XELJANZ


Ohio Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Litigation and drug injury cases
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Product Liability attorneys are investigating claims by Rheumatoid Arthritis (RA) patients who have developed severe Xeljanz complications like paraplegia or limb paralysis after taking the drug.

There are also reports of Xeljanz complications linked to blood clots, deep vein thrombosis and pulmonary embolism. The U.S. Food and Drug Administration (FDA) has received multiple adverse event reports for patients taking Xeljanz or Xeljanz XR, and in 2017 warned the public of certain risks.

At that time the FDA approved labeling changes for Xeljanz that printed warnings for new risks of appendicitis, interstitial lung disease, pancreatic cancer, and disseminated varicella zoster vaccine virus infection. Risks for lung cancer, breast cancer, melanoma, and prostate cancer were also added to the black box warning.

The FDA first approved Xeljanz in 2012 to treat moderate to severe active rheumatoid arthritis, one of the most common and disabling types of autoimmune arthritis, affecting more than 1.3 million people in the U.S. RA results in pain and swelling in the joints of the hands and feet, and can also affect the eyes, skin, or lungs.

Joe Lyon is a highly-rated Ohio product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical companies


Xeljanz Injury


The US Food and Drug Administration (FDA) has newly added a warning to tofacitinib (Xeljanz and Xeljanz XR) stating an increased risk for pulmonary embolism, and possible and death. The FDA warns that patients taking a 10-mg twice-daily dose of Xeljanz, recommended for patients with ulcerative colitis, could present an added blood clot risk.

Also, the FDA has limited the use of Xeljanz for ulcerative colitis to only patients who are treated inadequately or experience severe adverse effects with alternative drugs. The Xeljanz risk warnings follow a review of data from a post-marketing safety study of tofacitinib (Xeljanz) in patients with rheumatoid arthritis. Higher doses of the drug presented an added risk of pulmonary embolism.

The safety study found an increased occurrence of blood clots when patients are treated with 10 mg twice daily compared with patients treated with 5 mg twice daily. The 10-mg dose of tofacitinib is not approved for rheumatoid arthritis or psoriatic arthritis, only approved for ulcerative colitis.

The FDA stated in the recent warning: “While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.” The FDA first warned about the Xeljanz risk in February 2019.


Xeljanz Complications & Blood Clots


Pfizer and the FDA have warned adult patients with moderate to severe rheumatoid arthritis as well as doctors of the irregularities in dosage risks. The report underscores the longstanding issue with marketing and selling drugs to the public before such trials can be studied for short and long-term health risks like pulmonary embolism, deep vein thrombosis and other serious complications.

Xeljanz works by decreasing the activity of a patient’s immune system. It was first approved to treat adult RA patients who did not respond well to methotrexate. In 2017, the FDA approved the medicine to treat patients with psoriatic arthritis who did not respond well to non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

In 2018, the FDA approved tofacitinib to treat ulcerative colitis, a chronic, inflammatory bowel disease. During the most recent safety trial, researchers found an increased occurrence of blood clots in the lungs when patients are treated with tofacitinib 10 mg twice daily. The study results identified 19 cases of Pulmonary Embolism and 45 deaths.

Health care professionals and clinical trial researchers are still in the process of studying the drug safety risks of Xeljianz and other rheumatoid arthritis medications.

Serious Xeljanz side effects or complications that may be associated with the drug include:

  • Blood Clots
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism
  • Paraplegia
  • Limb paralysis
  • Perforations the stomach or intestines
  • Lymphoma
  • Liver damage
  • Non-melanoma skin cancers

Xeljanz Pulmonary Embolism


Pulmonary embolism occurs when material, most often a blood clot, gets wedged into an artery in the lungs, commonly coming from the deep veins of your legs, a condition known as deep vein thrombosis.

About one-third of people with undiagnosed and untreated pulmonary embolism die. When the condition is diagnosed and treated promptly, the prognosis is much improved.

There are complications that may include the development of pulmonary hypertension, a condition where the blood pressure in the lungs and in the right side of the heart is too high.

Pulmonary embolism symptoms can vary and depend mostly on how much of the lung is compromised, the size of the blood clots, and the presence of underlying lung or heart disease. Pulmonary embolism can be life-threatening. Common signs and symptoms may include:

  • Shortness of breath—worse with physical exertion
  • Severe chest pain
  • Cough—possible blood-streaked sputum
  • Leg pain or swelling
  • Clammy skin or skin discoloration
  • Fever
  • Excessive sweating
  • Rapid or irregular heartbeat (arrhythmia)
  • Lightheadedness or dizziness

Ohio Xeljanz Attorney


Following any drug injury incident, whether it is a blood clot or pulmonary embolism, kidney or liver damage, plaintiffs may choose to seek compensation. Defective drugs may be the cause of an illness and injury, and drug manufacturers may be held liable for damages.

The Lyon Firm has experience engaging large drug companies in complex drug injury litigation. Large settlements are likely for injured plaintiffs if there is evidence that the company failed to properly test their product or failed to warn consumers of the potential health risks and complications.


What is Rheumatoid Arthritis?


Rheumatoid arthritis (RA) is the most common and disabling types of autoimmune arthritis. It affects more than 1.3 million people in the U.S., most of them (75 percent) women. RA is caused by an ineffective immune system and results in pain and swelling of the wrist and small joints of the hands and feet.

Rheumatoid arthritis is a chronic inflammatory disorder that can affect more than just your joints. In some people, the condition also can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.

Rheumatoid arthritis affects the lining of your joints, causing a painful swelling that can eventually result in bone erosion and joint deformity. Common signs of RA include loss of energy, low-grade fevers, reduced appetite, a dry mouth associated with Sjogren’s syndrome, and rheumatoid nodules that form beneath the skin.

RA presents typically with tender, warm, swollen, stiff joints, usually worse in the mornings and after inactivity. As the disease progresses, symptoms can spread to the wrists, knees, ankles, elbows, hips and shoulders. In most cases, symptoms occur in the same joints on both sides of your body. Rheumatoid arthritis symptoms may vary in severity and come and go with increased disease activity, called flares.

Rheumatoid arthritis occurs when an immune system attacks the synovium, the lining of the membranes surrounding joints. The inflammation thickens the synovium, which can eventually destroy the cartilage and bone. Tendons and ligaments that hold a joint together weaken and stretch, and the joint loses its shape and alignment.

Risk factors for rheumatoid arthritis include gender (women are more likely to have RA), age, family history, obesity, smoking, and environmental exposures. Exposures to asbestos or silica may increase the risk for developing rheumatoid arthritis.

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A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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