Drug injury in the United States as a result of the side-effects of drugs prescribed by doctors is widespread. Prescription drugs must be approved by the FDA before sold to the U. S. public. Medical doctors, however, are authorized to prescribe these drugs for what is called off-label use for purposes not intended or approved by the FDA.
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Drug injury litigation is taken seriously by the pharmaceutical companies and is hard fought by them and by the physicians who are on their payroll. Many doctors prescribe medication based on their allegiance with the drug industry and not necessarily based on patient need.
For example, one drug may have been approved for one use by the FDA, but doctors, based on anecdotal evidence, are allowed to prescribe the drug for other purposes. This can be dangerous. Before taking a particular medication, it is important to read the allowed use and if the prescribed use does not match this then ask your physician why it is being prescribed.
Claims against the manufacturer for damage resulting from uses that are not disclosed as part of the package insert are problematic because the manufacturer may be immune from suit in certain instances provided it complied with the FDA required disclosures. Although the use may be off label some manufacturers in fact encourage physicians to prescribe for such usage in order to increase sales. This goes back to the sometimes all too cozy relationship that exists between physicians and the drug company representatives that are selling the drugs.
To appreciate the nature of drug injuries it is necessary to have some basic understanding of pharmacology. The field of pharmacology is divided into pharmacokinetics and pharmacodynamics. Pharmacokinetics deals with how the human body allows a drug to pass through it. Pharmacodynamics deals with the drug’s actual effect on the human body.
Pharmacokinetics addresses issues of how the body absorbs the drug; how the drug is distributed through the body after it reaches the first organ and how and whether it attaches to a protein; how enzymes within the body metabolize a drug or how it may metabolize more than one drug if there is more than one in the system; how the kidneys eliminate the drugs or, in some instances, retain them to the body’s detriment.
In terms of pharmacodynamics, typically drugs attach to a receptor or enzyme where a series of biochemical reactions begin. Because a cell only contains a limited number of receptors to which a drug can bind, it is important to know the availability of these receptors in order to determine the overall efficiency of the drug. The drug needs to be able to attach to the appropriate receptor and to serve as the key that unlocks the receptor in order for the drug to then do its work.
The drug, in opening up that lock (receptor), may have a beneficial effect or in some cases a harmful effect. For instance, the drug known as Rogaine was designed to treat high blood pressure. It was observed that it had the side effect of producing hair growth. Today Rogaine is marketed as a hair growth drug and not as a hypertensive drug.
Drug manufacturers prepare what are called package inserts that go with their products that they distribute. The information in this package insert is also contained in the Physicians’ Desk Reference (PDR). Only FDA approved uses are listed as being “indications” within the package insert or the PDR. The FDA takes the position that although it licenses drugs and devices it does not practice medicine. As a result, the FDA defers to doctors in terms of usage of drugs and devices. This off-label usage can of course be a financial bonanza to manufacturers. The FDA asserts that manufacturers cannot promote off label usage.
If off-label usage has resulted in injury to a client, then the claim against the physician may be a straight medical malpractice claim based upon the usage of the product or based upon a failure to obtained informed consent from the patient. That is, the disclosure of the intended use of this product by the manufacturer and the fact that it is now being used for a purpose not approved by the FDA may be information that is relevant to the patient. How strong that malpractice claim is may be a function of how far the doctor has strayed from the FDA approved usage. If the off-label use simply consists of a higher dosage that may not be significant. If on the other hand the medication has been prescribed for a condition not listed, that may be strong evidence of negligence on the part of the physician. If the resulting injury to the patient is a side effect that was warned about by the manufacturer but not disclosed by the doctor, then that may constitute a strong informed consent claim and the mere listing of this side effect by the manufacturer may establish causation.
Tainted steroids from a compounding pharmacy in Massachusetts have infected potentially hundreds of pain medicine patients. The particular drug that was contaminated is methyl-prednisolone acetate. This is an injectable pain medication that is injected into the spinal canal. This particular medication became contaminated with a fungus that is the cause of a very rare form of meningitis. The meningitis, in this case, is somewhat deceptive because the symptoms tend to be slow in coming on. The early symptoms might be easily confused with simply a headache or the flu and include such things as sensitivity to light, stiff neck, weakness or numbness and slurred speech. The fungus, however, can cause a very rare form of brain infection that requires months of antibiotic care in order to cure.
The pharmacy that prepared the compound was what is called a compounding pharmacy located in Framingham, Massachusetts. Compounding pharmacies typically are ones that custom make medicines for individual patients. In this particular case, the compounding pharmacy was shipping large doses of this medication to several locations.
Of 56,000 community pharmacies across the country 7,500 are considered to be compounding pharmacies. In this particular instance, the large volume of doses that were being prepared by this pharmacy raised significant questions as to whether or not it is really a pharmacy or a manufacturer. The pharmacies themselves are regulated by the State although the U.S. Food and Drug Administration claims oversight of drug compounding activities.
Drug injury from compounding pharmacies such as NECC of Framingham, Massachusetts are alarming. The fungus that contaminated the pain medication has caused several incidents of meningitis resulting in several deaths. The fungus causing the disease is very slow to grow and very difficult to identify. The particular medication that the fungus was in is a very high potency long acting steroid that was used to relieve inflammation and also relieve pain in people with herniated discs and also people with certain types of arthritis.
The U. S. Food and Drug Administration had been somewhat uncertain as to its ability to regulate compounding pharmacies since most compounding pharmacies are Mom and Pop operations that simply prepare specialized drugs for individual patients. This particular compounding pharmacy had gone far beyond that and was preparing large batches of medication for particular distributors.
The Food and Drug Administration has been on notice for many years of potential problems with compounding pharmacies. As the Washington Post reported on October 12, 2012 a 2006, a survey from the FDA found that almost one-third of compounded drugs had problems with them including contamination and incorrect strengths. Compounding pharmacies have also been engaging in copying commercially available drugs and therefore essentially acting as manufacturers. Compounding pharmacies are not authorized to act in that fashion as the whole idea of the regulatory scheme was to allow the compounding pharmacies to act simply as Mom and Pop operations and thereby avoid some of the formality associated with larger productions.
Following the money is an interesting concept especially in regard to the relationship between the pharmaceuticals and doctors. What it means is that you try to track where the money comes from or where it goes to in order to see who and what is being influenced.
In the field of medicine there is a great deal of money that flows between the pharmaceutical industry and doctors. What the pharmaceutical companies do is they offer physicians financial enticements to prescribe their drugs, ask physicians to participate in a speaker’s bureau that the pharmaceutical company sponsors and also to sign off on articles that are written by someone else, i.e. ghostwritten articles.
Dr. Jerome Kassirer, in a June 2012 article in Trial Magazine, reported on this. In his 2004 book entitled On the Take: How Medicine’s Complicity With Big Business Can Endanger Your Health (Oxford University Press 2004), is a commentary on this subject.
One thing in particular that concerned Dr. Kassirer is this issue of ghostwriting. He indicated that it exists not only in regards to journal articles that may be ghostwritten by the industry and signed off on by a respected physician but also indicated that it may be prevalent in regards to clinical trials. A clinical trial is where a particular medicine is being tested by a group of physicians to determine what effects it may have. The ghostwriting of these clinical trials is ominous because it then calls into question the validity of the results that are being reported.
Dr. Kassirer also reported that there is a very cozy relationship between the pharmaceutical industry and medical device making industry and the medical profession in terms of continuing medical education. The industry supplies a great deal of funding for these professional meetings in particular involving the American Heart Association, the American Gastroenterological Association and the American Society of Nephrology.
Within the recent health care law passed by the Obama administration there is a Sunshine Provision that is to go into effect in 2013 that requires pharmaceutical companies to report any physician who is making more than a small amount of money from them and to publish this information on a website that is available to the public. This does force disclosure but frequently these websites have a way of becoming difficult to identify.
In 2007 surveys that were done among doctors who belonged to the American Medical Association, it was reported that a large fraction of them had taken something from industry, 16% were receiving personal money for services on speaker’s bureaus and 18% were receiving personal money for consulting with the industry.
The overall accuracy of this survey is difficult to verify.
Although it goes without saying that the vast majority of physicians are beyond reproach when it comes to conflicts of interest involving the care of their patients, it needs to be said that there is a certain percentage of the medical community that may indeed be influenced as to health care decisions by direct or indirect payments they are receiving from the industry. For instance, a physician who attends a continuing medical education conference in Hawaii that is paid for by a particular pharmaceutical company may well be favorably inclined to prescribe that companies’ medication in the future. The decision making process may not even be a conscious one in that regard.
Physician speaking fees paid by Merck Pharmaceutical during the year 2010 totalled $20.4 million. During the year 2010 more than 2,000 U. S. doctors and health care professionals were paid that sum of money to discuss and, in effect, promote Merck’s various products and also to discuss other health care topics with professionals.To the extent that medical malpractice cases deal with pharmaceutical or medical device issues it may be worthwhile for medical malpractice attorneys to explore this relationship.
Merck had previously disclosed that for the second half of 2009 they had paid $9.4 million to approximately 1,700 different health care professionals to promote their products and to discuss health care topics. Other pharmaceutical companies may well be in the same ballpark in terms of the amount of money that they distribute to health care professionals to, in effect, promote their products.
These numbers are of interest since it shows the potential bias that many healthcare professionals may have towards certain pharmaceutical companies in terms of issuing prescriptions and also making professional decisions such as what medication to prescribe or in the case of medical device decisions, what medical device to use. All of that could be significant in terms of showing bias.
This raises the question of course of what does the patient do. Some issues that the well-informed consumer may want to research or perhaps even ask of the physician are the following:
Medication errors are on the rise according to the Agency for Healthcare Research and Quality,the lead federal agency charged with improving quality,safety and efficiency of health care for all Americans. This agency reports that in 2008 1.9 million people became ill or were injured from side effects of medication or because they were given the wrong type or dose or they simply took the wrong type or dose of medication. The report from the agency does not distinguish between errors made at the prescription level versus the dispensing level or errors made by the consumer in terms of taking the wrong or too much medication. The substances most often found at the center of the presumed error were steroids, pain relievers, blood thinners and heart and blood pressure medications.
Many of these errors could be avoided simply through better communication between the health care professional and the consumer and the more ready availability of information as to prescriptions so that consumers could check prescriptions on-line.
On September 10th,2013 the Food and Drug Administration (FDA) announced that it was requiring increased warnings on labels relating to certain injury pain killers. The focus is on OxyContin and oxycodone. The new requirements are going to apply to other narcotic painkillers known as opioids. The enhanced warnings are considered to be necessary because of the increased addiction, misuse and thousands of deaths that occur each year.
In 2010 the Center for Disease Control (CDC) reported that over 16,000 people died from overdoses involving opioids. That same year the CDC reports that enough opioid pain relievers were sold to medicate every adult in the United States with 5 milligrams of hydrocodone every four hours for a month.
The increased labeling will apply to all extended-release and long-acting opioid painkillers. Historically these were only prescribed for patients with what is called “acute pain”, i.e., short term. Over the past decade the use of painkillers has skyrocketed and now their use is common for everything from back pain to arthritis.
A study reported in The Washington Post article of September 11, 2013 reports that about 2 million Americans are addicted to or abusing prescription painkillers. Those are numbers that far exceed those who are addicted to cocaine or heroin.
The new warnings will require that manufacturers alert patients and providers that these opioids should be used only by patients for whom other treatment is not sufficient.
In addition the FDA will require that drug companies conduct more studies and clinical trials to further determine the risks of these painkillers. The FDA will also require new warnings relating to use of this medication by pregnant women in that chronic use can cause withdrawal symptoms in a newborn.
Vaccine maker’s immunity was reaffirmed in February 2011 in the case of Bruesewitz v. Wyeth where the Supreme Court of the United States dealt with the issue of whether federal law protects pharmaceutical companies from product liability lawsuits by parents who claim that vaccines have harmed their children. The Supreme Court sided with the pharmaceutical companies in a decision issued on February 22, 2011. The Court stated that Congress found that such a system of immunity was necessary to insure that vaccines remain readily available. The National Childhood Vaccine Injury Act of 1986, according to the Court, leaves complex judgments about vaccine design to the Food and Drug Administration and to the National Vaccine Program rather than to juries.
To some extent this decision is consistent with the Supreme Court’s ongoing tendency to find preemption, i.e. that federal laws and regulations in many instances displace state and actions and lawsuits.
In this particular case, Hannah Bruesewitz began to have seizures as an infant after receiving the DPT vaccine manufactured by Wyeth. The vaccine court ruled against Hannah. That tribunal ruled that she had not proved that the vaccine harmed her.
The Supreme Court ruled that no vaccine maker could be held liable for death or injuries arising from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
Failure to warn claims involving generic drugs took a significant hit on June 23, 2011 with the decision of Pliva, Inc. v. Mensing from the U.S. Supreme Court. In that decision, the Court diluted the Wyeth decision by concluding that manufacturers of generic drugs cannot be sued for failure to warn because such claims are preempted by federal law. In Wyeth the Court held that drug manufacturers could be sued for failure to warn in state court on the theory that the FDA approval process does not preclude drug companies from providing better warnings than what are required.
In particular under the Hatch-Waxman statute, the Court said that warning labels for generic drugs must be the same as those for brand name drugs approved by the FDA, and therefore failure to warn claims against manufacturers of generic drugs are preempted by federal law.
The decision affecting drug injury law is especially troubling in light of the fact that 75% of all prescriptions are filled with generic drugs.
The decision likewise creates an inconsistency between the generic drugs and brand name drugs in that now different standards apply to the two. The decision creates the incentive for manufacturers to push more generic drugs than brand name drugs and thereby potentially decrease their liability.
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If you have been injured as a result of the improper prescription of a drug you need a drug injury lawyer on your side. Brien Roche, a Fairfax, Virginia and Washington D.C. area attorney, has more than 40 years experience in personal injury and medical malpractice law and has garnered substantial compensation for his clients.
Contact Brien Roche today for a free consultation regarding your drug injury claim in Northern Virginia, Maryland, and Washington, DC.