Ohio Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Litigation and drug injury cases
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Johnson and Johnson faces thousands of lawsuits from plaintiffs linking injuries like gynecomastia to Risperdal, a popular antipsychotic medication. One recent jury awarded a plaintiff $8 billion in a show of overt disapproval of how the drug company marketed the drug without proper warnings.

The jury noted the company acted with noted self-interest, and did not properly warn young consumers of the risk of gynecomastia, a condition where men develop breasts.

Risperdal (risperidone) is an antipsychotic drug, first introduced in the early 1990s to treat patients suffering from various forms of behavioral disorders, including bipolar disorders and schizophrenia.

The drug was developed by a subsidiary of Johnson & Johnson, and it is still manufactured and marketed today, even with a long history of harmful side effects, which are arguably more serious than similar existing drugs on the market.

One of the most well-known side effects of Risperdal is the development of breasts, and lactation in young boys and men taking the medication. Risperdal gynecomastia risks have been documented.

Medical studies and doctors have discovered that patients using Risperdal show signs of gynecomastia and galactorrhea, from what experts believe to be excessive exposure to prolactin, a hormone used in the drug that may induce breast growth and lactation. This complication may lead to a painful operation and serious emotional trauma.

Similar to the medications Rexulti,  Invega and Abilify,  Risperdal (risperidone) is an antipsychotic medication used to treat symptoms of schizophrenia, bipolar disorder (manic depressive disorder), and symptoms of irritability in autistic children.

There have been medical debates about the safety of Risperdal. In 2000, a medical study concluded there is a possible link between males taking Risperdal and the enlargement of male breast tissue.

This has sparked numerous Risperdal lawsuits, and Johnson & Johnson, the manufacturer of the drug, confidentially settled several lawsuits in 2012. Other serious side effects have been noted by the FDA and other health agencies.

Joe Lyon is a highly-rated Cincinnati Drug Injury Attorney and Ohio Risperdal lawyer representing plaintiffs nationwide in a wide variety of product liability claims against pharmaceutical companies.  

Risperdal Complications & Side Effects

There are several side effects associated with taking Risperdal. Risperdal (risperidone) may impair your thinking or reactions. Stop using this medicine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face, tremors, trouble swallowing, or feel light-headed.

One of the more alarming side effects of risperidone is galactorrhea, the spontaneous flow of milk from the breasts not associated with pregnancy. Studies have shown that risperidone can lead to elevated levels of prolactin in the blood, leading to galactorrhea. This has been found in both women and men. Other common side effects include:

  • Drowsiness
  • Dizziness
  • Nausea
  • Diarrhea
  • Constipation
  • Increased Appetite & Weight Gain
  • Stomach Pain
  • Anxiety
  • Restlessness
  • Difficulty with Sleep
  • Decreased Libido
  • Problems with Vision
  • Pain in Muscles & Joints

FDA Risperdal Warnings

In 2005, the FDA added a Black Box Warning to the drug’s label after the government learned that the use of the drug among elderly patients with dementia could increase the risk of death.

In recent years, the FDA and the U.S. Department of Justice have questioned Johnson & Johnson, and tried to determine whether they have adequate labeling on their products. Investigations into Ohio Risperdal lawsuits are ongoing, and patients may still suffer from dangerous and deforming side effects each year.

Several million-dollar verdicts have been reached in recent years against Janssen Pharmaceuticals and Johnson & Johnson, the manufacturers of Risperdal, and hundreds of claims are still pending.

What is Gynecomastia?

Gynecomastia is the abnormal growth of breasts in a male, which develops as excess non-cancerous tissue growth. It is known to cause severe discomfort and certain degrees of psychological distress and emotional trauma. This condition is also associated with galactorhea, the white discharge that comes from a male’s breast.

Patients who have been diagnosed with gynecomstia must cope with abnormal tissue growth regularly, and breasts may continue to regrow even after some cases of surgical treatment. The longer a patient waits to treat the condition, the more difficult the removal process. To remove the breast tissue, a patient must undergo a surgical procedure that may include liposuction and mastectomy.

With any surgical procedures there are risks of complication. Patients may be at risk of hematomas, surgical infections, painful scarring, as well as possible nerve damage around the areas of the breast.

Symptoms of Gynecomastia Risperdal Injury

Gynecomastia is caused by a hormonal imbalance of estrogen and testosterone, and can affect one or both breasts. Men may suffer devastating emotional consequences and may also have pain in their breasts. Sometimes gynecomastia resolves on its own, but the condition can require surgical intervention to return the patient to his former condition.

Even after surgery the breasts may continue to show signs of growth. According to the Mayo Clinic, signs that a patient is experiencing gynecomastia include swollen breast gland tissue and breast tenderness.

Risperdal Injury & Complications

Risperdal has been sold to consumers for more than 20 years. Antipsychotic drugs like Risperdal have been regularly prescribed to patients diagnosed with manic depressive disorder, schizophrenia, and childhood autism.

Many patients have been helped by drugs like Risperdal, however others have suffered from deforming and debilitating side effects that include the enlargement and lactating of breasts in both men and women, cardiac issues, liver and kidney injuries, abnormal blood counts, and other serious adverse health outcomes.

As a result, many people that have been devastated by the unfortunate side effects of Risperdal have filed specific Risperdal lawsuits against Janssen Pharmaceuticals and Johnson & Johnson, the manufacturers and distributors of the drug. Risperdal Risks include:

  •          Heart disease
  •          Gynecomastia
  • High blood pressure
  • Stroke or heart attack
  • Diabetes
  • Low white blood cell counts
  • Liver or kidney disease
  • Seizures
  • Low bone mineral density
  • Rash / Hives
  • Problems Breathing & Swallowing
  • Breast swelling or tenderness (in men or women)
  • Severe nervous system reaction
  • Impotence

Risperdal (risperidone) Side Effects

In 1993, The U.S. Food and Drug Administration (FDA) approved the use of Johnson & Johnson and Janssen Pharmaceuticals drug, Risperdal, first approved to treat schizophrenia in adults. The drug makers moved quickly to try to expand the use of the drug to build profits, though risked injuries by seeking approval for multiple disorder uses.

In 2011, a recall of Risperdal and Risperidone was issued after consumers reported an uncharacteristic odor coming from the pills. Some patients claim that they suffered gastrointestinal problems.

More recently, concerns over gynecomastia have prompted thousands of lawsuits, filed against Johnson & Johnson.

Ohio Risperdal Lawyer & Recent Settlements

In 2015, Johnson & Johnson, the makers of Risperdal, paid $2.5 million in damages for neglecting to warn consumers that their medication can cause breast growth in men (gynecomastia). The case was spurred by the family of a seven-year-old autistic boy who took the medication for four years and developed large breasts.

In November, 2013, Johnson & Johnson settled a case for $2.2 billion resulting from illegal promotion of the drug for unapproved purposes in older adults, children, and those with developmental disabilities. Johnson & Johnson tried to acquire FDA approval for the use of Risperdal in older adults with dementia shortly after first marketing the drug, but were denied.

Despite this, a sales team continued to promote Risperdal use in geriatric patients. According to attorneys and a leading Ohio Risperdal lawyer, J&J was aware of the risk of stroke in elderly patients, but neglected to state it when marketing the drug.

Risperdal Gynecomastia Lawsuits

study published in 2000 identified the concern between Risperdal usage and the growth of male breasts. This study was completed a short time after Risperdal was approved for consumers by the FDA.

The study found that in just two weeks of taking Risperdal, a 38-year-old male developed male breast and began producing a milky white discharge. The researchers noted that the patient’s prolactin hormone levels were nearly double the normal range for males. When doctors pulled him off of the drug, the patient’s hormone levels dropped into the average range.

A Duke University study in 2006 concluded that Risperdal may cause male breast growth. The study also showed that the possibility for gynecomastia was stronger with Risperdal than with other antipsychotic medications.

The study revealed some female children taking the medication lactated before puberty. In 2008, several more reports surfaced claiming Risperdal stimulated the production of prolactin in boys, leading to lactation.

In 2010, a man who took Risperdal for five years filed a lawsuit against J&J after he developed breasts. By 2012, over 400 more Risperdal lawsuits were filed in courts throughout the country, and 130 of these lawsuits involved plaintiffs suffering from gynecomastia.

All of the lawsuits claimed that the drug makers failed to provide adequate warning labels of the side effects. Lawyers claimed that the company downplayed the danger of breast growth in adults and children.

In February, 2015, a young man who developed large breasts after taking Risperdal won a $2.5 million verdict against Johnson & Johnson. The jury found J&J negligent of failing to adequately warn users of specific side effects, particularly the risk of developing breast tissue.

In 2012 Johnson & Johnson was forced to pay $158 million to settle claims that they defrauded the Texas Medicaid program by marketing Risperdal for unapproved uses.

Johnson & Johnson advertised the drug as being effective in the treatment of psychiatric conditions in children, and the drug maker continued to illegally market the drug until its approval for pediatric use in 2006. Other million-dollar verdicts have been seen in recent years against Janssen Pharmaceuticals and Johnson & Johnson.

Rispredal Settlements

Risperdal litigation is heating up, and many Risperdal injury lawsuits are scheduled for trial as consumers and patients have claimed the drug has caused serious kidney damage and gynecomastia, a condition where young men develop breasts.

Attorneys allege that drug manufacturers often fail to properly test their product before they are marketed and sold to consumers, leading to preventable injuries. Victims may seek compensation and recover funds that may include past and future medical bills, lost wages, and damages related to pain and suffering.

The Lyon Firm is now reviewing Risperdal Gynecomstia claims as well as cases involving other serious Risperdal side effects. Recent settlements and verdicts have indicated that Risperdal injury lawsuits can be valuable and can compensate plaintiffs in a wide variety of cases.

Johnson & Johnson faces thousands of Risperdal lawsuits, with patients complaining of gynecomstia—developing breasts—as well as other severe side effects. J&J has faced scrutiny over anti-psychotic drugs, along with Eli Lilly, who paid $1.4 billion in 2009 for improperly marketing Zyprexa. AstraZeneca paid $520 million in 2010 to resolve marketing issues with Seroquel.

In 2013, Johnson & Johnson paid $2.2 billion in fines to settle accusations of illegally marketing Risperdal to dementia patients in nursing homes and to children with behavioral disabilities.

The Lyon Firm is accepting cases of Risperdal injury, and will review your case if you or a loved one has taken Risperdal and suffered with kidney issues, gynecomastia, or other serious side effects.

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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. 


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.


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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