Have you been affected by Cymbalta Discontinuation Syndrome?

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.

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Fluoroquinolone Study Reveals Double Risk of Peripheral Neuropathy

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.

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Fluoroquinolones Can Cause Peripheral Neuropathy

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.

Statutes of limitations to file your claim apply.

Zachary Mayberry, student intern Jacoby & Meyers, LLC.

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Risperdal: When Drug Manufacturers Profits Outweigh Patient Risk

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.

Gregory Posch, student intern Jacoby & Meyers, LLC.

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Boston Scientific’s latest in a Series of Mesh Sling Trials

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.

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Healthcare Network Liable for $1.6M for Overdosing Patient

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.

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Xolair: When Risk Outweigh the Benefit

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.

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Do you have a Cold or Cough? Be Careful.

Over the Counter Medication can be Dangerous – Because many of these medicines have the same ingredients, it can be easy to overdose.

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