five-year chain-wide corporate integrity agreement with the Department of Health and Human Services. This agreement will contain innovative staffing requirements intended to ensure that this type of misconduct will not happen again.”

Without people like Ms. Lovvorn, corporations will continue to effectively steal billions of dollars of taxpayer money from the government. Ms. Lovvorn is a true American hero.

Toni Kohlbeck, student intern Jacoby & Meyers.

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Benicar Lawsuits Continue to Grow

November 4, 2014

On June 17, 2014, California resident Susanne Ambler and her husband filed a lawsuit against Daichi Sankyo for injuries Ms. Ambler suffered while taking Benicar, a product manufactured by Daiichi Sankyo. Benicar was approved by the FDA in 2002 for use in the treatment of hypertension. According to court filings, Ambler claims that she suffered sprue-like enteropathy symptoms which resulted in numerous hospitalizations. Her case was transferred to federal court with a final pretrial conference scheduled for December of this year.

In Texas, another Benicar lawsuit was filed by George Williams against Daiichi Sankyo and Forest Laboratories, Inc. in the Superior Court of New Jersey for Atlantic County. The case was then removed to the U.S. District Court for the District of New Jersey. Like Ms. Ambler, Mr, Wiliams suffered sprue-like enteropathy symptoms and was hospitalized over 100 days over a four-year span. In addition to suffering from enteropathy, Mr. Williams is alleged to have developed villous atrophy that ultimately required the placement of a feeding tube. Mr. Williams claims that the use of Benicar and/or the use of steroids in the treatment caused him to get cataracts. Williams also suffered a compression fracture to his spine related to being prescribed Benicar.

New Jersey resident Christy Brooks also filed a claim against Daiichi Sankyo and Forest Laboratory, Inc. in the New Jersey courts for injuries she suffered from her use of Benicar. Similar to other victims of Benicar, because the side effects of Benicar may not appear in a user for months to years after initiating use, her doctors could not connect her mystery illness with her use of Benicar. They only made the connection when the FDA forced Daiichi Sankyo to include warnings in 2012 for the side effect of sprue-like enteropathy and in 2013 for the side effect of villous atrophy.

Ohio resident Brenda Baugh filed suit seeking damages for her injuries resulting from the use of Benicar on October 15th of this year. Baugh was hospitalized multiple times for the symptoms that are now known to be linked to the use of Benicar. Baugh’s suit was filed in Federal District Court in the Northern District of Ohio. Baugh was repeatedly misdiagnosed due to her physician’s lack of knowledge regarding the connection between Benicar and the symptoms she displayed.

Each plaintiff in these suits suffered similar injuries that are consistent with those found in research published by the Mayo Clinic in 2012. Those symptoms include sprue-like enteropathy including chronic diarrhea, weight loss, nausea and vomiting, as well as several forms of colitis. These symptoms have occurred long-term in the plaintiffs in these lawsuits, resulting in malnutrition and dehydration. The Mayo Clinic released additional research in 2013 that found the long-term occurrences of these symptoms also lead to villous atrophy, a permanent condition, which is characterized by damage to the villi in the intestinal tract which absorbs nutrients and causes malnutrition.

Unfortunately, the symptoms that people experience from injuries caused by Benicar use are often misdiagnosed as celiac disease. In these cases, the patient can suffer long-term damage. In some cases, the symptoms may subside after discontinuuing the use of Benicar.

Approximately 45 million people in the United States are being treated for hypertension. Currently, there are numerous cases pending across the country in state and federal district courts. With 1.9 million prescriptions for Benicar documented to date, that number is expected to grow.

Toni Kohlbeck, Intern Jacoby & Meyers, LLC.

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U.S. Judicial Panel on Multidistrict Litigation to hear Oral Arguments regarding Xarelto

On July 25, 2014, the McGowen family filed a claim in the U.S. District Court for the District of Vermont against Xarelto drug manufacturer, Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary for the wrongful death of Thomas C. Dunkley. Mr. Dunkley was diagnosed as suffering from atrial fibrillation, a heart-related disease that is characterized by an irregular and often rapid heart rate that usually causes reduced blood flow to the body. For his condition, Dunkley was prescribed Xarelto (rivaroxaban) to treat atrial fibrillation to reduce his risk of sustaining an embolic stroke. Dunkley passed away less than two weeks after he began using Xarelto.

According to the court filings, Dunkley began taking Xarelto on July 17, 2012. Seven days later, he experienced a brain hemorrhage and suffered a life-threatening, irreversible bleed.

Dunkely’s condition arose after taking Xarelto for only nine days. The family alleges that Mr. McGowen experienced pain and suffering due to the adverse effects from taking Xarelto. It is further alleged that the drug manufacturers of Xarelto failed to adequately warn the consumer of that one of Xarelto’s deadly side effects is uncontrolled bleeding. It is further alleged that the manufacturer concealed the safety risks from not only Mr. Dunkley, but also the FDA, the general public and the medical community. Finally, it is alleged that the manufacturer negligently and improperly failed to test Xarelto on humans in clinical trials before presenting it in the market for public use.

This is not the only claim regarding the adverse effects of Xarelto. In fact, there are now 21 product liability lawsuits in 10 federal district courts involving either injuries or deaths related associate with uncontrolled bleeding from the use of Xarelto. As a result, a group of plaintiffs have filed claims to present before one judge for pre-trial proceedings in a Multi-District Litigation (MDL).

An MDL is different than a class action in that each case in an MDL is separately prosecuted as an individual lawsuit. Cases in an MDL are coordinated together, usually for discovery purposes, but the trials are usually conducted on an individual basis. The U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear oral arguments by January 2015. The Dunkley case and the other claims that presently exist against Xarelto are in the early stages of litigation, and experts suggest that there will continue to be more claims that arise in the coming months.

Alexandra Bhatti, Intern Jacoby & Meyers.

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