Defective Drugs

A group of parents has filed a lawsuit against Pfizer, the maker of Zoloft, an antidepressant, which they say caused severe birth defects in babies born to women who took the drug while pregnant. The nine-count complaint that was filed December 2 in St. Clair County Michigan Circuit Court says the babies were born with major medical defects, including heart damage. At the time, studies showed the risks associated with Zoloft were known, such as the doubling of chances for heart damage in the unborn. The plaintiffs say Pfizer knew or should have known about the risks to users and their unborn children yet did not adequately warn parents and doctors about birth defects, which also include lung problems, neural defects, congenital birth defects, and limb malformation.

Zoloft is an SSRI (selective serotonin reuptake inhibitor) antidepressant.

Pfizer is accused of negligence, defective design, fraud, and a breach of warranties. The product liability lawsuit asks for damages to cover medical costs and for compensation, as well as a disgorgement of profits or the forced return of profits gained through illegal or unethical acts.

Defective Drugs

A defective drug is one that harms the user who was not adequately warned about the potential for harm. A manufacturer has a responsibility to put a safe product on the market. But if there is some risk involved, the manufacturer needs to inform the user about the potential risk of harm so that he or she can make an informed decision about whether the risk is worth the benefit. To fail to do so may make the manufacturer liable for the victim’s injuries.

A Jacksonville dangerous drug lawyer at Farah & Farah understands how to represent you fairly and adequately in a product liability action. Call us at (800) 533-3555 so we can begin a conversation about your defective drug injury.

Source: http://ageorgialawyer.blogspot.com/2012/01/parents-sue-claiming-zoloft-cause-birth.html; http://www.We madisonrecord.com/news/240766-parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft

The three women who alleged that taking the menopause drug, Prempro, made by Pfizer’s Wyeth and Pharmacia Upjohn units gave them breast cancer, had their day in court. After two days of deliberations before a Philadelphia jury, on December 6, the jury decided that the three should be awarded $72.3 million in damages. A Pfizer spokesman said they were disappointed with the verdict and would weigh their legal options.

Prempro was given to more than six million women to treat hot flashes and mood swings. While it is still on the market, a study in 2002, called the Women’s Health Initiative, found links to cancer. The drug combines Premarin, the estrogen-based drug made from a pregnant mare’s urine, with Provera, which contains progestin.

Litigation often comes down to numbers. There have been 18 Prempro cases, reports Bloomberg, and Wyeth/Upjohn has lost 10 before juries. There have been some successes for Pfizer as some cases were thrown out after and before trial, or settlements were offered and accepted.

Pfizer, the world’s largest drug company, agreed to the settlement one day before jurors were to consider the company’s liability, which could have included huge punitive damages.

Pfizer has set aside $772 million to help resolve the claims which so far, which represent just one-third of the pending cases.

Defective Product Cases

In a Florida pharmaceutical litigation case, a product on the market that has caused harm, is alleged to be defective in its manufacture, its design, or in a failure to warn. In this case, a damaging bit of evidence was an internal letter from a Wyeth manager who wrote “the desire for increased sales has overruled our company’s ethical responsibility to promote our products safely.”

Despite the additional evidence of a link to cancer, Pfizer/Wyeth never changed its label to better inform consumers and physicians of the safety issues associated with Prempro. If a consumer does not receive informed consent, that is negligence on the part of the manufacturer.

Farah & Farah’s Florida Prempro side effect attorneys can help evaluate your defective product case by calling (800) 533-3555.

Source: http://www.bloomberg.com/news/2011-12-06/pfizer-prempro-drug-caused-women-s-breast-cancer-jury-rules.html

In a lawsuit, the discovery process is the most important way to uncover documents that make your case. In this case, women who are suing Bayer AG, a large drugmaker from Germany, have uncovered documents that show the company tried to sell birth control pills in the Yasmin family for unapproved uses and downplayed the risks.

According to documents obtained by the plaintiffs, Bayer officials wanted to promote Yaz, a spinoff of Yasmin, for all types of premenstrual problems, even though it was only approved for severe premenstrual symptoms.

An article in Bloomberg reports a salesman cited an article in Woman’s Day magazine that the sales force could be used to broaden the symptoms Yaz could be prescribed for. At the same time, internal company documents show discussions about the link of the drug to heart attacks, strokes, and blood clots.

Dangers of Yasmin/Yaz

According to the Food and Drug Administration (FDA), there have been at least 50 deaths tied to the Yasmin/Yaz birth control pill from 2004 to 2008, with many occurring among young women. The FDA has said women taking pills from the Yasmin family have a 74 percent higher risk of suffering a blood clot than a woman taking a lower estrogen birth control pill.

The FDA is scheduled for December 8 to look at the data from 835,826 women taking Yasmin/Yaz. The drug is a blockbuster seller for Bayer and generated $1.58 billion in profit last year, according to Bloomberg.

Product Liability

Among the allegations against Bayer are that the company withheld important information on the dangers of taking the birth control pills and instead called it just as safe as older, more established birth control drugs. A product liability lawsuit can allege that the company knew or should have known about the dangers but failed to warn the public about a product that was defective in its manufacture or design.

Expect trials over whether Yasmin/Yaz caused blood-clots to begin in January in Illinois and Pennsylvania. Contact the Florida Yaz/Yasmin side effect attorneys at Farah & Farah today at (800) 533-3555 for a consultation on your case.

Source: http://www.bloomberg.com/news/2011-11-21/bayer-may-have-touted-birth-control-pills-for-unapproved-use-e-mails-show.html#

Yaz and Yasmin are the controversial birth control products made by Bayer and a new FDA safety report finds the pills may increase the risk of a blood clot (venous thromboembolic events) by as much as 75 percent when compared to the older generation of birth control pills.

Yaz and Yasmin contain the synthetic hormone, drospirenone. Last year the contraceptives were the second best selling drug for Bayer.

In this latest study involving 800,000 women, birth control pills containing the progestin drospirenone increased the risk of blood clots by as much as 75 percent over birth control pills that used progestin levonorgestrel. The risk for a heart attack or stroke was doubled in women new to birth control and some of the heart problems were seen in as little as three months after beginning Yaz or Yasmin.

That study is coupled with one from The British Medical Journal that also shows an increased risk of blood clots and will be considered by a U.S. Food and Drug Administration expert panel meeting in December to consider whether or not Yaz and Yasmin are a defective product and should remain on the market.

Florida Product Liability Lawsuits

The Florida yaz side effect attorneys at Farah & Farah understand that hundreds of defective product lawsuits have been filed on behalf of women who suffered blood clots, heart attacks, and/or death after taking Yaz and Yasmin.

A product can be defective in its design, its manufacture, or in a failure to warn about the side effects. In these complaints, the women allege Bayer did not issue an adequate warning about the side effects including the risk of blood clots. In the U.S., pharmaceutical companies are allowed to advertise direct-to-customer on television, which is an aggressive marketing tactic that encourages consumers to ask for a drug, even though it may not always be in the consumer’s best interest.

Source: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf

The U.S. Food and Drug Administration (FDA) has issued a warning that consumers not take over-the-counter weight loss aids, coffees, and teas because 20 were found to contain the prescription drug, sibutramine. That is the same active ingredient that was found in a drug pulled off store shelves last October, Meridia. Meridia was found to increase the risk of stroke, heart attack, and to increase blood pressure. For patients who already have heart conditions, drugs such as A-Slim 100% Natural Slimming Capsules or P57 Hoodia can present an additional risk for heart failure, stroke, and arrhythmia. The supplements may also interfere with medications the person has been prescribed.

Other tainted supplements include PhentaBurn Slimming Capsules and Dream Body Slimming Capsules and they are often labeled as “100% Natural,” reports Fair Warning. According to the FDA, a consumer should stop taking the pills, tea, or coffee and throw away the supplements.

If you are experiencing symptoms of heart problems or an irregular heartbeat after taking the slimming supplements, the FDA advises you seek medical attention immediately.

It is increasingly common for supplements to contain some amount of prescription medication and the FDA continues to send warning letters to supplement makers after several health problems and deaths have been linked to the supplements. The dietary supplement industry self-regulates, but sexual enhancement, weight-loss, and muscle building supplements have flooded the market and threatened the honest marketers who put out quality supplements and vitamins.

You can report the adverse event online at: www.fda.gov/MedWatch/report.htm

If you have been harmed by a defective product, an experienced Jacksonville product liability lawyer can help you explore your options including the filing of a product liability lawsuit against the manufacturer, distributor, and anyone in the supply line to seek compensation.

Source: http://www.fairwarning.org/2011/10/fda-issues-warning-over-20-drug-laced-weight-loss-aids/; http://news.consumerreports.org/health/2011/10/20-weight-loss-supplements-contain-undeclared-drug-fda-warns.html

On Friday, October 14, pharmaceutical giant Johnson & Johnson (JNJ) won a failure-to-warn product liability case over its antibiotic, Levaquin. Plaintiffs claim in more than 2,000 lawsuits that JNJ did not reveal the drug’s link to tendonitis.

Jurors in the New Jersey state court in Atlantic City heard lawyers for JNJ argue that the side effects were clearly displayed on the label which had been updated to make the warnings more prominent. Levaquin was approved in 1996 and had sales of about $1.5 billion last year, reports The New York Times. JNJ’s division, Ortho-McNeil-Janssen Pharmaceuticals, no longer markets the drug since its patent ran out and it is now sold as a generic. Two injured men filed the dangerous drug lawsuit after suffering tendon injuries and plan to appeal.

Their lawyers argued the tendon injuries were so serious that the FDA required the most serious warning, a “Black Box” warning, on the drug in 2008. Levaquin is found in the class of antibiotics known as fluoroquinolones.

This was the third case against JNJ over Levaquin. The plaintiff was awarded $1.8 million in the first case, which included punitive damages, and JNJ won the second case. A fourth case is set to go to trial in January.

Jacksonville product liability attorneys at Farah & Farah advise clients that just because a corporation markets a product does not mean it is safe and free from defects. Product liability law in Florida makes the manufacturer, the designer, the distributor, and even the entity in charge of producing the label liable if it fails the consumer in any of those areas and the user is injured. An experienced Florida product liability law firm will always offer you a complimentary consultation on your defective product case.

Source: http://www.nytimes.com/2011/10/15/business/johnson-johnson-wins-suit-over-levaquins-side-effects.html?_r=2

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/