Author: AboutLawsuits

Several asthma inhalers will be gradually phased out over the course of the year to comply with international agreements designed to protect the ozone layer. 

The FDA announced this week that it will remove seven metered-dose inhalers (MDI) from the market because they contain chlorofluorocarbons (CFCs) as propellants to spray the medicine out of the inhaler.

The drugs are used to treat asthma and chronic obstructive pulmonary disease (COPD), but the FDA indicates that alternative medications are available to replace all of the phased out inhalers.

The action is part of the United States’ obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer. CFCs have been found to deplete the ozone layer, which protects life on earth from the harmful ultraviolet rays of the sun.

The U.S. has banned the use of CFCs in commonly used aerosols for about 25 years. There have been no CFCs produced in the U.S. since 1996 except for limited uses, like MDIs.

Inhalers affected by the phase out include:

• Tilade Inhaler (nedocromil), by King Pharmaceuticals, with a phase-out date of June 14, 2010
• Alupent Inhalation Aerosol (metaproterenol), by Boehringer Ingelheim Pharmaceuticals, with a phase-out date of June 14, 2010
• Aerobid inhaler System (flunisolide), by Forest Laboratories, with a phase-out date of June 30, 2010
• Azmacort Inhalation Aerosol (triamcinolone), by Abbott Laboratories, with a phase-out date of December 31, 2010
• Intal Inhaler (cromolyn), by King Pharmaceuticals, with a phase-out date of December 31, 2010
• Combivent Inhalation Aerosol (albuterol and ipratropium in combination) by Boehringer Ingelheim Pharmaceuticals, with a phase-out date of December 31, 2010
• Maxair Autoinhaler (pirbuterol), by Graceway Pharmaceuticals, with a phase-out date of December 31, 2010.

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

A Florida woman has been awarded $10 million in a medical malpractice lawsuit against an ambulance service, which involved allegations that negligence by the paramedics caused her son to suffer a birth injury that resulted in cerebral palsy. 

The cerebral palsy lawsuit was filed by Margarita Chess, of Volusia County, against EVAC Ambulance, Bert Fish Medical Center, Halifax Medical Center, Arnold Palmer Hospital in Orlando, and two doctors. According to a report by the Orlando Sentinel, all of the defendants except EVAC settled with Chess before the case went to trial for $1.4 million.

Chess’s son, now six years old, was born when she was just six months pregnant. When Chess went into labor in 2003, she was initially treated at Bert Fish Medical Center in New Smyrna Beach. Then she was sent by EVAC Ambulance to Halifax Medical Center. However, the ambulance was routed instead to Arnold Palmer, 57 miles away, and her son, Addison Chess, was born en route.

The birth injury lawsuit alleges that Addison had trouble breathing when he was born, 15 minutes into the drive. Ambulance paramedics conducted CPR, but the boy suffered a lack of oxygen and brain damage as a result, which left him with life-long disabilities associated with cerebral palsy.

Cerebral palsy can be caused by an injury to an infant’s brain before, during or shortly after birth. If the brain of a baby is deprived of oxygen, it can result in irreversible damage that leaves the child with developmental problems, loss of motor functions and other life-long injuries and disabilities associated with cerebral palsy. The condition is also commonly associated with seizures, sensory impairments and cognitive limitation.

Medical malpractice lawsuits for cerebral palsy are often filed when a medical mistake or series of mistakes occur during prenatal care or delivery that result in the child’s brain being deprived of oxygen for an extended amount of time.

A request has been filed to centralize more than 60 Ethicon Gynecare pelvic mesh lawsuits that are currently pending in New Jersey state court, indicating that many more cases are likely to be filed over the allegedly defective vaginal mesh.

All of the cases involve allegations that problems with Gynecare Prolift, Gynecare Transvaginal Tape or Gynecare Gynemesh, which are pelvic mesh products manufactured by Ethicon for treatment of pelvic organ prolapse and stress urinary incontinence, caused women to experience vaginal erosion, infections, pain, urinary problems and other complications.

Ethicon is a wholly owned subsidiary of Johnson & Johnson, which is based in Middlesex County, New Jersey. All but one of the New Jersey cases are currently pending in that county, and attorneys for several plaintiffs are requesting that all of the lawsuits be assigned for centralized management in Middlesex County.

“Each case alleges violations of the Product Liability Act, and the determination of liability in each case will rely upon the same core of voluminous documents and medical literature,” lawyers argued in their request for centralization. “Common experts will in all likelihood be utilized in the cases, at least with regard to the liability issues. Therefore, the discovery and determination of the liability issues should be coordinated under the Centralized Case Management umbrella to promote efficiency, and prevent inconsistent legal rulings on the many common issues that will arise in the course of the litigation.”

In 2008, the FDA issued a public health notification warning of serious problems with vaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to reports received by the FDA from nine different manufacturers, over 1,000 people had suffered severe complications from the surgical mesh, often requiring additional surery to remove the mesh or treat complications.

A pelvic organ prolapse occurs when organs such as the bladder, uterus, bowel or rectum drop and push against the wall of the vagina. This happens when the muscles holding the pelvic organ in place become weak or stretched, often due to childbirth or surgery. The surgical mesh is used to support the muscle.

Female stress urinary incontinence is a condition where urine is involuntarily released during moments of physical stress due to weakened of the muscles that support the bladder and urethra. In repair procedures, the surgical mesh is designed to act like a hammock to reinforce the muscle.

Similar cases have been filed against manufacturers of other vaginal mesh products, including Mentor ObTape lawsuits, which are currently consolidated in federal court as part of an MDL, or multidistrict litigation.

According to a new medical study by Canadian researchers, side effects of antidepressants carry a similar risk of causing suicide in youths, regardless on the specific drug used.

The study, published online by the medical journal Pediatrics, looked at the use of Paxil, Zoloft, and Prozac and determined that all of the antidepressants carried roughly the same risk of causing a child to attempt suicide. Researchers say the findings support the FDA’s decision to place a “black box” suicide risk warning on all antidepressants on the market.

Researchers from British Columbia looked at nearly 21,000 youths between the ages of 10 and 18, and found three suicides and 266 attempted suicides among those who had taken antidepressants for a year.

That number represents five times the rate of suicide and suicide attempts among youths not taking antidepressants, but researchers said that the number remained roughly consistent regardless of what kind of antidepressant the child was prescribed. Overall, researchers estimate that the use of antidepressants raises the rate of suicidal acts among children to 27.04 per 1,000 person-years.

Antidepressants, particularly a class of drugs known as selective serotonin reuptake inhibitors (SSRIs), have come under fire in recent years over concerns that they may increase the risk suicidal tendencies.

In particular, a number of lawsuits have been filed against GlaxoSmithKline, the maker of Paxil (paroxetine), for failing to adequately warn users and the medical community about the risk of suicide. The drug maker has spent an estimated $390 million to settle Paxil suicide or attempted suicide lawsuits. In December, Bloomberg News indicated that about 150 suicide death cases have settled for an average of $2 million each and another 300 attempted suicide cases resolved for about $300,000 each.

A new report by the consumer advocacy group Public Citizen suggests that many state medical boards are not protecting patients from doctors practicing substandard medicine, potentially exposing consumers to a risk of medical mistakes by failing to take serious disciplinary actions against bad doctors.

The group released its annual ranking of state medical boards last week, looking at the number of serious disciplinary actions each state took against doctors from 2007 through 2009. Researchers said they found considerable evidence that most state medical boards are not disciplining doctors enough.

Public Citizen’s Health Research Group used recently released data from the Federation of State Medical Boards (FSMB) to calculate the number of severe disciplinary actions taken per 1,000 physicians in each state. To eliminate the large variability in states with fewer doctors, the researchers looked at data from a three-year period.

Researchers determined that on average only 3.05 serious disciplinary actions were taken for every 1,000 doctors. Minnesota ranked the lowest, with only 1.07 actions per 1,000 physicians. The state most likely to discipline doctors was Alaska, with 7.89 serious actions per 1,000 physicians.

“There is considerable evidence that most boards are under-disciplining physicians,” according to Dr. Sidney Wolf, director of Public Citizen’s Health Research Group. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Public Citizen researchers say that information from previous years show that the number of disciplinary actions reflects a failing on the part of state boards to appropriately penalize doctors. In 2006, the organization published a report on doctors penalized for criminal activity and found that in 67 percent of all insurance fraud convictions and 37 percent of all inappropriate drug use convictions, state medical boards only took non-severe disciplinary action.

The report details not only which states are the best and worst performers, but also which states have improved over time and which have fallen to lower levels of discipline. Public Citizen said one of the more disturbing trends is that the most populated states tend to rank low as far as disciplinary action. Florida is consistently in the bottom 10, and California ranked 11th worst this year. The only state among the 15 most populous states in the country to rank in the top 10 was Ohio, with 5.43 actions per 1,000 physicians.

Bayer is adding new information on blood clots to the warning section of the labels for Yaz and Yasmin birth control pills. The update comes as the drug maker faces thousands of Yasmin and Yaz blood clot lawsuits from women who allege that the company failed to adequately warn about the increased risk of serious and potentially life-threatening injuries. 

The label changes, which were approved on April 7 by FDA (pdf), are expected to be similar to updates made last month in the European Union about the potential risk of blood clots from side effects of Yaz and Yasmin, including new information from four epidemiological studies that provide conflicting information on the risk of Yaz and Yasmin blood clots compared to other birth control pills containing levonorgestrel.

Two of the studies, which were sponsored by Bayer, found that the risk of venous thromboembolism from Yasmin and Yaz was comparable to the risk found in women who use levonorgestrel-containing combined oral contraceptives, such as Microgynon 30. However, two independent studies found that the risk of blood clots from Yasmin and Yaz side effects was higher than with levonorgestrel.

One of those studies, conducted in the Netherlands and published in the British Medical Journal in August, determined that Yaz and Yasmin, both of which contain the progestin drospirenone, increased the risk of blood clots in women 6.3 times over those not on birth control, while levonorgestrel-based pills only increased the risk about 4 times.

Researchers determined that the benefits of Yaz and Yasmin, as well as some other newer forms of birth control pills, were no greater than the benefits of older birth control pills, and suggested women should use the pills with the least side effects. But Bayer has previously suggested that it has identified “several methodological issues” in the two independent studies that suggest Yaz and Yasmin carry higher blood clot risks.

Yaz and Yasmin are similar pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues.

About 1,100 Yaz lawsuits and Yasmin lawsuits have been filed in the U.S. on behalf of individual women who allege that they suffered injuries that were caused by the birth control pills, such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease and other injuries.

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.

Federal safety regulators have launched an investigation into reported brake problems that could affect as many as 6 million model year 1999 through 2003 GMC and Chevrolet pickup trucks and sport utility vehicles (SUV).

The investigation, launched on March 30, was announced late last week in a preliminary investigation report (pdf) by the National Highway Traffic Safety Administration (NHTSA). The report says that it’s Office of Defects Investigation (ODI) has received 110 owner complaints regarding the trucks, which are all made by General Motors. There have been at least three automobile accidents that may have been related to the potential GM brake problems, according to the ODI preliminary report.

Included in the investigation are the Chevrolet Avalanche, Chevrolet Silverado and Chevrolet Suburban trucks, as well as the GMC Sierra, GMC Tahoe and GMC Yukon. According to ODI, the complaints from drivers include reports that they lost braking effectiveness after brake lines ruptured due to corrosion. ODI investigator Chris Lash noted in his report that 37 of the complaints were confirmed by a dealer inspection.

The inspection was announced just weeks after GM issued a recall for 1.3 million Chevrolet Cobalt and Pontiac vehicles sold in the U.S., Canada, and Mexico. The recall was issued after the NHTSA received more than 1,000 reports of power steering failing in the vehicles, resulting in at least 14 crashes.

That GM recall affects the 2005-2010 model year Chevrolet Cobalt, the 2007-2010 Pontiac G5, the 2005-2006 Pontiac Pursuit, and the 2005-2006 G4. The Pursuit is sold in Canada and the G4 is sold in Mexico. GM said it has been investigating the problem since 2009, and determined that in rare cases, the power steering motor on the vehicles can die and cause difficulty steering at speeds under 15 m.p.h.

The U.S. Securities Exchange Commission (SEC), Financial Industry Regulatory Authority (FINRA) and four states have charged Morgan Keegan & Company with fraud and reckless business practices, saying the company caused bond fund investors to lose more than $1 billion during the subprime mortgage collapse. 

The SEC and FINRA say that James Kelsoe, managing director at Morgan Keegan and a leading mutual fund manager, directed staff to perform 262 “price adjustments” in 2007 that hid the declining values of bond funds that were heavily invested in subprime mortgages. In addition, the two financial authorities say the company, and its subsidiary, Morgan Asset Management, withheld vital information from investors about the value and security of their investments.

The SEC is also charging Joseph Weller, who heads Morgan Keegan’s accounting department, with failing to assure that the securities’ prices were set at the proper level.

The charges come as the company faces hundreds of Morgan Keegan bond fund arbitration claims from investors. Morgan Keegan officials say they have already bought back $100 million in securities to remediate investor losses.

Mississippi, Alabama, Kentucky and South Carolina have also announced that they intend to take administrative actions against Morgan Keegan, which could result in them being forced to compensate investors for more than $1 billion in losses and could also result in the company losing its license to do business in those states.

The bond funds were heavily invested in the subprime mortgage market, and lost as much as 82% in value after the market imploded. The funds were subsequently taken from Morgan Keegan by its parent company, Regions Financial Corp., and transferred to Hyperion Brookfield Assed Management, Inc., which has since liquidated and closed down two of the funds.

Morgan Keegan officials have said that the charges represent factual inaccuracies and misrepresentations of law and say the company plans to defend itself against the charges and claims.

Hundreds of Morgan Keegan lawsuits filed by individual investors are currently pending against the brokerage firm. The cases involve several different Morgan Keegan funds, including the RMK Strategic Income Fund, RMK Select High Income Fund and RMK Advantage Fund.

Federal drug safety reviewers say that the side effects of Byetta, a diabetes drug, may share thyroid cancer concerns of similar medications, which may result in black-box warning for a new long-acting version of the drug. 

In a report released earlier this month (pdf), FDA officials said animal testing revealing thyroid cancer links with Novo Nordisk’s Victoza, a long-acting diabetes treatment medication, could affect all similar drugs, including Amylin Pharmaceutical’s proposed once-weekly Byetta shot, Bydureon, also known as Byetta LAR. Therefore, strict label warnings may be necessary about the potential Byetta cancer risk to alert users to the possibility of thyroid tumors.

Byetta (exenatide) and Victoza (liraglutide) belong to the same class of drugs, known as GLP-1 analogs. The FDA report expresses concerns that all extended-release diabetes drugs belonging to that family may be linked to thyroid tumors based on tests conducted on rats and monkeys. Victoza was approved in January, but carries the black box warning on potential thyroid cancer. Amylin’s bid for approval of Bydureon was rejected by FDA last month, with the agency requesting more information before it could release the drug on the market.

In April of last year, when concerns regarding Byetta thyroid cancer side effects came up, Amylin pointed out that Victoza and Byetta are different molecules, and indicated that there was no evidence of any link between Byetta and thyroid cancer. However, a statement from company officials following the FDA report concedes that cancer concerns, while not proven, cannot be ruled out as a side effect of Byetta.

Byetta is a type 2 diabetes drug that is manufactured and distributed jointly by Amylin and Eli Lilly & Co. The drug is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.

FDA drug safety reviewers have already expressed concerns that Byetta may be linked to kidney failure and a possible increased risk of pancreatitis. In November, the FDA issued a warning indicating that they have received at least 78 post-marketing reports involving Byetta kidney problems, with 62 of those reports involving users experiencing kidney failure. The alert followed FDA warnings issued in October 2007 and August 2008 of reports involving cases of pancreatitis with Byetta, including severe reports of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.

Amylin and Eli Lilly also currently face a number of Byetta lawsuits involving allegations that the drug makers failed to adequately warn about the risk of pancreatitis and kidney failure.

The U.S. Judicial Panel on Multidistrict Litigation has decided that the federal Toyota litigation, involving class action lawsuits and individual injury lawsuits filed over sudden acceleration problems with millions of recalled vehicles, will be consolidated and centralized for pretrial litigation in the Central District of California. 

According to an order issued April 9, 2010, there are currently 11 Toyota sudden acceleration cases pending that involve sufficiently common questions of fact to support centralization in a multidistrict litigation, or MDL, for pretrial proceedings. In addition, the court knows of about 40 similar lawsuits which may be included in the MDL at a later date.

The consolidation of the Toyota recall litigation comes as federal regulators look for ways to penalize Toyota over what they say was an intentional cover up of problems with sudden acceleration in Toyota vehicles that put lives at risk. Last week, the Department of Transportation (DOT) announced that it was fining Toyota $16.4 million. However, U.S. officials also sent a letter to Toyota saying that if it were not for statutory limits, they would have fined the company more than $13 billion, and are considering other fines against the company.

While the $16.4 million is minor for a company the size of Toyota, experts say the real damage could be the inclusion of the federal government’s fines, condemnation, and documentation indicating a cover up in the Toyota recall lawsuits. The DOT says it has internal memos indicating that Toyota sat on the gas pedal problem for four months before issuing a recall, which could make the company vulnerable to punitive damages.

Toyota has recalled nearly 9 million vehicles since September 2009, with 8.5 million recalled due to complaints that they can accelerate out of control. The acceleration recalls were done in waves, starting with 4.2 million recalled for problems involving the floormats, and then later recalls indicated that there was a mechanical or electrical problem with the gas pedals.

The gas pedal problems have resulted in a number of Toyota consumer class action lawsuits, Toyota injury lawsuits and Toyota wrongful death lawsuits filed by family members of people allegedly killed when their vehicles accelerated out of control.

The federal Toyota litigation will be centralized before U.S. District Judge James V. Selna for coordinated handling. The panel indicated that the district, where Toyota’s USA division is headquartered, was best suited to handle the potential flood of Toyota gas pedal lawsuits.

The panel stated that Selna has the proper experience with complex litigation to handle the case, and pointed out that many of the witnesses are relevant documents are likely located in this district. The panel also said that consolidation under Selna will avoid duplicate discovery, inconsistent rulings from different judges and to serve the convenience of the court, the parties and witnesses.

“Though these cases have attracted an unusual amount of publicity to the Panel’s work, in all relevant aspects, the issues here are neither dramatically different nor more complex than those we regularly resolve,” the panel stated in its transfer order.

As Toyota sudden acceleration lawyers file additional cases in the future over problems with Toyota vehicle gas pedals, the lawsuits will be transferred into the MDL. If the cases do not settle or otherwise resolve during pretrial litigation, they will be returned to the district where they were filed for individual trials.

Photo Courtesy of: http://www.flickr.com/photos/danielctw/ / CC BY 2.0

A federal judge has awarded $2.6 million to seven Virginia families in the first Chinese drywall lawsuit verdict, but collecting the actual award may be difficult. 

The decision, issued Thursday by U.S. District Judge Eldon Fallon, could set the tone for hundreds of other lawsuits in both federal and state courts. However, it is unclear how the plaintiffs will recover money from the defendant in this case, Taishan Gypsum Co., since civil lawsuit decisions are not enforced in China.

Taishan did not respond to the lawsuits or send anyone to represent the company in the U.S. federal court. Some plaintiffs attorneys have recommended that Taishan inventory on ships in U.S. waters and on U.S. soil be seized.

According to the U.S. Consumer Product Safety Commission (CPSC), federal investigators have received nearly 3,000 complaints from across the United States from homeowners who say that toxic wallboard from China releases sulfuric odors, causes health problems, and corrodes wiring and appliances. Many of the problems with the Chinese drywall have been confirmed by laboratory testing.

Fallon’s summary judgment in the first lawsuit to go to trial details the extensive amount of gutting that will be required to remove the traces and side effects of Chinese drywall from the plaintiffs’ homes. Not only must all the drywall be removed, even if it was mixed with non-toxic wallboard, but all of the copper pipes, electrical wiring, many of the appliances, and all cabinets, trim, moulding, countertops, carpets, hardwood flooring, and bathroom fixtures must be replaced as well.

The lawsuits were limited to property damage, and did not address some homeowners’ concerns that Chinese drywall sulfur emissions could be affecting their health.

The judgment comes just days after the CPSC and the U.S. Department of Housing and Urban Development (HUD) released interim remediation guidance (pdf) for removing toxic Chinese drywall. Like Fallon’s ruling, the guidance recommends that consumers remove all drywall and replace electrical components, wiring, gas service pipes, and also recommends replacement of safety equipment like fire sprinklers, smoke alarms and carbon monoxide detectors.

Millions of sheets of toxic drywall were imported from China into the United States between 2004 and 2007 due to a domestic shortage caused by a housing boom and construction following a serious of hurricanes that struck the southeastern United States. The CPSC has confirmed more than 6 million sheets were imported into the country in 2006, and additional temporary support personnel are being brought in to verify more shipments.

A number of homeowners throughout the United States have filed contaminated Chinese drywall lawsuits against manufacturers and distributors. In June 2009, all of the federal drywall litigation was consolidated and centralized in an MDL, or Multidistrict Litigation under Judge Fallon.

To date, the only foreign drywall supplier that has agreed to participate in the lawsuits is Knauf Plasterboard Tianjin Co., a subsidiary of a German company. Knauf has been sued by both homeowners and homebuilders, and the company has said it will work with state and federal regulators to address plaintiffs’ concerns. A separate trial was held against Knauf earlier this year, but Fallon has not yet issued a ruling on that case.

The findings of a new government report indicate that the FDA is unable to keep up with food facility inspections, placing Americans at risk of food poisoning. 

The food inspection report (pdf), issued by the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services this month, found that the number of food processing plants and other facilities inspected by FDA is declining. The report also found that more than half of all food facilities currently in operation have gone five years or more without an inspection.

“Our report found significant weaknesses in FDA’s domestic inspections program,” the OIG report states. “We found that there was a significant decline in the number of food facility inspections as well as a decline in the number of violations identified by FDA inspectors. Further, when violations were identified, FDA did not routinely take swift and effective action to ensure that these violations were remedied.”

The report says that the findings indicate that more needs to be done to protect the public from food poisoning contamination and that FDA needs to be provided with better tools to prevent food poisoning outbreaks.

Specifically, the OIG report found that between 2004 and 2008, FDA inspected an average of 24 percent of food facilities. The report also found that the number of facilities inspected per year declined during that time period, even as the total number of food processing plants under FDA’s jurisdiction increased. The OIG said, of the 51,229 food facilities subject to FDA inspection, 56% were not inspected at all between 2004 and 2008, and 14% were only inspected once during that time period. Only 30% were inspected at least twice.

The report follows on the heels of a number of high-profile food illness outbreaks over the last several years, including a number of E. coli ground beef outbreaks, salmonella food poisoning outbreaks, and the massive 2007 peanut butter recall. The report also comes as multi-product recalls are still being issued over vegetable protein salmonella contamination and pepper salmonella contamination.

It also comes as the U.S. congress weighs the FDA Food Modernization Act, a bill that would significantly strengthen the FDA’s food inspection and regulatory powers. Senator Tom Harkin, Chair of the Senate Health, Education, Labor and Pensions Committee, said the report confirmed lawmakers’ fears.

“This is unacceptable in our modern society and an important reminder that we must provide FDA with the needed tools to properly inspect food facilities and effectively react to problems in order to ensure the safety of the food American families eat,” Sen. Harkin said in a press release this week. “Quite simply, picking up food at the grocery store should not be a health risk.”

A Texas jury has awarded a Houston woman $9 million in a defamation lawsuit against Walmart after she was wrongly arrested and accused of trying to cash fake money orders that were actually real. 

The plaintiff, Nitra Gipson, filed the defamation lawsuit against Walmart after she was jailed for two days when employees at a store in Meyer Park, Texas had her arrested for trying to cash counterfeit Walmart money orders.

The 24 year old student was later released after prosecutors determined that the money orders were real. Gipson had obtained the money orders from selling her car for $4,100 to raise money for college tuition.

Even after her release, Gipson alleged that Walmart continued to defame her by sending a letter stating that she owed the company money, and then threatened to file shoplifting charges against her if she did not compensate the company $200, according to a story in the Houston Chronicle.

Defamation lawsuits involve allegations that a defendant publicly made false statements that caused the plaintiff to be seen in a negative light. Following trial in Harris County, a jury ruled last month that Walmart defamed Gipson by wrongfully accusing her of forgery, counterfeiting, shoplifting and theft, and awarded her $8.2 million in actual damages. It then hit Walmart with another $820,000 in punitive damages.

The number of Americans who have been injured by tranquilizer, sedative and painkiller overdoses has jumped 65% in recent years, making prescription drug poisoning the second leading cause of unintentional injury death in the U.S., scientists report. 

According to a report issued on Wednesday by the American Journal of Preventative Medicine (PDF), prescription drug poisoning now surpasses automobile accidents as the leading cause of unintentional injury death among people between the ages of 35 and 54, and a scientific study to be published in the journal next month will show how prescription drug overdoses have skyrocketed since 2006.

Researchers from the West Virginia University School of Medicine say that the number of people hospitalized due to overdoses from drugs like OxyContin, fentanyl and morphine are now 65% higher than they were from 1999 through 2006. That number is twice the increase seen in hospitalizations for other drugs. Intentional poisonings using these drugs either illegally or in attempted suicides rose 130%, while accidental overdoses rose about 37%, researchers estimate.

The increases represent a rise from about 43,000 people hospitalized for painkiller overdoses every year, to about 71,000. The drug that saw the largest increase in poisoning hospitalizations was methadone, for which the rate of injury jumped 400%. Overdoses and hospitalizations for injuries from benzodiazepines, like Valium, increased 39%, while injuries from barbiturates and antidepressants have actually decreased.

The study comes as more attention has been focused on the abuse of prescription drugs. Earlier this week, the FDA announced that it has approved a new tamper-resistant version of OxyContin, which is supposed to resist efforts to cut, chew, or crush the pills in order to defeat the slow medication release design of the pills.

In 2008, about half a million people used OxyContin for non-medical reasons for the first time, according to data collected by the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.

The dismissal of a diabetes Seroquel lawsuit that was originally set for trial in February 2009 has been upheld by a federal appeals court. The decision comes as a mediator continues to try to bring plaintiffs and defendants to a settlement agreement for thousands of other cases that allege plaintiffs developed injuries from side effects of Seroquel. 

On Wednesday, the Eleventh Circuit Appellate Court upheld the decision of a trial court to dismiss a Seroquel lawsuit brought by Linda Guinn, which alleged that the drug maker failed to adequately warn about the risk of weight gain and diabetes. At the time of the original dismissal, the case was slated to be the first diabetes Seroquel trial in the federal multidistrict litigation (MDL).

U.S. District Judge Anne Conway, who is presiding over pretrial litigation for all of the federal lawsuits over Seroquel, dismissed Guinn’s lawsuit in January 2009 after excluding expert testimony that was necessary to establish she developed diabetes from Seroquel. The Court of Appeals rejected Guinn’s appeal, finding that her expert witness, Dr. Jennifer Marks, failed to adequately consider possible alternative causes for weight gain and diabetes.

The decision comes as a court appointed mediator is working to determine if a settlement agreement can be reached between AstraZeneca and an estimated 22,000 different plaintiffs. Earlier this month, Stephen A. Saltzburg, the court-assigned mediator, reported that the ability to reach a settlement could hinge on the plaintiffs’ ability to provide complete medical records.

In November, Judge Conway ordered lawyers for both sides to meet with Saltzburg to see if there is any possibility for a Seroquel settlement before as many as 6,000 cases are sent back to the districts where they were originally filed for trial.

Last week, Saltzburg filed a status report with Judge Conway indicating that the Court’s encouragement of prompt submission of medical records by plaintiff firms might help get medical records in more quickly, allowing AstraZeneca to make a realistic estimate of what the universe of claims actually is and enter discussions on the value of claims.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.

Three plaintiffs with Zimmer Durom Cup lawsuits pending in federal court, are asking that dozens of other similar claims involving injuries from the allegedly defective hip implant be consolidated and centralized before one judge for pretrial proceedings as a part of a multidistrict litigation, or MDL.

A motion was filed last month with the U.S. Judicial Panel on Multidistrict Litigation asking that at least 51 product liability lawsuits currently pending in ten different states involving the Zimmer Durom Cup be centralized in the U.S. District Court for the Eastern District of Texas. All of the cases involve similar allegations of injuries caused by a defective Durom Cup implainted as part of a hip replacement surgery.

Consolidating the federal Zimmer Durom Cup litigation before one judge would eliminate duplicative discovery, avoid contradictory rulings and serve the convenience of the court, witnesses and parties, according the motion. While the pretrial management of the cases in an MDL is often similar to how a Zimmer Durom Cup class action suit would be handled, each claim would still remain an individual lawsuit that would be returned back to the jurisdiction where it was originally filed for trial if it does not settle or otherwise resolve during pretrial litigation.

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. A temporary Zimmer Durom Cup recall was issued in July 2008, so that revisions could be made to the product’s warnings and instructions to ensure that doctors were properly trained on the surgical techniques needed to implant the artificial hip correctly.

Approximately 12,000 individuals had the Zimmer Durom Cup system implanted in their hip between 2006 and 2008. While Zimmer’s own estimates in July 2008 suggested that some doctors have experienced failure rates as high as 5.7%, the petition says that 14% of those who have had the Durom Cup hip replacement implanted have required hip revision surgery. As of the end of last year, more than 500 adverse event reports have been filed with the FDA regarding problems with the Zimmer Durom Cup and many experts anticipate that the rate of hip cup loosenings could increase as time passes after the surgery.

If the Judicial Panel decides to form an MDL for the pretrial proceedings, all pending cases would be transferred to the judge assigned to preside over the litigation. In addition, as Zimmer Durom Cup lawyers investigate and file new federal cases in the future, they will also be transferred to the MDL for coordinated handling.

In recent months, concerns have emerged about similar problems associated with a different type of implant, known as metal-on-metal hip implants. Last 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.

A recall of all Camolyn Eye Drops and Fisiolin Nasal Drops has been issued after it was discovered that they may not be sterile, which could cause infections or blindness. 

The nasal and eye drop recall was announced on Wednesday by FDA. According to a press release from the manufacturer, US Oftalmi Corporation, the recall was initiated after it was determined that conditions in the manufacturing facility could not guarantee the sterility of the drops. However, there have been no injuries or reports of problems from consumers.

The Camolyn Eye Drops recall and Fisiolin Nasal Drops recall affects all over-the-counter drops under those labels, including Camolyn Homeopathic; Camolyn Plus, Naphazoline + Chamomile; Camolyn Refresh; Camolyn-A, Naphazoline + Pheniramine; and Fisiolin Nasal Drops Sodium Chloride Pediatric Uses. All of the recalled eye drops and nasal drops were distributed nationwide to food and drug distributors and were packaged in 15 mL plastic bottles.

If a consumer uses non-sterile drops, they could develop an infection. Some eye infections could potentially lead to blindness. However, US Oftalmi has said that it believes the likelihood of users experience a severe adverse reaction is remote.

The company has ceased production of the nasal and eye drops until the manufacturing problem can be solved. It is recommended that any consumers with the recalled eye and nasal drops discard them immediately.

Anyone who experiences an adverse reaction from this product should report the incident to the FDA’s MedWatch Program at www.fda.gov/medwatch.

Guidant LLC, a subsidiary of Boston Scientific, has plead guilty to federal charges that it attempted to cover up problems with defective defibrillator implants.  

The guilty plea was entered last month before U.S. District Court Judge Donovan W. Frank, according to a press release issued Monday by the Department of Justice (DOJ). Under the terms of the deal, the medical device manufacturer will pay more than $296 million in criminal fines to resolve charges that it violated the Federal Food, Drug and Cosmetic Act by failing to report defects in some of its implantable defibrillators to FDA, and then trying to make changes to the implants without alerting the federal agency that there was a problem.

DOJ investigators filed charges against Guidant on February 25 in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs which in some cases resulted in death.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges allege that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.

The DOJ accused the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law. Even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

“Guidant’s guilty plea today is about accountability,” said DOJ Assistant Attorney General Tony West. “This successful prosecution serves as an important wake up call to all those who seek to withhold vital information about public health and safety. We will continue our efforts to prosecute those who jeopardize public health by evading their reporting obligations to the FDA.”

DOJ officials say that the $296 million penalty is the largest ever imposed on a medical device manufacturer for violating the Federal Food, Drug and Cosmetic Act. In 2007, Guidant settled thousands of defibrillator recall lawsuits for $195 million.

Federal regulators have cited Biogen Idec, Inc. for attempting to downplay the risks of a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. 

The FDA sent a warning letter (pdf) to the company on March 25, accusing the company of misleading statements made in a series of webcasts used to promote Tysabri. According to the FDA, Biogen aired the webcast eight times between late October and early November of 2009.

In the webcasts, the FDA says Biogen played down the risk of contracting progressive mutifocal luekoencephalopathy (PML), which is a serious infection in the brain that can be caused by side effects of Tysabri. In addition, the FDA said that the webcasts failed to inform the viewer of Tysabri’s approved uses.

Tysabri (natalizumab) is an intravenous injection given every 28 days to treat MS and Crohn’s Disease. Manufactured by Biogen Idec Inc. and marketed with Elan Corp PLC, Tysabri has been shown to prevent relapse, cognitive decline and vision loss associated with MS. Sales of Tysabri bring in about $1 billion annually.

A Tysabri recall was issued in 2005 after three users developed the rare and life-threatening brain infection, which attacks the central nervous system, damaging and inflaming the white matter areas of the brain. The drug was reintroduced in July 2006 with stronger warnings about the potential risk of a PML brain infection from Tysabri and the drug was only made available under strict usage guidelines.

PML is believed to be caused by the common JC virus, and Tysabri may reduce the ability of the immune system to combat the virus. There have been 31 cases of Tysabri brain infections since the drug was reintroduced.

In February, the FDA issued a Tysabri PML warning saying that it now appears that the risk of developing PML increases with the number of Tysabri infusions patients receive.

“We are particularly concerned with this webcast because it presents numerous statements that seriously minimize the risk of PML,” the FDA said in its warning letter. “This presentation misleadingly implies that Tysabri patients who developed PML and received treatment…experienced lessened effects of PML and that patient outcomes will necessarily be improved if Tysabri treatment is stopped at the first sign of PML; this has not been established.”

The FDA said that, in truth, no one knows if early detection of PML or discontinuing use of Tysabri once it’s been detected will mitigate the disease. The FDA also points out that there is no evidence that plasma exchanges, a treatment touted in the webcasts, have any benefit in treating PML or other opportunistic infections.

A New Jersey judge is calling for a statewide consolidation of all Reglan lawsuits, which involve claims that the heartburn drug causes a rare movement disorder, arguing that the New Jersey court system can better handle the growing number cases if they are centralized in one court. 

Judge Eugene J. Codey, Jr., presiding judge of the Essex County Superior Court, filed a request last month with the administrative director of the courts of New Jersey to centralize all Reglan movement disorder lawsuits pending throughout the New Jersey state court system.

Wyeth Pharmaceuticals, which is the primary defendant in the Reglan litigation is headquartered in New Jersey, leading many cases to be filed in the state’s court system.

In a letter dated March 16, Codey warns that there may be a flood of new cases involving the gastrointestinal drug on the way, all of which similar allegations that side effects of Reglan caused tardive dyskinesia, a rare movement disorder involving involuntary twitches or movements that can affect the face and body.

“Cases have started coming to Essex on a weekly basis,” Codey wrote in his consolidation request. He indicated that two law firms are planning to file between 75 and 100 cases, and a number of other Reglan lawyers are advertising on the internet for individuals who have experienced problems with the drug.

Acting Administrative Director of the Courts in New Jersey, Glenn A. Grant, has issued a notice to the state bar indicating that they have until May 14, 2010 to comment on or object to the application for consolidation.

Reglan, which is also known as generic metocrlopramide, is a drug approved for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has been shown to increase the risk of tardive dyskinesia and other injuries.

Tardive dyskinesia is a neurological movement disorder that causes repetitive and involuntary movements of the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the disorder, and involuntary movements can become permanent, persisting after use of the drug has stopped.

The lawsuits over Reglan all involve common allegations that the manufacturers failed to adequately investigate and study their drugs, or warn about the potential tardive dyskinesia side effects of Reglan associated with use over longer periods of time. In June 2009, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal Reglan litigation. Therefore, all federal cases are proceeding in individual courts across the country.