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Celebrex Injuries

Synopsis of Prescription Drug Litigation

Celebrex is a pain medications that is sold by Pfizer to millions of Americans. Also known as selective COX-2 enzyme inhibitors, the drugs reduce pain and inflammation in the back and neck and pain from arthritis. However, they have also been linked to increased cardiovascular risk, including heart attacks and strokes.

Celebrex® (Celecoxib): Marketed by Pfizer and approved by the FDA in 1998, Celebrex was the first FDA approved medication in a new class of arthritis drugs known as COX-2 selective inhibitors.

Why is this medication prescribed?: Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Celecoxib is also used to treat painful menstrual periods and pain from other causes. It is also used with surgery and other treatments to reduce the number of polyps (abnormal growths) in the colon (large intestine) and rectum in patients with familial adenomatous polyposis (a condition in which hundreds or thousands of polyps form in the colon and cancer may develop). Celecoxib is in a class of NSAIDs called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation

FDA indications: CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, primary dysmenorrheal, familial adenomatous polyposis and ankylosing spondylitis, and for the management of acute pain in adults.

What special precautions should I follow when taking Celebrex?
Before taking celecoxib,

  • tell your doctor and pharmacist if you are allergic to celecoxib, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), sulfa medications, any other medications, or any of the inactive ingredients in celecoxib capsules. Ask your pharmacist for a list of the inactive ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone);angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); certain antidepressants (mood elevators); atazanavir (Reyataz);clopidogrel (Plavix);codeine (in some cough medications and some pain medications); dextromethorphan (in some cough medications); diuretics ('water pills'); efavirenz (Sustiva); fluconazole (Diflucan); fluvastatin (Lescol); lithium (Eskalith, Lithobid); certain medications for mental illness; metoprolol (Lopressor, Toprol XL); metronidazole (Flagyl); mexiletine (Mexitil); ondansetron (Zofran); propafenone (Rhythmol); ritonavir (Norvir, in Kaletra); sulfamethoxazole (Bactrim, Septra); sulfinpyrazone (Anturane);tamoxifen (Nolvadex) timolol (Blocadren, Timolide, in some eye drops); tramadol (Ultram); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); swelling of the hands, arms, feet, ankles, or lower legs; or liver or kidney disease.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking celecoxib, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking celecoxib.

Black Box  Warning:


WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
See full prescribing information for complete boxed warning
Cardiovascular Risk
CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

• CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk
NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.

Lawsuits:  On December 17, 2004 Pfizer publicly announced that patients who are taking Celebrex may have an elevated risk of suffering heart attack and stroke. The National Cancer Institute designed a study to research the effects of Celebrex on cancer. This Pfizer-sponsored study was suspended after preliminary evidence showed that clinical trial patients who were taking 400 to 800 milligrams of Celebrex were two and a half times more likely to suffer from heart attack or cardiovascular stroke than patients in the control group.

The findings came just two months after the recall of a medication quite similar to Celebrex in form and function. Vioxx was voluntarily pulled off the market by Merck pharmaceuticals, after internal clinical studies revealed that patients who had taken Vioxx for eighteen months were twice as likely to suffer from stroke or heart attack as the general population. Since the Vioxx recall on September 30, 2004, Merck has been subject to thousands of Vioxx lawsuits.

All Celebrex cases were consolidated into a federal multidistrict litigation (MDL) proceeding before the US District Court for Northern California in September 2005. (The lawsuit is In re Bextra & Celebrex Marketing, Sales Practice and Product Liability Litigation, N.D. Cal., No. 05-cv-01699-CRB)

On July 5, 2007, the Court dismissed the claims of all associational plaintiffs, including PAL members Health Care for All, Wisconsin Citizen Action, United Senior Action of Indiana, and North Carolina Fair Share, because all of the members of these organizations had not purchased Celebrex (or Bextra, a similar Pfizer pain-reliever.)

In July 2007, the case survived a Motion to Dismiss, and the complaint was amended to define the proposed nationwide class as "all Consumers and Third-Party Payors ... who purchased or paid for... Celebrex" from February 2001 to the present.

On February 14, 2008, Special Discovery Master Judge Smith decided against allowing the trial of a few individual cases before class certification, but did choose, for reasons of judicial efficiency, to proceed with class certification for Bextra (which is more straight-forward because Bextra is off the market.) The parties are negotiating discovery issues, with a class certification hearing for Bextra planned for late 2008 at the earliest, and Celebrex class certification to follow.

On October 17, 2008 Pfizer announced that it had reached agreements in principle to settle this class action suit, as well as 90% of the personal injury lawsuits that had been brought concerning Celebrex and Bextra, and cases brought by 33 state Attorneys General related to Bextra marketing. The $894 million deal includes $745 million to settle the personal injury cases, $60 million to settle the Attorney General cases, and $89 million to settle the consumer and third party payor claims related to Pfizer's alleged fraud.

On March 20, 2009, a federal judge gave preliminary approval to the $894 million settlement.  The settlement is for U.S. consumers and third party payers who purchased the drugs prior to July 29, 2005.
After a fairness hearing, the settlement received final approval on October 7, 2009.  Pfizer paid $89 million to settle the consumer and third party payer fraud actions.  Of this $89 million, 70% of the net settlement will go toward the third party payers and the remainder will be used to settle the consumer claims.

When to call the Venardi Law Firm:  The Venardi Law Firm is waiting to take your Celebrex case. If you or a loved one has been diagnosed with a stroke, blood clot, heart disease or other serious cardiovascular condition it could potentially be linked with the regular use of Celebrex. A Celebrex lawsuit can help victims of Celebrex injuries to receive compensation for related medical expenses, loss of income or earning potential, and pain and suffering. There are a number of side effect injuries that a patient can suffer that might constitute a Celebrex lawsuit. Let the Venardi Firm determine if you have been damaged. The consultation is free and cases are taken on contingency.

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