Defective Drugs

A Southern California man has been awarded $48 million in a negligence product liability case concerning the ibuprofen over-the-counter pain reliever, Motrin. The man, now 22, began taking Motrin for aches and pains when he was 16 and an active soccer player. He broke out with blood blisters in his mouth and a severe rash and lesions. Motrin is made by McNeil Consumer Healthcare, which is a subsidiary of Johnson & Johnson.

The action claimed that the product insert did not contain enough of a warning about the devastating side effects causing a condition known as toxic epidermal necrolysis. The Los Angeles Superior Court panel awarded $48 million even though the plaintiff’s attorney had asked for $102 million based on Johnson & Johnson’s revenue from the sale of Motrin. The jury also awarded $8.97 million in punitive damages against Johnson & Johnson and another $6.8 million against McNeil. The company did not announce whether it would appeal.

The U.S. Food and Drug Administration (FDA) ordered additional information added to the labels of ibuprofen regarding skin rashes and blistering.

Product Liability and Defective Products
A product liability lawsuit can be filed when a product either has a manufacturing defect or is defective by design, or the company is negligent in containing adequate warnings to the public about the risks. Product liability actions can name the manufacturer, the designer, the distributor, or anyone who profits from selling a defective product. Punitive awards send a clear message to the manufacturer that if you are going to profit from a product, you have the responsibility to first make sure it is safe.

Farah & Farah has been filing Florida product liability cases over defective products since we opened our doors in Jacksonville in 1979. Call us with any questions and we can set up a complimentary consultation on your injury that resulted from a defective product. Our number is 1-800-533-3555.

Source: http://www.contracostatimes.com/california/ci_19034864; http://abcnews.go.com/US/wireStory/48m-awarded-man-motrin-blood-blisters-case-14664737

While an award of $10 million will help cover some of the costs associated with a life-threatening injury, this family from Philadelphia wishes the injury had never occurred in the first place. A jury has decided the family should be compensated after their now 13-year-old daughter suffered a dangerous reaction to the drug Children’s Motrin brand ibuprofen. The girl was given the over-the-counter drug when she was 3-and-a-half and almost immediately a rash appeared on her body and around her eyes. Then burns and blisters formed on her body. She was blinded in one eye and was taken to a burn union at Shriners Burn Hospital in Galveston, Texas where it determined her reaction was an allergic one to Children’s Motrin.

Florida Product Liability Law
A product can be defective in its design, its manufacture or its labeling. In this case the Children’s Motrin label did not mention the girl’s eventual diagnosis, Stevens-Johnson syndrome and toxic epidermal necrolysis syndrome (TENS). Stevens-Johnson compromises the mucus membranes in the mouth, cornea, urethra, vagina and rectum. TENS is more severe and affects a larger percentage of the membranes. The disease is rare, affecting about one in one million, or eight to one million people. The girls has suffered seizures, eye and lung infections, lost the majority of her skin, suffered brain damage and lost about half of her lung capacity.

The lawyers for the family pointed out that the prescription version of Children’s Motrin has warnings. It is the obligation of a product manufacturer to inform the medical community and patients about the potential for harm, but that didn’t happen in the over-the-counter version. If the family had known, they would have discontinued the medication.

If you or a loved one has suffered at the hands of a product that did not contain an adequate warning, there may be avenues for recovery of your family’s medical expenses. Let an experienced Florida failure to warn attorney help guide you through the complexities of these cases.

Sources: http://philadelphia.cbslocal.com/2011/05/26/philadelphia-jury-awards-10m-to-girl-in-motrin-drug-lawsuit/ and http://www.lexisnexis.com/community/tortslaw/blogs/productsliabilityandtoxictortsblog/archive/2011/05/20/10-million-awarded-to-girl-in-children-s-motrin-case.aspx

There are more manufacturing woes for corporate giant Johnson & Johnson (J&J) as the company announced on Tuesday, June 28, it will launch another recall of Extra Strength Tylenol Caplets. The 60,000 bottles recalled were produced in 2009 and once again have a musty odor that has plagued other medicines made by J&J.

The bad smell has been linked to the chemical, 2,4,6-tribromoanisole, a preservative used on wooden pallets that ship drugs which can cause unpleasant gastrointestinal symptoms but is not serious. The antipsychotic drug Risperdal was contaminated with the same odor as was the HIV/AIDS drug Prezista, anti-epilepsy drug Topamax, and different types of Tylenol, reports the Wall Street Journal.

This time Tylenol 225 count caplets with a lot number ABA619 and a UPC Code of 300450444271 should not be consumed. Consumers should contact J & J subsidiary, McNeil Consumer Healthcare at 1-888-222-6036 for a refund or coupon for another product.

There have been about two dozen recalls of J&J products since September 2009 including prescription and nonprescription medicines with a bad smell, contact lenses that irritated eyes, replacement hips that didn’t work, and defective Tylenol and Motrin. J&J lost about $900 million in sales last year due to the recalls.

The company’s Fort Washington, Pennsylvania plant, which was closed by the Food and Drug Administration in April 2010 because of unsanitary conditions, has still not been re-opened.

If you or a loved one is injured by a defective product, the manufacturer, designer, and every entity involved in the distribution of that product can be held liable for those injuries. To find out more, contact a knowledgeable product liability lawyer in Florida.

Sources: http://blogs.wsj.com/health/2011/06/28/jj-recall-watch-extra-strength-tylenol-pulled-due-to-smell/?mod=google_news_blog and http://finance.yahoo.com/news/JJ-recalls-more-Tylenol-Extra-apf-4194662331.html?x=0

An investigation by Consumer Reports released on Tuesday, June 28, finds that drug labels are often missing critical safety warnings to keep patients safe from a prescription error or overdose. The researchers wanted to find out whether drugstores were including medication guidelines that are federally mandated for certain drugs. They also looked at the information consumers receive on the labels, stickers, or printed information that comes with the medication.

Here is what they found when they filled a prescription for the blood thinner, warfarin:

• 4 out of 5 pharmacies did not include the medication guide which is required for warfarin. That includes Target, CVS, Walmart, and Walgreens. Costco got it right.
• The pharmacies included their own printed material but they were different from the FDA-guide approved for warfarin and had conflicting information about alcohol consumption. (FDA says not to drink while on the drug).
• The font size was very small and difficult to read.
• Medical jargon has the potential to confuse a patient. There is no nationwide standard for language.

When a consumer receives a drug without an adequate warning, a product liability lawsuit can generally be filed if an injury occurs however, in a further erosion of American citizen’s rights, the Supreme Court in a June 5-4 ruling, decided consumers should be barred from suing the makers of generic drugs if the warning that accompanies the drug is inadequate. The ruling means generics drug companies do not have to update drug labels if there are new safety concerns, making them riskier for consumers. For brand name drugs, consumers can sue drugmakers for a failure to warn about a drug’s dangers.

Consumer Reports says the burden for checking a prescription falls on the consumer since about 1.5 million prescription errors occur every year which are preventable. Take your prescription to the pharmacist to double check he got it right. Ask about whether the drug should be taken with food, whether you can take vitamins, whether you can drink alcohol, and the common side effects, among other questions.

Sources: http://www.webmd.com/news/20110628/some-drugs-sold-without-safety-information and http://blog.pharmexec.com/2011/06/23/supreme-court-ruling-makes-generics-more-dangerous/

This is good news for Genentech, a unit of the Swiss company, Roche Holding AG. The Centers for Medicare and Medicaid Services said it will continue to pay for the expensive drugs, Avastin and another drug Provenge, for prostate cancer, despite the conclusion of a U.S. Food and Drug Administration (FDA) advisory panel that Avastin, a breast cancer drug, does not increase the life of patients and is unsafe. By a 6-0 vote the advisory panel decided Wednesday, June 29, to rescind the drugs’ approval for use in breast cancer patients.

The panel did not make mention of the cost – Avastin is very expensive –about $88,000 a year. Women under treatment for breast cancer panicked believing if it was taken off the market they would have to pay the full price to receive the drug for off-label use. Avastin would remain on the market for use against other forms of cancer, such as colon cancer where it has been found to be successful.

One year ago, another FDA panel voted 12-1 to revoke the approval of Avastin for use in breast cancer patients. Provenge is used by men whose prostate cancer has spread beyond the prostate. On Thursday, June 30, the panel concluded that Provenge improved health outcomes and was reasonable and necessary for treatment. Provenge is also expensive at $93,000 a year.

Critics said the government was singling out two expensive drugs for elimination, something the FDA and Medicare denied. Public comment can be made up until July 28 and the FDA does not have to follow the recommendation of its panel, though it usually does.

Sources: http://www.ibtimes.com/articles/173584/20110703/medicare-to-pay-for-avastin-regardless-of-fda.htm, http://www.consumeraffairs.com/news04/2011/06/panel-avastin-not-a-treatment-for-breast-cancer.html, http://www.nytimes.com/2011/07/01/business/01drug.html?_r=2&ref=health and http://www.ibtimes.com/articles/172032/20110630/is-avastin-useless-in-treating-breast-cancer-abigail-alliance-criticism-patients.htm

It had been a problem for Johnson & Johnson before and once again a chemical smell is plaguing bottles of a prescription drug, making them unusable. This time J & J is recalling about 16,000 bottles of Risperdal, an antipsychotic made by the Ortho-McNeil-Janssen division. In the past, a wood preservative used on the wooden pallets that store bottles and transport drugs in overseas plants was found to have transferred to the bottles and its contents. The HIV drug, Prezista, two lots of Topamax, an epilepsy drug, and different types of Tylenol have all been affected in past exposures. Besides an unpleasant smell, the chemical can cause GI upset.

Some of the other J &J drugs affected:

• 2,000 bottles of Prezista pulled from European countries because of a bad smell
• 34,000 bottles of Tylenol 8-Hour Extended Release pulled because of the musty chemical odor

In January, J & J pulled 43 million bottles of Tylenol, Benadryl, Sinutab and Sudafed made at the Ft. Washington, Pennsylvania plant that the FDA later closed because of unsanitary conditions.

The company signed a consent decree with the Department of Justice that will require government oversight for five years because of the ongoing problems at the Fort Washington plant. The Wall Street Journal says a string of J & J recalls cost the company about $900 million in sales last year.

The Food and Drug Administration reports there have been no injuries associated with the musty odor problem in J & J products but 121 people suffered hallucinations, vomiting, and an inability to speak or see after ingesting a Benadryl Itch Stop Gel made by J & J that was inadequately labeled.

If a defective product or an inadequate label injures a consumer, they have the right to sue the product maker for damages under Florida product liability law. Depending on the situation, the action could include anyone involved in the product’s production from the retailer to assembler, and requires the defendant to cover the damages caused to the plaintiff.

Ultimately, the law encourages manufacturers to make a safe and reliable product.

Source: http://blogs.wsj.com/health/2011/06/17/jj-recall-watch-risperdal-is-recalled-due-to-odor/

The key ingredient in the popular cholesterol lowering drugs – Zocor, Vytorin, and Simcor – is receiving an additional warning from the U.S. Food & Drug Administration (FDA). On Wednesday, June 8, the agency recommended changes on its label concerning safety criteria for simvastatin, the key ingredient in these drugs. The label will now include restrictions concerning the highest dose, an 80 mg dose, on the label of simvastatin, Simcor, Zocor, and Vytorin. The label change will also include a warning about mixing the drug with certain medications that can increase the level of simvastatin the body.

The 80 milligram dose has been associated with a risk of myopathy, especially in the first year of use. Myopathy affects the muscle tissues and results in weakness, inflammation, or paralysis or spasms. Progressed myopathy, the most serious form, can lead to kidney damage, kidney failure, and even death.

Because of the potential for problems, the FDA recommends only patients who have been on simvastatin 80 mg for a year or more who have NOT had any muscle toxicity be allowed to continue its use. The agency is discouraging any new patients be prescribed the drug and those patients taking other drugs should be reevaluated for a dose limitation. Any patients on the drug who experiences dark colored urine, tiredness, muscle pain or weakness should talk to their healthcare provider immediately.

In a Florida product liability action, the fault can rest with the manufacturer, the wholesaler, a retailer or some entity in the chain of distribution. Another type of a product liability case is a failure to warn that led to injuries. In this case, the manufacturer knew or should have known that there were dangers inherent in the product but failed to warn the public.

Product liability law holds those people responsible if they were in a position to prevent injuries but failed to do so. The product liability attorneys in Gainesville at Farah & Farah are always available for a complimentary consultation on your possible product liability case.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258338.htm

GlaxoSmithKline Plc (GSK), the drug company that makes Poligrip, has decided to settle a class action lawsuit paying $120 million over claims that zinc in the preparation caused neurological disorders. The action resolves more than 100 lawsuits, reports Bloomberg. Plaintiffs had claimed that the drugmaker failed to warn consumers about health risks associated with denture adhesives such as nerve damage that can result from zinc, which is used to make the product bond more effectively. The company makes Super Poligrip Original, Ultra Fresh and Extra care products all with zinc. GSK agreed to remove zinc from its formulations last February. Meanwhile Procter & Gamble which makes Fixodent, the leading competitor to Poligrip, is accused by consumers of hiding its zinc-related health risks. Consumers will face off with the manufacturers in court in Miami in June.

Plaintiffs in a product liability lawsuit must prove the product that injured them was defective. The product can either be defective in its manufacture, its design or in its marketing. Marketing must accurately and completely tell consumers both the positive and the negative aspects of the product so they can make an informed decision whether or not to purchase it. A marketing defect can also include an improper label or insufficient instructions.

The Florida product liability lawyers at Farah & Farah have an open door policy to discuss the injuries a victim has suffered as a result of using a defective product. Please don’t assume if a product is on the market it has been cleared for your safety and health. If you have questions about your legal rights as an injured consumer, contact Farah & Farah today.

After being injected with Humira, an Abbott laboratories drug, for five years to treat her arthritis, a woman has filed a lawsuit saying the drug caused her breast cancer, reports Consumer Affairs. The case has been filed in Boston and charges Abbott of failing to warn about the drug’s cancer risks. Humira is a drug that is made from the body’s own natural substances using human cells to treat rheumatoid arthritis.

Injected bimonthly, Humira inhibits the body’s own Tumor Necrosis Factor (TNF) linked to inflammation and rheumatoid arthritis. But TNF also plays a role in cell death within the body, which may include cancer cells. The lawsuit says Abbott downplayed the risks of developing lymphoma and other cancers, even though the rate of cancers was higher in clinical trials. The lawsuit says that by the end of 2003, there were 365 adverse reports involving some form of cancer but the FDA and Abbott failed to issue stronger warnings. Not until 2009, under Food and Drug Administration (FDA) guidance did Abbott issue a stronger warning. The plaintiff discovered a lump in her breast in February of 2008. She stopped taking Humira and the cancer is now reported to be in remission.

Approved since 2002, Humira is used in 83 countries by almost 500,000 patients. The blockbuster drug has produced revenue of $6.5 billion.

Besides manufacturing and design defects, product liability law allows a plaintiff to file an action based on marketing defects. That may include the improper labeling of a drug or product, insufficient instructions, or a failure to disclose all of the hidden dangers of the product. Whether negligent or intentional misrepresentation, a successful product liability claim can be made against the manufacturer who fails to warn the public about the dangers that can lead to injury and death. The Florida product liability attorneys at Farah & Farah will always make time for a complimentary initial consultation to determine whether or not the product you used was defective in a way that led to your injury.

Just how dangerous is the prescription drug Paxil? A Louisiana couple argues that the depression drug presented an unreasonable danger to the couple’s unborn child when it was taken by the mother during pregnancy, reports Consumer Affairs. The child suffered birth defects including a club foot, congenital defects, as well as other disorders. The couple has filed a federal lawsuit against Glaxo SmithKline (GSK), maker of Paxil, arguing the drug is “dangerous in design.”

The couple says they did not connect the dots linking Paxil to their son’s problems until years after his 2003 birth. That’s because the Food and Drug Administration (FDA), along with GSK, issued warning about Paxil in September 2005 warning women there was a risk of major congenital malformations of babies whose mothers took Paxil and Paxil CR during the first three months of pregnancy. The warning is directed to healthcare workers to discuss alternatives with patients. The mother was prescribed Paxil by her physician for treatment of depression during pregnancy and was not properly advised of the risks, she says, otherwise she would not have taken the drug. At the time, GSK had not issued warnings against using the drug during pregnancy. The couple will seek legal fees and damages, enough to cover their son’s medical needs for the rest of his life.

Product liability law allows individuals harmed by a dangerous consumer product to file an action if the product was defectively designed, manufactured, or lacked adequate warnings to protect the public from unreasonable dangers that can lead to injury or death. Call Farah & Farah’s Florida pharmaceutical litigation attorneys if you would like to discuss an injury you feel resulted from a defective or dangerous drug.