Author: AboutLawsuits

U.S. District Judge John Tunheim, who is presiding over all Levaquin lawsuits in federal court, has identified six cases that will serve as “bellwether” trials in the litigation, with early trial dates to help gauge how juries will respond to evidence and testimony that is likely to be presented in hundreds of other similar lawsuits that allege Johnson & Johnson’s popular antibiotic increases the risk of tendon damage.

All lawsuits over Levaquin filed in various federal district courts throughout the United States are centralized before Judge Tunheim for pretrial litigation in the U.S. District Court for the District of Minnesota. The cases involve similar allegations that the drug maker failed to adequately warn about the increased risk of tendon ruptures and other tendon injuries that can occur from side effects of Levaquin.

According to a pretrial order issued on February 12, the plaintiffs and defendants have agreed on the first six cases that will be prepared for trial. The lawsuits were picked from a pool of 15 cases that were previously identified as potential bellwether cases, and include Levaquin suits brought by Sharon Johnson, Calvin Christensen, Richard Kirkes, John Schedin, Edward Karkoska and Eugene Markina.

The order calls for depositions of experts in the cases to be completed by June 30, and the first case should be ready for trial by the end of October. However, Judge Tunheim did not say when the first trial will start, indicating that decisions will be made at a later date about the order in which the cases will be tried and whether they will be submitted to juries individually or as part of a consolidated trial.

In December, Judge Tunheim denied a motion by plaintiffs to consolidate three of the bellwether Levaquin trials. Plaintiffs argued that the consolidation of the cases into one trial would promote judicial efficiency while still testing the merits of the arguments of future cases. After defendants opposed the plan, Judge Tunheim determined that it was too early to determine whether the cases were alike enough to try them together. He left the door open for plaintiffs to submit a new motion later in the discovery process when more was known about the cases.

Two arbitration panels have ordered Morgan Keegan & Co. to pay a combined total of $3.6 million to two investors who lost money in the brokerage firm’s bond funds, which collapsed after the subprime mortgage crash in 2007.

The Financial Industry Regulatory Authority (FINRA) ruled in favor of the investors in two seperate bond fund arbitration claims filed against the company by Andrew Stein, of Jupiter, Florida, and General Henry Cobb, of Birmingham, Alabama. Cobb’s claim, which resulted in a $1.1 million award, was filed on behalf of three investment holding companies founded by the World War II Army veteran. Stein’s claim, which resulted in a $2.5 million award, was filed on behalf of the 38 year old investor and two of his companies.

Both arbitration claims involved similar allegations that Morgan Keegan was responsible for substantial losses in certain bond funds offered by the company as a result of negligence and failing to disclose the true amount of risk associated with the investments. The brokerage firm was also accused of artificially inflating the value of the funds’ assets to make them more stable.

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.

Cobb sought $1.4 million in compensation for his losses and was awarded $1.1 million. Stein sought $12 million, and received $2.5 million. Stein’s award is the largest so far against Morgan Keegan over the bond funds, which has lost about a dozen cases and settled some others. FINRA, which oversees about 5,000 brokerage firms throughout the United States, did not provide an explanation for the rulings.

The decisions follow a September victory against Morgan Keegan by former National Basketball Association star Horace Grant, who was awarded $1.46 million for losses he suffered while invested in the funds. Morgan Keegan is appealing that decision.

Hundreds of other similar Morgan Keegan bond fund arbitration claims 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. Some analysts speculate that Morgan Keegan bond fund awards may eventually exceed $200 million.

The Securities Exchange Commission (SEC) issued a “Wells Notice” last year to Morgan Keegan over the funds, an indication that it is considering criminal charges for violations of investment laws.

GlaxoSmithKline PLC has released a 30-page rebuttal to a U.S. Senate report that accused the company of intentionally trying to conceal potential heart problems with Avandia, a diabetes treatment that used to be a blockbuster drug for the pharmaceutical company.

The British drug maker released a “white paper” on Wednesday, arguing that the Senate Finance Committee’s Avandia report “does not present an accurate, balanced, or complete view of the currently available information on Avandia.”

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs 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 heart problems.

In May 2007, a meta-analysis of 42 different clinical trials published in the New England Journal of Medicine suggested that users face an increased risk of a heart attack from Avandia. The FDA has since added a black box heart attack warning to Avandia, and some experts have estimated that the diabetes drug could have caused as many as 100,000 heart attacks since it was first introduced.

The Senate report, which was released last weekend, indicates that the pharmaceutical company was not only aware of the dangers of Avandia and chose to ignore them, but also suggests that the company attempted to conceal the risk of heart problems prior to release of this study by directing attention away from the drug’s pitfalls. The report says that the company intimidated physicians and worked to suppress and minimize findings that highlighted Avandia heart problems. The report also blasts the FDA for ignoring recommendations of drug safety reviewers who called for an Avandia recall as early as 2007.

Glaxo’s rebuttal claims that the Senate committee staff cherry-picked data, taking it out of context and not accurately reporting the results of other clinical trials in an effort to misconstrue the side effects of Avandia.

Since the Senate report’s release, GlaxoSmithKline has come under increased pressure to issue a recall of Avandia. Earlier this week U.S. Representative Rosa DeLauro called for the FDA to remove Avandia from the market. DeLauro is the chair of the subcommittee on agriculture for the House Appropriations Committee, which controls the FDA’s funding.

The Glaxo response argues that the company kept the FDA continually abreast of safety information on potential problems with Avandia, and notes that an FDA committee looked at numerous clinical trials before determining that Avandia should be left on the market. The company says that a number of other clinical trials do not show an increased risk of heart attack from taking the drug, but accuses the Senate of leaving that information out of its report.

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.

Chrysler Group LLC is pulling about 356,000 Dodge Caravan, Grand Caravan and Chrysler Town & Country minivans off the road in so-called “salt belt” states due to problems with the airbags. 

The Chrysler minivan recall only affects 2005 and 2006 model year minivans sold or registered in 28 states in the Midwest, the East, New England, and the District of Columbia. The affected region is often known as the “salt belt” due to the heavy use of salt on roads during winter. It also affects vehicles in Canada.

The company says that an airbag sensor can crack under certain environmental conditions. Water could enter the sensor and damage it, causing the airbag not to deploy properly when needed. If the sensor fails, the driver would receive a warning light indicating there was an airbag problem, the company stated.

The sensor determines the speed and how the airbag should be deployed in case of an accident. They are not the main sensor that decides that the airbag should be deployed. There have been no injuries or incidents reported in connection to the faulty airbag sensors.

The Chrysler recall affects 355,562 of the 2005-2006 Chrysler Town & Country, Dodge Caravan and Dodge Grand Caravan minivans. Drivers in the U.S. own 259,437 of those vehicles, while the remaining 72,035 are owned by drivers in Canada.

Chrysler is not calling the action a recall, saying that it is a “safety improvement campaign” because the loss of the airbags does not affect the roadworthiness of the cars and that the vehicles would still meet federal crash standards. However, officials in the National Highway Traffic Safety Administration (NHTSA) say the agency considers the campaign to be a recall.

All lawsuits over Yaz, Yasmin and Ocella birth control in New Jersey state courts have been designated as a mass tort, and will be centralized under one judge for coordinated handling.

New Jersey’s Administrative Office of the Courts ordered on February 18 that the litigation will be assigned to Judge Brian R. Martinotti in Bergen County Superior Court. All pending and future New Jersey state court Yaz lawsuits, Yasmin lawsuits and Ocella lawsuits filed over Bayer’s popular birth control pills will be handled by Judge Martinotti, who will oversee the case management and trial issues.

The cases have been centralized to avoid duplication and to prevent conflicting rulings in different cases throughout the state. However, the cases are not consolidated and each will remain an individual action. In the future, Judge Martinotti may, at his discretion, return the cases back to the original county where they were filed for trial or resolution.

All of the lawsuits involve similar allegations that side effects of Yaz, Yasmin and Ocella increase the risk that women may suffer a stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease or other injury. 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.

The request to centralize the Yaz birth control cases in New Jersey came from Assignment Judge Donald Volkert, Jr. in November. At that time there were 39 complaints in New Jersey courts throughout the state involving the popular birth control pills pending, with 13 in Volkert’s district of Passaic County. Some experts predict New Jersey courts could see as many as 1,000 Yaz, Yasmin and Ocella cases.

Similar coordination has been ordered for Yaz lawsuits pending in Pennsylvania state courts, and the federal Yaz litigation has been consolidated for pretrial proceedings in a multidistrict litigation (MDL), under Chief Judge David Herndon in the U.S. District Court for the Southern District of Illinois.

Yaz, Yasmin and Ocella are among the most widely used types of oral birth control pills. They all contain a combination of ethinyl estradiol with a new type of progestin, drospirenone, which can increase blood potassium levels and cause serious heart and health problems.

Yaz and Yasmin birth control are manufactured by Bayer Healthcare Pharmaceuticals and Ocella birth control is a generic version that is marketed by Teva Pharmaceuticals.

According to an initial order for case management order issued by Judge Martinotti last week, the first conference has been scheduled for Monday, April 26. At the meeting, it is expected that the parties and the court will discuss procedures that will facilitate the resolution of the litigation. Prior to the conference, the parties will provide lists of witnesses expected to testify, the status of any settlement talks, and a list of any anticipated motions.

The FDA has announced that it is reviewing the possibility of dangerous heart side effects when the HIV drugs Invirase and Norvir are used together.

The Invirase safety review was announced on February 23, and the FDA reports that their preliminary findings indicate that when the two drugs are combined it could increase the risk of heart abnormalities leading to irregular heart rhythms. The abnormal heart rhythms, a condition called torsades de pointes, can cause fainting, lightheadedness and could leave to life-threatening irregular heart beats.

Invirase (saquinavir) is an antiretroviral medication manufactured by Genentech, which is a subsidiary or Roche AG. The drug was first approved in 1995. It is often used in combination with Abbott Laboratories’ Norvir (ritonavir), another antiretroviral drug approved by FDA in 1996.

Both drugs are classed as protease inhibitors, which prevent viral replication. Norvir is generally used specifically to boost Invirase’s abilities to combat the replication of HIV in the body.

FDA reviewers said that the current data suggests that using the two drugs together can affect the electrical activity of the heart, causing prolonged electrical signals called QT and PR intervals that can increase the risk for abnormal rhythms or even cause the heart beat to slow or stop, a condition known as a heart block.

The FDA is cautioning physicians to be aware of the possibility that the use of the two drugs can change electrical activity in the heart. The agency advises that neither drug should be given to patients who are already taking medications which have been identified as causing QT interval prolongation, including Class IA and Class III antiarrhythmic drugs. The drugs should also not be given to patients with a history of QT interval prolongation.

The FDA said that its investigation is ongoing, and the agency will update the public when the review is complete. Currently, the FDA is advising that patients should not stop taking the drugs without first consulting a health care professional.

About 1,300 Arctic Cat 500 Sno Pro snowmobiles have been recalled due to the risk of a fuel leak that could result in fire and injury.

The Arctic Cat snow mobile recall was announced by the U.S. Consumer Product Safety Commission (CPSC) on February 23, after two reports were received of fuel leakage at the fuel pump mounting screws on the 2010 model year snowmobiles. There have been no injuries reported in connection with the defect.

The recall affects all 2010 Arctic Cat 500 Sno Pro models, which have the model name and number displayed on the side of the seat and engine cowling. The snowmobiles were sold at Arctic Cat dealerships nationwide between October 2009 and February 2010 for between $7,800 and $8,200.

This is the third snow mobile recall issued by Arctic Cat due to fuel and oil leaks in less than two years. In December 2008, the company was forced to recall about 10,000 of the 2009 Mountain Cat and Crossfire models due to mounting hardware defects that caused the fuel pump to leak. They then recalled about 3,000 Z1 Turbo, Z1 Turbo Sno Pro and TZ1 Turbo 2009 model year snowmobiles in October 2009 after eight of the vehicles burst into flames.

The CPSC recommends that anyone who owns or uses one of the snowmobiles affected by the latest Arctic Cat recall should stop using them immediately and contact their local Arctic Cat dealer for a free repair. The company has contacted registered owners by mail.

In yet another loss for Pfizer’s Wyeth unit involving side effects of Prempro, a Philadelphia jury awarded $9.45 million this week to an Alabama woman who said that the hormone replacement therapy caused her to develop breast cancer.

The verdict, which is the fifth Prempro lawsuit loss in a row for Wyeth, included $3.45 million in compensatory damages and $6 million in punitive damages awarded to punish the company for their conduct. In the case, Audrey Singleton alleged that Wyeth knew about the risk of breast cancer from Prempro and failed to warn the public about the risk of the drug. According to a report by Bloomberg News, the jury took only minutes to determine that Pfizer, which bought Wyeth last year, should be penalized for the drug maker’s conduct.

Late last year, Pfizer was ordered to pay punitive damages over Prempro by two other Philadelphia juries who found that Wyeth purposefully hid Prempro’s breast cancer risk. Overall, Wyeth has lost seven of the last 10 lawsuits over the hormone replacement therapy (HRT).

Hormone replacement therapy involves the use of hormones and progestins to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women, to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

In 2002 the National Institutes of Health released the results of studies that found women receiving HRT were at higher risk of breast cancer, strokes and heart attacks. The studies, part of the Women’s Health Initiative, sparked most of the hormone replacement therapy breast cancer lawsuits currently pending throughout the country.

There are an estimated 9,000 Prempro lawsuits pending against Wyeth and Pfizer. All of the lawsuits include similar allegations that the drug company’s failure to warn consumers and the medical community about the risk of Prempro side effects caused them to develop invasive breast cancer.

The results of a new study suggest that exposure to antidepressants like Zoloft and Paxil during pregnancy may delay infant developmental goals, such as sitting and walking. 

In the study, published in this month’s issue of the medical journal Pediatrics, Danish scientists at Aarhus University in Denmark found that children born to women who took antidepressants were later in hitting developmental milestones than children of mothers who did not.

Sifting through a database of 82,000 pregnant women, researchers examined 415 women who used an antidepressant, such as Paxil, Zoloft and Prozac, during pregnancy to combat depression, and 489 women with depression who did not. Among children born to these women, looking at the six and 19-month milestones of their development, researchers found that children exposed to antidepressants learned to sit upright 16 days later and to walk a month later than children who were not exposed to antidepressants.

Researchers concluded that the children still learned to sit up and walk within an accepted time frame for development, but it was clear that the antidepressants were delaying fetal brain development, which could result in a reversible or permanent effect on the brain. Researchers said the amount of developmental delay could also be affected by when the pregnant mother exposed the fetus to antidepressants.

The use of GlaxoSmithKline’s Paxil during pregnancy has already been linked to an increased risk of persistent pulmonary hypertension in newborns (PPHN) and other heart problems The drug maker faces more than 600 Paxil lawsuits, in which plaintiffs allege that GlaxoSmithKline hid test data and misled doctors and consumers about the risk.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008. GlaxoSmithKline has reportedly paid about $1 billion to settle lawsuits over Paxil, which have included allegations of birth defects and suicide. And with hundreds of Paxil birth defect lawsuits still pending, the company is likely to spend substantially more to satisfy jury verdicts or settle all Paxil cases.

Following the release of a scathing Senate report, which revealed that some federal health officials have been calling for a recall of Avandia since at least 2007, the FDA announced Monday that the agency is still reviewing safety data on the diabetes drug and conclusions will likely not be released until a public meeting scheduled for July 2010.

Over the weekend, a staff report by the Senate Finance Committee highlighted concerns about the heart side effects of Avandia, indicating that removing the drug from the market may prevent 500 heart attacks and 300 cases of heart failure each month if diabetes patients were given a different drug instead. The report also suggested that the drug’s maker, GlaxoSmithKline PLC, was aware of the cardiac problems with Avandia, but attempted to minimize or misprepresent the risks to keep the drug on the market.

According to a statement posted late Monday on the FDA MedWatch website about the agency’s ongoing review of Avandia heart safety data, the FDA indicates that no conclusions or recommendations about the use of Avandia to treat type 2 diabetes have been reached at this time. However, the FDA cautioned that patients should continue taking Avandia unless they are told by the doctors to stop.

The FDA is currently reviewing a new GlaxoSmithKline study, the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), which suggests Avandia side effects include the same heart risks as other drugs in its class. However, the RECORD study has already come under fire by a number of critics who say that the 2,000-patient study was too small and not well designed to look for cardiovascular risk. The original 2007 study looked at more than 14,000 patients.

“Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010,” the FDA announced. “At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.”

GlaxoSmithKline released a statement following the Senate report claiming that congressional staff members cherry-picked data and findings, and pointed to the FDA’s previous conclusions that Avandia was still safe enough to be left on the market. The company says it has consistently shared data with the FDA, contrary to the reports assertions that it knew about and tried to hide and downplay data that revealed Avandia heart attack risks.

However, a March 2008 FDA warning letter to the company in the wake of inspections of its U.S. corporate headquarters concluded the opposite.

“Our inspection revealed that your firm failed to report data relating to clinical experience, along with other data and information, for Avandia,” the letter states.

The drug maker currently faces thousands of Avandia heart 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.

Toyota Motor Corp. is now the target of a federal criminal investigation and a Securities and Exchange Commission (SEC) probe into how it responded to safety problems with Toyota and Lexus vehicles, which have resulted in the recall of millions of cars.

The subpoenas were sent by a federal grand jury in the Southern District of New York on February 8 and the SEC on February 19, the company announced on Monday. Both appear to be looking at how the company reacted to complaints about Toyota safety problems and whether the automaker attempted to cover up or downplay the seriousness and number of problems being reported.

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. More than 400,000 Prius and Lexus HS250h 2010 model year vehicles were also recalled this month due to problems with the brakes. In addition, Toyota is considering a recall of some Corolla models due to complaints about steering.

The investigations come as Toyota executives prepare to face Congress this week in a highly-anticipated hearing that will feature Toyota’s president, Akio Toyoda, who is also the grandson of the company’s founder. In an op-ed piece published in the Wall Street Journal, Toyoda gave a possible preview of his testimony, apologizing and dedicating that he would improve his company’s response to complaints.

“[I]t is clear to me that in recent years we didn’t listen as carefully as we should – or respond as quickly as we must – to our customers’ concerns,” Toyoda wrote. “While we investigated malfunctions in good faith, we focused too narrowly on technical issues without taking full account of how our customers use our vehicles.”

U.S. lawmakers have given indications that Toyoda and James E. Lentz, the president of Toyota Motor Sales U.S.A., are in for a rough ride when they face questioning over their company’s handling of the recalls and customer complaints. In a letter to Lentz from the House Committee on Energy and Commerce, Chairman Henry Waxman expressed skepticism that the company moved to respond to complaints in good faith.

“In the documents provided to the Committee, Toyota representatives commonly responded to drivers reporting sudden unintended acceleration by concluding that the events the consumer described could not have happened,” Waxman wrote. “Toyota’s internal files are replete with such statements from the company.”

The Toyota accelerator pedal recalls have resulted in more than 60 Toyota lawsuits, including over a dozen wrongful death and personal injury claims.

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

GE Healthcare and a Danish scientist have reached a settlement in a libel lawsuit over statements made about the side effects of Omniscan, an MRI contrast agent that has been linked to nephrogenic systemic fibrosis (NSF), a severe and debilitating injury.

Neither party disclosed details of the settlement, but both GE Healthcare and Henrik Thomsen, Professor of Radiology at Herley Hospital in Copenhagen, made conciliatory statements last week. Thomsen has been an outspoken crusader against Omniscan, speaking at medical conferences and writing several papers about the risk of problems from the gadolinium MRI contrast agent, which is used to improve scan results.

Thomsen sounded the warning bell about potential risks with Omniscan after noticed that 20 of his patients were suffering from NSF, which causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement. Sometimes referred to as nephrogenic fibrosing dermopathy (NFD), the rare condition is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. There is no cure for the painful and debilitating disorder, and in many cases it results in death.

GE hit Thomsen with a libel suit in British courts, and Thomsen responded with a counterclaim, saying that the company was trying to gag scientific debate over the issue. Now, both say that their reactions were due to a misunderstanding, according to a press release by GE Healthcare.

“My purpose was to share with fellow clinicians and healthcare professionals my experience in managing a serious problem at our hospital where we found 20 patients suffering from NSF. The cause was unknown, but in early 2006, it was clear to us that all of our nephrology patients with NSF had only one factor in common; they had all been exposed to Omniscan,” Thomsen said. “It was not my intention to suggest on the basis of the evidence then available to me that GE Healthcare had marketed Omniscan knowing that it might cause NSF.”

GE officials also said their actions were misunderstood.

“It was not the intention of GE Healthcare by bringing proceedings for libel against Professor Thomsen to stifle academic debate,” said Dr. Lynne Gailey, executive vice-president of GE Healthcare communications. “GE Healthcare objected to statements made by Professor Thomsen which it interpreted as suggesting that it had known from the outset that Omniscan caused NSF. GE Healthcare accepts, however, that Professor Thomsen’s concerns were expressed in good faith. GE Healthcare regrets that these proceedings were necessary to reach the common understanding described in this statement.”

Although all types of gadolinium MRI contrast agents have been linked to nephrogenic systemic fibrosis, multiple reports have suggested that the risk of NSF associated with Omniscan may be higher than other contrast agents.

In 2007, the manufacturers of all types of gadolinium-based agents in the United States were required by the FDA to add a “black box” warning to their products, indicating that individuals with severe kidney problems could develop NSF. However, many have argued that the warnings about the risk of NSF from Omniscan should be stronger, possibly calling for a ban on use of the product in some patients.

Approximately 350 nephrogenic systemic fibrosis lawsuits have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.

Researchers analyzing recent data about cholesterol-lowering drugs like Lipitor and Zocor, known as statins, believe they have discovered a link between the medications and an increased 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 results of the analysis were published last week in the medical journal The Lancet.

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 popular cholesterol controlling drugs, including Crestor, Lipitor, Zocor, Mevacor, Lescol and Pravachol.

Researchers looked at studies involving a total of 91,140 participants performed between 1994 and 2009. They discovered that there was about a 9% increase in the risk of type 2 diabetes among those who use statins. While they eliminated a number of other potential causes of the increased diabetes risk, they do not make a causal link between statins and diabetes, however.

Researchers said that the increased risk did not offset the health benefits of lowered cholesterol and the reduction of the risk of coronary health problems due to high cholesterol. Therefore, they recommended no change in the use of the drugs for high-cholesterol patients.

Other studies have found that about 1 in 10,000 statin users develop a sometimes-fatal muscle condition known as rhabdomyolysis. The rare condition causes skeletal muscle damage and releases myoglobin into the bloodstream. The myoglobin can cause severe kidney failure or death.

In 2002 and 2008, the FDA issued warnings about the increased risk of rhabdomylosis when statins are used in combination with heart medication containing amiodarone. In 2001, the statin-based drug Baycol was removed from the market due to its links with rhabdomyolysis.

Pediatricians are pushing for new food labeling requirements, which they hope will cut down on the number of child choking deaths.

The proposed warning labels would target foods known to carry a high risk of causing children to choke, such as hot dogs, grapes, raw carrots, apples and peanuts. The American Academy of Pediatrics (AAP) says that those foods and others make choking the leading cause of death among children under the age of 14. The group is pushing both for the new labeling and for a redesign or recall of foods known to easily choke children.

The AAP’s Committee on Injury, Violence and Poison Prevention has released a policy statement in the March issue of Pediatrics calling for child choking risk from food to be treated the same as choking risk from toys. The statement was published online on February 22, urging the FDA and U.S. Consumer Product Safety Commission (CPSC) to enact new regulations.

“The US Food and Drug Administration should establish a systematic, institutionalized process for examining and addressing the hazards of food-related choking,” the AAP states. “This process should include the establishment of the necessary surveillance, hazard evaluation, enforcement, and public education activities to prevent food-related choking among children.”

The statement says that while the FDA should work with the CPSC, the Department of Agriculture, and other agencies, the FDA should have regulating authority.

According to the AAP, an average of one child every five days chokes to death on food in the U.S. In most cases, the pediatricians say, this is because the shape of the food allows it to get lodged in a child’s throat. Children under four are at the highest risk, because many of them lack molars to properly chew their food, doctors said.

Hot dogs are the most dangerous, due to their cylindrical shape, the AAP warns. Grapes, raw carrots, apples and peanuts also rank high. The AAP recommends that teachers and parents:

• ever let small children run, play or lie down while eating
• Avoid giving children high-risk foods, like hard candy, nuts and seeds
• Cut grapes into quarters and cut hot dogs lengthwise to change the shape and minimize choking risk
• Learn CPR and choking first aid.

St. Joseph Medical Center in Towson, Maryland, is now the target of a Senate probe into health care fraud and abuses following allegations that a doctor there performed hundreds of unnecessary stent procedures.

Senators Max Baucus and Charles Grassley, who head the U.S. Senate Finance Committee, have demanded that St. Joseph turn over three years of records related to coronary stent implant operations performed by Dr. Mark Midei. Federal investigators say Midei lied to patients about the severity of coronary blockages, convincing them to undergo unnecessary and dangerous coronary stent implant operations. The senators say they are looking for signs of Medicare fraud or other ways the hospital may have profited from Dr. Midei’s activities.

At the end of December, St. Joseph sent letters to 369 patients notifying them that a subsequent clinical review of their procedure found that they did not need the heart stent implanted by Dr. Midei. The problem was discovered after a patient complained, sparking a probe into Dr. Midei’s actions. When St. Joseph called in other coronary experts to examine the patients’ catheterization films, hundreds of discrepancies were discovered.

Cardiac catheterization procedures with stent placement, which cost about $10,000.00, are designed to keep open significantly blocked arteries. Typically it is only considered necessary for a stent to be implanted when an artery is at least 70% blocked, with anything under 50% considered “insignificant” and treatable without a stent. Some patients were exposed to the risks associated with stent placement by Dr. Midei when they had blockages as low as 10%.

Dr. Mark Midei headed up the cardiac catheterization unit at St. Joseph until he was stripped of his position and privileges at the hospital last summer amid a federal investigation involving cardiac stent procedures performed at the Towson, Maryland hospital.

According to a report by the Baltimore Sun, Baucus and Grassley have given the hospital until March 12 to turn over records covering stent implant procedures at the hospital over the last three years. The senators say they are protecting taxpayers from waste, fraud and abuse, and are looking to see if there are any signs that the hospital was purposefully defrauding the federal government by charging for heart surgeries that it knew was bogus.

The hospital has indicated they will cooperate fully with the investigation.

The probe comes as a number of St. Joseph stent lawsuits have been filed against the Maryland hospital. In late January, a class action lawsuit was filed against St. Joseph, seeking to force the hospital to pay for a review of patient records and impose certain requirements before the hospital can perform stent operations. However, many lawyers pursuing St. Joseph lawsuits indicate that individuals treated by Dr. Midei may be in a better position to investigate their claim and obtain more complete compensation for their damages by pursuing an individual claim.

A Senate report released over the weekend reveals that some FDA officials have been calling for a recall of Avandia since at least 2007, and accuses GlaxoSmithKline, the manufacture of the diabetes drug, of intimidating doctors and failing to adequately warn patients about the risk of a heart attack from side effects of Avandia.

The Senate Finance Committee report (PDF) estimates that about 500 heart attacks and 300 cases of heart failure each month may be avoided if Avandia were recalled, and patients taking it were given Takeda Pharmaceuticals’ Actos instead. The report is filled with a number of never-before-released documents that were provided to the Senate by GlaxoSmithKline whistleblowers and FDA officials concerned over problems with Avandia.

The Senate report indicates that the pharmaceutical company was not only aware of the dangers of Avandia and chose to ignore them, but also suggests that the company attempted to direct attention away from the drug’s pitfalls.

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report states.

Avandia (rosiglitazone) is manufactured by GlaxoSmithKline PLC, and is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels.

Concerns about the Avandia heart attack risk 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. The FDA has since added a black box heart attack warning to Avandia, and some experts have estimated that the diabetes drug could have caused as many as 100,000 heart attacks since it was first introduced.

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.

In 2008, Public Citizen filed a petition with the FDA calling on the agency to issue an Avandia recall, indicating that the number of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug. The FDA has not yet taken any action on the petition. However, internally, calls for an Avandia recall by FDA’s own safety reviewers actually predate Public Citizen’s petition.

According to a July 30, 2007 report by Dr. Kate Gelperin and Dr. David J. Graham, from the FDA’s Office of Surveillance and Epidemiology, there were no health benefits that justified leaving Avandia available for public consumption. “[Avandia] should be removed from the market,” the reviewers concluded more than two and a half years ago.

GlaxoSmithKline officials continue to say that Avandia heart problems have never been establish, and point out that the FDA has allowed the drug to remain on the market. The company has undertaken a new drug trial to examine the risks, but it will not be completed until 2020, and the company’s patent on Avandia will run out in 2012. At that time, generics will likely flood the market and the company’s profits from Avandia, once one of the biggest selling drugs in the world, will bottom out. Some have suggested that the new study is simply an attempt by the company to “run out the clock.”

A letter by Senators Max Baucus and Charles Grassley (PDF), the chairman and ranking member, respectively, of the powerful Senate Finance Committee, urges FDA to take more stringent actions to protect the public from Avandia health risks. The letter also expresses concerns that the new Avandia drug trial underway by Glaxo, called the TIDE trials, was allowed to go forward despite protests from FDA reviewers who were concerned about the safety of the human test subjects to be given Avandia.

In response to growing concerns about the side effects of radiation exposure during medical procedures, the FDA has launched a new initiative designed to reduce unnecessary exposure from CT scans, nuclear medicine studies and fluoroscopy.

The initiative, announced this month by the FDA, seeks to reduce the risk of radiation exposure from medical procedures through promotion of the safe use of medical devices, by providing support for informed clinical decision-making, and by making patients more aware of their total radiation exposure. The FDA is also considering increased requirements for computed tomography (CT) scanners and fluoroscopic devices that would call for increased safeguards and training to protect against radiation overexposure.

The agency will hold public hearings on March 30 and 31 to discuss possible new industry-wide requirements.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said the FDA’s director of it’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

The guidance comes as the FDA is investigating cases of radiation problems with CT scan procedures, after the discovery that a number of patients across the country have suffered radiation overexposure from scans performed incorrectly. The FDA released interim guidance in December for health care professionals and radiologists as it continues its investigation. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

In many cases, patients received radiation doses to the wrong parts of the body, or were subjected to radiation several times higher than prescribed. Diversified Clinical Services, the country’s largest wound care company, treated 3,000 radiation injuries in 2009 alone.

A CT scan radiation exposure study published in December in the Archives of Internal Medicine, which studied 1,119 adults who received CT scans in San Francisco in 2008, found a high amount of variation between radiation doses, with some radiation exposure varying as much as 13-fold between scans. The study estimated that 1 in 270 women who received a CT heart scan would develop cancer, compared to 1 in 600 men.

The family of a New York woman who died after teeth extraction surgery is filing a wrongful death lawsuit against the dentist, saying that a dose of fentanyl painkiller he gave her turned deadly. 

The dental surgery malpractice lawsuit was filed by the family of Felita Dowdy earlier this month in Bronx Supreme Court against Dr. Bruce Lish and St. Luke’s Hospital in Manhattan. Dowdy, a 33-year-old woman with cerebral palsy, died on October 14 after three months in the hospital due to complications from the dental extraction surgery. The family claims that Lish gave Dowdy fentanyl, which contributed to her death.

Fentanyl is a powerful opioid pain killer that is often prescribed to patients suffering from chronic, severe pain. It is considered 100 times more powerful than heroine and is linked to hundreds of drug overdoses.

Dowdy’s family sent her to Lish to have her teeth extracted because they had been ruined as a side effect of her cerebral palsy. However, the family was informed that during the surgery something went wrong. Dowdy went into respiratory arrest and was hospitalized with brain damage due to complications of the dental surgery.

The family accuses Lish of having made a surgical mistake that led to Dowdy’s injuries, and believe that fentanyl played a role. The dental surgery wrongful death lawsuit indicates that fentanyl was found to be a contributing factor in Dowdy’s death. According to a report in the NY Daily News, the family seeks unspecified damages and accuses Lish and the hospital of failing to correctly monitor Dowdy’s post-operative care.

Jury selection in the first Seroquel trial began Thursday, with opening statements set to begin Monday in a lawsuit filed by a Vietnam vet who says he developed diabetes after taking the blockbuster antipsychotic to treat post-traumatic stress disorder. 

The Seroquel diabetes lawsuit, brought by Ted Baker, is the first of an estimated 26,000 claims against AstraZeneca over side effects of Seroquel to reach a jury. The case will be heard by a group of five women and four men in New Jersey state court in New Brunswick.

Baker’s case will involve allegations similar to those raised by thousands of other individuals in state and federal cases filed throughout the country. The Seroquel lawsuits involve allegations that AstraZeneca failed to adequately warn users about the risks of weight gain from Seroquel, and the increased risk of diabetes and other serious injuries.

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.

All federal Seroquel lawsuits over diabetes are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida. In November, U.S. District Judge Anne Conway ordered lawyers for both sides to met with a mediator 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.

AstraZeneca has maintained that they intend to defend all cases. According to a report by Bloomberg News, AstraZeneca is expected to try to convince the jury that Seroquel did not cause diabetes for Baker, suggesting that his lifestyle was more likely the cause of his illness. Baker’s attorneys are likely to employ evidence that AstraZeneca covered up the weight gain side effects of the drugs to show that the drug maker knew for years that it caused weight and diabetes problems.

Internal documents produced during the litigation suggest that the drug maker was aware of the potential weight-gain Seroquel side effects and continued to promote the drug as weight-neutral for years after clinical evidence demonstrated significant problems that could lead to diabetes and other injuries.

The company has racked up $656 million in legal defense costs fighting the failure-to-warn lawsuits over Seroquel. In addition, Seroquel lawyers continue to file new cases for individuals who have developed diabetes, pancreatitis and a rare movement disorder known as tardive dyskinesia, so the cost of the litigation is expected to continue to increase.

GlaxoSmithKline PLC will discontinue Super Poligrip with zinc, due to the risk that use of the denture adhesive may cause serious and potentially debilitating problems from zinc poisoning.

Super Poligrip Original, Ultra Fresh and Extra Care denture cream products will be removed from shelves and replaced with zinc-free versions, the British drug company announced on Thursday. The product change comes as the company faces mounting Poligrip lawsuits over health problems allegedly caused by zinc in the denture adhesive products. Excess levels of zinc entering the body from the denture cream could cause users to suffer neurological damage from zinc poisoning.

GlaxoSmithKline says that it is discontinuing the products due to the “health problems associated with the long-tern excessive use of our zinc-containing denture adhesive products.” However, the company said it still believes that the products are safe when used in recommended amounts. GlaxoSmithKline has maintained that users are only in danger when they use more than the recommended amount in order to compensate for ill-fitting dentures.

Eventually, GlaxoSmithKline says there will be zinc-free versions of all of the discontinued denture creams, but did not announce when those products would be available. There is already a Super Poligrip Free on the market, which does not contain zinc. The replacement products will be clearly marked as being zinc-free, the company said.

A number of denture cream lawsuits have been filed against GlaxoSmithKline over its Poligrip cream, and against Proctor and Gamble over its Fixodent denture adhesive. All cases filed in federal courts throughout the United States have been centralized in a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

Proctor & Gamble officials say they have no plans to discontinue Fixodent, maintaining that it has half the zinc as Super Poligrip and is safe for use. Both companies have faced calls from critics for zinc to be removed from the products, which previously contained no warnings about the risk of zinc poisoning.

Increased levels of zinc in the body can deplete copper levels, causing a condition known as hypocupremia, which is known to increase the risk of significant neurological problems that can leave users with permanent and debilitating physical injuries. Although the recommended daily allowance of zinc is 11 mg for men and 8 mg for women, with 40 mg being the maximum amount of zinc that can be safely tolerated, some denture creams have been found to expose users to levels as high as 330 mg per day.

Zinc is believed to help with the adhesive properties of the denture creams. However, until recently neither GlaxoSmithKline or Proctor and Gamble had alerted users that zinc was an ingredient in their products.

In October, GlaxoSmithKline added a new Super Poligrip zinc warning to the denture cream, notifying consumers that the product contains zinc and that excessive use of the cream could result in serious health effects.