Product Defect

Why don’t the warning labels on Actemra list its most dangerous side effects?

According to a June 7, 2017 PharmaLive.com report, Actemra (tocilizumab), an FDA-approved medication manufactured by Roche/Genentech for the treatment of rheumatoid arthritis, has been associated with the deaths of more than 1,000 patients. Especially troubling is that the causes of these deaths are not listed on the drug’s label as among the drug’s potential side effects.

Frightening as this is for patients who have been prescribed Actemra, it is, unfortunately, not an isolated situation. Over the years, a number of theoretically “safe” medications have resulted in serious unpredicted side effects, sometimes resulting in the deaths of unsuspecting patients. If you, or someone in your family, has suffered a severe reaction to a drug, you should be aware that you have legal recourse. A personal injury attorney experienced in product defects will be able to fight to ensure that you and your family receive the compensation you deserve.

What is Actemra used for?

Actemra is a biologic drug approved to treat moderate to severe rheumatoid arthritis (RA) in adults and particular types of juvenile rheumatoid arthritis and idiopathic arthritis in children. Biologic medications are designed to reduce the inflammation which is the primary symptom of rheumatoid arthritis.

How many patients have taken Actemra?

The problems associated with Actemra are not small ones. Since the drug was approved for use in 2010, it has been prescribed to more than three-quarters of a million patients. Many had severe reactions, and for over 1,100 such reactions resulted in fatalities.

Side Effects of Actemra Listed on the Label

The milder side effects listed on the Actemra label include:

• Runny or stuffy nose
• Sinus pain, headache, dizziness
• Sore throat
• Itching
• Mild stomach cramps
• Urinary tract infection (UTI).

The more severe side effects mentioned include:

• Severe stomach pain with constipation
• Bloody, tarry, or clay-colored stools
• Coughing up blood or vomiting
• Painful blistering skin rash upper stomach pain
• Dark urine
• Jaundice

While some of the latter symptoms imply gallbladder or pancreatic involvement, pancreatitis, one of the dangerous side effects observed by doctors in patients taking Actemra, is not listed.

The Serious Unmentioned Side Effects of Actemra

Stat News has reported that the hundreds of people whose deaths were associated with the drug died from cardiovascular and pulmonary complications, other side effects for which Actemra labels carry no warnings. During an investigation of more than 500,000 reports of side effects from rheumatoid arthritis drugs, Stat News found clear evidence that, even though Actemra labels contain no warnings relative to heart attack, stroke, or pancreatitis, the risk of having of experiencing such life-threatening events was as high, or higher, for Actemra patients than for patients taking other biologics that carried warnings of such events.

Numerous doctors have suggested that Actemra has had a significant involvement in the deaths of their patients, suggesting a link between the drug  and cardiovascular events and/or pancreatitis. Various experts who have reviewed the evidence, which although still circumstantial is statistically compelling, recommend that the FDA consider adding a warning label to Actemra that includes the dangers of heart and lung problems and pancreatitis. Because of the time lapses in FDA reporting, it is essential that you be aware of the dangers of any medications that may be prescribed to you or your loved ones. If you suffer a severe medical episode while on a new medication, you should investigate the possibility that the two events are connected and contact a skilled personal injury attorney promptly.

When it comes to defective products, commercial airliners are probably one of the last pieces of machinery consumers would want to see malfunctioning – especially at 30,000 feet in the air. As technology advances, aircraft become more and more intricate – and presumably safer for commercial passengers. However, tragically, airplanes can be susceptible to faulty parts, inadequate assembly or defective design – which inevitably leads to product liability litigation.

Recently, the U.S. Court of Appeals for the Third Circuit issued a controversial decision in a product liability lawsuit involving the issue as to what jurisdiction – state or federal – has final say in the compliance of a particular aircraft design with regulatory guidelines. In sum, the appeals court concluded that state law controls with regard to the requisite “standard of care” needed when considering claims of aircraft malfunction, notwithstanding the Federal Aviation Administration’s (FAA) comprehensive guidelines – which may or may not overlap with a particular state’s standards.

The case emerged in 2005 following the fatal crash of a Cessna 172N after, as plaintiffs allege, the engine shut down shortly after takeoff. The aircraft was recently fitted with a new carburetor – pursuant to federal standards – which plaintiffs assert was the main cause of the failure. At odds in the case are the state law standards of care and safety, and the federal standards. Under this case, the Third Circuit adopted the notion that the states can decide the requisite level of care necessary in aviation product liability claims, which has caused much chagrin in the aviation industry. In the appeal of the Third Circuit’s decision, the national Pilots Association filed an amicus brief encouraging the Supreme Court to not only grant review of the case, but issue an opinion in favor of the FAA having final say in the standard of care required in the manufacturing and design of all aircraft nationwide.

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Everyone knows laundry day is dull; but an exploding washing machine is hardly the solution to the bore of the chore. Hot on the heels of the Samsung Galaxy S7 explosion issue, the company is now facing a slew of claims that their washing machines contain a similar malfunction – which has dangerous property damage and increased risk of injury. As a result, the company voluntarily recalled three million washing machines in early November, and have warned users to immediately stop using the product until a replacement can be installed.

According to consumers, a malfunction in the drum of the machine can cause the lid to “violently” pop off, which could severely injure anyone standing nearby. In the words of one individual with the issue, the lid popped off violently it actually penetrated the wall of her garage.

According to the company, if the machine contains bulky bedding or other heavier items, it can cause the drum to dislodge from its components during the spin cycle. As a result, the machine will begin vigorously vibrating, which in turn causes the lid to eventually dislodge. Samsung has warned consumers to stop using the washing machine immediately, particularly when washing large or water-resistant items.

Under product liability laws, despite issuing a voluntary recall, the company could still face liability for placing an unreasonably dangerous product in the marketplace. As a manufacturer of consumer goods, Samsung is responsible for warning consumers of known risks, as well as risks the company should have uncovered through testing and troubleshooting. Liability will be an even greater issue if it comes to light the company knew about the malfunction and did not take steps to correct it and/or warn consumers. In a typical product liability action, a consumer can win compensation for any physical injuries or damage to surrounding property. If a consumer product causes an extremely debilitating injury, or the total effects of the injury have yet to be determined, a plaintiff may win an even greater sum.

Contact an experienced personal injury law firm today!

If you would like to discuss your personal injury case with a team of professionals, please contact Chandler Mathis & Zivley today: 1-800-657-2230.