Supreme Court Ruling May Foreshadow Big Pharma Protection
In February, the U.S. Supreme Court ruled 8-1 that a patient injured by a balloon catheter manufactured by Medtronic Inc. was not entitled to damages because Medtronic was shielded from liability. The Supreme Court ruled in Medtronic's favor because the device in question met the specifications of the Food and Drug Administration (FDA). Early last week, former U.S. Solicitor General Paul Clement spoke to the Philadelphia chapter of the Federalist Society that this ruling may be a precursor of "sweeping protections for pharmaceutical makers." Clement served as solicitor general from June 2005 until June of this year.
Clement stated that a case involving a pharmaceutical is up for review this fall and bears a striking resemblance to the Medtronic case last February. In the case coming up, a patient sued Wyeth, alleging the anti-nausea drug Phenergan injured her. She contends Wyeth, the drug's maker is liable, while Wyeth contends the patient violated FDA rules and administered the drug in an unsafe way. Wyeth is based in Madison, N.J. and employs 5,300 people at its pharmaceutical headquarters.
As solicitor general, Clement filed a brief in favor of liability protection for manufacturers of pharmaceuticals. He believes that because the Supreme Court relied on the finding that the FDA extensively tested medical devices in the Medtronic ruling, they will apply the same kind of protections for drug makers. This principle is known as preemption.
Perhaps in a related note, both Chief Justice John Roberts and Justice Samuel A. Alito Jr. were once active members of the Federalist Society, a conservative legal group that leans toward siding with pro-business concerns, and has been the source for many of the Bush administration's judicial nominees and the top executive branch. However, Clement notes that the assumption of the Roberts court being pro-business many not be correct because they have ruled against corporate defendants in many employment cases.
As has been noted elsewhere, the FDA may not be the best judge of what is ready for the market. They are admittedly understaffed and underfunded, and we can assume this will affect all aspects of the agency's oversight, including what medical devices and pharmaceuticals are used by consumers.
If you or a loved one has been injured by a defective pharmaceutical or medical device, please contact an experienced injury lawyer in your area to find out if you have a claim. Labels: corporations, defective pharmaceutical, defective product, FDA
Punitive Damages Significantly Slashed in Exxon Valdez Ruling
Fourteen years ago, Exxon Mobil Corp. was ordered to pay $5 billion in punitive damages for the destruction of beaches and wildlife in Prince William Sound, Alaska. This was then reduced to $2.5 billion in 1994 by a federal appeals court. On Wednesday, June 25th, this was further reduced to $500 million by the U.S Supreme Court. In a 5-3 decision, Justice David Souter, writing for the court, stated that because the company has already exceeded the $2.5 billion amount in compensation to victims for economic losses, punitive damages have already been paid out. Exxon has asked the high court to throw out the punitive damages claiming it has spent $3.4 billion due to the damages which occurred along 1,200 miles of coast line.
Writing for the dissent, Justice John Paul Stevens stated that it was Congress who chose not to impose restrictions on punitive damages under the circumstances. Also in dissent, Justice Ruth Bader Ginsburg said the court was "engaging in lawmaking" with their conclusion. She believes the decision should have been left to Congress. Justice Stephen Breyer agreed with her by opposing a one to one ratio of punitive damages to victim compensation.
Justice Samuel Alito took no part in the decision because he owns Exxon stock.
This decision has left many Alaskans affected and in line for compensation in dismay. Under the original award nearly 33,000 would have collected $75,000 each. Now they stand to gain only $15,000 a person. According to Supreme Court lawyer Jeffrey Fisher, Native Alaskans, landowners, businesses, local governments, and commercial fishermen have had "their lives and livelihood destroyed and haven't received a dime of emotional-distress damages."
Revenue and profit margins of Exxon Mobil have surpassed $330 billion a year for the last several years, and is currently the world's richest corporation whose net income was almost $40 billion last year. As other oil companies, Exxon Mobil is under the threat of investigation for price gouging during a time of record gas prices, as well as for funding global warming skeptics while spending less than a percent on researching alternative energy sources.
While the Exxon Valdez was captained by an alcoholic who had five double vodkas the night of the spill, the fact remains that massive oil tankers continue to dump oil into the oceans, polluting the beaches and killing wildlife, which affects many people's livelihood. Because of this, environmental litigation is sure to have some kind of staying power. However, due to the Supreme Court's ruling, potential punitive damage claims may be significantly reduced.
Labels: corporations, damages, environmental litigation, governmental affairs
KBR Asks Judge to Throw Out Family's Lawsuit
Over the Memorial Day weekend, the military contractor once tied to Halliburton, KBR, asked a judge to throw out a lawsuit brought by the family of a soldier who died in Iraq when he was electrocuted while showering. Staff Sgt. Ryan Maseth, a 24-year-old stationed with the Green Berets in Baghdad, was killed in January, and an Army investigation found that the electric pump that supplied water to the building was improperly grounded. His death is considered an accident, yet the Maseth family believes since KBR was responsible for supplying the military with things such as showers and food, they are also responsible for Sgt. Maseth's death.
Though Sgt. Maseth's death is tragic, he is one of at least twelve soldiers who have been electrocuted in Iraq. The Maseth family is trying to find out what KBR knew and what - and when - the government knew. Because KBR was attached to Halliburton, there is some suspicion that Dick Cheney, who once led the energy company before becoming vice president, knows what was going on as the US invaded Iraq and began parceling out contracts to their companies the Bush administration favored. Cheney has denied having any contact with Halliburton or KBR since he joined the administration. KBR is also accused of price gouging the military and government even though they deliver questionable service.
The Maseth family may wonder why their son, a highly trained soldier, died in this manner, but they are not alone. Democratic chairman of the House Committee on Oversight and Government Reform, Henry Waxman, asked Defense Secretary Robert Gates to hand over documents relating to the electrical systems managed by the military. Many are concerned about the pattern they see which extends into KBR's management - or lack thereof.
Handing out government contracts to your friends is certainly undemocratic. But what's the word for it when your friends may be responsible for the deaths of at least twelve soldiers whose lives were contingent on your friends' corporations doing their job? And what do you call it when your friends' corporations ask a judge to throw out a lawsuit like this over Memorial Day weekend?
If you have lost a loved one in Iraq who was killed in an accident where negligence may have been a factor, please contact an experienced injury lawyer in your area to see if you have a claim. Labels: corporations, governmental affairs, wrongful death
Sinkhole Suspicion Points toward Company Involvement
A massive sinkhole that opened up near Daisetta, Texas may have been the result of too much saltwater being pumped into the ground by a company called Deloach Vacuum Services. Deloach was given a permit by the Texas Railroad Commission to dispose saltwater waste. Saltwater is a byproduct of oil production, and is stored underground to avoid contaminating the environment.
The sinkhole measuring 900 feet across and 260 feet deep has reportedly slowed or even stopped. It swallowed trees, telephone poles, oil barrels, and a number of vehicles between Tuesday and Thursday. It has also closed the main street of Daisetta. While geologists believe the sinkhole may be related to pumping saltwater into the ground, Daisetta sits on a salt dome where oil and natural gas have accumulated for millions of years. The town was "poised for potential sinkhole problems."
Deloach has received two violations in the past: One for exceeding the amount of wastewater it was allowed to inject into the ground, and one for failing to test for leaks on the disposal well before the end of April. The first violation resulted from Deloach injecting between 128,000 and 192,000 barrels of waste water per month when they were only supposed to inject 90,000 barrels per month.
Small sinkholes began opening up around Daisetta in the 1980s, but this is the biggest the town has seen. The next time might be even bigger, swallowing houses and more. And, though the cause of the sinkhole has not been determined, fingers are pointing at Deloach for helping to bring on the damage. Does this make them responsible, and if so, are they going to be held responsible, or is the state of Texas going to be the sole party doling out financial assistance, as seems the case right now?
If you are in need of an injury lawyer with experienced in premises liability, construction accidents, or any other type of negligence, please contact one in your area to have your claim evaluated.
Labels: construction accident, corporations, premises liability
Oil Companies Agree to Settle Water Suit
Some of the largest oil companies, including Citgo, Sunoco, BP, Royal Dutch Shell, Conoco Phillips, Chevron, Valero, and Marathon Oil have agreed to pay out nearly $424 million to settle a lawsuit brought by over a hundred public water companies. They will also pay for 70 percent of future cleanup costs over the next 30 years. Companies who refused the deal include Exxon Mobile, who has seen record profits over the last several years.
The gasoline additive methyl tertiary butyl ether, better known by its acronym MTBE, has allegedly contaminated drinking water supplies across the nation. The plaintiffs include water systems in over 15 states, including New York and California. The suit claims that the chemical additive contaminated groundwater and lead to the drinking water becoming "unpalatable," and tasting like turpentine. It also caused cancer in lab rats, according to the Environmental Protection Agency.
MTBE was originally added to gasoline in 1979 to increase octane levels, but it became more widespread in the 1990s after the Clean Air Act of 1990. The Clean Air Act mandated its use in cities to reduce smog and pollution. Fuel burns more thoroughly when MTBE is mixed with gasoline. However, it was found to contaminate the groundwater when it was put into use. It has since been banned in 23 states.
Oil companies have been looking for another additive to use in place of MTBE. This has lead to the use of ethanol as a replacement.
Defective Product Oil companies have fought hard to avoid paying penalties for cleanups, claiming they were forced to use MTBE. It is estimated a total cleanup will cost tens of billions of dollars. A lawyer representing Chevron and Shell has noted that the settlement does not claim MTBE is a defective product, and that the oil companies "are prepared to vigorously defend the product."
A lawyer for Exxon says that the company has no plan to settle, and states, "When [Exxon] engages in conduct that injures people, it pays recompense for that. In all these cases, our conduct did not cause injury, or cause damages. Our conduct was lawful."
Although this might be Exxon's official line, the lawsuit contends that oil companies continued to use MTBE even though they knew there were health and environmental risks posed by the chemical.
There have been hundreds of lawsuits brought against oil companies and their use of MTBE since the 1990s. If this deal is approved, it will be the largest settlement regarding the chemical to date. In 2003 the Republican-led Congress tried to shield MTBE manufacturers from litigation with a provision, but failed due to strong opposition.
The case will go to trial in New York this September.
Though MTBE has not been ruled a defective product by any court in the land, if you feel you or a loved one has suffered injuries due to contaminated groundwater, please contact an experienced injury lawyer in your area to see if you have a claim. Labels: corporations, defective product
Blood Substitute Tests Allowed by FDA Despite Known Risks
In a report to be released this Monday, May 5, by the Journal of the American Medical Association (JAMA), experimental blood substitute tests allowed by US regulators raised the risk of heart attack and death. The report is written by scientists with the National Institutes of Health Clinical Center and advocates from the watchdog organization Public Citizen.
Biomedical companies and the government have been looking for a way to substitute the need for blood for several years. If a blood substitute is found, it will become a financial boon to companies that market it, as well as save lives in such places as battlefields. Theoretically it could be stored for years without the need for refrigeration, as well as not run the risk of carrying infections such as hepatitis or HIV. According to JAMA, the FDA had completed a dozen studies of blood substitutes by the end of 2000, and the risks were well known at that time. Dr. Charles Natanson of the NIH Clinical Center states that the FDA used their data to look at each product and each use (trauma, surgery, and in stroke patients) separately rather than pooling it to see the whole picture.
Ethical Concerns
After Public Citizen filed a lawsuit in 2006 to protest closed-door hearings, the FDA halted a planned test by the Navy to use the substitute on civilians without their knowledge or consent. While this raises certain ethical questions, American companies are testing products on people in South Africa and in some European countries. Cambridge, Mass.-based Biopure Corp. is using their blood substitute, Hemopure, on anemic surgery patients in South Africa. Study co-author Sidney Wolfe of Public Citizen states it is highly unlikely or even impossible, that these countries are aware of the risks, even though the governments have approved the tests.
Findings
The report shows 16 random control studies of five different blood substitutes with 3,700 patients involved. These patients include trauma, elective surgery, and victims of stroke. The findings show:
- A 30 percent higher risk of death for those who received blood substitute transfusions. 164 patients died compared to 123 who received ordinary blood or saline transfusions.
- Risk of heart attack tripled with blood substitutes. 59 patients suffered heart attacks with the new product compared to 16 who did not. Experts speculate that hemoglobin in the blood substitute removes nitric oxide from the blood, which causes blood vessels to constrict and a buildup of sticky platelets
Perhaps predictably, two of the companies whose products were included in the study call the analysis "flawed." Biopure vice president, Dr. A.G. Greenburg states, "There are vast differences among these products that make any pooling of data flawed, especially across different clinical experiences." Evanston, Ill.-based Northfield Laboratories Inc.'s CEO, Dr. Steven Gould explains that though pooled data can be useful to raise questions, it does not "provide answers about specific products or to examine fully the risk-benefit ratio of any particular product."
Defending the FDA's decision, Dr. Jay Epstein, the director of the FDA's office of blood research and review, says there are enough differences among the blood substitute products and their intended uses to allow some of the studies to continue. Dr. Natanson does give the FDA some credit, but says that while the agency may know more than any one individual at any of the companies, "they may not know the whole story" and there may be information being withheld from the FDA by these companies.
Dr. Natanson's theory seems to be backed up by Dr. William Hoffman, former chief medical officer at Biopure. He left in 2000 because management there wouldn't let him tell the FDA that he believed one of the studies should be halted. However, he states that management at Biopure has changed since then.
While it would be a huge break though to have a blood substitute, especially in times of crisis, there seems to be little doubt that the products being tested are far from ready. Clinical tests on people are an important step, but the individuals should be able to give their consent, and know the risks.
If you or a loved one has been injured due to a product risk you were not made aware of, please contact an experienced injury lawyer in your area. Labels: corporations, defective product, FDA
Makers of Vytorin Withheld Findings
The Senate's Finance Committee and the House's Energy and Commerce Committee allege that the makers of the cholesterol drug, Vytorin, withheld negative findings to boost sales. Drug makers Merck & Co. and Schering-Plough Corp. are accused of suppressing data that shows Vytorin is only as effective as another generic drug called Zocor, made by Merck. The findings were partially released in January due to congressional pressure. Vytorin combines Zocor and Schering-Plough's Zetia, and was heavily advertised as a new and improved cholesterol fighting drug. This cooperative endeavor brought the companies $5.1 billion in sales in 2007. Not only does Vytorin cost much more than Zocor, but Sen. Chuck Grassley of Iowa said in a letter that delaying the results affected medical decisions, as well as put financial strain on patients and the government. Hundreds of millions of dollars have been spent by the government since the study ended nearly two years ago. Cardiologists are recommending that doctors go back to older tried-and-true cholesterol fighting drugs. Two Versions of Why The government alleges that the two drug companies withheld their poor findings in order to pump up their profits, even though they realized Vytorin was not as powerful as they claimed. Sen. Grassley's letter also cites emails to Schering Plough executives from cardiologist Dr. John Kastelein. Kastelein stated that the suppression of the data was beginning to seem like it was done "for no other reason (than) political reasons." A spokeswoman for Merck stated that executives did not find out about the findings until after January, and that interpreting the data took longer than expected. Schering-Plough's spokeswoman claims the company "did not deliberately delay" the findings to boost sales. Stocks of both companies fell sharply after this story was reported on Monday, and has "cast a shadow" over the futures of both companies, though Merck is expected to fare better than Schering-Plough. Do you get the feeling this isn't the last time Big Pharma will choose profits over the health of patients? If you, or a loved one, feel that your health has been put in jeopardy by the actions of another party, please contact a personal injury lawyer in your area. Labels: corporations
Chiquita's FARC Relationship Center of Wrongful Death Suit
The banana company, Chiquita Brands International Inc., is involved in yet another legal battle for its payouts to Columbia's left-wing paramilitary group, the Fuerza Amadas Revolucionarias de Colombia (FARC). Families of five missionaries killed by the FARC in the 1990s have filed a wrongful death suit claiming that Chiquita's payments to the rebel group contributed to the deaths.
Bananas and War: A Brief Overview
Chiquita's history in Latin America dates back to the beginning of the 20th century when they were called the United Fruit Company. Chiquita was trademarked in the 1940s, but the company didn't become Chiquita Brands International Inc. until 1985. As a giant corporation, they faced criticism over their amount of influence on the banana republics of Latin America. There is also speculation that Chiquita's lobbying against the democratically elected president of Guatemala in the 1950s led to a CIA-led military coup in that country that overthrew the government. The company was already in Columbia when a guerilla war began in the 1960s.
In 2007, Chiquita agreed to a $25 million fine based on its having paid Columbia's left-wing FARC and ELN (National Liberation Army), and right-wing AUC (United Self-Defense Forces of Columbia) for protection. However, Chiquita claims the payments were extortion and made only under duress. These groups have been labeled terrorist organizations by the US government. In addition to a litany of human rights abuses, these groups have also been tied to Columbia's drug trade.
Wrongful Death Suit
The evangelical New Tribes Mission, based in Florida, has missionaries all over the world. In the 1990s, they were in Columbia. The families of the slain claim that their family members were abducted from two small villages by the FARC in 1994, and were killed because the missionary group couldn't come up with the ransom money. Chiquita is involved because they were allegedly financing the FARC's operations at the time of the abductions. The suit also claims that Chiquita provided weapons and logistical support to the FARC at this time.
The law suit seeks unspecified damages.
Unfortunately, this seems to be another case of foreign missionaries caught up in events bigger than they are. While they certainly have the right to go to places as dangerous as Columbia, and they do believe in their calling, they also know the risks. What could not be foreseen is a major US corporation aiding the same rebel group that would eventually kill them. Rarely does the American public think about multi-national corporations giving guns and money to armed groups that may turn around and use them against US civilians.
If you, or a loved one, believe a family member's death may have been caused by another party's negligence, recklessness, or intentional behavior, please contact a personal injury lawyer with experience in wrongful death cases. Labels: corporations, governmental affairs, wrongful death
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