Drug Recall Attorneys Blog

Skechers Shape-Up customers expected their sneakers would help them tone and lose weight...instead the shoes caused many of them to suffer debilitating injuries. Although their injuries may be permanent, a newly announced settlement deal will at least put some money back in their pockets.

On May 16, 2012, Skechers agreed to pay $40 million for making false claims about its toning shoes. A special rocker-shaped sole on the sneakers purportedly forced customers to work harder, making them slimmer and stronger. Regular consumers and high-profile celebrities such as Kim Kardashian immediately jumped on the toning shoe bandwagon. Sales peaked at $1.1 billion in 2010, with Skechers dominating nearly half of the toning shoe market. Unfortunately, it appears that the shoes have no health benefits and may lead to serious health risks.

According to the Federal Trade Commission, Skechers executives used false or deliberately misrepresented evidence to hype up the toning shoes. Instead of losing weight, some Shape-Up customers actually gained weight. Even more concerning are the injuries that many of them suffered. The rounded toe design of the shoe reportedly led to tendinitis, broken bones, muscle spasms, ruptured Achilles tendons, and serious foot, leg, and hip pain. These are traumatic injuries that generally require expensive treatments and long-term medical care.

Skechers violated federal law by making false claims that its shoes could strengthen, tone, or produce other health benefits. The FTC requires truthful advertising that is supported by scientific evidence. A deceptive advertising claim is one that misleads consumers through express or implied statements. Regulators allege that Skechers violated Section 5(a) of the FTC Act, which prohibits deceptive and unfair advertising, as well as Section 12, which bans false advertising.

The toning shoe sneaker company continues to stand by its claims, although the settlement bars any promotion that is not backed by scientific evidence. Still, Skechers will be allowed to continue making and selling the shoes, which could lead to further injuries.

Skechers is not the only toning shoe company to face legal woes. In September, Reebok agreed to a $25 million settlement for making similar claims about its line of EasyTone sneakers. Other toning footwear makers, such as Fila and New Balance, may eventually face legal action.

Any customer who bought a pair of Skechers Shape-Ups since August 1, 2008, may be eligible for a refund. More information can be found at www.skecherssettlement.com. If you suffered an injury as a result of wearing a toning shoe, you may also be entitled to significant compensation. An experienced Chicago defective product lawyer can help you file a claim and receive substantial damages.

Continue reading "Even if the Shoe Fits, You May Still be in Danger If You Wear It: Skechers Customers Will Get Refund" »

Birth defect lawyers at Pintas & Mullins Law Firm have warned about the side effect risks associated with SSRI antidepressants since researchers first identified their potential to cause serious harm. Congenital heart defects, clubfoot, and dozens of other severe birth injuries have been linked to SSRI antidepressants. These dangerous drugs are widely used by women of child-bearing age, and many women taking these drugs do not even know that they are pregnant until it is too late to avoid the risk.

Now new research confirms that some of the most popular SSRI antidepressants, including Paxil, Zoloft, and LexaPro, do more harm than good. These prescription drugs boost serotonin levels in the brain in an attempt to regulate mood and sleeping patterns. However, the benefit of these drugs is far outweighed by the dangers. Medical experts have identified a strong link between SSRI antidepressants and a wide range of serious birth defects.

Study after study has pointed out serious side effect risks associated with these dangerous drugs. In 1996, a study in the New England Journal of Medicine revealed that women taking Prozac during pregnancy were twice as likely to deliver a baby with minor birth defects. Evidence of potential dangers continued to mount. In 2005, a Danish study revealed that women taking Prozac, Zoloft, and similar antidepressants early on in their pregnancies had a significantly increased risk of delivering children with congenital heart defects.

Birth defects such as hyoplastic left heart syndrome, tetralogy of the fallot, and abdominal wall malformations dramatically impact the lives of newborns and their families. Although surgery may be possible in the first few years of a child's life, some of these defects may require heart transplants and other serious medical treatments. In some cases, the child may be affected well into his or her adulthood.

Many other severe side effects have been linked to SSRI antidepressants. These include depression relapse, cognitive impairment, cardiovascular disease, and even death. The latest study, published online by the journal Frontiers in Evolutionary Psychology, states that selective serotonin reuptake inhibitor drugs are neither safe nor effective.

Evidence shows that the companies that manufactured these antidepressant drugs knew of the potential side effect risk, yet failed to warn consumers. Pharmaceutical manufacturers have a legal responsibility to ensure that their products are safe. If the side effect risk cannot be eliminated before the drug hits the market, manufacturers must provide adequate warnings. Failure to warn may be grounds for a product liability lawsuit against a negligent manufacturer.

Continue reading "New Research Shows Risks Outweigh the Benefits of SSRI Antidepressants" »

Internal emails and confidential letters recently obtained by the New York Times reveal disturbing information about serious safety issues relating to the DePuy ASR hip implant. According to the article, the U.S. Food and Drug Administration raised legitimate concerns over the defective product design more than a year before hip manufacturer Johnson & Johnson officially issued a recall. Meanwhile, DePuy executives worked behind the scenes to quietly phase out the flawed hip until the entire inventory was depleted.

Our product liability attorneys at Pintas & Mullins recognize the serious potential for injury or death when drug manufacturers put profits ahead of patient safety. More than 93,000 patients around the world received the defective ASR metal-on-metal artificial hip device. The latest reports suggest that company executives knew of high failure rates associated with the device as early as 2009 but did not issue a recall until August 2010.

Newly released FDA documents show that the agency asked the company for additional safety information about the implant, citing blood tests of some patients who showed a high level of metal ions in their bloodstream. Just a few weeks later, the company decided to phase out the device inventory and sell the remaining stock. A company executive defended the decision, stating that slowing product sales rather than safety issues motivated the business plan.

Another confidential document that was not disclosed to doctors or patients until the recent New York Times report is an FDA letter that was sent to the company in 2009. The letter exposed serious problems with a resurfacing version of the implant that was being used abroad. The agency refused to approve the device for sale in the United States, because a number of patients reported high failure rates just a few years after implantation. However, the potential for harm remained because a similar version of the device, based on the same flawed metal-on-metal design, had been on the market since 2005. This version was cleared through a fast-track program that did not require extensive testing and clinical studies.

DePuy manufacturers finally issued a recall in August 2010, after 13 percent of the ASR hip implants were shown to fail within 5 years. The device was expected to last at least 15 years. In addition to early failure rates, patients also suffered debilitating injuries caused by shedding particles of metallic debris. This led to adverse reactions such as loss of mobility, hip pain, and metal toxicity.
 

Continue reading "New Report Claims DePuy Hip Implant Manufacturer Knowingly Sold Defective Hip Implants" »

Vaginal mesh attorneys at Pintas & Mullins Law Firm are warning patients of a recent spike in serious injuries and death associated with the use of defective transvaginal mesh devices. In response to growing number of complications such as pain, bleeding, infection, and erosion reported by women implanted with the mesh sling, federal regulators recently ordered manufacturers to conduct new medical studies to evaluate the safety and effectiveness of these devices.

On January 3, 2012, the U.S. Food and Drug Administration mandated additional postmarket studies from more than 30 transvaginal mesh manufacturers, including Johnson & Johnson, American Medical Systems (AMS) and C.S. Bard. As Bloomberg News is reporting, these mesh manufacturers must provide three years of research data to the FDA in order to determine whether the devices should remain on the market.

The vaginal mesh products were originally approved though the FDA's controversial fast-track approval process, which allows products to reach the market without clinical studies or tests. In 2010, nearly 300,000 women were implanted with a mesh sling in order to treat stress urinary incontinence and pelvic organ prolapse (POP). Unfortunately, studies show that the edges of the mesh fibers can erode through the vaginal wall, tear the body's internal organs, and cause serious pelvic pain and infections. The FDA has already received more than 1,500 reports of serious complications involving transvaginal mesh.

In July of 2011, the FDA acknowledged the serious safety risks associated with transvaginal mesh products and issued a safety alert to patients. At that time, the agency also admitted that it found no benefit in using transvaginal mesh to treat POP in place of other, safer alternatives. An advisory panel recommended that the FDA re-categorize the mesh products as "high-risk" but the agency has yet to act on that recommendation.

Vaginal mesh erosion is one of the most serious side effects that many women have suffered, and requires removal of the vaginal mesh. Other serious and painful complications include bladder perforation, vaginal scarring and recurrent organ prolapse.

Continue reading "FDA Orders Transvaginal Mesh Manufacturers to Conduct More Safety Tests to Study Serious Risks" »

Our drug recall attorneys at Pintas & Mullins Law Firm are warning of new research that shows the blood pressure drug Tekturna (Aliskiren) may increase the risk of stroke or serious heart and kidney problems. This is a major setback for the hypertension drug that could potentially lead to a recall, according to recent reports by Bloomberg News.

Tekturna is sold by Novartis and was originally approved in 2007 to lower blood pressure. Tekturna was the 16th best selling drug in 2010 for drug maker Novartis, who recently conducted a study to determine whether the medication could help patients suffering from type 2 diabetes and renal impairment. The ALTITUDE study evaluated the effectiveness of Tekturna in reducing or delaying heart and kidney events, along with the drug's ability to resuscitate sudden death or heart attack patients. Shockingly, the clinical trial came to a halt in January of 2012 when serious safety issues were revealed. Instead of benefiting from the medication, Tekturna study participants actually suffered an increased rate of hypertension, stroke, and renal complications.

As a precautionary measure, Novartis issued a drug warning to healthcare professionals, urging them to stop treating diabetic patients with Tekturna and to consider other, safer alternative treatments as necessary. The drug maker also pledged to stop promoting Tekturna for use in combination with other drugs such as ACE-inhibitors until federal regulators determine whether further changes need to be made. However, for many patients who already suffered serious side effects, these warnings came too late.

The large number of adverse health events recently exposed through clinical trials will likely hurt Novartis financially. Tekturna brought in close to $450 million in sales during the first nine months of 2011, and sales are expected to plummet now that the company has stopped advertising the dangerous drug. Over 1,000 sales jobs could be lost as a direct result of the clinical findings. Analysts suspect that the drug may eventually be sold to another company or completely removed from the market.

Even more concerning to our defective drug lawyers is the harm that many patients have already suffered or the potential harm that they may suffer in the future as a result of using the medication. We are aware that Novartis engaged in off-label marketing, recklessly promoting the use of Tekturna for diabetes patients. In addition to a lack of evidence supporting any positive health benefits for the diabetic population, research now shows that these patients may be seriously harmed by use of the drug.

Continue reading "Tekturna Hypertension Drug Linked to Stroke and Kidney Problems among Diabetes Patients" »

A new report by the Wall Street Journal details a troubling epidemic that is putting millions of prescription drug patients at risk. Research shows a significant increase in the number of Americans taking powerful antidepressant and antipsychotic drugs, despite the fact that some of these patients have no psychiatric diagnosis. Drug injury lawyers at Pintas & Mullins Law Firm are concerned with the serious complications and potentially fatal side effects that can result from overmedication, particularly in cases involving children and the elderly.
The latest pharmacy data shows that overall use of psychiatric drugs grew more than 20 percent in the last decade. At least one out of every five adults in this country is now taking at least one type of behavioral health medication, and the trend extends to all age groups. These medications are bringing in billions of dollars of year for the pharmaceutical industry and leading to serious adverse effects in patients nationwide.

A major area of growth involved the use of drugs for adults with attention-deficit hyperactivity disorder, or ADHD. Although diagnoses typically occur at childhood, prescriptions for ADHD drugs such as Vyvanse and Concerta have more than tripled since 2001 among adults aged 20 to 44. Drug makers explain the increase by pointing to aggressive marketing campaigns, which have increased awareness about adult ADHD. However, the rise in potential side effects is extremely worrisome. High cholesterol, weight gain, and diabetes are all associated with these drugs, and careful monitoring is needed to ensure patient safety. Unfortunately, drug companies may omit or at least downplay information about these serious side effects while highlighting more positive information in order to appeal to consumers. This is a dangerous marketing practice that may subject pharmaceutical companies to liability. The law requires that drug manufacturers exercise due care, which includes a duty to warn of the dangers of its drug products. If this duty of care is violated, compensation may be available to patients who are harmed by use of the drug.

ADHD drugs are not the only type of prescription drugs that lead to serious side effects. Evidence continues to grow about possible complications involving all types of psychiatric drugs, especially when taken by young people and the elderly. In 2004, the U.S. Food and Drug Administration issued a black box warning, alerting consumers about the potential for increased suicidal thoughts among children and teens using antidepressants. To minimize these effects, medical experts generally recommend a combination of psychotherapy and medication or lifestyle changes for adolescents diagnosed with depression. Antidepressant drugs should not be used as a "quick-fix," but prescribed only after careful consideration of the adverse side effects they may cause.

Continue reading "Drug Injury Lawyers Warn of the Dangers of Overmedicating Vulnerable Patients" »

Defective drug lawyers at Pintas & Mullins Law Firm are warning of the dangerous side effects that breast cancer patients may experience if they are using Avastin to control their tumors. The FDA recently revoked its provisional approval of the drug for the treatment of metastatic breast cancer amid concerns that it causes serious health complications such as hemorrhaging, high blood pressure and heart attacks.

Avastin was first approved in 2004 to treat colon cancer, and has since become one of the best selling cancer drugs in the world. It is also one of the most expensive drugs on the market, bringing in about $6 billion a year for the pharmaceutical company Roche. The FDA approved Avastin for advanced breast cancer as part of its accelerated approval program, which allows patients access to new drugs subject to further confirmation of their effectiveness.

An initial study of Avastin showed that it delayed the progression of breast cancer by about 5 months when combined with different chemotherapy drugs, even though patients did not live significantly longer and many of them suffered severe side effects. Subsequent studies reported in the New York Times showed that the drug delayed the disease by as little as one month and the significant risk of potentially fatal side effects did not justify its use.

Although Avastin is no longer approved to treat breast cancer patients, our concern is that it will still remain on the market. Physicians can still prescribe the drug to treat colon, kidney, lung, and brain cancers, along with any other uses they see fit. This includes prescribing the drug off-label for the treatment of breast cancer. Although most insurers have already stopped paying for Avastin for the treatment of advanced breast cancer, coverage will still be available through Medicare.

Our experienced drug injury lawyers are warning all cancer patients taking Avastin that they may be at risk for life-threatening complications. Some patients may develop holes in their colon, leading to internal bleeding and impaired wound healing. Heart failure and kidney damage are also possible side effects. When Avastin is combined with other chemotherapy drugs, the results may be even more dangerous. In 2006, several cancer patients suddenly died while being treated with a combination of Avastin and Xelox.

Breast cancer patients and all cancer patients taking the drug can file an Avastin lawsuit for their drug-related injuries. With the help of an Avastin attorney, the drug's manufacturer may be held liable for failing to warn of the serious side effects associated with Avastin use. Failure to warn can also subject physicians to liability, because the law requires that medical professionals explain the risks of medications that they prescribe.

Continue reading "FDA Says Risk of Dangerous Avastin Breast Cancer Drug Side Effects Outweighs Benefits" »

A recent lawsuit challenging the Consumer Product Safety Commission's new product safety database, www.saferproducts.gov, could have serious implications for the online consumer reporting site and other comparable federal tools. According to the Washington Post, the lawsuit was filed in October 2011 by an unnamed company seeking to block a posting that its product allegedly harmed a child.

Our product liability and drug recall attorneys at Pintas & Mullins Law Firm recognize that the database is an important consumer tool to keep the public informed about potential product hazards without waiting for a recall. The online portal was created as part of the Consumer Product Safety Improvement Act, and allows consumers to post complaints about products that posed dangers to children, as well as fire, electric, or mechanical dangers. Due to the potential for serious injury caused by defective products, manufacturers are legally responsible for guarding against negligence and providing a reasonably safe product to the public.

Although critics of the consumer reporting site argue that it unfairly threatens a company's reputation and profits by allowing inaccurate claims to reach the public, companies can use several protective measures to prevent baseless allegations from being published. First, the site contains a disclaimer that consumer complaints may not have been verified. The law also requires that all complaints are forwarded to the relevant manufacturer, who has 10 days to respond before the complaints are published. Additionally, companies have an option to post their own comments along with the report.

A recent study by the Government Accountability Office confirms that the CPSC has been highly effective at resolving inaccuracy claims. Only one-third of all complaints received from March through July of 2011 contained the required information for publication. Of those, the small percentage that contained materially inaccurate information were quickly identified and corrected.

Continue reading "New Consumer Product Safety Database Faces Legal Challenge " »

Drug recall attorneys at the Pintas and Mullins Law Firm are warning of serious eye problems reported by consumers using Avaira Toric contact lenses. Complaints range from blurred vision to torn corneas, and federal health officials are threatening to step in with a nationwide public alert.

The contact lenses are manufactured by CooperVision and sold widely by major retailers including Wal-Mart, Costco, and Lens Crafters. The corrective lenses are designed for people with astigmatism, and are fairly new to the market, launching in April of 2011.
However, after several months on store shelves, consumers began to complain of eye problems such as hazy vision, discomfort, and eye irritation. As msnbc.com is reporting, a limited number of lenses were eventually recalled in August, after "unidentified residue" was found on some of the lenses that appeared to be causing the reported eye complications. The recall affected about 10 percent of all Avaira Toric lenses sold in the last year.

CooperVision issued a press release notifying customers of the recall, and retailers who received shipments of the affected lenses also reached out to customers. Unfortunately, the notification was not prompt or adequate enough, and there are still many customers who continue to wear the dangerous lenses without any awareness of the serious health risk that they may cause. At least a dozen costumers have gone to hospitals and emergency rooms with impaired vision or pain since the recall was announced. Their injuries go far beyond "temporary hazy vision," and include corneal abrasions and other serious eye problems.

The U.S. Food and Drug Administration is concerned about the lack of widespread public notice and resulting eye injuries. The agency is asking for a broader, more public recall that will alert more retailers and their customers about problems associated with the defective lenses. Other countries, such as Hong Kong, Spain, and Australia, have already issued much wider recalls that include a list of more than 200 defective lots.

Continue reading "Drug Recall Lawyers Warn of Dangerous Contact Lens Side Effects" »

Illinois personal injury lawyers at Pintas & Mullins have previously warned of the dangers associated with Yaz, Yasmin, and other newer birth control pills containing the synthetic hormone drospirenone. Earlier this year, two European studies found that the risk of developing blood clots for women using these birth control pills is up to two or three times higher compared to users of other hormonal contraceptives. Now the Food and Drug Administration is publicly expressing its concern over the dangerous and potentially deadly side effects these birth control pills may cause.

As USA Today is reporting, the FDA posted a warning to its agency website on September 26, 2011, about the potential increased risk of blood clots for women using drospirenone-containing birth control pills. These pills include Yaz, Yasmin, and a number of generic versions such as Ocella. The new drug warning is the result of a preliminary agency-funded study involving 800,000 women in the U.S. Researchers found that women taking the contraceptives were nearly two times more likely to experience dangerous side effects than women taking other, older birth control pills. This supports earlier findings by the European Medicines Agency, which also found an elevated risk.

The FDA plans to meet with two advisory panels in December to sort through more than half dozen different studies containing information about the blood-clot risk. At that time, the study's complete findings will be releases, and an outside panel of medical experts will analyze the safety of these contraceptives. There are a wide range of actions that the FDA might take, including a stronger drug label warning, or a requirement that the contraceptives be pulled from the shelves.

Although the FDA study is new, health warnings about complications associated with birth control pills such as Yaz and Yasmin are not. In 2001, Yazmin became the first birth control pill to contain the drospirenone hormone. Just one year after its approval, the consumer advocacy group Public Citizen issued a warning about the dangers of the drug. Since that time, our experienced drug litigation attorneys were notified of many otherwise healthy women who suddenly died or suffered serious side effects while taking Yaz, Yasmin, and similar medications.

Blood clots linked to these dangerous contraceptives typically form in the vein of the lower leg or thigh, and can break loose and move to other areas of the body such as the lungs. These dangerous blood clots, known as deep vein thrombosis (DVT), can cause chronic leg pain, chest pain, or shortness of breath.

Continue reading "Illinois Drug Litigation Attorneys Caution Yaz and Yasmin Drug Users about New FDA Warning " »

Dapagliflozin, a new experimental diabetes drug, is already under scrutiny for possibly causing cancer. The drug has not even hit the market yet, however, if approved, it would be the first in a new line of diabetes drugs that treat type 2 diabetes by eliminating access sugar in the urine. Unfortunately, bladder and breast cancer side effect concerns may prevent the drug from ever being sold. Based on the clinical research that our defective drug lawyers reviewed, the new diabetes drug is strikingly similar to other defective diabetes drugs that have led to numerous drug injury lawsuits, posing a serious health risk for consumers.

Dapagliflozin would be a new option for diabetes patients that typically turn to diabetes drugs to reduce the amount of sugar they absorb from food. The drug is being developed by Bristol-Myers Squibb and AstraZeneca, and other major manufacturers such as Johnson & Johnson and Eli Lilly are pursing similar drugs. Unfortunately, the drug's safety and effectiveness is creating major concerns.

The New York Times is reporting that the new diabetes drug is tied to an increased risk of bladder cancer and brain cancer. Nearly 5,500 patients participated in clinical trials testing the experimental drug, and the results were alarming. At the end of the two-year study, doctors diagnosed nine dapagliflozin users with breast cancer and another nine with bladder cancer. At least one serious liver injury was also reported.

Federal regulators are concerned that the benefits of dapagliflozin, which include lower blood sugar and weight loss, do not outweigh the serious health risks. An FDA advisory committee met on July 19, 2011, and a final approval decision is expected in October of 2011. Bladder and breast cancer are the most serious health concerns, but other safety problems also exist that may prevent the drug from reaching the market. The new experimental diabetes drug is not as effective on patients with impaired kidney functions, and it also increases the risk of urinary and genital infections. Serious side effects like these have led to a number of drug injury lawsuits for similar diabetes drugs. When a drug injury occurs, designers, manufacturers, and others involved in the distribution chain can be liable for the defective drug product.

Continue reading "New Diabetes Drug May Lead to Bladder and Breast Cancer" »

Illinois pharmacists who fail to warn customers of the dangers of prescription drugs like Yasmin or Yaz may escape liability under a recent decision by the Seventh U.S. Circuit Court of Appeals. This case marks a significant departure from the recent position the Southern District of Illinois has taken towards pharmacy liability for prescription drugs. Unlike similar state-court suits alleging failure to warn, the Seventh Circuit found that pharmacy liability was barred under Illinois law, provided the pharmacy does not have specific knowledge that a customer is especially susceptible to the side effects of a defective drug.

In Walton v. Bayer Corporation, Cathy Walton alleges serious permanent injuries resulting from Yasmin use. She filed suit in an Illinois state court against several out-of-state Bayer-affiliated distributors and Neimann Foods, the Illinois-based pharmacy that sold her the drug. She alleged that the defendants failed to warn her of the dangerous side effects of Yasmin, forcing her to suffer severe physical pain and mental anguish, lifelong medical treatment, and significant medical expenses.

The Bayer defendants immediately moved the case to federal court and argued that the Illinois pharmacy owner should be dismissed from the case. Walton wanted to litigate in state court because numerous Southern District of Illinois decisions have suggested that pharmacies should be liable for the prescription drugs they sell. Unfortunately, the federal court sided agreed to dismiss Neiman, allowing the case to stay in federal court.
Walton abandoned the entire case and the district court dismissed the suit. The Seventh Circuit upheld the dismissal on appeal.

The decision raised several key issues with respect to Yasmin and Yaz side effects and failure to warn prescription drug lawsuits. Most significantly, Judge Posner, writing for the majority, rejected Walton's principal claim the pharmacy had a duty to warn her of Yasmin's side effects. The Court looked to the "learned intermediary doctrine," which the Illinois Supreme Court has repeatedly used to reject pharmacy liability. Under this doctrine, pharmacists are barred from liability for failing to directly warn customers of prescription drug risks, unless the pharmacist knows the customer is abnormally susceptible to a particular side effect of the drug. In that case, the pharmacy must warn the customer or the customer's prescribing physician. However, unless the pharmacy knows of a pre-existing mental or physical condition or a potential interaction with other drugs the pharmacy is dispensing, liability will not attach. This doctrine also applies in 47 other states.

Applying the "learned intermediary doctrine" to absolve the pharmacy of liability in this case, the Court reasoned that it would be senseless to expect pharmacies to warn customers of potential prescription drug side effects outside of special known circumstances, given federal drug regulation and the extensive tort liability of prescription drug manufacturers. Therefore, the Court held that the claim against Neimann has so little merit that it was properly dismissed.

Continue reading "Seventh Circuit Dismisses Illinois Yasmin Lawsuit, Shields Pharmacy from Liability for Failure to Warn" »

Chantix, a controversial smoking cessation drug already associated with various safety concerns, is now linked to a significantly increased risk of heart attack and other cardiovascular events. Researchers analyzing data from 14 previous Chantix studies found that Chantix users were substantially more likely to suffer heart problems than those taking a placebo to quit smoking. The FDA has already raised serious concerns about the drug, and the study's co-authors are urging regulators to consider a complete Chantix recall in light of the latest drug safety data. Drug recall attorneys at Pintas & Mullins continue to review Chantix lawsuits filed on behalf of injured patients who have died or suffered serious injuries caused by the dangerous drug.

The new Chantix research was released in the Canadian Medical Association Journal on July 4, 2011. Clinical trials involving more than 8,200 healthy participants revealed that the risk of heart attack, stroke, and similar cardiovascular events was 72 percent higher among Chantix users. The magnitude of risk for a serious heart event is surprising, because Chantix appears to be causing the very problem it is intended to prevent. Smoking also increases the risk for heart disease, and the benefits of the popular anti-smoking drug do not seem to outweigh the risks. Researchers estimate that just one of every 10 Chantix users actually quit smoking for more than a year.

Previous studies found that Chantix raises the risk of heart attack among those with a history of heart disease, and as such the FDA recently updated the drug's warning label to reflect the increased risk. But the latest study is significant because it reveals a serious risk of heart problems for otherwise healthy people. This is one of the primary reasons the study's authors are calling for removal of the drug.

Cardiovascular risk is only one of the side effects attributed to the use of Chantix. The drug has also been linked to severe mental health problems, leading to more than 1,500 drug injury lawsuits in Illinois and around the nation. According to USA Today, many smokers and smokeless tobacco users who took Chantix to quit smoking reportedly experienced depression, suicidal thoughts and unusually aggressive behavior. In 2009, the FDA gave the drug a black box warning, the most restrictive type, due to possible psychiatric side effects. The agency also ordered Pfizer to conduct a post-marketing study to further evaluate the safety risks. Results from the final report are scheduled to be released in 2017.

Continue reading "Smokers Beware: New Review of Studies Shows Taking Chantix to Quit Smoking Could Increase Risk of Heart Attack" »

Paxil and other selective serotonin reuptake inhibitors (SSRI) used to treat depression are among the most commonly prescribed drugs in the United States. Unfortunately, new research confirms that SSRI use during pregnancy greatly increases the risk of women giving birth to children with catastrophic heart birth defects. Some of the most common congenital heart defects our product liability lawyers have seen include ventricular septal defects and atrial septal defects. These are life-threatening birth defects that have already led to hundreds of Paxil lawsuits and significant settlement agreements.

The new research, published in the Obstetrics and Gynecology medical journal, found that 31 of every 10,000 women taking the Paxil antidepressant during pregnancy gave birth to a child with right ventricular outflow tract defects. This particular heart defect obstructs blood flow from the right side of the heart to the rest of the body. Alarmingly, pregnant Paxil users are more than four times more likely to give birth to an infant with this heart defect than women who do not take Paxil.

Researchers also found that women who use Prozac during pregnancy are twice as likely to give birth to infants with isolated ventrical septal defects. Additionally, infants born to women who take any type of SSRI antidepressant while pregnant are more than twice as likely to suffer isolated ventrical septal defects. With millions of Americans using SSRI's to treat depression nationwide, these statistics are troubling.

Another study in the New England Journal of Medicine warns that Paxil is linked to an increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN). This study showed that PPHN was approximately six times more common in infants whose mothers exposed them to SSRI antidepressants during pregnancy, compared to infants of mothers who did not use any type of antidepressant. In response, the FDA issued a safety alert about the increased risk of birth defects and required Paxil manufacturer GlaxoSmithKline to update the drug's warning label.

Birth defects are not the only concern pregnant Paxil users need to be aware of. In June of 2011, researchers from Kaiser Permanente found that SSRI's may be linked to autism. Out of a control group of more than 1,500 children, mothers who used an SSRI antidepressant while pregnant were twice as likely to give birth to a child with an autism spectrum disorder, especially if the drugs were taken during the first trimester.

Continue reading "Defective Drug Lawyers Warn of Studies Confirming Increased Risk of Heart Birth Defects for Pregnant Paxil Users" »

Illinois product liability lawyers at Pintas & Mullins support a powerful new documentary on the famous McDonald's "Hot Coffee" case that reveals important information about the devastating effects of medical malpractice tort reform. The film exposes efforts by major corporations and insurance companies to limit damage awards and deprive medical negligence victims of their right to sue. We agree with filmmaker and personal injury lawyer Susan Saladoff that tort reform increases the bottom line for big businesses at the expense of innocent patients and their families.

The true facts behind the "Hot Coffee" case that led to this film are not as well-known as most people believe. Major corporations invested a significant amount of money and lobbying efforts to convince the public that the spilled coffee case was nothing more than a frivolous lawsuit by a greedy plaintiff. To the contrary, the horrific burns requiring hospitalization and skin grafts that the victim suffered speak for themselves. Like many of us do every day, the victim merely attempting to put cream and sugar in her coffee while stopped in the passenger's seat of her car when the coffee spilled, causing her to suffer excruciating pain. The coffee was intentionally heated to 190 degrees, a scalding temperature that can cause skin to burn in just 2 seconds.

79-year-old Stella Liebeck had serious third-degree burns, requiring seven days in the hospital and $200,000 in medical expenses. Evidence brought to light at trial showed that McDonald's knew that its coffee caused severe burns, defending itself against more than 700 other burn claims in a ten-year period. Still, the negligent company continued to expose consumers to the risk of harm.

The verdict may be the most controversial part of the spilled coffee case, with the jury awarding the victim $2.7 million for McDonald's willful, reckless, and malicious conduct. However, as "Hot Coffee" points out, this award is equivalent to just two days of McDonald's coffee sales. We do not believe this is enough to deter negligent behavior by a corporation who showed a continuous disregard for consumer safety. On appeal, a judge reduced the award to a mere $480,000, barely enough to cover Liebeck's medical and attorney fees.

The documentary also points out the effect of damage caps on taxpayers, who are forced to pay for the negligence of others. It also tells the story of a Nebraska boy who suffered severe brain damage at birth. Although the jury awarded his family $5.6 million in damages to cover the cost of lifetime medical care, a state mandated medical malpractice damage cap reduced the award to $1.25 million. After all of the legal expenses were paid, the boy's family was left with a few hundred thousand dollars and taxpayers were left to foot the bill for the rest of his medical expenses.

Another important topic the film addresses are arbitration clauses. These clauses are often buried in the fine print of a number of contracts, from employment to cell phones, and are often overlooked, resulting in dangerous consequences. A key example is the woman who was drugged, raped and placed in a shopping container while working in Iraq, but an arbitration clause in her employment contract nearly prevented her from going to court. Luckily, the 5th U.S. Circuit Court of Appeals stepped in, and her trial is underway in Houston, but other arbitration clause victims may not be so fortunate.

Continue reading "McDonald's "Hot Coffee" Documentary Reveals Important Truths about Tort Reform and Medical Malpractice Damage Caps" »