Parker Waichman LLP Injury Alerts
The Wrongful Use of Federal Preemption and FDA Rules to Protect the Rich and Powerful Instead of the PublicJan 1, 2008
The Wrongful Use of Federal "Preemption" and FDA Rules to Protect the Rich and Powerful Instead of the Public
In the "Bizarro World," a fictional planet created as part of Superman Comics, everything is the opposite of what it is in on Earth. Even the name of the planet, Htrae, is Earth spelled backwards. Thus, in that illogical world of opposites, good is evil, right is wrong, and the truth is a lie.
If this irrational perversion of our world was limited to comic books, it might make for interesting fiction reading. Unfortunately, the Bizarro World is alive and well in Washington, D.C., where your government has determined that the wealthiest and most powerful corporations are entitled to be protected from the people they injure or kill as long as a dysfunctional, impotent, and incompetent federal agency, which has catered to special interests and influence peddling for years, has put its stamp of approval on a product that maims or kills the very people it was supposed to help.
Just so that there is no mistake, the President (Executive Branch), Congress (Legislative Branch), and Judiciary (Judicial Branch), are supposed to protect the people of this country. For over two centuries, laws were passed (and enforced) that controlled corporate greed and dishonesty, and provided citizens with the means and ability to recover for injuries caused by dangerous products.
Then, almost imperceptibly at first, this intricately woven net of protection afforded our citizens began to unravel. This was not because of any breakdown in the system, however. It was because those who were supposed to be enforcing the rules and protecting the average person from all types of evils simply sold out to the other side; nothing more, nothing less.
The shift in protection from the weak to the powerful, the poor to the rich, and the voters to the special interests, has spread across a wide range of subjects from the environment to outsourcing industries and jobs to immigration policy. One area, however, wherein the shift in protection has been most dramatic and one-sided in favor of special interests representing the wealthy and powerful has been with respect to the medical and pharmaceutical industries.
At first it was permitting pharmaceutical companies to spend hundreds of millions of dollars on Direct-to-Consumer advertising, which has resulted in nothing more than the triumph of marketing over science.
Whether it was the Young Rascals singing "It's a Beautiful Morning" while Dorothy Hammil hawked Vioxx, or the most recent absurdity, six middle-aged men with erectile dysfunction singing "Viva Viagra" to the music of Elvis Presley's "Viva Las Vegas," the public was, and still is, being force-fed drugs that are dangerous, inadequately tested, and far more expensive than older and safer alternatives (2/1/2005).
Next came the assault on what has been labeled the medical malpractice litigation crisis. This so-called "crisis" has been shown, time and time again, to have been nothing more than a "Big Lie" created by powerful special interest groups and the politicians they control. (See Injury Alerts for 9/1/2004 and 4/1/2003).
Now, however, we are witnessing the ultimate example of governmental regulation gone haywire. The area of individual and societal protection being eroded is personal injury and wrongful death litigation involving dangerous medical devices and pharmaceutical products.
In order to understand the severity of the problem, two factors must be understood. The first is what is known as "preemption." The second is the severely compromised effectiveness and reliability of the Food and Drug Administration (FDA), an agency that was created to protect the public but which no longer seems able or even inclined to do that. (See Injury Alert for 1/1/2005).
The concept of preemption itself is a simple one and necessary to prevent any number of situations that would infringe on the power of the federal government or impede the orderly enforcement of regulations on a nation-wide basis. A simple definition would be "the judicial principle asserting the supremacy of federal over state legislation on the same subject." Thus, when there is a conflict between federal law and state law, the federal law is said to preempt state law thereby displacing the effect of the state law.
For example, the individual states are "preempted" from imposing their own individual speed limits on interstate highways under federal control. Likewise the states cannot pass laws regulating immigration, air travel, or set a minimum wage that is lower than the one passed by Congress.
The doctrine of Federal preemption can be found in the so-called "Supremacy Clause" of the United States Constitution. Its origin is attributable to the Framers who envisioned potential conflicts between the two separate and distinct yet competing bodies of government. The Supremacy Clause (U.S. Const. Art. VI, Cl. 2) mandates that federal law will supersede any state law that interferes with or runs contrary to that federal law:
"This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Law of any State to the Contrary notwithstanding."
The two main categories of federal preemption are express and implied. "Express preemption" occurs when Congress makes its intent known through explicit statutory language to preempt an area of state law. Congress can define explicitly the extent to which its enactments pre-empt state law.
If explicit statutory language is absent, one of two types of "implied" preemption may exist. "Field preemption" occurs when federal law exclusively regulates or occupies an area such that Congress left no room for state regulation in that area. "Conflict preemption" occurs when state law is in actual conflict with federal law.
Courts have found conflict preemption where it is impossible for a private party to comply with both state and federal requirements, or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.
On February 20, the United States Supreme Court injected the idea of preemption into the field of medical device litigation in a way that defies logic and puts the public at the mercy of manufacturers.
The ruling confers immunity, from liability for injuries or deaths, on medical device manufacturers once their products are approved by the FDA. Thus, even if experts conclude a medical device was defectively designed, the mere fact that the FDA approved it will be enough to shield the manufacturer from any liability under state law.
This is the same FDA that has proven itself to be completely unable to protect consumers from a steadily growing number of dangerous drugs that have been pulled from the market after they were approved by the FDA.
If the FDA cannot get it right with respect to the drugs it is approving, why should the public believe the FDA stamp of approval on a medical device is the "gold standard" by which such products should be measured.
Thus, it is especially disturbing that the Supreme Court ruled that patients injured (or even killed) by defective medical devices cannot sue for damages in state courts if the device was approved for marketing by the FDA and made to the agency's specifications.
In short, that means that consumers harmed or killed by a defectively designed device such as an implanted defibrillator, heart pump or artificial hip, will have no chance of obtaining compensation unless the device is manufactured improperly or not made to the specifications approved by the FDA.
Such a ruling will simply encourage manufacturers to step up their relentless lobbying efforts to push new device applications through an agency already besieged with claims of favoritism and suffering from a dubious reputation for pervasive untrustworthiness.
This decision is particularly unsettling at a time when the current administration has been attempting to weaken federal regulations (in many areas of consumer and environmental protection), and regulatory agencies (specifically charged with protecting the public), while also seeking to preempt the power of individual states to impose stricter safety standards to protect consumers in those very areas.
The Supreme Court ruling came in a case where a New Yorker was injured when a balloon catheter made by Medtronic burst while being inserted to dilate a coronary artery.
The decision turned on whether the Medical Device Amendments of 1976, which gave the FDA primary responsibility for regulating medical devices, pre-empted the right of injured patients to sue for damages in state courts. In an 8-1 decision, the Supreme Court has concluded that it does.
The majority opinion by Justice Antonin Scalia, relied heavily on the presumption that intricate medical devices are subjected to a thorough assessment process in which FDA "experts" balance potential risks against the claimed benefits to consumers in general, while a jury looks only at the damage allegedly done to an individual patient and is not concerned with potential benefits to other patients.
Of course, Justice Scalia and the other seven Justices concurring in this result have chosen to put absolute faith in an approval process that has proven to be undependable time and time with such failures as Rezulin, Baycol, Vioxx, Bextra, Fen-Phen, and Trasylol.
The "expert" and "rigorous" FDA reviewers are anything but infallible. They repeatedly approve medical devices and prescription drugs based on incomplete data, flawed testing, questionable test results, and without long-term (longitudinal) test results or despite manufacturers' failure to live up to post-approval testing requirements. In addition, the FDA has a miserable track record when it comes to pulling dangerous products off the market immediately once they found to be dangerous.
In the past several years, numerous trustworthy sources such as the Institute of Medicine of the National Academy of Sciences, the Government Accountability Office (GAO), the FDA's own science board as well as highly respected "whistleblowers" within the agency itself have detailed serious flaws in the agency's management, approval process, scientific capabilities, information technologies, policing conflicts of interest (especially on drug-approval panels), as well as personnel shortages, poorly funded post-approval monitoring and testing of drugs with respect to adverse reactions all of which weaken its ability to protect the public.
It stands to reason that permitting injured consumers to sue would serve as an additional measure of protection for the public since it would: (1) encourage companies to market only products that have been fully tested; (2) ensure the prompt removal of dangerous products from the market once dangers in them have been brought to light; (3) provide a level of oversight sorely lacking at the FDA.
Clearly, there would be no feeding frenzy of litigation since judges would have the ultimate say concerning which cases would proceed and which would be dismissed. Moreover, it would still be the injured party's obligation to prove his or her case before a manufacturer could be found liable. This seems far more just and fair than having severely injured people turned away by the courts simply because some agency approved a product that may or may not be safe.
When the original law passed in 1976, there could not have been any intention of terminating an injured person's right to sue. Had that been Congress' intent, this ruling would have come years ago. Both Senator Edward Kennedy, the Senate sponsor of the law, and Representative Henry Waxman, who sat on the House panel that approved it, have both stated that Congress had no intention of granting immunity to medical device manufacturers for injuries and deaths caused by their products.
The use (or misuse) of the "preemption card" to prohibit most state-approved litigation against medical device manufacturers has brought this country to a perilous point where protecting the multi-billon dollar pharmaceutical industry from all accountability for the injuries and death caused by its products is simply the next step waiting to be taken by a markedly conservative Supreme Court.
The logic that will be used is quite simple, really. All that must happen is that the Court adopt the position that an approval by the FDA is the "gold standard" by which the safety and effectiveness of prescription and over-the-counter (OTC) is to be measured.
Of course, this may once have
been a credible assumption when the FDA was not: (1) overwhelmed by new drug applications; (2) significantly understaffed; (3) greatly under funded with respect to post-approval testing and investigation of adverse reactions; (4) the subject of serious accusations of ineffectiveness; and (5) aligned too closely with the pharmaceutical companies and their paid "expert" and lobbyists.
Between 1997 and the beginning of 2008, alone, at least 24 drugs have been withdrawn from the market. These include:
" Lapdap - 2008
" Zelnorm - 2007
" Permax (pergolide) - 2007
" Trasylol - 2007
" Palladone - 2005
" Cylert (Pemoline) - 2005
" Bextra (valdecoxib) - 2005
" Tysabri (natalizumab) - 2005
" Vioxx (rofecoxib) - 2004
" Duragesic Patch (fentanyl transdermal patch) - 2004
" Ephedra - 2004
" Baycol (cerivastatin) - 2001
" Raplon (rapacuronium bromide) - 2001
" Rezulin (troglitazone) - 2000
" Propulsid (cisapride) - 2000
" Lotronex (alosetron) - 2000
" Hismanal (astemizole) - 1999
" Raxar (grepafloxacin) - 1999
" Posicor (mibefradil) - 1998
" Duract (bromfenac) - 1998
" Seldane (terfenadine) - 1997
" The Diet "Cocktail": Fen-Phen (fenfluramine); Pondimim; and Redux (dexfenfluramine) - 1997
In addition to the numerous recalls, dozens of other drugs have escaped being pulled from the market only because the FDA has required the inclusion of Black-Box (the strongest and most serious) Warnings when the drugs are dispensed.
These warnings are regarded by many independent experts as little more than "giving in" to multi-billion dollar pharmaceutical companies so that they can keep reaping immense profits from harmful drugs.
The average consumer is neither inclined to read nor sophisticated enough to comprehend the massive amount of material incorporated in the information accompanying any prescription or OTC drug. Thus, simply tacking on a Black-Box Warning as if it will somehow protect the public from the danger or dangers contained in the warning is nothing short of preposterous and the FDA as well as the drug manufacturers know this.
Many Black-Box Warnings are so serious they would normally be more than sufficient to cause a drug to be recalled. Serious risks such as fatal reactions or interactions, heart attacks, suicide, neurological problems, respiratory problems, and other serious or even life-threatening reactions or side-effects are now regularly disregarded as reasons to recall a drug. Instead, the FDA is routinely permitting dangerous drugs to remain on the market longer and longer or until not even an ominous Black-Box Warning can justify their further use by the public.
There is also the sad reality that in the majority of cases, once a drug is approved and placed on the market, the company manufacturing the drug fails to complete its post-approval testing and reporting to the FDA with little fear of any penalty from the agency. Certainly, no drug, to our knowledge, has been ordered off the market by the FDA because of non-compliance with post-approval reporting and testing requirements.
Finally, one must consider the unnerving fact that as the FDA's "fast tract" approval process has progressed, drugs that make it to market are actually getting more, and not less, hazardous. That is because of the relative absence of longitudinal (long-term) clinical testing.
While the goal of the fast-track approval process has been described as a method to bring life-saving drugs to market quicker, this has not been the case at all. In fact, when it comes to approving new drugs, most independent experts, consumer advocates, and public watchdog organizations agree that the only thing fast-tracking drug approvals does is to ensure that more and more dangerous drugs make it to market.
The reason for this is simple. Unlike other more conventional products which can be marketed once they pass a certain number of tests or which can prove their safety after purely quantitative testing, drugs require far different testing procedures in order to prove their safety.
For example, a new tire can be tested mechanically millions of times over a relatively short period of time. It can be driven on test tracks under all types of conditions 24 hours a day for weeks or months. It can be pushed far beyond the limits it will experience in everyday use. Design flaws can be corrected before it is put on the market. Most products also wear out long before they fail for other reasons.
The biggest difference, however, is that a tire can be sold indiscriminately to anyone regardless of their age, weight, race, medical history, or genetic profile. A person with diabetes, high blood pressure, and elevated cholesterol can buy and use a newly marketed tire in the same way a world-class athlete can without regard to his physical condition.
Drugs, on the other hand, depend on an enormous number of variables when determining their safety. The following list is only some indication of the considerations that must be accounted for in the drug approval process:
" Interaction with other prescription medications
" Interactions with OTC medications
" Interaction with normal foods and drinks
" Interactions with alcohol and tobacco products
" Interactions with environmental variable like sunlight
" Adverse or side-effects observed during clinical testing
" Adverse reactions precipitated by various medical or even psychiatric problems or conditions
" Adverse effects linked to ethnic or genetic background
" Adverse effects linked to dosage amount or frequency
" Effects the drug might have on the efficacy of other drugs
" Does the drug actually do what it has been designed to do?
" Are children affected by the drug differently than adults?
" Is the drug stable or does it lose its effectiveness too quickly?
" Does the drug need to be refrigerated?
" How will the patient take the drug (injection, etc.)?
" Do the benefits of the drug outweigh its risks?
" What are the long-term effects of the drug?
Obviously, many of these factors cannot be determined with exactness regardless of how much testing is done and some of them will actually need years (if not decades) to determine, since time is the critical element involved. Since time cannot be accelerated for purposes of longitudinal studies, no drug is ever approved that can offer any assurance that it will safe when used over a protracted length of time.
In fact, the consumer watchdog organization, Public Citizen, advocates a seven-year rule, which advises consumers to avoid any new drug until it has been on the market, without serious problems, for a minimum of seven years.
Thus, neither the fast-track approval process nor even the normal approval process provides anything more than the illusion of safety. There is simply no way the FDA can vouch for the safety of any drug in terms of its long-term safety.
This is made all the more obvious by the fact that all the prescription drugs pulled from the market in the past 10 years failed to last seven years. Some of the drugs lasted only a few months.
Based on these facts, it is clear that regarding an FDA approval as the "gold standard" is not proper at all. Moreover, using that unimpressive approval to shield drug makers from liability for the deaths and injuries caused by their drugs is preposterous, illogical, and unscientific.
To use the Supremacy Clause of the Constitution to make all of this appear to be a legitimate use of preemption to deprive those injured (or the estates of those killed) by a dangerous drug of any right to damages would be a sad day indeed for our system of justice.
David Vladeck, a professor at Georgetown University Law Center, regards what has already occurred as leaving members of the public facing the worst of both worlds: an FDA that cannot protect them and rules that block them from winning compensation when injured.
Notwithstanding all of the evidence to the contrary, the agency maintains it is improving in terms of dealing with its deficiencies and improving, and those speaking for the Bush administration claim that despite recent reports, the FDA remains a far better judge of product safety than the courts.
This logic represents a major shift in position for the FDA since 2001, when President Bush took office. During the Clinton administration, FDA officials maintained that courts provided patients additional protection. In fact, in a 1997 brief, the FDA's chief counsel wrote that "even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems."
Now, however, Daniel Troy, a former FDA general counsel, who advocated the new policy, claims that: "Anyone who is in favor of a strong FDA cannot also be in favor of unlearned, unscientific state juries second-guessing FDA's science-based decisions."
Of course, such a simplistic statement disregards the fact that juries are always aided by highly qualified experts who testify on behalf of the plaintiffs as well as the device manufacturer or drug company. It also disregards the role of the trial judge to dismiss baseless cases or set aside unsupported verdicts.
Thus, the current administration's claim that the courts interfere with rather than reinforce FDA oversight has led it to adopt a position that seeks to protect drug and device makers from lawsuits. This includes filing briefs on behalf of the FDA in the Supreme Court and other courts and changing federal rules to limit liability on the part of device manufacturers and drug makers.
As a result of the recent decision, the Bush administration has handed medical device makers a stunning but far from deserved victory. Additional cases (one argued and one yet to be heard) will determine the applicability of preemption to shield the multi-billion dollar pharmaceutical industry as well.
In strategically placing conservative judges in the federal system over the past 30 years, the Regan, Bush, Sr., and Bush, Jr., administrations have successfully eroded individual rights that had remained inviolate for over 200 years. The rich and powerful, be they individuals or corporations, now enjoy the ability to pollute the environment at an alarming rate, engage in price gouging of unprecedented proportions, and even hide behind the Supremacy Clause of the Constitution in order to make billions of dollars in profits without fear of legal action when their products injure or kill thousands of innocent victims. The administration has also weakened highway and consumer safety regulations.
In his majority opinion, the unabashedly conservative Justice Antonin Scalia stated that the FDA's interpretation of its rules deserves "substantial deference." Since the Bush administration interprets those rules to provide the same blanket protection from liability to drug makers, this opinion seems to be telegraphing the Court's predisposition to extend similar immunity to pharmaceutical companies as well.
In its zeal to undermine the plaintiffs' trial Bar by attacking jury damage awards in any way possible, this administration has embarked on a policy of pushing through numerous rules and regulations designed to significantly limit or otherwise restrict state control in areas where Republican administrations typically defer to state oversight and refrain from over regulation.
In an upcoming case to be argued I October, a professional guitarist suffered a serious migraine and went to a health clinic for a shot of Phenergan. The drug was improperly injected into her artery where it caused an arterial spasm, gangrene, and the ultimate amputation of the plaintiff's hand and forearm.
The plaintiff sued the manufacturer, Wyeth, claiming the drug's label should have contained a strong warning of this known risk. The jury returned a verdict of $6.8 million. On appeal, Wyeth has argued that the FDA did not require such a strong warning and only approved a label that stated a preference for a less risky method of administration.
The question to be determined is who controlled the drug's label, the lengthy listing of the drug's uses, dosages and risks. Traditionally, FDA rules had allowed manufacturers to change labels without federal approval. This was primarily because the companies knew their products better than the FDA and were also more likely to learn of adverse events or other problems before the agency. In fact, the original labels on any drug, as approved by the FDA, were regarded as a starting point that set minimum safety standards that the companies were then free to enhance as necessary.
In January 2008, however, the FDA issued a proposed rule to limit when companies can list new warnings without federal approval in order to improve and strengthens the agency's control of the label.
The brief submitted by the administration now argues that the label, as approved, represents the minimum and maximum in terms of the warnings permitted. The logic in this being that if you clutter a label, people will not understand it in the right way and there is a risk of overreaction and ignoring it.
Of course, such a statement undermines the logic behind the agency's ordering of a Black-Box Warning. If cluttering the label with too much information only leads to confusion, misunderstanding, and ignoring of the label, why does the FDA believe the consumer will read or understand a serious warning that is simply added to the massive amount of information already included on any drug label?
Obviously, in the case of a Black-Box Warning, a double standard exists since it is only being added to permit the manufacturer to continue marketing a drug that should really be pulled from the market.
When it comes to an unstated warning, however, it is the administrations position that this is a deliberate decision by the FDA to protect against undue alarm, and, as a result, companies cannot be held liable for such nonwarnings. It is behind this convenient argument that Wyeth is attempting to hide claiming it is being punished for failing to issue a warning that the FDA implicitly rejected.
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said that the FDA oversees drug safety and labeling because its "expert staff is the most qualified to make such highly scientific and technical judgments."
Such a claim, however, is hardly supported by the evidence of the FDA's repeated failures in the areas of drug approvals and warnings. Trusting the FDA as the "gold standard" for warnings too is simply one more way in which to strip consumers of their rights.
Andy Vickery, a plaintiffs' lawyer in Houston, said that without the threat of litigation, companies would be less careful and patients would suffer. "Many of the problems with drugs have been found out only because of vigorous litigation."
While Phenergan's label now includes a lengthy warning about the dangers of intravenous injections, it is doubtful such a warning would have been brought about by a single adverse event. What about the fact that the warning is now there? Doesn't that demonstrate that it should have been there in the first place?
Moreover, if a drug is pulled from the market after less than a year, should it have been approved at all? The answer is obvious.
Why should the manufacturers of recalled drugs like the 24 listed above receive immunity when the FDA approved what it later admits was a dangerous drug that should not be on the market?
Why should manufacturers that disregard post-approval reporting and testing requirements be able to avoid liability for injuries and deaths caused by their drugs?
Why should a drug that was never approved on the basis of longitudinal clinical tests be cloaked with protection it neither earned nor deserved simply because it was pushed through the "fast-track" approval process?
If all of this bothers you and you now realize the degree to which your government has decided to embrace the logic found in the Bizarro World, please call or write your Congressional representatives and let them know it is time to stop protecting the rich and powerful at the expense of the average American citizen.
Of course, law suits may still be brought with respect to medical devices if they are not manufactured in accordance with the specifications approved by the FDA or if a particular device or category of devices is defectively manufactured.
The Supreme Court decision will probably also not protect a manufacturer in a case where a plaintiff is able to prove fraud or some other wrongdoing on the part of the manufacturer in obtaining the FDA's approval or in keeping it from being revoked. Similar exceptions would also have to apply with respect to drug cases if, and when, the Supreme Court confers immunity on the pharmaceutical industry.
As always, if you or a loved one has been injured by a defective product, including a medical device or medication, do not hesitate to contact us at www.yourlawyer.com for a free consultation with one of our experienced attorneys.