The use of epidural steroid injections to quickly alleviate neck and back pain has grown across the country, with close to 9 million Americans receiving the injection shots last year alone. However, the number of reports of paralysis and even death linked to the steroid injections has also been increasing. The Food and Drug Administration has now become concerned enough to begin a review of the safety of these steroid injections.

These injections often known as corticosteroids contain anti-inflammatory properties that provide immediate relief from neck and back pain, shoulder pain and inflammation in the hip, knee and other parts of the body. California product liability lawyers have found a number of reasons for this increase in the popularity of epidural painkilling shots. They're quick to administer, and have proved profitable for doctors in the form of reimbursements from Medicare and private insurance companies. In fact, epidural shots have become the single most popular way for doctors in America to treat neck and back pain.

According to research by the Society of Interventional Pain Physicians, the number of epidural injections administered to Medicare patients increased by a startling 159% over an 11-year period between 2000 and 2010. Americans are spending more money on painkilling treatments than ever before, amounting to a total of $300 million a year. Out of this, interventional procedures like epidurals account for about $23 billion a year.

According to doctors, the number of persons receiving epidural injections is rising not just because of the profitable reimbursements, but also because of an increasingly aging population that complains frequently of neck and back pain. The number of seniors around the country has been increasing, and is likely to spike in the next few years as the baby boomer population enters its 70s. The Food And Drug Administration has now confirmed that it is conducting a review of the safety of epidural injections.

The Food and Drug Administration's fast track medical device approval process, also known as the 510(k) program, will be the subject of scrutiny this week at a Senate hearing.  The Government Accountability Office is scheduled to address concerns about misuse of the fast-track approval process for the approval of sensitive devices like hip joints and cardiac devices.

The Senate Special Committee on Aging will hear from the Government Accountability Office.  In 2009, the Government Accountability Office had cited the Food and Drug Administration for its misuse of the fast-track approval process.  According to the Government Accountability Office, the Food and Drug Administration has approved at least 67 medical devices through the fast-track process since 2009 alone. 

The concerns over the misuse of the 510(k) process have heightened since the nationwide scrutiny involving Johnson & Johnson’s subsidiary, DePuy Orthopedics’ hip joint devices.  Last year, the company was forced to recall more than 93,000 hip implants for the high risk of revision surgery associated with these.  Thousands of people who were implanted with the devices have chronic complaints of consistent pain, swelling, and other complaints.  These patients were advised to have revision surgery to replace the devices. 

Studies have indicated that the revision surgery rate for these hip implants is approximately 12% over a period of five years.  Revision surgeries that have been performed on some of the patients have revealed horrifying signs of bone damage and degeneration.  Surgeons have found masses of dead tissue around the implant area.  These implants had been approved through the 510(k) process.

The 510(k) process was initially developed for the quick approval of power wheelchairs, catheters and other devices that were sufficiently similar to existing approved devices already in the market.  However, the Food and Drug Administration now uses the fast-track process to clear even critical and sensitive devices, like hip implants and cardiac devices.  The risks of defective medical devices slipping through the cracks of this flimsy program are too great for California pharmaceutical liability attorneys to ignore.

It's the latest setback for Johnson & Johnson, which has already been rocked by a series of safety crisis over the past year. In the latest blow to the company, a Minnesota jury has ruled that the company failed to properly warn consumers about the risks of tendon damage from the use of its antibiotic Levaquin.

The verdict came in a case involving 82-year-old John Schedin, who claimed that he ruptured both of his Achilles tendons, after taking the antibiotic. He sued both Johnson & Johnson and its Ortho-McNeill-Janssen pharmaceuticals unit. The jury assigned 75 % of liability to Ortho-McNeill-Janssen, 10% to Schedin and 15% to his doctor. Schedin was awarded approximately $700,000 in damages for his claim that Johnson & Johnson failed to warn about the risks of taking the antibiotic. However, the jury rejected his claim that Johnson & Johnson violated state consumer fraud law by concealing information about the antibiotic.

In 2008, the Food and Drug Administration ordered Johnson & Johnson and other manufacturers of a special category of antibiotics called fluoroquinolones, to include a warning about the risk of tendon damage from the use of the drugs. According to the Food and Drug Administration, the risk of tendon damage was greater in patients older than 60 years of age. Patients who took steroids and those who had undergone kidney, heart and lung transplants were also at a high risk of tendon damage.

The company has been sued by dangerous drug lawyers who claim that the warning should have been enhanced earlier and that the warning continues to remain inadequate. According to plaintiffs, Johnson & Johnson tried to maximize its profits by downplaying the risks of taking Levaquin. Johnson & Johnson continues to face an investigation into safety issues at its plant that have emerged after a series of recalls involving high-profile children’s medications including the blockbuster drug Tylenol.

Researchers are in the process of developing a tracking system that will track and help trace potentially faulty medical devices. The system was put through a test run recently. It compared seven cardiac devices that were used in patients in Massachusetts between 2003 and 2007. The test run resulted in the identification of two medical devices with potential safety problems. California pharmaceutical liability attorneys believe that systems like this could help track devices, especially older ones and possibly save lives.

Currently, there is no system to track problems with medical devices after they are implanted. The Food and Drug Administration is entrusted with the unenviable task of collecting safety data from patients or doctors who find problems with devices. Unfortunately, the rate of reporting for safety data is still very low. Only about 5% of adverse events involving medical devices ever get reported to the FDA. That means that the agency has to look for any safety trends, by sifting through available data.

Needless to say, the current process is extremely inefficient, and does very little to identify and locate safety problems in medical devices that are already implanted. However, a computerized tracking system like the one that's in development could give the FDA the ability to track specific problems.

During the test run, the group evaluated data from more than 74,000 cardiac surgeries. They investigated seven cardiac devices, looking for at least three common problems that could occur with each. Two of the cardiac devices, a cardiac stent called Taxus Express by Boston Scientific and a device called Angio-Seal STS were found to have potential safety problems. That doesn't mean that both of these devices are defective. What it means is that using the information gained from the study of these two devices, regulators can look for similar problems that exist in other devices. The system therefore helps provide clues about other possibly defective medical devices.

According to a new study, Pfizer's hormone pill Prempro almost doubled the risk of dying from breast cancer for women who took the medication to deal with symptoms of menopause.  This is a critical study which conclusively links Prempro to a dramatically heightened risk of death from breast cancer.  There have been earlier studies, however, that have linked Prempro to a higher risk of breast cancer and heart disease.

The researchers tracked 12,788 women over a period of almost 8 years.  They found a total of 658 cases of invasive breast cancer, including 385 in women who took the hormones and 293 in women who took a placebo.  According to the researchers, there were 2.6 fatalities caused by breast cancer for 100,000 persons who took Prempro.  In contrast, there were just 1.3 fatalities for every 100,000 persons taking a placebo. According to lead researcher Rowan Chlebowski, there isn't just a greater risk of developing cancer, but also a risk of developing advanced stage cancer. 

The findings will be exceedingly important because they conflict with earlier studies that show that these hormone pills lower the risk of breast cancer.  They also come as Pfizer has won at least six of its 13 jury cases related to health risks from Prempro.  Those victories for Pfizer came prior to the publication of this study in the Journal of the American Medical Association.

Pfizer currently faces about 8,000 lawsuits from pharmaceutical negligence attorneys related to the health effects of the use of Prempro and its other hormone therapy, Premarin.  Meanwhile, the research showing a link between a higher risk of death from breast cancer and Prempro, comes on the heels of another study which shows that women taking these pills have a higher risk of dying from lung cancer.

A series of pharmaceutical safety scandals over the past couple of years has most Americans clamoring for stronger safeguards that can protect them from pharmaceutical injuries.

A new poll conducted by the Pew Prescription Project shows that 89% of Americans would support legislation implementing stronger drug safety measures.  However, the poll also suggests that Americans don't have a great opinion about the job that the Food and Drug Administration is doing to ensure the safety of drugs manufactured in the United States. 

There are other interesting findings from the study.  70% of the respondents in the study said they are concerned about the quality of drugs manufactured in the United States.  When it comes to the safety of drugs manufactured in other countries, Americans want the FDA to do more.  55% want the Food and Drug Administration to get more involved in ensuring the safety of drugs manufactured in other countries. 

The Pew poll showed overwhelming support for greater legislative action to increase the FDA's powers.  For example, 94% of respondents in the survey said they would favor giving the FDA power to issue recalls of pharmaceutical drugs and devices.  95% of the respondents favored legislation that would give the FDA the power to destroy imported drugs that it believed were contaminated.  96% wanted legislation that would require drug makers to inform the agency when they discovered contamination.  86% of the respondents wanted the FDA to conduct more frequent inspections of foreign plants.  In fact, these respondents wanted foreign plant inspections every two years, which is the same frequency for domestic plants.

Irregular inspections of foreign pharmaceutical plants have been a major concern for California pharmaceutical liability attorneys.  Soon after the Baxter heparin scandal in which tainted heparin that had been manufactured in China injured several people, we learned that the Food and Drug Administration simply does not have the resources to conduct frequent inspections of foreign plants.  Some of these foreign plants are go for years without inspections.

Some of these concerns may soon be addressed.  Senator Michael Bennett - Democrat Colorado is expected to soon introduce a bill called the Drug Safety and Accountability Act that provides for better consumer safeguards against contaminated drugs.

Pfizer Inc., one of the largest pharmaceutical companies in the world, offered a settlement to a wrongful death lawsuit brought by Linda Shearer of Massachusetts. The suit alleged that her husband's use of Pfizer's anti-seizure medication, Neurontin, caused him to commit suicide in 2002.

Pfizer representatives claimed that the settlement was made on favorable terms, judging that the cost of the settlement would be less than the defense costs of carrying the case to completion. Bloomberg News claimed that Pfizer had settled for $400,000, but no confirmation is available, as Pfizer and the plaintiff have both said the terms are to remain confidential.

Shearer brought the case following her husband's suicide in 2002. Hartley Shearer was prescribed Neurontin after being paralyzed, in an effort to control the effects of the condition. The plaintiff's suit alleged that Pfizer promoted the drug despite it being unapproved for the use of paralysis management by U.S. regulators. Additionally, Shearer argued that Pfizer knew the drug was associated with suicide risks, but failed to provide her husband with proper warnings about it.

The settlement is still subject to court approval. The case lasted less than a week before the settlement was offered.

This is not the first legal headache involving this drug, one of Pfizer's strongest sellers. Pfizer recently was judged to have violated anti-racketeering laws by promoting Neurontin for off-label use. Damages of $47 million were awarded, and under racketeering law the amount could automatically triple. Pfizer also pleaded guilty in 2004 to a single criminal charge and agreed to a $430 million settlement pertaining to government investigation into Neurontin's promotion.

Pfizer has stated it intends to appeal the racketeering case. The corporation also has disclosed that other cases alleging wrongful death due to the potential for Neurontin to cause suicide are pending. These cases will continue to draw significant interest, because Neurontin recently lost patent protection and is being produced in generic form by Pfizer's competition.