If you or a loved one has been harmed by contaminated food products, you may be entitled to financial compensation. Contact our experienced lawyers today to explore your legal options.

The use of testosterone therapy drugs like AndroGel surged this decade, peaking at nearly five million total prescriptions in 2013.¹ However, the U.S. Food and Drug Association (FDA) recently linked testosterone therapy with some serious health conditions. AndroGel has since been implicated as the cause of injury in more than 6,000 lawsuits.² Here’s what AndroGel users and family members of users need to know to ensure their safety and protection.

What is AndroGel?

AndroGel is the most popular testosterone therapy drug available on the market. Of the 1.8 million total testosterone gel prescriptions in 2017, more than 994,000 were for AndroGel.¹

The testosterone therapy gel is used to increase or replace testosterone in men with abnormally low or no testosterone. This condition is called hypogonadism, and it can be caused by many factors, including illness, trauma to the testicles, pituitary gland or hypothalamus issues or a side effect of chemotherapy.

Ample testosterone levels are important as they help maintain critical bodily processes, including:

• Bone density
• Fat distribution
• Muscle mass
• Sperm production and vitality

What Are the Concerns?

In recent years, drug manufacturers shifted their marketing campaigns to advertise products like AndroGel as a solution to “low T” and the natural effects of aging, such as fatigue, low sex drive and increased body fat. Essentially, a drug designed to replace testosterone in men with serious health problems began to be improperly prescribed to treat the normal effects of aging, leading to adverse effects.¹

The concerns are larger than misleading advertising. In early 2014, the FDA began investigating whether testosterone therapy products increase the likelihood of potentially life-threatening side effects, such as heart attack, blood clots and stroke.

The FDA later issued a warning stating the product is not designed to treat low testosterone levels due to aging. All manufacturers are now required to provide a warning of increased risk of heart attack and stroke on the label. Additionally, the FDA states patients experiencing chest pain, shortness of breath, weakness in one part of the body or slurred speech while using testosterone therapy should seek immediate medical attention.⁵

A January 2014 study found that men with pre-existing heart conditions taking testosterone have a “substantially” higher risk of heart attack, while another in March 2014 concluded men undergoing testosterone therapy have an “increased risk of adverse outcomes.”^3,4

Ongoing Legal Precedent

More than 6,000 people have filed lawsuits against AndroGel manufacturer, AbbVie, alleging that the company promoted the product as cure for “low T,” while failing to advertise that the drug was only approved for hypogonadism and has potentially deadly side effects.² The lawsuits have had mixed results.

Most recently, a jury decided that AndroGel was not to blame when a 72-year-old Arizona retiree suffered from a pulmonary embolism after using the drug for more than two years. AbbVie’s attorneys successfully argued that a genetic predisposition to heart problems and his own choices were to blame.¹

Just months prior, two separate cases heard in Chicago federal courts resulted in favor of the plaintiffs – one was awarded a $150 million verdict and the other $140 million. Both plaintiffs suffered heart attacks while using AndroGel. Despite AbbVie convincing the judge to throw out the $150 million verdict, the plaintiff was awarded more than $3 million in punitive and compensatory damages after a second trial.⁶

These are just a few examples of the ongoing product liability battle between the thousands of men who claim AbbVie’s drug has caused them serious injuries. The manufacturer has been named the defendant in more than 4,000 cases as of June 2018.²

Product Liability Compensation

Product liability cases like these hold negligent product manufacturers accountable for causing serious injury to consumers. The attorneys at Farris, Riley & Pitt, LLP have many years of experience handling dangerous drug cases in Alabama. If you or a family member were seriously injured while using a testosterone drug like AndroGel, you may be entitled to financial compensation.

To find out if you have a case by calling (205) 324-1212 or filling out the form on our website for a FREE consultation.

¹ https://www.chicagotribune.com/business/ct-biz-abbvie-androgel-lawsuits-20180205-story.html

² https://www.drugwatch.com/news/2018/04/26/androgel-testosterone-lawsuits-set-for-federal-trials/

³ https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805

⁴ https://www.ncbi.nlm.nih.gov/pubmed/24193080

⁵ https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm

⁶ https://www.drugwatch.com/news/2018/03/27/jurors-award-3-2m-verdict-androgel-lawsuit/

It’s not uncommon for a recalled product to cause serious injury and, in extreme circumstances, death. If you or a loved one has been harmed by a faulty product, contact the experienced lawyers at Farris, Riley & Pitt, LLP.

If you or a loved one has been injured in an auto accident due to a defective vehicle component, contact Farris, Riley & Pitt, LLP today.

A relatively new medication on the market, Onglyza®, is used to treat type 2 diabetes in adults. It was first approved by the FDA in 2009 to be used in conjunction with diet and exercise to lower blood sugar.¹ Onglyza works by boosting incretin levels in the body. Incretins control blood sugar by increasing the release of insulin, especially after meals. They also decrease the amount of sugar your liver produces.

The drug has grown in popularity because it’s less likely to cause weight gain than other diabetes drugs, but this benefit comes with potentially dangerous side effects, such as:

• Risk of heart failure: An FDA safety review has found that medicines containing saxagliptin (the active ingredient in Onglyza) may increase the risk of heart failure, especially in patients who already have heart or kidney disease. The study found a 27 percent increase in hospitalization for heart failure in those who took saxagliptin versus those on a placebo.² Signs of heart failure include shortness of breath, trouble breathing when lying down, tiredness and weight gain with swelling in the legs and stomach.
• Low blood sugar: Hypoglycemia may worsen in people who are taking other diabetes drugs, such as insulin, in addition to Onglyza. Symptoms of low blood sugar are shakiness, hunger, sweating, headache, rapid heartbeat and vision changes.
• Joint pain: Some people who take Onglyza develop severe and disabling joint pain.
• Pancreatitis: Researchers at UCLA and the University of Florida linked Onglyza to abnormal pancreatic growth. They found that cell mass was increased 40 percent in the pancreases of patients with type 2 diabetes who were treated with incretin therapy.³

Talk to your doctor right away if you notice any of these symptoms, or report them to the FDA.

Preventing Severe Side Effects

Your doctor will prescribe Onglyza to you if they determine that the benefits outweigh the risks. That said, there are steps you can take to lower your chance of experiencing severe side effects.

1. Tell your doctor/pharmacist if you are allergic to saxagliptin or any other ingredient.
2. Explain your medical history, including any history of kidney disease, pancreatitis, high levels of fats in the blood and heart failure.
3. The drug can cause blurred vision and drowsiness, so don’t drive or use machinery while taking it until you determine that it’s safe to do so.
4. Limit alcohol while taking this medicine because it can increase the risk of low blood sugar and pancreatitis.
5. Pregnancy may cause or worsen diabetes. If you are pregnant, talk with your doctor about your plan to manage your blood sugar, without medication if possible.

Onglyza Lawsuits

Onglyza met the FDA’s cardiovascular safety criteria when it was approved, but the agency had concerns about the clinical trials and asked manufacturer AstraZeneca to perform a post-marketing study. That trial found the connection between Onglyza and heart failure. The drug is now required to carry warnings about the risk of heart failure, joint pain and pancreatitis.

Despite these printed warnings, numerous lawsuits have been filed against AstraZeneca claiming the company didn’t sufficiently warn patients about heart failure risks. The heart failure side effect was not made public until 2014, and a warning label was not added until 2016.⁴ Some of these cases are geared toward compensation for alleged losses, such as medical bills, lost wages and pain and suffering. Others are wrongful death lawsuits filed by grieving family members who claim their loved one died from taking Onglyza.

Should I File a Lawsuit?

If you or a family member has experienced severe side effects after taking Onglyza, you’re may be eligible to file a lawsuit. These are some of the benefits of filing:

• Compensation for financial hardships
• Relief from emotional pain and suffering

Filing a Lawsuit in Alabama

When a loved one dies or becomes ill due to something unexpected, such as taking Onglyza, their family is often left shocked, heartbroken and not sure where to turn. Though this is a difficult time, it’s likely in your family’s best interest to contact a lawyer and determine if a lawsuit is justified.

The attorneys at Farris, Riley & Pitt are experienced with Alabama law and have represented many families who have lost loved ones as well as those dealing with an unexpected illness. Our firm has worked with personal injury victims in the Birmingham area for more than 20 years, and we’ll never stop fighting to get the compensation you and your family deserve.

Farris, Riley & Pitt, LLP is here to help serve justice. Visit us online or call 205-324-1212 to speak with our team about a free case evaluation.

¹ https://www.drugs.com/history/onglyza.html

² https://www.fda.gov/Drugs/DrugSafety/ucm486096.htm

³ http://newsroom.ucla.edu/releases/ucla-university-of-florida-research-244467

⁴ https://www.classaction.com/onglyza/lawsuit/

Earlier this year, HP recalled more than 50,000 laptops due to overheating and melting lithium-ion batteries. A year earlier, Samsung dealt with a PR nightmare when many of their new Galaxy Note 7 phones were catching fire due to faulty lithium-ion batteries. They had to issue a recall not once, but twice due to a design failure in the first batch and a manufacturing defect in the replacement batch. (more…)

According to data compiled by the National Highway Traffic Safety Administration (NHTSA), more than 42.6 million Americans were affected by 899 new recalls of vehicles, auto equipment, child safety seats and tires in 2017. Even worse, these astronomical numbers are low when compared to recent years. 2015 saw more than 86.3 million safety recalls, and 2016 wasn’t far behind at around 78.8 million.¹

Given how widespread the issue is, you may expect that many vehicle owners affected by recalls would promptly bring their vehicles in for repairs. Unfortunately, that is not the case. Data suggests that only 70 percent of those eligible for repairs act upon vehicle recalls. That means 30 percent of warned drivers are operating a vehicle that could fail on them, endangering not only themselves and their passengers, but also everyone else on the road.²

These numbers are even more abysmal for certain types of recalls. According to J.D. Power, the percentage of remedied recalls is much lower for:

• Recalls impacting more than one million vehicles – 49 percent
• Suspension issues – 48 percent
• Airbags – 47 percent
• Older vehicles – 44 percent
• Large SUVs – 33 percent
• Mid-premium sports cars – 31 percent

These percentages are startling, but they don’t have to be. Vehicle recalls are serious and easily remedied, which is why every owner should heed recall notices and check the recall status of their vehicle twice a year.

The Defects Are Dangerous

Many vehicle owners don’t realize auto recalls always pertain to mechanisms that pose a significant safety risk if they were to malfunction. Minor issues like paint misapplications, air conditioning defects and exterior rust do not warrant a recall. Neither does general wear and tear, as the vehicle owner would be expected to handle this on their own through regular vehicle inspection and maintenance. However, manufacturing problems that directly impact safe operation of a motor vehicle are subject to recalls, including:

• Steering mechanisms
• Brakes
• Airbags
• Seatbelts
• Tires
• Lighting
• Accelerators
• Child safety seats
• Fire hazards
• Major structural problems

Recalls are issued either through the manufacturer themselves or through NHTSA. Since manufacturers generally want to preserve their public image and NHTSA only has jurisdiction over safety issues, you can be sure that any vehicle recall poses a real danger.

Many People Have Complained

Some recalls are initiated by the manufacturer themselves if they become aware of a manufacturing problem or if they realize their vehicle does not meet the Federal Motor Vehicle Safety Standards (FMVSS), which dictate the minimum performance acceptable for vehicles and vehicle parts. Much of the time, however, vigilant consumers draw NHTSA’s attention to a problem by submitting complaints.

Any person can submit a complaint:

• Online – Simply fill out and submit a Vehicle Safety Complaint or Non-Vehicle Complaint on safercar.gov.
• Via the Vehicle Safety Hotline – Consumers can call toll-free at 1-888-327-4236 or at 1-800-424-9153 if they have a hearing impairment.
• By mail – Send a letter describing the problem to NHTSA in Washington, D.C.

After reviewing the complaints, NHTSA compiles the information and identifies trends. If they feel there is a safety concern, or if they grant a petition to open an investigation, they will begin a Preliminary Evaluation (PE), which can last up to four months. If the PE indicates an issue and the manufacturer refuses to send out a recall, NHTSA conducts an in-depth Engineering Analysis (EA) that can last up to a year. With sufficient evidence of a safety issue, they will send a Recall Request Letter to the manufacturer. In some cases, the manufacturer will still resist and a Public Meeting will be ordered to decide the matter. The manufacturer is also allowed to dispute a recall decision in Federal District Court.

As you can see, the recall process is thorough and often time consuming, relying upon stringent federal regulations and vehicle testing and analysis. Input from hundreds to thousands of concerned consumers is also considered. By the time the recall notice arrives in your mailbox, your vehicle may be well overdue for repair or replacement.

There Is No Drawback to Getting the Recall Fixed

Maybe you figure you’ll hedge your bets by skipping repair, replacement or a refund and continue driving your vehicle as is. While going in for a repair may be a minor inconvenience, there is really no downside to remedying a recalled vehicle or part. The manufacturer is required to offer repair free of charge, a suitable replacement or a refund that matches the value of your vehicle, taking depreciation into account. All you have to do is take advantage of the offer by going to your local dealer!

You may even be eligible for reimbursement if you already paid for repair or replacement of the vehicle or part in question. Be sure to keep receipts for all vehicle repairs so you can supply documentation to the manufacturer.

Find Out If Your Vehicle or Its Parts Have Been Recalled

If you are unsure whether your vehicle, auto equipment, child safety seat or tires have been recalled, visit this NHTSA recall page. To use the vehicle search, you will need to know your vehicle identification number (VIN). The VIN is usually located on the:

• Driver’s side dashboard, looking through the windshield from outside the car
• Car door jamb or pillar near the driver’s seat, which is only visible by opening the door
• Vehicle title, registration or insurance papers

You can also contact the manufacturer if you cannot find your VIN.

Protect Yourself Against Defective Automobiles and Equipment in Birmingham, AL

Sometimes an auto recall reaches a consumer too late to prevent catastrophe. If you have been injured in an accident due to a defective vehicle or vehicle part, the lawyers at Farris, Riley & Pitt, LLP will fight for your compensation.

We have more than 20 years of experience in the Birmingham area, including extensive experience advocating for clients in all types of product liability cases. Call us today at (205) 324-1212 for your free consultation.

¹https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/2017_recall_annual_report_updated011818_0.pdf
²https://www.nhtsa.gov/press-releases/us-dot-and-maryland-mva-collaborate-improve-recall-remedy-rates