By: U. Kelley Riedel, Attorney at Law
PRODUCT LIABILITY LITIGATION – Some of the most prominent news stories this year again centered on recalls and problems associated with widely used pharmaceuticals, including prescription and over-the-counter medications. Given this publicity, Americans are now even more confused and frightened than ever when it comes to safety considerations surrounding the use of medications that are available in our country.
Are there in fact serious problems with medications currently available in our Country? If so, what is being done about it? And what effect will newly proposed tort reform legislation have on the safety of drugs available in the American marketplace?
The United States Food and Drug Administration (FDA) has some of the most stringent regulations in the world regarding pharmaceuticals and medical devices. However, although the FDA’s policies and procedures are rigorous, its role is mainly as a gatekeeper when it comes to certifying drugs for use. And while it oversees and enforces regulations under the powers given to the Agency by the Food, Drug and Cosmetic Act enacted by the U.S. Congress, the FDA does not guarantee the safety of the U.S. pharmaceuticals market.
How are problematic medicines identified and removed from the market?
Every year the FDA issues consumer safety alerts and product recalls on prescription and over-the-counter medications for various reasons, including contamination or potential for adverse side effects. In addition to the FDA’s directives, some manufacturers who become aware of problems or adverse reactions involving their products voluntarily issue consumer alerts or even recall their products. While there appears to be no noticeable increase in the number of consumer alerts or product recalls over the past few years, the problems associated with the recent voluntary recalls of drugs like Vioxx® and Bextra® have taught us that many of our approved drugs, while groundbreaking in terms of their ability to help people live better lives, are not as safe as originally thought.
Virtually every product on the market has side effects, both known and unknown at the time it is placed on the market. For the known risks, the manufacturer is required to inform the prescribing physician and the public of potential adverse symptoms and reactions. As for the unknown side effects, unfortunately by their very definition there is no way of predicting when and under what circumstances an adverse response to a pharmaceutical will present itself.
And to further compound the potential for adverse reactions to pharmaceuticals, several FDA employees recently testified before the United States Congress that the FDA is under-staffed and ill-equipped to properly oversee the development and marketing of pharmaceuticals by private manufacturers. The FDA employees also expressed concern that once a drug is on the market, the FDA has very few resources to follow up with complaints of problems associated with the drug or to disseminate that information to the healthcare industry and the general public. In fact, Dr. David Graham, Associate Director of Science for the Office of Drug Safety, went so far as to state: “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless. It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something that is far more dangerous to the safety of the American people.”
So what is the FDA doing to prevent unsafe drugs from reaching the marketplace?
Wisely, the FDA is seizing the opportunity presented by the public’s heightened concern regarding the safety of drugs available in the U.S. marketplace by requesting that the federal government bolster its drug oversight division. The FDA recently sent a $1.9 billion budget proposal for the Fiscal Year 2006 to expand, among other things, its drug safety and medical device review division. The FDA also unveiled its plan to establish a new, independent Drug Safety Oversight Board to oversee the management of drug safety issues, as well as provide emerging information to health care providers and patients about the risks and benefits of medicines currently available on the market. The FDA hopes that these new tools for disseminating information, including a new web page containing bulletins regarding drug risks, will enable patients and their healthcare professionals to make better-informed decisions about individual treatment options.
How have our lawmakers responded to the recent concerns regarding pharmaceutical regulation and safety?
Ironically, despite the FDA’s acknowledgment that the current drug enforcement system is badly in need of an overhaul, some lawmakers and political analysts are lobbying heavily to pass legislation giving pharmaceutical manufacturers immunity from civil liability for products which have been approved by the FDA. Their reasoning is that without the threat of civil liability for adverse reactions caused by their products, pharmaceutical manufacturers will be able to concentrate more of their time, effort and finances on developing more effective medicines. Interestingly enough, these pleas for civil immunity in the pharmaceutical arena are coming at a time when drug companies are seeing record profits. The 2005 Fortune 500 list is dominated by pharmaceutical manufacturers, including at least 5 companies in the top 40who have profits totaling well over $30 billion combined.
Is this really an industry which needs financial protection through tort reform?
In reality, the effect of removing civil liability for truly negligent acts of pharmaceutical manufacturers will only destabilize the accountability which our civil justice system provides. Though the research and development of newer and more effective medicines provides significant health benefits to Americans, giving pharmaceutical companies immunity from tortious conduct will take away the only effective means that private citizens have to hold manufacturers accountable when their products cause serious harm or even death. With the FDA openly professing its inability to properly regulate and police the pharmaceutical industry, it is left up to the general public to hold drug manufacturers responsible if they knowingly place or allow defective products to be sold on the open market.
What we are talking about here is not strict liability, but culpability. If a drug manufacturer can show that it did everything it could to make a safe product, and that it could not have reasonably known or predicted that a drug would have harmful side effects, of course a jury should heavily consider such evidence. However, given the admitted inadequacies of the FDA to properly police the pharmaceutical industry, the current situation is ripe for more harmful pharmaceutical products to reach the open market after receiving FDA approval. A drug manufacturer should not be given immunity from civil liability simply because it fills out all the proper FDA forms and passes all of the FDA-mandated tests. Such blanket immunity is particularly undeserved where there is evidence that a company could have done more to improve upon the safety of its products, or warn of the potential for adverse effects, yet failed to do so.
While we should applaud the FDA’s efforts to give Americans access to the safest and most innovative drugs in the world, we need to recognize that these efforts may not have a significant impact on the market for several years. Even then it would be foolish to discount the irreplaceable value that our civil justice system provides in holding companies accountable for their negligence in manufacturing, marketing and/or disseminating harmful products for public use. Manufacturers in the drug industry should have no better immunities bestowed upon them than any other companies who manufacture, market and/or disseminate products that prove harmful to the public.
What can you do to protect yourself?
Be aware that every drug you take, whether obtained over-the-counter or through a doctor’s prescription, has inherent risks. Talk to your doctor about all the medications you and your family take so that you can better understand these risks and make an informed decision regarding whether to continue their use. Read each label to familiarize yourself with the potential side effects of each particular drug, as well as other adverse reactions which may occur if the drug is taken in combination with other medications, alcohol or other substances. For more information regarding pharmaceutical consumer alerts and recalls, please visit www.fda.gov and www.cpsc.gov.
U. Kelley Riedel is a Partner with the firm Berman & Riedel, LLP, a personal injury firm with extensive experience in litigating catastrophic personal injury and wrongful death cases throughout the State of California, including matters arising from the use of dangerous or defective products of all kinds. If you or someone you know has suffered injury or death as a result of a dangerous or defective product, please feel free to contact an attorney at Berman & Riedel, LLP, to discuss the matter.
