Ibrance is a brand-name medication approved by the FDA to treat advanced breast cancer in some men and women. Ibrance is a form of target therapy that targets and interferes with cancerous cells’ processes, blocking their growth and spread. The biological name of this target therapy drug is Palbociclib. If you have advanced breast cancer, Ibrance is an effective treatment.
Unfortunately, the latest research shows that this breast cancer drug increases severe lung inflammation among its users. If you are a breast cancer patient suffering lung inflammation because of this drug, Consumer Alert Now is ready to help.
We help patients with advanced breast cancer spread to other body parts suffering from severe lung inflammation to file mass torts against Pfizer Inc, the manufacturer of Ibrance. Besides, we help victims understand the purpose of the drug, its side effects, and the process of joining a mass tort.
Overview of Ibrance
Ibrance, also called CDK 4/6 Inhibitor, is a targeted therapy used in combination with particular hormonal therapies. The drug is different from traditional chemotherapy because it’s orally administered. It is taken in advanced breast cancer cases and not for patients in the early stages. It slows down the progression of cancer by putting brakes or blocking the growth of cancer cells. Although the drug is effective in breast cancer treatment, it has side effects, some of which are severe.
Ibrance is used in combination with hormone therapies to treat various types of breast cancer. These include:
- Metastatic or advanced breast cancer — This is breast cancer in an advanced stage and has spread to other parts of the body.
- HR+ — Ibrance is used in treating breast cancer patients with hormone receptor-positive. HR+ means the growth of cancer cells is stimulated by the estrogen receptor-positive (ER+), Progesterone receptor-positive (PR+), or both.
- HER2 - negative — Ibrance is used in cases where your cancer cells lack abnormally high or have fewer levels of proteins known as HER2. If you have a HER2 subtype, the few proteins in your cancer cells will make it almost impossible for cancer to respond to anti-HER2 therapies.
Ibrance has proved to be a useful target therapy for the above types of cancer. The drug puts brakes on breast cancer cell processes, making the cells grow and spread uncontrollably. The drug comes in the form of a capsule that you take through the mouth.
In two clinical trials, Ibrance used together with letrozole has proved to delay cancer advancement for postmenopausal women with HR+, HER2-negative, or both. Note that in this case, progression or advancement means worsening or spreading of cancer to other parts of the body.
The first clinical trial was performed over 666 postmenopausal women who hadn’t already received hormone therapy for their advanced breast cancer. The patients were divided into two groups. The first group took Ibrance with letrozole, while the second group took letrozole and placebo, a treatment with no active drug.
The combination of Ibrance and aromatase inhibitor put brakes on disease advancement for an average period of two years. On the other end, patients who took letrozole and placebo blocked the disease from advancing for a median duration of 14.5 months.
As per the clinical studies, patients who combined Ibrance with Femara had a 42 percent lower risk of breast cancer progression than those who took a combination of letrozole and placebo. This demonstrates that a combination of Ibrance and letrozole is highly effective in blocking the spread of advanced breast cancer.
The dosage of Ibrance your doctor is likely to prescribe depends on whether you are on other medications, your liver function, and if you experience side effects.
Ibrance often comes in a capsule whose strength can be 125, 100, or 75mg. The tablet with 125mg strength is the standard one and is usually taken once a day for twenty-one days. The 21 days are followed by another seven days, where you take a break from the medication. This cycle is repeated for the duration your doctor deems necessary.
If you are on other medications or your liver is not well-functioning, the doctor will prescribe Ibrance capsules with lower strength. In case the drugs’ side effects are severe, the doctor will recommend that you take a break from the treatment.
Keep in mind that this medication is used as a long term target therapy. While taking the drugs, make sure you follow instructions, and whenever you miss a dose, skip and take the next one. Taking an extra dose to cover for the one you missed can cause more problems.
Why is Ibrance Dangerous?
The FDA gave a warning that Ibrance (Palbociclib), used to treat patients with advanced breast cancer, increases the risk of developing rare but severe lung inflammation. However, the drug has not been recalled because the overall benefits of taking the drugs are more than the risks when prescribed by a doctor.
The FDA now requires that all the approved new warnings about the dangers of prescribing the drug be contained in the entire class of CDK 4/6 Inhibitor drugs prescribing information. Doctors prescribing these drugs have also been informed to monitor patients taking these drugs for pulmonary symptoms. These symptoms include:
The FDA recommends that when a doctor observes any of these symptoms in a patient, they put on hold the treatment. However, if you have pneumonitis or severe interstitial lung disease, the treatment should be stopped permanently.
If you are using these drugs, you shouldn't stop. Instead, the agency recommends that you alert the doctor right away if you develop a new or deteriorating lung issue like difficulties or discomfort while breathing or shortness of breath after a short activity.
Possible Side Effects of Taking Ibrance
While receiving target therapy, remember to inform your doctor about the symptoms that you experience. The common side effects of the drug include:
- A low number of red blood cells
- Low energy
- Decreased number of blood cells known as platelets
- Loss of appetite
Severe side effects of Ibrance include:
- Low white blood cell count (neutropenia) can cause severe infection, some of which are fatal. Before and during treatment, your doctor should check your white blood cells count. If you begin experiencing fever or chills, it indicates infection, so you should immediately reach out to your doctor. You can also learn to prevent infections by staying away from people with infections and regularly washing your hands.
- Lung problems, also called pneumonitis, is the severe inflammation of the lungs. You should immediately talk to your doctor if you are taking Ibrance with other hormone therapies and begin to experience pain in the chest, shortness of breath, and cough with or without mucus.
Discussed below are the negative side effects of Ibrance in detail:
In most cases, taking Ibrance can result in hair thinning, but you will rarely experience hair loss. The drug causes hair loss because it is often taken together with letrozole or fulvestrant, whose use is associated with hair loss.
During clinical trials, 33 percent of the people taking Ibrance with letrozole reported hair loss, while only 16 percent reported hair loss after taking letrozole with placebo. In case you have concerns about your hair loss during treatment, speak to your attorney about it.
Although the allergic reaction was not a side effect reported during clinical trials, if you experience any allergic reaction after taking Ibrance, you should talk to your doctor. However, if the allergic reaction is life-threatening, you can call 911 for an emergency response team.
Some of the signs that can indicate that you have a severe allergic reaction include:
- Difficulties breathing
- Swelling of the tongue, mouth, or throat
- Swelling on the feet, eyelids, hands, or hips
Hormone therapy treatments for breast cancer can cause headaches. So, when undergoing breast cancer treatment, a headache is something familiar. People using Ibrance with fulvestrant are 20 percent more likely to experience headaches. When headaches become persistent, you should talk to your pharmacist to prescribe pain-relieving medication.
Nausea and Vomiting
During Ibrance clinical trials, nausea and vomiting were prevalent among patients. Thirty-five percent of the patients using Ibrance with letrozole experienced a nauseous feeling, while sixteen percent experienced vomiting. Of the patients under letrozole and placebo treatment, 26 percent reported nausea, while 17 percent experienced vomiting.
You can prevent nausea during treatment by taking small portions of food in a day. Doing so is great if you have lost appetite, and it helps keep your energy levels high. You can manage nausea and vomiting by taking anti-nausea medication or speaking to your doctor.
When taking Ibrance, diarrhea is something you will experience often. Based on clinical trials done on the drug, 26 percent of the people taking Ibrance with letrozole experience diarrhea. Of those taking letrozole with placebo, 16% percent experience diarrhea. For patients taking Ibrance with fulvestrant, 24 percent of them develop diarrhea. Studies further discovered that 19 percent of patients using fulvestrant and placebo experienced diarrhea.
If you take Ibrance with other hormone therapies and get diarrhea, drink a lot of fluids to prevent dehydration. However, if diarrhea doesn’t stop, you should consider talking to your doctor.
Lawsuits Filed Against Ibrance or Pfizer
Pfizer failed to warn patients with advanced breast cancer about the dangerous side effects of their drug Ibrance. So, suppose you are one of the people who have suffered Pneumonitis after using Ibrance. In that case, you can file a dangerous drug suit against Pfizer for not adequately warning or updating its consumers on the severe side effects of the drug. If you have suffered or lost a loved one because of severe lung inflammation, you can file a lawsuit alleging that:
- Pfizer put up Ibrance for sale without any proper tests
- They failed to disclose the severe side effects of the drug
- They failed to corroborate the safety of the drug before releasing it to the market.
- They produced a dangerous drug.
- Ibrance had manufacturing defects.
Reimbursement for Victims of Ibrance Dangerous Side Effects
The above suits are by victims of Ibrance seeking financial compensation from Pfizer due to their dangerous drug. The damages you are seeking help cover the following losses:
- Doctor bills resulting from diagnosis and treatment of severe lung inflammation
- Professional consequences caused by the injury like loss of income
- Physical pain and suffering associated with severe lung inflammation
Victims of this drug that develop severe lung inflammation require regular treatment. So, it’s only right that if you are one of these victims, you pursue damages. Some patients using Ibrance even end up losing their lives because of lung problems while avoiding death by cancer. Suppose you have lost a loved one due to these dangerous side effects. You can file a wrongful death claim.
You could also pursue punitive damages, not for monetary damages but to punish Pfizer for not adequately warning consumers of their drug about its dangerous side effects.
Product Liability Law
Product liability law provides legal recourse for individuals who have sustained injuries after consuming a dangerous product. Naturally, the law requires producers, distributors, designers, or manufacturers of a product to ensure that it meets the consumer’s ordinary expectations. If the product has an inadequate warning on consumer information, the manufacturer should be held accountable.
The common types of product defects include:
- Marketing defects — This is where the manufacturer fails to provide adequate warnings or instructions about a product.
- Design defects
- Manufacturing defects
As a plaintiff in a product liability case, you don’t need circumstantial evidence to prove the defendant was negligent. Instead, you need to show that you suffered injuries or harm because of a dangerous product by the manufacturer. The elements you need to prove are:
- The defendant designed, produced, and distributed a defective product
- When the product was leaving the defendant’s hands, it was already defective.
- You, as the plaintiff, used the product in a reasonably foreseeable way.
- The defect or flaws of the product caused you harm
In the case of Pfizer, you can sue them for designing, producing, and distributing an advanced breast cancer drug that didn’t contain sufficient warning about severe lung inflammation side effects. Pfizer had the responsibility to foresee possible use and misuse of Ibrance to try and minimize the harm of injuries of this dangerous drug before it leaves for the market. Although drug manufacturers cannot eliminate the side effects, they must mitigate its risk of causing injuries or harm.
Pfizer had minimized the drug’s risk of causing harm or injuries before the FDA’s approval. However, they failed to provide adequate warning because the warning label on Ibrance could not indicate the drug increases the risk of severe lung inflammation. However, Ibrance was not recalled because its benefits in treating advanced breast cancer surpass the risks. Severe lung inflammation is a rare side effect that only occurs in a few patients.
When you file a lawsuit against Pfizer, you should expect them to challenge your case using the following defenses:
- They didn’t manufacture, design, or distribute a dangerous drug.
- Ibrance was not defective.
- The plaintiff used Ibrance in a fashion that wasn’t reasonably foreseeable.
- Negligence by the plaintiff caused the injuries.
- Severe lung inflammation was caused by something else other than Ibrance.
Remember that to build a strong case, you need someone with legal experience. So, it’s critical to have an attorney by your side when suing a large company like Pfizer Inc.
When a civil wrong is committed by a person or organization causing injuries or harm to someone else's, it is a tort. On the other end, a mass tort is a civil action by multiple plaintiffs who have developed similar injuries, suing a company for producing a dangerous product. Mass, in this case, means several plaintiffs participating in the civil action. It could also mean the media is being used to recruit plaintiffs who have suffered injuries or lost a loved one because of the defective product.
Mass torts are established when many people suffer harm because of a defective product. In this case, many of the patients using Ibrance develop cancer and have developed severe lung inflammation causing a lot of suffering and, in some cases, death. Many law firms are investigating Pfizer because of Ibrance. So, you and others, victims of this dangerous drug, should join a mass tort to sue Pfizer for the pain and agony caused by their metastatic breast cancer drug.
Suing a company like Pfizer is a great deal because their legal team could delay the case for years. With your limited resources, it will be impossible to win the case. However, if all the victims who have suffered severe lung inflammation join a mass tort, one judge can coordinate the issue. Also, hearing all the plaintiffs under one litigation, the court and the plaintiffs save on resources.
The Process of Creating a Mass Tort
Although mass torts differ, the majority of proceedings involves:
- You, as the plaintiff, filing the first complaint backed with all the relevant documents.
- You filing a motion to consolidate a lawsuit.
Note that courts have guidelines on how petitions should be unified. For this reason, you will need an attorney to petition the court to put together with other litigations into a unified process called multidistrict litigation.
The next step is the status conference, where you and other plaintiffs update the judge hearing the case on the various developments.
In the discovery stage, the court allows the opposing sides to share facts about the case and crucial documents. If you would like to file a motion or petition, this is the time to do it.
In case you want to get some in-depth knowledge of what to expect in other lawsuits, bellwether programs are the way to go. The program allows small lawsuits to be heard by a jury, and although the ruling in these cases doesn’t affect the outcome of the multidistrict litigation, it gives you knowledge on what to expect.
The last but not least stage of this process is the settlement negotiation. If the outcome of the mass tort isn’t in your favor, you can appeal the decision.
Factors That Might Influence the Length of a Mass Tort
When you join a mass tort seeking compensation for severe lung inflammation caused by Ibrance, you want the case to be concluded fast. However, many factors can influence the length of the lawsuit.
You will require pharmaceutical researchers and physicians to testify about the rare risk of severe lung inflammation caused by Ibrance. The duration takes to locate these experts and have them testify will influence the length of the case.
Your attorneys and other people investigating the case will need to move a lot to locate advanced breast cancer patients who have been harmed by Ibrance. The time spent in travel will also affect the length of the mass tort.
Another aspect that might influence the length of the case is evidence collection and planning. Remember, you will need medical reports for various breast cancer patients who have been taking Ibrance and analyze them to confirm that they developed severe lung inflammation. This might take weeks or months, and it’s likely to influence the length of the lawsuit.
Differences Between a Mass Tort and a Class Action
Mass torts and class actions are two collective actions with critical differences. In a mass tort, even though you are part of a group, you are treated individually. It means that you will get a separate trial where you need to prove the individual harm you suffered and the defendant’s actions contributed to the injury.
On the other hand, class action involves a class of plaintiffs, which means they are not treated separately. Instead, they are considered as a class under one representative. The case is heard in one trial with the class rep[resentative representing all the plaintiffs.
In a mass tort, the number of plaintiffs is smaller than that of a class action.
Find a Mass Tort Attorney Near Me
If you are being treated for advanced breast cancer using Ibrance and experience severe lung inflammation, you need to seek financial compensation. Consumer Alert Now has the resources and knowledge to help you and other plaintiffs nationwide who are victims of this dangerous drug to take on a large pharmaceutical company like Pfizer for failing to warn consumers of Ibrance’s severe side effects adequately. Reach out to us today at 800-511-0747 to speak to our legal representatives at zero cost.