San Antonio Injury Lawyer Blog

On March 6, 2009 in an article entitled "Political Lobbying Drove FDA Process” the Wall Street Journal chronicled how a medical device manufacturer had its product that is intended to be implanted into patients knees quickley approved because of its lobbying efforts. The medical device had the normal review and investigation short circuited.

Medical devices can get quick approval if the device is similar to a product already on the market. The rational is that the first product went through a vigorous review and had studies backing its efficacy and safety; therefore a second product (a copy cat of sorts) shouldn't have to go through the vigorous studies and review. This fast-track review is called a 510(k) by the FDA, and is intended to be used only when similar products have already been reviewed and approved. This 510(k) fast-track review saves companies money and speeds products to the market where profits can sooner be realized.

The Wall Street Journal Article reported on how ReGen Biologics Inc. was able to have its Menaflex knee device quickly approved through the 510(k) fast track review even though some within the FDA did not believe that it should qualify for the fast track review process and instead should have had to go through a more vigorous vetting process. According to the article, the head of the FDA, when asked about the 510(k) allowance for this particular product, was quoted as saying "There's something wrong with how that decision was made." This provides more evidence that consumers need to be able to pursue claims against manufacturers of faulty medical devices if they are injured. The Government Accountability Office, in January, issued a statement indicating that the FDA is too quick to allow 510(k) approvals. Quite simply, the FDA is incapable of monitoring all of the products they are supposed to oversee.

We have no opinion regarding, and this entry is not a comment on, the safety or efficacy of the ReGen Menaflex device; this entry merely points out that the FDA appears unable to adequately perform its functions and therefore puts American consumers at risk. The only safety net for the American consumer when regulation fails, is the ability to bring a private suit seeking compensation for losses. If manufacturers are allowed to hide behind the laws that give immunity to many FDA approved devices, and obtain approvals perhaps without a full review and proper vetting, our citizens will remain at risk.

The Food and Drug Administration (FDA) is responsible for researching and approving new medicines, staying abreast of those medicines on the market, regulating medical devices, and monitoring and ensuring the safety of approximately 80% of our food supply. Most people don’t realize the FDA also regulates many devices that emit radiation such as cell phones, computer monitors, as well as a host of other products. The FDA also regulates cosmetics and many products used in the production of food, including animal feed.

With the globalization of food and drug production it is no surprise to find that the FDA has been unable to do its job as mandated. The FDA's budget has essentially been flat for years even though many managers and administrators in the FDA have called for a doubling of their budget. Recently an article published March 14, 2009 in the New England Journal of Medicine pointed out the difficulties faced by the FDA. The article entitled "A To-Do List for the New FDA Commissioner" points out many of the difficulties faced by an increasing workload at the FDA and suggests many changes that need to be addressed.

The primary focus of the FDA is the protection of the United States consumer. It is obvious that the FDA is not capable of monitoring all of the products under its umbrella that are made in the United States and certainly not those entering the U.S from foreign countries such as China. With the FDA stretched beyond its limit and the Federal Budget unable to fully fund the FDA an obvious choice is to remove the private lawsuit protections that medical device makers and drug manufacturers have taken advantage of in the past. Congress originally attempted to essentially grant immunity to drug and device manufacturers in many circumstances, if the FDA had approved a product. Inasmuch as the FDA cannot properly research and evaluate every product, private consumer litigation is the only avenue to seek redress from harmful drugs and devices. Legislation has been introduced in the current session of Congress to accomplish this task. We as a country need to either fully fund the FDA or allow consumer protection lawsuits. Innocent people are being harmed or killed by unsafe food, drugs or medical devices and many of those harmed currently have no relief in the courts.

Drug Companies appear to have too much influence over the regulatory governmental agencies that are supposed to determine whether a drug is effective and safe.

Federal Regulators with the Food and Drug Administration (the "FDA") admitted that they should not have "uninvited" a leading cardiologist to a panel that was going to decide whether to approve a cardiovascular anticlotting drug (prasugrel hydrochloride) made by Eli Lilly & Co. As was reported in the Wall Street Journal this week, Dr. Sanjay Kaul is a well known cardiologist that had been critical of Eli Lilly's drug prasugrel and Dr. Kaul had even written several articles critical of the new drug. Dr. Kaul was scheduled to participate in the FDA committee meeting that was assigned with the task of reviewing the drug and deciding whether to grant FDA approval to Eli Lilly & Co. to manufacture and sell the drug. Prasugrel, according the Wall Street Journal article ("FDA Says it Erred on Doctor", Favole, J., February 24, 2009), has been linked to dangerous internal bleeding.

The all day meeting of the Cardiovascular and Renal Drugs Advisory Committee was scheduled for February 3, 2009 in Maryland. In the days prior to the scheduled meeting Eli Lilly contacted certain FDA managers and questioned the decision to have Dr. Kaul's included on the panel because of his published articles critical of the new drug. Apparently, following the calls from the drug manufacturer, FDA managers told Dr. Kaul to not take his flight from Los Angeles to Maryland; he was essentially told he was not welcome at the meeting.

FDA managers are supposed to screen potential advisory panel members for financial conflicts of interest - having received money or other compensation from a company being reviewed - or for intellectual bias - if a person has already made a decision prior to hearing the evidence presented. Although Dr. Kaul was screened for financial conflict of interest, and he had none, apparently there was no other screening done upon which to base a decision to exclude him. The only basis for excluding Dr. Kaul appears to be the phone calls from the Eli Lilly & Co. representatives. With Dr. Kaul removed, the panel unanimously voted to recommend approval.

The Director of the FDA Drug Division, Dr. Janet Woodcock, has been quoted as saying, "At every step of the way there were errors by multiple parties. Dr. Woodcock was apparently never informed, nor were other higher level FDA officials about the phone call from the drug manufacturer or the decision to uninvite Dr. Kaul from the panel. John Jenkins, the Director of the FDA Office of New Drugs stated, "I think he [Dr. Kaul] would have been a very valuable member [of the panel]."

The drug is not on the market yet, and the final decision to approve or not approve is still pending.

The exclusion of Dr. Kaul from the committee meeting, alone, does not mean that the drug is unsafe or is not effective for its indication. However, our system of FDA review only works if sound science presented by competent researchers is allowed to be presented at committee meetings - even if it is counter to the drug company’s financial interest. In order for patients to be protected, the FDA must allow for an open and robust dialogue and cannot allow pressure from drug manufacturers to sway or interfere with the application and review process. Drugs that have undergone the approval process can still harm patients or even be fatal; and the patient or their family suffer a further injustice if the approval process was affected by the very company selling the drug.

"Off-label" uses for drugs and medical devices have been in the news lately. What is "off-label" use? Essentially, when the Food and Drug Administration (FDA) approves a drug or medical device, the specific conditions for which the drug or device is approved are listed. Some drugs and devices, however, can provide positive benefits to patients if used for conditions or symptoms that have not yet been investigated and approved by the FDA. Only licensed medical doctors are allowed to use and prescribe drugs and medical devices in ways and for conditions not approved by the FDA, if based on sound medical judgment, the "off-label" use of the drug or device can help a patient. Even so, a physician can be held liable if the "off-label" use is unreasonable and not based on good medical judgment. However, drug companies and medical device manufacturers (and particularly the sales reps that promote the use of the drugs and devices to physicians) are not allowed to advertise their products for uses not approved by the FDA.

Lawsuits against drug manufacturers alleging that the company promoted the off-label use of its drugs or medical devices often include the allegation that the doctors also received secret inducements to prescribe the drug in a manner not intended by the FDA. Clearly, if a physician is accepting payments or incentives to use a drug or device in an unapproved manner, the basis for such a decision is subject to scrutiny.

In an unusual case the Department of Justice is investigating Medtronic Inc. for the off-label use of its Infuse Bone Graft. The Infuse Bone Graft was approved by the FDA for use in the lumbar (low back) spine area. Infuse Bone Graft, if used properly in the lumbar region, would cause bone growth that fills in the gap between the vertebrae and replaces damaged discs. The FDA, however, only approved the use of this bone grafting material in a small area of the lower lumbar spine.

A number of patients have complained that they were injured when the Medtronic Infuse Bone Graft was used in an off-label manner. In July the FDA issued a safety alert about the off-label use of the Infuse Bone Graft in the neck or cervical region of the spine. Some of the complications that occurred when the Infuse Bone Graft was used in the cervical region included severe breathing problems and difficulty swallowing. Using the Infuse Bone Graft in the cervical region has caused some patients to lose the ability to breath or to swallow resulting in tracheotomies in order to breathe, while others had to have feeding tubes installed.

Medical malpractice lawyers in Texas need to investigate all potential causes of injuries, especially in light of the $250,000.00 cap on non-economic damages when suing medical providers. The cap on damages would not apply to suits against the medical device manufacturer if the manufacturer promoted its product for an off-label use and the off-label use caused injury. If off-label uses, and perhaps incentive payments to physicians, have caused serious or catastrophic injury, a manufacturing company can be held to fully compensate a patient.

It was recently reported in the Wall Street Journal (WSJ) that President Bush is attempting to use his last months in office to enact rules that will prevent consumers injured by dangerous products from seeking compensation. Issuing rules, rather than having Congress review and pass laws, the administration is attempting to protect corporations and is using federal agencies to affect these changes. The Food and Drug Administration (FDA), along with the Department of Transportation (DOT) and the Office of Management and Budget (OMB) among others, have sought to add rules that will preempt consumers from seeking compensation if a corporation follows federal guidelines when developing and marketing a product. While this sounds all well and good - the idea of having federal guidelines in place that must be followed and the prevention of requiring a company to try and follow up to 50 different states laws and regulations - the reality is quite different.

Federal agencies such as the FDA are under funded and understaffed. These agencies do not have the ability to evaluate the pitfalls and dangers in every product put before them, or every product placed in the market place. The result is that products that have not been properly tested, or that are inherently dangerous, can end up on store shelves. Each state has laws in place to protect it citizens and consumers. Supporters claim that preemption protects corporations from having to follow 50 different guidelines. However, the majority of states have similar laws that simply require a product manufacturer to exercise reasonable care in their efforts and these laws protect consumers when a company places a product that is inherently dangerous in the stream of commerce. Similarly, most states have laws that require a company to market, or advertise its products by providing reasonable warnings that need to be followed to use a product safely.

By utilizing rule making authority, the administration and the federal agencies are avoiding the oversight and review of congress, and further, are implementing rules that cannot be simply undone. Although avoiding the review process to enact these rules, a lengthy federal review is necessary to retract these rules, making the process seem backward. Some examples of recent rules that have been enacted include: October 8, a Department of Transportation issued rule that limits the number of seatbelts auto manufacturers can be required to install in vehicles
AND then prohibits suits for injuries and losses suffered if a passenger is hurt as a result of not having an available seatbelt; currently, the Office of Management and Budget, together with the Federal Railroad Administration is seeking to add federal preemption into a tank car rule; and the Food and Drug Administration has extensively tried to enact rules that would prevent patients and consumers from bringing claims when harmed by drugs that have been "approved" by the FDA. A rule was entered that requires manufacturers to make mattresses that burn more slowly, but also prohibits a person injured in a mattress fire from bringing a claim against the manufacturer. Similarly, rules require railroad car manufacturers to use stronger materials and construction efforts, but prevent a suit if a railcar catches fire.

All in all, consumers are being told, essentially, "trust the government, we will keep a watchful eye on the corporations that manufacture the products you buy." Unfortunately, time and time again, it has been proven that the federal bureaucracy is not capable (due to lack of funds and lack of personnel, if not due to allegiance to the corporations that fund political campaigns) of adequately protecting all consumers; however, if you are injured the federal agencies have decided that you are not entitled to investigate or seek a review of the manufacturing process that may well have caused your injury.

Source: Mundy, A., "Bush Rule Changes Could Block Product-Safety Suits" Wall Street Journal, October 15, 2008

Federal regulatory agencies have become increasingly lax in their enforcement of rules and regulation that have been enacted to protect consumers. Many agencies have relied upon self regulation and enforcement which is essentially no regulation. The recent meltdown in the United States financial sector is some evidence that companies and individuals cannot be left to self-regulate.

It's a sad fact that federal regulatory agencies have become to closely aligned to the industries they are supposed to regulate for the public's well-being.

One of the most important regulatory agencies, the U.S. Food and Drug Administration (FDA), has become particularly lax in ensuring the health and safety of those who take medication and rely on properly functioning medical devices.

In an attempt to provide additional oversight in this critical area a small group of Senators introduced the Medical Device Safety Act of 2008.

The proposed legislation would allow victims of faulty medical devices to sue for injuries in state courts even if the medical device had been approved for use by the FDA. Such legislation, would not be needed if the FDA would perform its traditional regulatory role.

The United States Supreme Court recently ruled 8-1 that a federal law, the Medical Device Amendments of 1976, preempts state laws that provide for stricter standards for medical devices than does the federal statute. The Supreme Court Opinion stated that tort laws disrupted the "federal scheme" and that the FDA is the sole determining body to approve medical devices. This essentially makes it impossible to sue the company that manufactured the defective product.

The Courts Ruling subjects patients to possible death or debilitating conditions resulting from faulty medical devices approved by the FDA, while denying them the recourse of seeking compensation for damages in state courts. The Courts use of the word "scheme" correctly describes how the system works in the real world. In the current system a drug or medical device manufacturer develops a drug or device that if approved by the FDA may make the company billions of dollars and the executives millions of dollars in bonuses. The company seeking approval submits its studies for the drug or device to the FDA and the FDA reviews the material. Obviously, the drug or device company's desire is to get an approval with as little research and restriction as possible. Upon approval by the FDA the drug or device company is essentially shielded from any harm caused by its product. As we have previously noted in other articles the FDA is understaffed and under funded. This results in the FDA having to rely upon the information given to them by the parties seeking approval.

The medicine/device industry vigorously opposes the legislation precisely because it has been able to duck behind the FDA shield to deflect claims by patients harmed by medical devices that didn't live up to the government's seal of approval.

Public advocacy groups have chronicled an increasing list of patients seriously injured by faulty medical devices over the last decade. Among the devices: Trident prosthetic hips, Prodisc spinal implants, Medtronic and Guidant defibrillators, St. Jude's Silzone-coated heart valves and Sulzer's hip and knee implants.

We believe the bill would ensure safer products by allowing personal injury lawyers to file lawsuits against manufacturers at the state level. Even officials at the FDA have questioned the agency's ability to monitor and ensure the safety of medical devices.

Enactment of the Medical Device Safety Act of 2008 would be a good first step toward correcting the lax enforcement that leads to serious injuries and deaths for patients who put their trust in the miracles of modern medicine. Obviously, you cannot protect the public when you do not have the funding or the staff to regulate and at the same time you remove the threat of being held accountable in Court.

The Food and Drug Administration (FDA) has recently classified a “warning” sent out by Medtronic, Inc. to health professionals as a Class 1 recall. A Class 1 recall is the most serious type of recall order issued and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The device being recalled is an implantable pump that delivers drugs into the body. The product technical name is: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. This is an illustration of a typical intrathecal medicine delivery system.

Patients receive infused drugs (typically for pain management) through the pump, and it was recently reported in the Minneapolis Star-Tribune that 83 patients have been identified as having pumps with improper connections, and one patient has died.

Patients are urged to immediately contact their physicians regarding these devices. The connections, if improper, can cause leaking of pain medication into the body, with the potential for fatal overdose.

Earlier this year, Medtronic the FDA considered a warning issued by Medtronic regarding another of its infusion devices, and also determined that the issue warranted a Class 1 recall. The Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps were recalled after a letter was sent reporting inflammatory masses at the site of these pumps – also used for pain management, as well as cancer treatment infusion.

If you have any questions or concerns regarding medical devices and cannot find answers through the FDA website, contact an experienced attorney and seek advice.

We were excited to learn about the new Food and Drug Administration (FDA) list of drugs being investigated. We often get calls from medical patients who suffered severe injuries potentially from prescription medicines. Often it is impossible to determine whether the FDA is investigating the adverse event or even whether the medical issue was an adverse event caused by the prescription drug.

The Food and Drug Administration (FDA) started a new program where they will list on their website drugs that they are investigating for possible side effects. The change in policy of providing advance warnings is meant to warn patients and health care professionals about possible side effects. The current list of 20 drugs is varied and includes potential side effects ranging from heart attacks and cancer to Purple Glove Syndrome which can result in the amputation of a patient's arms.

Being on the list doesn't mean that it has been determined that the drug has the side effect being investigated; also, not being on the list doesn't mean that a particular drug doesn't have side effects. The list is merely an advance warning that a particular side effect is being investigated. Any decisions about whether to take a particular medicine should be made after consulting with our health care provider.

The stated purpose of the list is to get more patients reporting adverse events as well as to open a dialogue between patients and their physicians about possible side effects. The list is not meant to contain all drugs under review or being investigated by the FDA; furthermore, the list will be issued on a quarterly basis with drugs being added or removed from the list. It is unclear whether the list will be cumulative or whether each quarter the old list will be replaced with a new list of approximately 20 drugs.

Current drugs on the list include: antidepressant Cymbalta and painkiller Oxycontin.

The Food and Drug Administration (FDA) is obligated to monitor our nation’s food supply for safety as well as evaluate and approve for sale in the United States prescription drugs and medical devices. However, recent reports of large scale outbreaks of food poisoning, dangerous drugs causing death and injury as well as tampering with chemicals imported from China that were used in the drug manufacturing process have called into question the FDA's ability to protect consumers.

The New England Journal of Medicine recently published an article that questioned whether the FDA can adequately monitor and evaluate the prescription drugs being approved. Also, members of the House of Representatives jointly sent a letter on February 4, 2008 to an officer of the Eli Lilly Company stating that the decrease in Funding for the FDA over the past 35 years has forced a 78% reduction in food inspections and that their scientific core has been eroded to the point that they can no longer fulfill its core regulatory functions.

During the current election year cycle and while listening to the debates it is important to remember that the Federal Government has many important fundamental functions one of which is to keep its citizens safe. The FDA is currently unable to perform its functions and is therefore placing everyone at risk of death or injury from dangerous food, drugs and medical devices.

The FDA's lack of funding is made even more dangerous by a Supreme Court that has routinely denied people the right to sue for dangerous drugs or medical devices. Currently there is a theory called preemption that is gaining acceptance by the Supreme Court. Under preemption if the FDA approves a drug or medical device you probably could not sue for damages, even if the drug or device clearly caused the injury.

The reasoning used by the pro-business court is that we cannot let 12 untrained citizens second guess scientist at the FDA. That sounds reasonable until you learn how the under funded FDA operates. The FDA often takes the information and studies provided by the drug or device manufacturer and reviews it with an under funded staff. They do not do their own studies and have to rely on the honesty and integrity of the companies that profit only if their drug or device is approved.

Needless to say if the threat of a lawsuit is taken away by preemption there will be more dangerous drugs and devices in the marketplace.