Author: AboutLawsuits

The family of a bicyclist who was killed when he was struck by a vehicle in August 2008, has filed a wrongful death lawsuit in Florida that alleges the driver was text messaging while driving.

The accident lawsuit was filed in Collier Circuit Court by the family of James L. Caskey, Jr., who was killed while riding his bicycle in North Naples, according to a story in Naples News. The family accuses Lawrence A. Daniels, 42, of running Caskey down after driving through a stop sign, and alleges that Daniels was distracted by sending text messages at the time of the accident. Astellas Phara US Inc., which owned the car Daniels was driving, is also named as a defendant in the wrongful death lawsuit.

Daniels was previously found guilty for failing to yield at the stop sign, was fined for causing the fatal crash and had his license suspended for six months.

The bicycle accident lawsuit charges Daniels with intentional misconduct or gross negligence, and says that he intentionally removed his eyes from the road to send the text message, constituting a conscious disregard or indifference to life, safety and the rights of others.

The Florida Highway Patrol Investigation that resulted from the accident did not look into whether Daniels had been sending text messages.

Florida lawmakers are currently considering whether to join a growing list of states who have made texting-while-driving a criminal offense. Proposed legislation under consideration would ban text messaging while operating a car or could be expanded to ban all cell phone use by drivers.

There are currently 19 other states which have enacted text messaging bans for drivers, and in January the federal government banned texting while driving for all large commercial trucks and buses.

The bans come after a study last year by the Virginia Tech Transportation Institute found that tasks that drew the drivers’ eyes away from the road ahead of them significantly increased the risk of an accident. The study was compiled from several driving studies conducted by the institute, and the collected data equaled about six million miles of driving.

Heavy vehicle and truck drivers were 23.2 times more likely than a non-distracted driver to have a truck accident if they were texting, 6.7 times as likely to crash while reaching for, or using, an electronic device, and 5.9 times as likely to have an accident while dialing on a cell phone.

Drivers of light vehicles and cars were at much less risk of having an accident, but still faced a 2.8 times greater risk of an automobile accident while dialing a cell phone than a non-distracted driver and were 1.4 times more likely to crash while reaching for an object and 1.3 times as likely to have an auto accident while talking on the cell phone.

A new study, funded by the makers of Fosamax and other osteoporosis drugs, has concluded that oral bisphosphonate drugs are safe, and that the risk of low-trauma femur fractures with the medications are rare. 

The femur fracture study was reported in the latest issue of the New England Medical Journal. The drug company researchers found that bone fractures with Fosamax, Boniva and Reclast were extremely rare and were outweighed by the number of bone breaks prevented by the osteoporosis drugs. The study was funded, in part, by Merck & Co., which makes Fosamax, and Novartis, which makes Reclast.

Fosamax has come under scrutiny recently due to an increasing number of reports of low-trauma bone breaks among Fosamax users, usually in the femur, which is one of the strongest bones in the human body.

A number of Fosamax femur fracture lawsuits have been filed against Merck alleging that the drug maker failed to adequately research their medication or warn users about the risk of the bone breaks. The drug maker also already faces hundreds of lawsuits over Fosamax jaw side effects, involving a rare condition known as osteonecrosis of the jaw (ONJ), which cause portions of the jaw to decay or die.

Fosamax (alendronate sodium), Boniva (ibandronate) and Reclast (zoledronic acid), are all members of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis. Fosamax, which is the most widely used of the three medications, was approved by the FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.

In the latest study, researchers analyzed results from previous trials that looked at the number of bone breaks in more than 14,000 women taking Fosamax or other bisphosphonates. The researchers found that, out of 284 hip or femur fractures, only 12 fit the profile of the low-trauma femur fractures. The researchers acknowledged that sudden bone breaks associated with Fosamax and the other drugs were likely real, but rare.

“The occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years,” researchers concluded, but cautioned that their study was limited. “There was no significant increase in risk associated with bisphosphonate use, but the study was underpowered for definitive conclusions.”

The study follows a recent FDA announcement that the agency is continuing to review the potential Fosamax bone fracture side effects, but has yet to find a clear link between the breaks and Fosamax. Other studies, however, have had results that suggest there may be a connection.

A study published in the May/June 2008 issue of the Journal of Orthopedic Trauma found a pattern of femur fractures among Fosamax users that was 98% specific to the osteoporosis drug, involving low-energy fractures that were typically caused by falls from a standing height or less. The study also found that the average duration of Fosamax use was longer among those who had signs of these specific femur fractures than those who did not.

In addition, a Fosamax fracture case study published in September 2009, in the Journal of Bone and Mineral Research examined a patient suffering from rheumatoid arthritis with multiple risks for bone fractures who took Fosamax for eight years and developed femur fractures. The report found that the patient had an imbalance between bone resorption and bone formation at the site of a rare femur fracture known as a spontaneous bilateral subtrochanteric/diaphyseal fracture, which suggested a possible connection to the osteoporosis drug.

Merck & Co. faces about 1,000 Fosamax lawsuits over ONJ. The federal Fosamax cases have been consolidated into a multidistrict litigation (NDL) for pretrial proceedings in the U.S. District Court for the Southern District of New York. In December, District Judge John Keenan, overseeing the cases, ruled that at least one Fosamax femur fracture lawsuit should be handled separately, due to the differences between those cases and the Fosamax ONJ suits.

An editorial in a leading medical journal is calling for all scientific publications to enact reform measures, citing troubling behavior by GlaxoSmithKline and scientists on its payroll in studies the drug maker sponsored attempting to downplay the risk of health problems from Avandia, which was a top-selling diabetes drug at the time. 

In a blistering editorial, writers for the Journal of the American Medical Association (JAMA), lambasted GlaxoSmithKline’s activities in research over potential side effects of Avandia, which some say are responsible for tens of thousands of heart attacks and deaths. The authors are calling for new, stringent, medical and scientific journal reforms that would ensure integrity and minimize the ability of corporations to obfuscate scientific data.

As an example, the authors, Drs. Catherine DeAngelis and Phil Fontanarosa, cite GlaxoSmithKline’s RECORD trial, which was purported to study the heart attack problems with the Avandia. The editorial calls Glaxo’s RECORD trial “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of [Avandia] and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.”

DeAngelis and Fontanarosa went on to say that “[a]nalyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first.”

The harshly worded editorial follows revelations resulting from an investigation by the Mayo Clinic that found an alarming number scientists and medical experts, who supported Avandia after it was linked to an increased risk of heart attacks, had undeclared financial ties to GlaxoSmithKline. The Mayo Clinic study found that 87% of scientists who downplayed Avandia side effects had links to the drug maker, and about a quarter of them failed to declare the potential conflict of interest.

Avandia (rosiglitazone) was approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of potentially life-threatening side effects. GlaxoSmithKline currently faces several thousand lawsuits over Avandia filed by users who allege that serious injuries were caused by the drug makers failure to adequately research their medication or warn about the risk of problems.

Among a host of industry-wide reforms proposed by the JAMA editorial, the authors are calling for medical journals to require an independent statistical analysis of all corporate-sponsored studies before the articles are published. They also say that academic researchers should have full access to all clinical data.

Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.

Avandia was placed back under the spotlight last month by a U.S. Senate report that blasted GlaxoSmithKline for allegedly trying to cover up Avandia heart attack risks by deceiving the FDA and pressuring scientists to support the drug. The report revealed that some drug reviewers in FDA have been calling for an Avandia recall since 2007.

Stryker Corp. announced this week that it has been declared in compliance with FDA manufacturing standards after more than two years of concerns over operations at one of its medical device plants that manufactured the Stryker Trident hip implant. 

In a press release issued on Tuesday, the company said it had been informed by FDA that it satisfied issues raised in a 2007 warning letter over quality issues in its reconstructive implant factory in Mahwah, New Jersey. However, the announcement does not mention two remaining outstanding warnings from FDA over manufacturing in Ireland or how the company sterilized its discontinued cranial implant kits.

The warning letter for the New Jersey facility was issued on November 28, 2007, when FDA inspectors found that quality control failures contributed to problems with Stryker Trident hip implants, including the presence of staph infections causing bacteria and other quality control issues. The issues included reports of patients who continued to experience discomfort and pain after hip replacement surgery, improper wear of the hip implants and squeaking Trident hips. The warning letter was one of several the company has been battling to resolve.

According to a 2008 study in the Journal of Arthroplasty, about 7% of individuals who received ceramic hip implants from 2003 to 2005 developed squeaking hips, compared with no reports of squeaking among the control group who received metal and plastic hip parts. A number of Stryker Trident hip lawsuits have been filed by individuals who experienced the squeaking hip implants or other problems. The lawsuits allege that Stryker negligently designed the hip implant and failed to adequately warn about the risk that individuals may end up with a hip that squeaks. In many cases, plaintiffs have required additional hip surgery to replace components.

The most recent FDA warning letter sent to Stryker, which was issued in May 2009, involved a custom cranial implant kit that has since been discontinued. The FDA said Stryker did not get proper approval for that device as well before releasing it to the market. In December 2008, Stryker issued a recall for the cranial implant kits, saying that the devices may not be sterile and could pose a risk of serious infections for individuals who received the implants to correct traumas or defects in the jaw and face or cranium and face.

In March 2007, an FDA warning letter was issued about quality levels at the Ireland plant, indicating that the company failed to fix problematic products and known risks.

In October, Stryker announced that it had resolved a fourth warning issued by FDA inspectors who said that the company did not get the proper FDA approval for the OP-1 implant, a bone growth material meant for use as an alternative to autografting. The agency also expressed concerns over Institutional Review Board (IRB) documents that appeared to have been falsified by Stryker sales personnel.

More than a million Infantino “SlingRider” and “Wendy Bellissimo” baby slings are being recalled after at least three deaths were attributed to the infant sling’s design. 

The Infantino sling recall was announced Wednesday by the U.S. Consumer Product Safety Commission (CPSC) and Health Canada. The CPSC said that it was aware of at least three infant deaths that occurred in these slings within the last year, including a 7-week old infant in Philadelphia, Pennsylvania; a six-day-old infant in Salem, Oregon; and a 3-month-old infant in Cincinnati, Ohio.

The baby sling recall comes after a CPSC warning earlier this month alerting parents to the risk that babies could suffocate against someone’s body while in the sling. Overall, the CPSC reported that there had been at least seven baby sling deaths reported. The CPSC also suspects that some other deaths, reported as cases of Sudden Infant Death Syndrome (SIDS), might be attributed to the slings as well.

The Infantino SlingRider and Wendy Bellissimo sling recalls affect about one million baby slings sold in the U.S., and 15,000 sold in Canada. The slings are soft fabric baby carriers that have a padded shoulder strap. They are worn by parents and caregivers and used to transport infants weighing 20 pounds or less.

The SlingRiders have “Infantino” printed on the plastic slider on the shoulder strap, and “Infantino and “SlingRider” are also printed on the instruction and warning label inside the baby carrier. The Wendy Bellissimo slings have a label sewn into the inside of the sling strap that says “Wendy Bellissimo Media, Inc.” on it and has the item numbers 3937500H7 and 3937501H7.

The slings were sold in the U.S. and Canada from January 2003 through March 2010 for between $25 and $30. The Wendy Bellissimo slings were sold exclusively at Babies ‘R’ Us, while the SlingRiders were sold there, as well as at Wal-Mart, Burlington Coat Factory, Target, BJ’s Wholesale and other baby stores, children’s stores and retailers nationwide.

The CPSC is recommending that people immediately stop using these slings, and warns that they should not attempt to fix the baby carriers and then use them. Consumers can contact Infantino for a free replacement product via their website at www.infantino.com.

A wrongful death lawsuit has been filed in Texas, alleging that a malfunctioning electronic throttle on a Harley-Davidson motorcycle caused a fatal accident in 2008.

The Harley-Davidson lawsuit was filed in Tarrant County court by Cindy DeBartolo, whose husband, John, was killed on March 24, 2008 when he lost control of his 2008 FLHX Harley-Davidson days after repairs were supposedly made to address problems with the throttle. Cindy DeBartolo was also riding on the bike at the time of the crash and sustained serious injuries in the motorcycle accident as well.

According to the complaint, the electronic throttle malfunctioned on the motorcycle just a week after John DeBartolo purchased the Harley-Davidson bike on March 15, 2008 from Longhorn Harley-Davidson in Grand Prarie, Texas. He took the motorcycle back to the dealership for repair, and it was returned to him on March 22. The motorcycle accident lawsuit alleges that couple was riding the bike two days later when the electronic throttle failed again, causing the fatal crash.

Harley-Davidson Motor Company, Inc. and LHD Partners L.P., doing business as Longhorn Harley-Davidson, are named as defendants in the lawsuit. DeBartolo alleges that the motorcycle was defectively manufactured and unreasonably dangerous, and that the dealership failed to properly repair the electronic throttle.

In December 2009, Harley-Davidson issued an unrelated recall for more than 111,000 family touring motorcycles due to fuel tanks that could leak or catch fire after a crash. The Harley-Davidson motorcycle recall affects 22 different models of 2009 and 2010 Harley-Davidson Touring, CVO and Trike motorcycles, which were manufactured between June 6, 2008 and November 19, 2009.

Photo Attribute: http://www.flickr.com/photos/rbitting/ / CC BY 2.0

Doctors are still trying to figure out what to do about recent warnings over problems with Plavix, involving a genetic variant that could make the heart drug ineffective in some patients. 

There are between 2.5 million and 3 million Plavix prescriptions handed out each month in the U.S., and doctors are debating who should get Plavix genetic testing to determine whether the blood thinner might not work on them. The debate started after the FDA announced a new Plavix black box warning earlier this month, alerting doctors and patients about the risk of serious or potentially life-threatening injuries that could be suffered by individuals who are poor metabolizers of Plavix, rendering the drug ineffective.

Plavix (clopidogrel) is a blood thinner that prevents blood platelets from sticking together to form clots. It is a blockbuster medication, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.

In August 2009, researchers from the University of Maryland identified a gene variant found in about one-third of the population that may signal a reduced effectiveness of Plavix. People with the CYP2C19 variant have reduced functioning of a liver enzyme that is supposed to covert Plavix from its inactive form to its active form, potentially making Plavix ineffective at reducing the risk of blood clots.

The genetic variant is found in about 30% of Caucasians and blacks, and up to 60% of Asians. People with two copies of the genetic variation, between 2-4% of the overall population, were found to be poor Plavix metabolizers. However, according to a Wall Street Journal article, doctors are still concerned about whether those with only one copy of the gene metabolize Plavix differently.

A 2008 study conducted by researchers from Brigham and Women’s Hospital found that people with only one copy of the genetic variant had a 53% increased risk of suffering a heart attack while using Plavix than those without the variant. They were also found to suffer three times as many blood clots as people without the variant as well.

Doctors are not yet certain who should be tested for the variant, whether the tests will be effective, or whether the problem can be overcome by increasing the dosage for patients with the CYP2C19 variant.

The tests are estimated to cost about $500. However, identifying poor Plavix metabolizers could prevent patients from being unnecessarily exposed to risk of Plavix side effects, such as an increased risk of gastrointestinal bleeding, ulcers and a possible increase in the risk of heart attacks or strokes for those with high cholesterol or high blood pressure.

Bristol Myers Squibb Co. and Sanofi-Aventis currently face a number of Plavix lawsuits filed by plaintiffs who claim that the drug maker failed to adequately research the medication and warn about the risk of side effects.

A Zimmer Durom Cup lawsuit has been filed by a Texas man who alleges that his hip replacement implant was defectively designed and did not bond to bone as it should. 

The product liability lawsuit was filed on March 10 by Victor Barakat in the Marshall Division of the Eastern District of Texas. According to a report in the Southeast Texas Record, Barakat experienced pain for three years because of a loosened Zimmer Durom cup hip replacement, which was surgically removed in April 2009.

Barakat’s lawsuit is the latest of dozens of Durom Cup hip replacement lawsuits filed against Zimmer throughout the United States, since the manufacturer issued a temporary Durom Cup recall in July 2008.

Sales of the artificial hip implant were suspended until revisions could be made to the warning label and so that additional training could be developed for surgeons about the special surgical techniques needed to reduce the risk of problems after hip replacement surgery.

The Zimmer Durom Cup was first introduced in the United States in 2006, as a more advanced form of an artificial hip. The hip resurfacing system is designed out of a single piece of material and is designed to avoid problems associated with traditional hip replacement components, such as instability, limited range of motion and wear of the bearing.

However, after it was introduced in the United States, concerns emerged about a high number of hip replacement failures involving the Durom Cup, where the component loosened and required revision surgery.

Barakat said his cup was one of those that became loose, resulting in pain and discomfort. Barakat’s complaint alleges that the cup was supposed to allow bone to grow through the porous shell, cementing it into place. But instead, the cup came loose instead of joining with the bone.

Approximately 12,000 patients had the Zimmer Durom Cup system implanted between 2006 and 2008, before the product was temporarily recalled. According to Zimmer’s own estimates, some doctors have experienced failure rates as high as 5.7%, and experts have suggested that the rate of hip replacement cup loosenings could increase as time passes after the surgery.

Barakat’s lawsuit accuses the company of designing a defective device that did not meet FDA medical device specifications and guidelines. The lawsuit includes charges of failure to warn, design defect, negligence and breach of warranty. The lawsuit seeks both compensatory damages for Barakat and is also seeking punitive damages against Zimmer as well.

In recent months, concerns have emerged about similar problems associated with a different type of implant, known as metal-on-metal hip implants. Earlier this month, DePuy Orthopaedics, a division of Johnson & Johnson, announced that it was removing its DePuy ASR hip replacement system from the market. While the company initially claimed the removal was due to low sales, on March 6 they sent a letter warning doctors that many patients have experienced hip failures soon after the devices were implanted.

The Georgia Supreme Court has unanimously ruled that limits placed on medical malpractice lawsuit awards in Georgia violate the state constitution’s right to trial by jury. 

The decision strikes down a 2005 law that was included in a tort reform package limiting the amount of non-economic damages that a plaintiff could be awarded in a Georgia malpractice lawsuit. The court declared that the $350,000 cap was unconstitutional.

The lawsuit that led to the cap’s demise was brought by Betty Nestlehutt, who sued Atlanta Oculoplastic Surgery for plastic surgery malpractice, claiming that they disfigured her by destroying the blood supply to her face. A Fulton County jury awarded her $115,000 for medical expenses, and $900,000 for pain and suffering. Her husband also received $250,000 for loss of consortium.

Following the jury’s decision, the medical malpractice damage cap in Georgia overrode the non-economic damages portion of the verdict, reducing everything but the medical expenses to $350,000. Nestlehutt appealed, saying that her right to trial by jury under the Georgia constitution had been violated. The high court agreed, saying that malpractice caps interfered with the right to a jury trial by stepping on the jury’s jurisdiction.

The 7-0 decision, agreed to by judges from both sides of the political spectrum, mirrors a decision in February by the Illinois Supreme Court, which struck down caps on Illinois malpractice lawsuits under similar grounds. The decision also follows a split decision last month by the same court that upheld tort reform provisions requiring plaintiffs to prove “gross negligence” in emergency room malpractice cases.

California was the first state to enact a damage cap in 1975, specifically limiting the non-economic damages in medical malpractice lawsuits. According to the National Conference of State Legislatures, as of 2005 ten states capped recoveries specifically on medical malpractice cases and another 22 have caps that are not limited to medical malpractice. About a dozen states also have caps on punitive damages.

Similar caps are facing legal challenges in Missouri and Indiana.

Just days before an advisory committee meeting is scheduled to discuss regulation of tanning beds, the FDA has released a report pointing out that there is growing evidence that tanning beds cause skin cancer. 

The tanning bed report (pdf) was released by the FDA on Tuesday, providing background information to the FDA’s General and Plastic Surgery Devices Panel, a subcommittee of the Medical Devices Advisory Committee. The panel will meet in a public hearing on Friday to discuss tanning bed regulation concerns that have arisen in the wake of a World Health Organization (WHO) decision to reclassify tanning beds as known carcinogens last year.

“There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer,” the report states.

One of the studies was by WHO itself in July 2009. WHO’s report determined that the use of tanning beds before the age of 30 increases the risk of skin cancer by 75%. As a result of the study, WHO reclassified ultraviolet radiation from tanning beds and other sources as a definite carcinogen. Previously, they were considered “probable” carcinogens.

Some studies have shown that the use of tanning beds by young adults results in eight times the risk of developing melanoma, a deadly form of skin cancer once found mainly in the elderly, but which has increasingly become a problem for younger adults. The American Cancer Society says that melanoma, the most dangerous form of skin cancer, is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. Less dangerous, but more common, basal and squamous cell carcinomas affect more than one million Americans each year and cause about 2,000 deaths annually.

The FDA’s report notes that the tanning industry has grown rapidly over the last two decades. The agency estimates that each year at least 30 million Americans visit one of the nation’s 25,000 indoor tanning businesses.

The report states that a growing number of children are counted among the ranks of tanning bed users, with nearly 10% going to indoor tanning businesses in 1999. The report also expresses concerns by some researchers that as many as 95% of indoor tanning customers are exceeding the recommended safe time in tanning beds.

Concerns over tanning bed cancer has resulted in bipartisan legislation aimed at lowering tanning bed cancer risks. The Tanning Bed Cancer Control Act, was introduced in late January by U.S. Representatives Carolyn Maloney (D-New York) and Charlie Dent (R-Pennsylvania). The bill would allow federal regulators to set controls on the amount of ultraviolet radiation emitted by tanning beds as well as set limits on the amount of time users can use the devices.

An autopsy report has linked the use of alcohol and Chantix to the suicide death of Donald Walker, the former mayor of Warner Robins, a small town in Georgia. The popular stop-smoking drug Chantix has been connected to more than 100 other suicides in recent years, and the death of Walker is likely to draw additional attention to the serious psychological side effects of Chantix

Walker served as the mayor of Warner Robins, Georgia for 15 years, and was in the middle of a re-election campaign in September 2009 when he is believed to have shot himself in the head while in bed.

According to a report released last week by Houston County Medical Examiner James Q. Whitaker, Walker suffered severe depression from Chantix, which lead him to drink a large amount of alcohol the night of his death and then kill himself. The alcohol in Walker’s blood exacerbated Walker’s Chantix depression and he was found to have a blood alcohol level of .4 at the time of death.

Chantix (varenicline) was approved by the FDA in 2006 as a prescription treatment to help people quit smoking. The drug works by blocking receptors in the brain that are commonly stimulated by nicotine, reducing the positive feelings that come from cigarettes. However, reports of suicide with Chantix began to surface shortly after it introduced, and the drug has been linked to depression, suicidal thoughts and other abnormal behavior.

Walker is the second high-profile death that has been linked to Chantix. In September 2007, Carter Albrecht, who was a popular musician in the Dallas area and a member of Edie Brickell & the New Bohemians, was shot to death after he began violently banging on a neighbor’s door in the middle of the night as a result of hallucinations, vivid nightmares and a violent shift in behavior that the family attributed to the drug he was taking to help him quit smoking, according to a Chantix wrongful death lawsuit filed last year.

Following Albrecht’s death, media attention and an investigation by the FDA into reports of problems with Chantix led Pfizer to add information to the drug’s warning label about the potential psychiatric side effects.

Last year, the FDA required that a new Chantix black box warning be placed prominently on the label to warn users about the potentially life-threatening side effects, which is the strongest warning that can be placed on a prescription medication. The black box warning came after the FDA received nearly 100 reports of Chantix suicide and 198 reports of attempted suicide.

Dozens of Chantix suicide lawsuits and other injury claims have been filed against Pfizer in various state and federal courts throughout the United States. The complaints allege that Pfizer, who excluded individuals with depression or a history of mental illness from many clinical trials, failed to adequately research the adverse effects of their drug before marketing it heavily as an easy solution to help people stop smoking.

All federal lawsuits over Chantix have been consolidated in an MDL, or multidistrict litigation, which is centralized in the U.S. District Court for the Northern District of Alabama, where the first trials are not expected to begin until at least 2012.

CORRECTION: An earlier version of this article indicated that Donald Walker was the mayor of Houston, Texas, which is incorrect and we apologize for the error and any confusion it may have caused. Walker was the mayor of Warner Robins, which is located primarily in Houston County, Georgia, with a small portion also extending into Peach County.

Canadian drug reviewers are warning doctors to watch out for the potential risk of a liver injury from Avelox, an antibiotic that health officials in Canada say can lead to liver failure and death. 

Health Canada issued the Avelox liver injury warning to health care professionals on Monday, following a safety review of Avelox side effects. The reviewers concluded that Avelox can cause rare, but potentially fatal, liver injury and liver failure.

Health Canada is requiring Bayer to update the label warnings of the drug in Canada to include the association with severe liver injury.

Avelox (moxifloxacin) is an antibiotic sold by Bayer, which was approved in the United States by the FDA in 1999. It is currently sold in more than 80 countries. Avelox is a member of a family of drugs known as fluoroquinolones, which includes other antibiotics such as Levaquin, Cipro, Proquin, and Floxin. They are used to prevent infection by stopping the reproduction of bacteria and are a popular class of medications.

All of the drugs of this class have been linked with an increased risk of tendon ruptures, but the risk appears to be greatest with Ortho-McNeil-Janssen Pharmaceuticals, Inc.’s Levaquin (levofloxacin). According to reports received by the FDA, Levaquin tendon ruptures accounted for 61% of all fluoroquinolone-associated ruptures between November 1997 and December 2005. However, the drug only accounted for about 45% of all prescriptions written for fluoroquinolones during that time.

Fluoroquinolones, as a group, were also linked to vision problems by a September 2010 study by researchers from the Casey Eye Institute in Oregon. They found that the drugs could cause double vision, a condition that goes away when patients stop taking the drug.

Saudia Arabia has banned new shipments of the diabetes drug Avandia for at least six months as a result of concerns over Avandia side effects, which could increase the risk of heart attacks, congestive heart failure, fractures and other injuries.

The Saudi Food and Drug Authority (SFDA) announced an Avandia ban on March 17, saying that the Avandia health risks appear to outweigh the benefits provided by the type 2 diabetes drug and that there are safer alternatives. The country has suspended GlaxoSmithKline PLC’s ability to market the drug in the country and has halted new shipments, but the medication will still be available in pharmacies while supplies last.

In a SFDA Avandia safety evaluation report (pdf) from February 27, Saudi investigators cited a recent U.S. Senate report that determined GlaxoSmithKline knew that Avandia caused heart problems, but failed to inform the U.S. drug regulators. The Senate report also revealed that some FDA drug safety reviewers have been calling for an Avandia recall since 2007.

Avandia (rosiglitazone) was approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as Avandia concerns have mounted about the risk of serious and potentially life-threatening side effects. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

“There is no evidence that rosiglitazone offers any unique health benefit while there is strong evidence that rosiglitazone results in an increased risk of acute myocardial infarction and heart failure compared to pioglitazone,” the Saudi report concluded.

Pioglitazone is the medical name for Actos, manufactured by Takeda Pharmaceuticals North America, Inc. and is a competitor drug to Avandia. Both are members of a class of medications known as thiazolidinedione agents, which are used to treat type 2 diabetes by helping control blood sugar levels.

GlaxoSmithKline will have six months to present evidence to the SFDA to convince the Saudi agency that the ban should be reversed, otherwise it is likely that a permanent recall for Avandia will be issued.

Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.

In the United States, GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin later this year.

A lawsuit has been filed against Bayer by a California woman who suffered gallbladder failure after using Yasmin, alleging that the drug maker knew the birth control pill carried unacceptable health risk but released it any way.

The Yasmin gallbladder lawsuit was filed in San Mateo County Superior Court by Louise Thanos, who alleges that the oral contraceptive caused her to suffer organ failure in March 2008. Thanos indicates that she started using Yasmin birth control, which is an older version of the popular Yaz birth control pill, in November 2007 and has experienced gallbladder failure and other health problems.

The case is one of about 1,100 Yaz and Yasmin lawsuits filed on behalf of individual women who allege that they suffered injuries as a side effect of the birth control pills. In addition to lawsuits for gallbladder problems, cases have been filed by women who allege the pills caused them to suffer blood-clot related injuries, such as a stroke, heart attack, pulmonary embolism or deep vein thrombosis. The plaintiffs claim that Bayer failed to adequately research the birth control pills or warn about the increased risks when compared to other available forms of oral birth control.

Bayer has responded to the complaint by saying that the health risks of Yaz were included in the label, according to a report in the San Mateo County Times. The drug maker indicates that it intends to vigorously defend against the Yaz suits and Yasmin suits that have been filed in various state and federal courts throughout the United States.

Yaz and Yasmin are newer types of birth control pills, which contain a “fourth” generation progestin known as drospirenone. The progestin is only found in Yaz and Yasmin, which are both manufactured by Bayer, and a generic version of Yasmin marketed as Ocella. Thanos’s lawsuit claims that Bayer did not sufficiently test drospirenone before marketing it to the public.

Gallbladder problems from Yaz and Yasmin have been reported among many former users of the birth control. The gallbladder assists the body in the digestive process and stores bile produced by the liver, and many women indicate that they have experienced gallbladder failure as a side effect of Yaz or Yasmin, often requiring removal of the organ.

All federal Yaz and Yasmin cases are consolidated in an MDL, or multidistrict litigation, centralized in the Southern District of Illinois for pretrial litigation. There are also state level Yaz and Yasmin lawsuits consolidated in Pennsylvania and New Jersey courts. As Yasmin and Yaz lawyers continue to investigate and review potential new cases, it is expected that the number of cases filed will increase dramatically over the next year.

GlaxoSmithKline’s Rotarix vaccine, which is given to infants to inoculate them against the rotavirus, may be contaminated with viral DNA that should not be there and federal regulators are warning pediatricians not to use the vaccine.

The FDA issued the Rotarix warning on Monday, recommending that health care practitioners stop using the vaccine until the agency further examines the situation. However, the agency indicates that there is no evidence at this time that the extraneous viral DNA found in the vaccines poses a safety risk to infants.

The FDA says that an independent U.S. academic research team discovered genetic material from the porcine circovirus 1 (PVC1) in Rotarix. The FDA then confirmed through it’s own tests that extraneous viral DNA was in Rotarix. However, the virus is not known to cause illness in humans, the FDA stated.

Rotarix is an oral vaccine given to infants six weeks or older to prevent rotavirus, which can cause vomiting, diarrhea and fever. Most adults are protected against rotavirus due to immunities acquired during childhood, and it is generally considered to be most dangerous among children two years old and younger.

The first rotavirus vaccine, Merck & Co.’s RotaTeq, was approved in 2006, and GlaxoSmithKline’s Rotarix was approved in 2008. About 55,000 children were hospitalized annually in the United States due to rotavirus before the vaccinations began.

“We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Beyond the warning, FDA is taking no action at this time. However, the agency announced it will hold an expert advisory committee meeting and determine what other recommendations should be made.

An alarming number scientists and medical experts who came out in support of GlaxoSmithKline’s diabetes drug Avandia after it was linked to an increased risk of heart attacks and other side effects have been found to have undeclared financial ties to the company, according to a new study.

Researchers from the Mayo Clinic have analyzed more than 202 scientific papers, letters, and studies published in the wake of a 2007 study that first suggested that side effects of Avandia increase the risk of heart attack, and published the results of their analysis in the British Medical Journal. They found that authors who rushed to the drug’s defense were likely to have ties either directly to GlaxoSmithKline, or to a pharmaceutical company with a similar drug.

Avandia (rosiglitazone) was approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia side effects. Some experts have estimated that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

Researchers found that out of the 202 studies and papers they reviewed, 31 authors expressed favorable opinions of Avandia. Of those 31 authors, 27 (87%) had financial ties to GlaxoSmithKline. The researchers found that nearly a quarter of the studies they looked at had undeclared conflicts of interest. They also found that scientists who considered Avandia to be dangerous were most likely independent and free of any pharmaceutical company ties or funding.

“Our findings underscore the need for accountability by both authors and journals,” the study’s authors concluded. “Given the potential influence of financial conflicts of interest on the views expressed in articles, the low rate of disclosure by authors of editorials and commentaries is disappointing.”

 The researchers said that the results of the study underscores the need to improve scientific reporting methods.

Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.

Avandia was placed back under the spotlight last month by a U.S. Senate report that blasted GlaxoSmithKline for allegedly trying to cover up Avandia heart attack risks by deceiving the FDA and pressuring scientists to support the drug. The report revealed that some drug reviewers in FDA have been calling for an Avandia recall since 2007.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin later this year.

At least 78 people have fallen ill from a Shigellosis food poisoning outbreak linked to a Chicago-area Subway restaurant. The outbreak has hospitalized 11 people and has already resulted in a number of lawsuits.

According to the DuPage County Health Department in Illinois, at least 78 people have shown signs of being infected by the Shigella bacteria since the beginning of the month. All of the food poisoning victims ate at the Subway restaurant at 1009 E. Roosevelt Road in Lombard between February 24 and March 1. Of the 11 people who have been hospitalized, 10 have been released.

The restaurant was closed as a result of the Shigella outbreak, and remains closed as health investigators continue to look into the cause of the outbreak.

At least three Shigellosis lawsuits have been filed against Neel Subway, Inc., the Subway franchise that owns the restaurant. The lawsuits have all been filed in the DuPage County Circuit Court, and charge the company with strict liability, negligence and breach of warranty.

Shigella is a type of bacteria that is highly infectious and that causes sudden and severe diarrhea in humans. It is most likely to spread from fecal material through food, contaminated water, and person-to-person contact when basic hygiene needs are not met. Symptoms can include:

• Stomach cramps
• Diarrhea
• Bloody Diarrhea
• Rectal spasms
• Seizures in children under the age of two

Shigellosis is the third most common form of food poisoning in the U.S. and has been the culprit behind a number of high-profile cruise ship food poisoning incidents in recent years.

There are an estimated 450,000 cases of Shigella poisoning, known as Shigellosis, in the U.S. each year, according to the U.S. Centers for Disease, Control and Prevention (CDC). The CDC estimates that about 50,000 Shigellosis victims are hospitalized in the U.S. every year and about 7,000 die. Young children, the elderly, and people with compromised immune systems are the most at risk.

The results of a new study suggest that the number of infections in hospitals from C. diff (Clostridium difficile) are on the rise, just as medical facilities began to get a handle on MRSA hospital infections, which are commonly referred to as an antibiotic resistant “super bug.” 

The report, presented by Duke University researchers over the weekend at the Fifth Decennial International Conference on Healthcare-Associated Infections in Atlanta, revealed that C. diff hospital infections were 25% more common than methicillin-resistant Staphylococcus aureus (MRSA) in hospitals that were part of the study.

Researchers looked at 28 community hospitals in the southeastern U.S. which were part of the Duke Infection Control Outreach Network. The hospitals recorded 847 C. diff infections in 2008 and 2009, and only 680 cases of MRSA.

Not only did they find that hospital-acquired C. diff was on the rise as MRSA infections declined, but they also discovered that 90% of all hospital-acquired C. diff infections occurred after the patient had been given antibiotics. Researchers say that this is because antibiotics kill off much of the “good” bacteria that helps the body combat infections, allowing C. diff to flourish.

C. diff lives in the human gut and its spores can be found in feces. It can live for weeks on hard surfaces and can withstand cleaning by many disinfectants and alcohol-based sanitizers and still live on to infect humans. C. diff causes intestinal infections that can be very painful and in rare cases can be deadly.

According to the U.S. Centers for Disease Control and Prevention, There are about 215,000 hospital C. diff infections in the U.S. each year, and 263,000 cases of nursing home C. diff infections. The bacteria claims about 9,000 lives in the U.S. annually.

C. diff still has quite a ways to catch up to the prevalence of MRSA. The CDC reports that there are more than 2 million hospital infections acquired each year, resulting in about 90,000 deaths annually. Another 1.5 million long term care and nursing home infections occur every year. MRSA, which resists treatment by many antibiotics, has accounted for more than 60 percent of hospital staph infections in recent years.

In recent years, there has been an increasing number of hospital infection lawsuits filed throughout the United States, as experts believe that most of these potentially life-threatening infections can be prevented if steps are taken by the hospital and staff.

These steps could include improved methods of handling catheter during insertion, leaving them in for shorter periods and improved hygiene. Many hospitals have instituted new rules to ensure that hands are washed and increased efforts are being taken to keep areas lie the ICU more sterile and catheters clean.

High doses of the cholesterol-fighting drug Zocor can increase the risk of rhabdomyolysis, a serious and potentially fatal muscle disease, according to federal regulators.  

The FDA released a Zocor rhabdomyolysis warning on March 19, as part of an ongoing investigation into the side effects of Zocor and other cholesterol medications that belong to a family of drugs known as statins. All statins have been found to carry a risk of muscle injury, known as myopathy, and rhabdomyolysis is the most severe form, potentially causing severe kidney damage, kidney failure and death.

All statins currently contain a warning that myopathy and rhabdomyolysis are rare possible side effects, however this is the first time the FDA has warned that the conditions may be dose specific.

Statins are the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. Statin is used in a number of other popular cholesterol controlling drugs, including Crestor, Lipitor, Mevacor, Lescol and Pravachol.

Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is now available as a generic. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.

The FDA’s drug safety communication warns that data from a large clinical trial indicates that the highest approved doses of Zocor, 80 mg, carry an increased risk of muscle injury over lower doses. Zocor rhabdomyolysis causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream.

Zocor is also used in the combination cholesterol lowering drugs Vytorin (Exetimibe/simvastatin) and Simcor (Niaspan/simvastatin). Vytorin is produced and marketed as part of a joint venture between Merck & Co. and Schering-Plough, while Simcor is manufactured by Abbot Laboratories.

Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.

The connection between Zocor, other statins and myopathy has been under investigation by FDA for some time. In August 2008, the FDA warned healthcare professionals not to administer more than 20 mg/day of simvastatin to patients receiving heart drugs containing amiodarune, such as Cordarone and Pacerone.

In addition, researchers from Europe warned last month that statins can increase the risk of diabetes. University of Glasgow scientists analyzed the results of 13 different studies into the side effects of statins and found that people using the cholesterol drugs faced a 9% increased risk of being diagnosed with type 2 diabetes.

The FDA recommended that patients not stop taking Zocor unless told to by their health care professional. They should contact their doctor if they experience muscle pain, tenderness or weakness, dark or red-colored urine or unexplained tiredness.

A Texas man and his wife have been awarded $3 million in an asbestos injury lawsuit filed against Union Carbide and other defendants over the development of mesothelioma cancer. 

Oscar and Dora Torres sued Union Carbide Corporation, Garlock Sealing Technologies and Brown & Root over injuries caused by exposure to asbestos fibers while Oscar worked at the Union Carbide plant in Brownsville, Texas in the late 1970s.

Oscar Torres alleged that he developed mesothelioma, a rare and deadly form of cancer that is found in the lining of the chest and lung, as a result of inhaling asbestos fibers.

The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed for 20 to 40 years after exposure. As a result of the long latency period, the cancer is very advanced when it is diagnosed and life expectancy with the disease is limited.

Torres worked for Brown & Root at the Union Carbide plant, and the lawsuit alleged that Garlock parts he came in contact with used asbestos. The lawsuit alleged that workers were not properly protected against asbestos exposure and claimed that they were not warned of the potentially lethal consequences.

On March 6, a 107th District Court jury awarded the couple $1 million for past damages and $2 million for future damages. The jury apportioned 45% of the liability to Union Carbide, 45% to Garlock Sealing Technologies and 10% to Brown & Root.

Asbestos litigation is the longest running mass tort in U.S. history, with the first asbestos exposure lawsuit filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.