Fresenius Medical Care is under attack for putting public health and safety at risk. It is believed that the company was aware of the serious medical conditions that these dialysis products caused, but continued to market them anyway without informing doctors and patients. The manufacturer allegedly did not provide doctors with adequate instructions regarding proper dosage of the products. This resulted in dosage errors, with doctors administering the products at doses too high for human consumption.

More on the Recall

Fresenius Medical Care, in November 2011, issued a memo stating that GranuFlo and NaturaLyte were associated with an increased risk of cardiac arrest, but that memo was issued internally only. It went to Fresenius centers and not to outside centers, doctors or the general public. This means that most of the patients were unaware of this information and were continuing to use the products despite its serious risks. Many argue that the manufacturer’s warning was not enough and much more could have been done to protect patients’ health and safety.

The products have been linked to a heart attack rate of up to eight times higher than other dialysis products. Just in 2010 alone, 941 cases of cardiac arrest associated with NaturaLyte and GranuFlo usage were reported. So far, victims and their families have filed federal lawsuits in numerous states, including Massachusetts, California, Ohio, New York, New Jersey, Alabama and Pennsylvania. Fresenius Medical Care recently settled a wrongful death lawsuit after a patient suffered from a hemorrhage after a dialysis treatment in 2009. This patient’s five children received a seven-figure settlement from the company.

A certain amount of bicarbonate in the body is needed in dialysis. GranuFlo and NaturaLyte, however, create an overabundance of bicarbonate, which leads to metabolic alkalosis. This, in turn, results in serious medical conditions such as low blood pressure, stroke, rapid heartbeat and lack of oxygen in the blood. These conditions lead to cardiac arrest. Many users of the products have suffered serious health problems, some of which have been fatal.

Those who have suffered a heart attack or other serious medical condition as a result of GranuFlo and NaturaLyte have the legal right to seek help from an attorney focused in product liability. Surviving family members whose loved ones have died from use of these products may be able to file wrongful death lawsuits as well and recover compensation.

However, this boost may be at a cost to overall health. Young people who consume too much of the drinks may find themselves experiencing the “crash” effect of too much sugar and caffeine. A popular way among young people to consume the beverage is to combine it with alcohol, and the effects on some people can be even more severe. Reports of energy drink related emergency room visits have been on the rise.

Recent testing by the respected publication, Consumer Reports tested 27 energy drinks for caffeine levels and for a review of their product labels. The magazine revealed that 20% of the products included in its testing actually contained caffeine levels higher than the amount listed on the can. Additionally, it found many manufacturers did not specify all of the ingredients on their labels, leaving their consumers unclear as to what they are actually consuming.

Some manufacturers even claim in their marketing that their products have health benefits. Several groups, including a University of California study, have found insufficient evidence to substantiate these claims. While the cited ingredients may not be harmful, neither can they be scientifically proven to be beneficial.

Effects of Caffeine

Caffeine falls into this category. It has no proven health benefits, though it has also not been proven to be harmful. Moderately used, it can provide short-term benefits such as boosting your mental or cognitive performance, increasing your attention and physical endurance and overall providing a lift in alertness. It can be used as a general stimulant.

However, it can also leave you with the “crash” effect of feeling jittery, unable to sleep and may potentially and dangerously increase your heart rate or cause an abnormal heart rhythm. Young people may be especially sensitive to the negative effects of caffeine.

Recently, a Maryland family filed a lawsuit against the Monster Beverage Company. The suit claims that their 14-year-old daughter died of caffeine toxicity after consuming two Monster drinks in a 24 hour period. The case highlights the need for further study and potential government oversight of the now loosely regulated energy drink industry.

Transocean, Ltd., based in Vernier, Switzerland, was the owner of the Deepwater Horizon drilling rig. The rig was the site of an explosion in April of 2010 which caused the death of 11 oil rig workers. The explosion was triggered by the blowout of the BP-owned Macondo well, and led to the 2010 Gulf of Mexico oil spill disaster.

Discussions of Settlement Amounts are Ongoing

Lawsuits have ensued against BP and Transocean with the federal government suing Transocean in 2010, stating that they allegedly violated U.S. government pollution laws. The $1.5 billion settlement in discussion would be aimed at resolving all federal, criminal and civil claims against Transocean.

Earlier this year the company rejected a settlement offer from BP and plaintiffs’ attorneys stating that the amount requested was excessive. The private attorneys represented Gulf Coast businesses and residents who claim economic damages due to the oil spill.

Previously, Transocean has stated that it had set aside $2 billion to cover anticipated claims stemming from the Deepwater Horizon explosion.

This is in contrast to BP which estimates it will end up paying approximately $7.8 billion to cover claims related to its role in the spill. Litigation continues and in May, a U.S. District Judge in New Orleans provided preliminary approval for a proposed class action settlement agreement between plaintiffs and BP.

Settlement Talks Still Have Outstanding Issues

In its filing with the Securities and Exchange Commission, Transocean said, “There can be no assurance that the parties will enter into agreements on the terms described or at all.”

In its regulatory filing, Transocean notes that there are still several issues to be resolved before an agreement can be reached, including:

• The exact wording of the agreement
• The time period provided to Transocean for payment
• Whether claims of environmental damage, covered under the Oil Pollution Act of 1990, would be included

Meanwhile, Transocean continues to lead the way in deep water oil exploration. In April 2011, in 10,194 feet of water off the coast of India, Transocean set the record for the deepest fossil fuel well. The company also plans to fund the construction of two new drilling ships. These rigs will be able to drill in water depths of up to 12,000 feet with wells extending up to 40,000 feet.

A complicated web of litigation relating to the oil spill still remains between Transocean, BP, the federal government and private parties. A January 14, 2013 trial date has been set to continue the legal process for any unsettled litigation.

According to Reuters, French drugmaker Servier and its founder went to trial on Monday, May 14, in Nanterre, France. The company has reportedly been accused of misleading authorities and patients about a diabetes drug prescribed for weight loss that officials have blamed for hundreds of deaths.

The drug, called Mediator, was often prescribed as a means to help people lose weight, according to the news provider. However, the licensed diabetes treatment is now suspected of causing heart valve disorders and was pulled from the market in France, Spain, Italy and the U.S.

Similar to the Actos lawsuits filed against Takeda, the plaintiffs in the Mediator case claim Servier purposely hid the dangers of the medication from doctors despite knowing of the potential risks since the 1990s, according to Reuters.

State health inspectors have reportedly determined that the drug should have been taken off the market in France a decade earlier, when such action was taken by Spain, Italy and the U.S., the news source said. As a result, plaintiffs are seeking interest and damages of $129,000 a piece.

"Servier let people use a toxic product for years. There is no debate about it," an attorney for one of the plaintiffs in the case, told the media outlet.

Statistics cited by Reuters indicate Mediator was sold to approximately 5 million people in France between 1976 and November 2009. France's health ministry estimates that at least 500 people died of heart valve issues due to exposure to benfluorex, the active ingredient in Mediator. However, Reuters notes that other extrapolated estimates show that figure to be closer to 2,000.

The case against Mediator is similar to that against Actos, a diabetes drug that has also been suspended in France and subjected to significant scrutiny. Both the U.S. Food and Drug Administration and the European Medicines Agency have called for increased warnings to be placed on the drug's label following studies pointing to a bladder cancer link. Patients suing Takeda claim they never would have taken Actos if they had been aware of these potentially life-threatening side effects.

Takeda, which is facing a number of Actos lawsuits over the diabetes drug's link to bladder cancer in patients, is also looking to combat impending patent expirations, the news provider said.

"We will be looking for those things that are a very good fit with what we have already put in place," Anna Protopapas, a corporate officer at Takeda, told the Journal during a recent interview. "I think we'll be very disciplined in what we do, really convincing ourselves that it's a great strategic fit and it's at the right price."

Protopapas added that the company is interested in investing in scientific research for potential new products. Recently, Takeda's successor to Actos, which is facing patent expiration in addition to the lawsuits, was rejected by the U.S. Food and Drug Administration.

The drug manufacturer's pursuit of overseas deals comes despite the fact that Takeda projects a 40 percent decline in operating profit for the current year through March, though costs on deals and research accounts for much of that total, according to the Journal.

Specifically, Protopapas told the news source that Takeda's acquisition of Swiss drugmaker Nycomed last year for $13.7 billion was an effort to fill the hole left by the Actos departure and to improve the company's "global footprint."

This improvement effort is an uphill climb for Takeda due to the serious allegations leveled at its Actos type 2 diabetes medication. With studies pointing toward the link between an increased risk of bladder cancer, the FDA and the European Medicines Agency both called for Actos warnings to be updated on the drug's label. Additionally, Actos has been suspended in France and restricted in Germany.

Across the U.S. and in Canada, a number of diabetics have launched lawsuits against Takeda claiming they would not have taken Actos if they had been aware of the potentially life-threatening consequences. Some claims even assert that Takeda knowingly concealed information about the bladder cancer risk in an effort to maintain strong profit margins, according to reports.

Though evidence continues to pile up and Actos warnings have been called for across the globe about the potential risk of bladder cancer associated with the drug, the researchers said that patients given the drug reported fewer depression symptoms after six weeks of treatment, the Daily Mail reports.

The study, conducted by professor Shahin Akhondzadeh and colleagues, examined 40 patients with moderate to severe depression who were taking the antidepressant citalopram either with or without Actos. Published online in the journal Neuropsychopharmacology, the researchers admit that it needs to be conducted again on a larger scale, but added that it could have implications for other diabetes drugs in relation to treating depression.

"Our study showed pioglitazone is an effective and safe adjunct to citalopram in patients with moderate-to-severe [major depressive disorder]," Akhondzadeh said in the study. "In particular pioglitazone is associated with high rate of early improvement – and thus response and remission – which makes this drug a potentially useful augmentative strategy in patients with moderate-to-severe MDD."

Actos, which is designed to help control blood sugar levels, previously ranked as the most popular type 2 diabetes medication. Since the release of studies indicating the association between Actos use and bladder cancer however, manufacturer Takeda Pharmaceutical Company has taken a significant hit in sales.

The bladder cancer risk has also been the subject of a number of Actos lawsuits across the U.S. and in Canada, with plaintiffs claiming they would not have taken the drug had they been aware of the potentially life-threatening consequences.

Both the U.S. Food and Drug Administration and the European Medicines Association have called for Actos warnings about the bladder cancer to be added to the drug's label, while France has suspended use of the medication. Actos has also been linked to macular edema, an eye disease that ranks as a leading cause of blindness among working adults.

Actos is not the first diabetes medication to receive such negative attention, as GlaxoSmithKline was forced to pull its Avandia drug from pharmacy shelves in the U.S. following studies linking it to heart disease in patients. 

According to the media outlet, diagnosing a teen with type 2 diabetes was a rare occurrence only 15 years ago. But today, one-third of U.S. children and teens are either overweight or obese, and could be on track to develop type 2 diabetes – a condition in which the body can't produce enough insulin on its own.

In a study released on April 29 in the New England Journal of Medicine, experts analyzed several ways to maintain a healthy blood sugar level in overweight and obese teens who have recently been diagnosed with the disease. The findings showed nearly half of the teens failed to properly manage their blood sugar within a few years, and one in five suffered from serious complications. The findings, the researchers said, could be problematic for the U.S., which is currently facing unprecedented rates of "diabesity," or type 2 diabetes that is spurred by obesity.

Treatment for the condition most commonly starts with metformin, which is used to lower blood sugar. If these measures fail, more drugs and daily shots of insulin may become necessary. If high blood sugar is not tended to, it can result in vision loss, nerve damage, kidney failure, limb amputation, heart attacks or strokes.

According to CBS, researchers analyzed 699 overweight and obese teens who were recently diagnosed with diabetes. All were treated first with metformin, then were given one of three further treatments: metformin by itself, the drug with diet and exercise changes or metformin alongside diabetes drug Avandia.

After nearly four years, half of those in the metformin group struggled to control their blood sugar, while the numbers were only slightly better for the other two groups.

"Two drugs right off the bat, that's an important finding," said Dr. Robin Goland, professor of clinical medicine and pediatrics at Columbia University in New York City. "Taking medicines chronically, especially two drugs, would be very difficult for a teenager."

Diabetes drugs, such as Avandia, that are used to control the disease have also been at the front of a number of lawsuits. After Avandia was found to be linked to a higher risk of heart attacks, many turned to what was said to be a safer alternative: Actos. However, further studies on the drug concluded it is linked to a higher risk of bladder cancer, which has had a significant impact on its manufacturer, Takeda Pharmaceutical Company. 

According to Reuters, Public Citizen said recently that Victoza increases the risk of serious health issues including kidney failure and thyroid cancer. Novo Nordisk, the Danish manufacturer of the medication, called such complaints baseless and noted it did not expect the FDA to take any action on its best-selling diabetes drug.

Mads Krogsgaard Thomsen, chief science officer for Novo Nordisk, told the news source that Public Citizen had been citing old data from studies on mice and rats taking Victoza. Thomsen argued that such information had no bearing on human response to the drug.

"We do not expect any consequences for Victoza from Public Citizen's petition," Thomsen said. "There is nothing in it."

The drugmaker added that the FDA reviewed data from nearly 4,000 patients prior to approving Victoza, according to the news source.

Serious side effects being linked to diabetes treatments is nothing new, as Takeda Pharmaceutical Company's Actos has been associated with bladder cancer, according to studies.

This link has led to a significant number of Actos lawsuits being filed by patients from across the U.S. and in Canada. In these lawsuits, the patients claim they were not sufficiently warned about the potential life-threatening side effects and that they never would have taken the medication had they known about the possible health issues.

Actos, which is Takeda's best-selling drug, has seen sales decline as the FDA and European Medicines Agency have called on warnings to be placed on the drug's label. 

According to Bloomberg, Merck's net income rose 67 percent from the previous year, while revenue increased 1.3 percent. The Whitehouse Station, New Jersey-based company was boosted significantly by higher sales of its Januvia and Janumet diabetes medications. Analysts believe Merck's drugs in development will be key to its turnaround.

"Merck is emerging from a challenging 2011," Tony Butler, an analyst with Barclays Capital Inc., said in a research report. "The stock has been on a path of recovery since last November, but this has been more correlated with the dividend increase and flow into the pharma sector as a whole than a restoration of sentiment around Merck’s innovation core."

In terms of its diabetes drug market specifically, Merck saw sales of Januvia rise 24 percent during the first quarter, while Janumet revenue climbed 29 percent. Januvia's sales sit at $919 million while Janumet's are $392 million, according to Bloomberg.

Merck's diabetes drugs are trending in the opposite direction of Japan-based Takeda Pharmaceutical's Actos, a treatment for type 2 diabetes. Actos, which was once seen as a safer alternative to GlaxoSmithKline's Avandia due to the latter's association with heart disease, has been linked in various studies to an increased risk of bladder cancer.

As a result of this association, both the U.S. Food and Drug Administration and the European Medicines Agency (EMA) called for Actos warnings to be updated. The medication has since been suspended in France and heavily restricted in Germany, while doctors all over are beginning to scale back their prescriptions of the drug.

With the link to bladder cancer, Actos has taken a significant sales hit, which has negatively impacted Takeda's finances. The company, which has announced a significant number of job cuts, also recently failed to win approval for a new diabetes drug from the FDA, according to multiple reports.

In addition to bladder cancer, Actos has also been linked to macular edema, an eye disease counted as one of the leading causes of blindness among working adults. 

Bloomberg reports regulators said in a response letter to Takeda they wanted more information on the use of the diabetes medication in other countries. Takeda said the letter from the U.S. Food and Drug Administration calls for new data collected from outside the U.S. and from patient studies that are being conducted.

The rejection of the type 2 diabetes medication, which is known chemically as alogliptin, is a significant setback for Takeda, which is set to lose patent protection on its best-selling Actos drug in four months, according to the news source.

The application had initially been rejected in 2009 by the FDA, which asked for more information on potential cardiovascular risks, the news provider said.

"We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues," Thomas Harris, vice president of regulatory affairs for the Japanese drugmaker, said in the statement. "We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved."

The rejection of approval for its new drug and the impending patent loss for Actos are only a few of the pressing concerns Actos currently faces. Actos, which is designed to treat type 2 diabetes, has faced considerable scrutiny over its association with bladder cancer. Actos, which was once seen as a safer alternative to GlaxoSmithKline's Avandia, has been the subject of a number of lawsuits spanning from California to Ontario. In these cases, individuals charge that they never would have taken the drug had they been aware of the serious side effects associated with it.

Recently, Health Canada announced the link between bladder cancer and Actos, but the FDA and the European Medicines Agency (EMA) have also previously called for an update to the drug's warning labels. Actos use has been suspended in France and heavily restricted in Germany.

In addition to the bladder cancer risk, Actos has also been linked in studies to macular edema, an eye disease that is considered a leading cause of blindness among working adults. Avandia, the similar medication which has been pulled from pharmacy shelves in the U.S., was tied to an increased risk of heart disease.

Over the past five years, Takeda's shares have lost half their value as the company deals with backlash over the Actos bladder cancer risk and a number of drug development failures, according to Bloomberg. Annual sales of alogliptin are poised to reach $1.8 billion worldwide in five years, but Actos generated $4.5 billion in sales for the company, which accounted for 27 percent of its revenue. In addition to declining sales for Actos, Takeda has recently announced a significant number of job cuts as part of a restructuring effort, according to reports.

In Japan, alogliptin is sold under the brand name Nesina. When the FDA responded to Takeda's approval request, the company was told that its clinical data on the drug was not sufficient because of new guidelines over diabetes treatments and cardiovascular treatments that came out in December 2008, Bloomberg reported. Following that, Takeda reportedly continued to conduct trials in an attempt to receive approval.