In September 2014, a study published in the journal of Neurology, University of British Columbia researcher, Dr. Mahyar Etminan, PharmD proves a scientific link between fluoroquinolones and peripheral neuropathy (PN). PN is a potentially painful condition that occurs when nerves are damaged, resulting in weakness, numbing or pain, usually in the face, hands or feet. It can also affect other parts of the body. The symptoms can also include muscle twitching, and hypersensitivity to touch. Sensations of tingling, buzzing, electrical zaps and burning in the extremities can also occur. PN can be permanent even after discontinuation of fluoroquinolone. PN can be debilitating.
Commonly prescribed fluoroquinolones include brand-name antibiotics Cipro (ciprofloxacin), Levaquin (levofloxacin), and Avelox (moxifloxacin). Manufacturers of these drugs were required to add black box warnings for the risk of tendonitis and tendon rupture in 2008. In 2013, the FDA required a label change addressing the risk of PN after releasing a communication to the public.
Previously PN was connected with type 2 diabetes.
The study completed by a joint British Columbia and United States research team followed a group of males ages 45 to 80 years in the US from 2001 to 2011. Each case was matched to 4 controls. The researchers found that current users are at a higher risk of developing PN. New users of fluoroquinolone were found to be at the highest risk. The study indicates that almost half the reported cases of PN resulting from the use of fluoroquinolones occurred in older men. The study did not include women, but Dr. Etminan stated that the researchers do not think the risk differs in women.
Dr. Etminan explained that antibiotics work in different ways. Fluoroquinolones are designed to change the DNA of bacteria that cause infection. Etminan thinks it may be possible that this line of medicines is changing human DNA also. These are highly potent antibiotics. Dr. Etminan suggests that prescribing other types of antibiotics may be more appropriate.
Prior litigation targeted fluoroquinolone manufacturers for failure to warn of the side effects of tendonitis and tendon rupture. New actions are being filed in US courts; the most recent case filed in Maryland related to damage caused by Levaquin. Physicians wrote more than 20 million prescriptions for Cipro in 2010. In the US, Cipro is the 35th-most commonly prescribed drug; it ranked the 5th most prescribed antibiotic.
If you use or have used any fluoroquinolone and have suffered any of the serious side effects discussed here, you may be entitled to compensation for your injuries. The attorneys associated with Jacoby & Meyers are qualified to assist you in evaluating your case. An attorney experienced in litigation can help you file your lawsuit and protect your rights within the statute of limitations allowed by the law.
Please call 800-977-5614 to contact our defective drug lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.
Toni Zeller Kohlbeck, student intern Jacoby & Meyers.
A Baltimore County Maryland woman filed a lawsuit against the manufacturers of the antibiotic drug Levaquin. The defendants in the lawsuit are Johnson & Johnson; Johnson and Johnson Pharmaceutical Research and Development L.L.C.; Ortho-McNeil-Janssen Pharmaceutical, Inc.; and McKesson Corporation. The plaintiff claims that the pharmaceutical defendants failed to warn of the dangerous risks associated with the drug including peripheral neuropathy and that as a result of the defendant’s actions the plaintiff developed peripheral neuropathy among other damages.
In 1996, Levaquin was approved by the FDA to treat certain bacterial infections including lung, sinus, skin and urinary tract infection. Levaquin (levofloxacin) is a subset of antibiotics known as fluoroquinolones. Fluoroquinolones include the drugs Cipro (ciprofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin), and Factive (gemifloxacin).
In 2013, the FDA required manufacturers to update products labels to include the risk of possible nerve damage. Label updates regarding the risk of peripheral neuropathy associated with the use of fluoroquinolone were included in a 2004 label update, however, “the potential rapid onset and risk of permanent damage were not adequately described.” Peripheral neuropathy is a serious nerve disorder characterized by damage to the nerves that extend from the spinal cord to the bodies extremities. Symptoms include numbness, tingling, burning, unusual sensations, weakness and chronic pain experienced typically in the arms, hands, legs, and feet.
If you used Levaquin or any fluoroquinolone antibiotic prior to 2013, and developed peripheral neuropathy, you may be entitled to compensation for your injuries. Call 800-977-5614 to speak to Jacoby & Meyers attorney today.
There is a saying that the “treatment is sometimes worse than the disease.” A good example of this is the drug Risperdal.
In 1993, the Food and Drug Administration (FDA) approved Risperdal for the treatment of adult schizophrenia. In 2006 and 2007, the FDA extended the permitted use of Risperdal to the treatment of schizophrenia in children, bipolar disorder in adults and children, and behavioral disorders for autistic children. Risperdal is the second most prescribed antipsychotic in the U.S., with annual sales exceeding $4.5 billion. It is estimated that Janssen Pharmaceuticals (Janssen), the manufacturer of Risperdal, has profited about $40 billion from the sale of the drug. Unfortunately, in its quest for profits, Janssen has failed to provide full disclosure of the horrible potential side effects of Risperdal. These side effects include:
breast development in boys
lactation in girls
diabetes and death in the elderly
Needless to say, the emotional side effects of young boys who develop breasts is severe, not to mention the trauma associated with reconstructive surgery to remove the permanent damage. According to Bloomberg, Janssen acted in a “calculated manner with intent to maximize profit with no regard to risk” when marketing Risperdal.
In 2010, the first civil suit regarding Risperdal was filed by a 21 year-old man who developed breasts. The man took Risperdal for a FDA unapproved use, yet Janssen marketed use for 5 years. He suffered physical damage and emotional trauma. In 2012, the case was settled by J & J on the first day of trial for an undisclosed amount.
In that same year, J & J was accused of improper marketing practices and fined $1.2 billion by an Arkansas federal court of Medicaid fraud and deceptive practices of marketing. It’s believed that J&J could see the writing on the wall, and settled lawsuits with 36 states and the District of Columbia for improperly marketing Risperdal toward the treatment of children. These cases resulted in combined settlements of more than $666 million.
In addition to state improper marketing lawsuits, civil suits are on the rise. Of the 420 civil lawsuits filed so far, 100 of these lawsuits are for breast development in boys, as a result of J & J’s failure to adequately warn of Risperdal’s risks.
In 2013, Janssen entered into a settlement with U.S. prosecutors for $2.2 billion. This is the government’s third largest whistle-blower suit with a pharmaceutical company, and includes $1.6 billion in civil payments. Under the plea agreement, Janssen will pay a $334 million fine and forfeit $66 million. Janssen ultimately accepted accountability for the actions in the guilty plea but denied liability or wrongdoing in the civil settlement associated with the suit.
The deadline for filing lawsuits for the side effects of Risperal based upon the applicable statutes of limitations will soon be approaching. If you or someone you know has suffered from the effects of Gynecomastia after taking Risperdal, you should contact Jacoby & Meyers who can put you in contact with an attorney who is experienced in litigating Risperdal cases.
Boston Scientific Corporation (BSC) is an international medical device manufacturer and creator of a transvaginal mesh device that is used to treat incontinence and a condition called pelvic organ prolapse in women. Pelvic organ prolapse occurs when the bladder drops (prolapses) from its normal place in the lower belly and pushes against the walls of the vagina.
The number of women who have undergone vaginal mesh surgery is quite staggering. The FDA estimates that hundreds of thousands of women have undergone implantation of a vaginal mesh device by various manufacturers, including BSC. Unfortunately, in various studies reported to the FDA, it has been estimated that 10% of the women that receive an implant will experience mesh erosion within 12 months of surgery and more than half will need to undergo an additional surgery to remove the mesh.
Boston Scientific is one of seven major manufacturers named in lawsuits filed by thousands of women who have experienced injuries as result of surgical mesh implants. In fact there are more than 49,000 federal lawsuits against these manufacturers and BSC is facing about 23,000 defective product lawsuits. Plaintiffs in these cases claim that BSC knew about the risks and dangers associated with the mesh implant and failed to warn consumers.
Earlier in the year, in September, a state court in Texas ordered BSC to pay $73 million dollars to a Martha Salazar who claimed injuries due to BSC’s product. The state court later reduced the damages to 34.6 million dollars.
The first in the series of federal lawsuits against BSC was decided November 13, 2014 in Miami where the jurors found in favor of a group of four woman, and ordered that BSC pay $26.7 million to them. November 20, 2014, one week after the Miami case was decided, a jury in West Virginia awarded four more women 18.5 million dollars in damages which included 4 million dollars for gross negligence. In all of these cases the compensatory damages far exceed the punitive damages. Where injured parties received 1 million in punitive damages and the remaining, starting at 3.25 million, in compensatory damages. These initial cases that have been heard in federal court are bellwether cases, and while they are not binding on the remaining cases yet to be heard, they display an indication of how courts may allocate damages if BSC is found guilty.
These large verdicts may put pressure on BSC and other companies facing mesh sling injury claims, to settle prior to avoid going before a jury. There are actual strong rumors that BSC and other manufacturers are presently engaged in settlement discussions to globally settle the cases against them. In fact, Boston Scientific has reserved $945 million for settlement and defense costs according to a U.S. Securities and Exchange Commission filing.
Thus, for anyone who has a potential claim arising from a transvaginal mesh device, it is important to contact an attorney skilled in handling pharmaceutical cases as soon as possible.
Legal Help
If you have had a vaginal mesh implanted and are experiencing problems, contact an experienced attorney at Jacoby & Meyers for a free consultation.
Alexandra Bhatti, student intern Jacoby & Meyers, LLC.
A jury in the Second District Court of Utah returned a verdict for $1.6 million in a wrongful-death and medical malpractice action against Intermountain Healthcare for fatally overdosing a patient with a cocktail of medications.
The original complaint alleged Intermountain negligently and carelessly acted below the standard of care by prescribing a combination of medications.
Intermountain is a large healthcare network based in Salt Lake City, Utah. The healthcare provider has 22 hospitals in the state and more than 185 clinics in the Intermountain Medical Group.
Following the unexpected death of her husband Randy Krambule, Bobbie Krambule filed suit against Intermountain in 2010. Randy Krambule had been seeking treatment for chronic back pain. The treating physician was employed by the Defendant in its North Ogden, Utah medical center.
Krambule’s treatment included sedatives, pain killers and sleep aids, that reached to more tjan 30 pills per day, according to the Standard Examiner. As a result, the cocktail of medications “metabolized and accumulated” in Randy Krambule’s body, which led to drug toxicity and ultimately caused his death on April 3, 2008.
Wrongful Death
In Utah, a wrongful death suit may be brought by the surviving spouse or the victim’s heirs against the person responsible for the conduct or as in this case, the employer who is responsible for the [employee’s] misconduct. Utah Code Ann. § 78B-3-106.
Families may recover damages as a remedy for financial injuries suffered as a result of the death. In Utah, damages are measured by the conditions existing at the time of death. See Shields v. Utah Light & Traction Co., 105 P.2d 347, 351-52 (Utah 1940).
There are several factors used to determine the damages for heirs. The possible factors may include age, health, habits and the victim’s disposition to earn money. Moore v. Utah Idaho Cent. R. Co., 174 P. 873, 880 (Utah 1918).
Medical Malpractice Requirements
Medical malpractice is also a tort action grounded in negligence. Generally, wrongful death and medical malpractice claims are joined together because the death occurred from medical negligence.
In this case Bobbie Krambule had to prove the following elements:
A duty existed on the part of the physician to conform to the specific standard of care.
The applicable standard of care.
The physician failed to perform the standard.
Breach of the duty was a proximate cause of [Randy Krumbule’s] injuries.
See H. Beau Baez III, Tort Law in the United States 56-57 (Roger Blanpain et al. eds. 2nd eds., 2014).
A medical malpractice claim differs from general negligence because the treating physician shares a special relationship with the patient. This special relationship increases the standard of care from general reasonableness to whether the physician fails to follow the custom of the medical profession.
The medical professional is required to treat each patient with reasonable diligence, skill, competence and prudence as is practiced by other professionals in the same specialty or general field . As long as the conduct in question is a custom practiced among others in the profession a malpractice claim will be unsuccessful. Generally, the customs and appropriate standard of care is proved through expert testimony,
Krambule v. Intermountain proves that it is uncommon for physicians to prescribe a number of medications without acknowledging the potential side effects and dangers to the patient.
Bobbie Krambule was represented by Peter Summerill, The Law Offices of Peter Summerill, Utah.
This case is Bobbie Krambule v. Intermountain Healthcare, Case No. 100907050, Second Judicial District Court, Ogden, Utah.
The drug Xolair, which is manufactured and marketed by Genentech and Novartis, has been determined to potentially cause some severe side effects that were never previously disclosed to consumers.
Xolair is an FDA approved treatment of allergic asthma, as well as the treatment for Chronic Idiopathic Urticaria (CIU) that cannot be controlled by H1 antihistamine. However, in September 2014, during the course of an ongoing safety review of the generic equivalent of Xolair called Omalizumab, the FDA found that there were side effects that the manufacturer did not previously warn consumers about. These include the risk that Xolair can cause mini-strokes, heart attacks, sudden chest pain, pulmonary hypertension, blood clots in the lungs and veins, and may increase the risk of developing cancer.
Prior to September 2014, the manufacturers were required to have a “black box” warning that Xolair can cause a potential life-threatening allergic reaction called anaphylaxis. Further in May of this year the Institute for Safe Medication Practices said in a report that of the drugs it was testing for hypersensitivity reactions, Xolair has the highest risk and raised questions about a potential recall of the drug. Now, these additional risks of pulmonary hypertension, blood clots in the lungs and veins, and the potential increase the risk of developing cancer must be disclosed.
Of course, these new disclosure requirements cannot help all the people who sustained injuries as a result of Xolair – but were never warned about the side effects. In pending lawsuits, there are plaintiffs who are alleging that Genentech and Novartis had actual knowledge about the serious risks that are associated with taking Xolair, but failed to provide adequate warnings to patients receiving treatment.
Currently, patients who believe they were injured from taking Xolair are still filing lawsuits on an individual basis but a class action could be filed if enough people come forward.
If you or someone you love has been impacted by the effects of Xolair (Omalizumab), you should contact an attorney who has experience handling pharmaceutical cases. You should contact Jacoby & Meyers, who will place you in contact with the skilled attorneys who specialize in these kind of cases.
Joseph Coughlin, student intern Jacoby & Meyers, LLC.
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.
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.
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.
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