Drug injury in the United States is widespread. Most drugs must be approved by the FDA before sold to the U. S. public. However, doctors are allowed to prescribe drugs for what is called off label use. That is, for purposes not intended or approved by the FDA.
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Drug injury lawsuits are hard fought by drug companies. In addition they are hard fought by the doctors who are on their payroll. Many doctors prescribe drugs based on being aligned with the drug maker. The prescribing is not always based on patient need.
For instance, a drug may have been approved for one use by the FDA, but doctors are allowed to prescribe the drug for other purposes. This can pose a danger. So before taking a drug you should read what is the allowed use. Furthermore if the prescribed use does not match this then ask your doctor why it is being prescribed.
Claims against the drug maker for damage from uses that are not disclosed as part of the package insert are a problem. The maker may be immune from suit in certain cases provided it complied with what the FDA requires to be disclosed. Although the use may be off label some makers allow such usage in order to increase sales. This goes back to the sometimes all too cozy fit that exists between doctors and the drug sales people that are selling the drugs. Call, or contact us for a free consult.
To grasp the nature of drug injuries you must have some basic facts about pharmacology. This field 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. In other words it deals with how the drug passes through the body after it reaches the first organ and how and whether it attaches to a protein. Within the body the drug is broken down. How it is broken down may be affected by the presence of other drugs. How the kidneys get rid of the drugs or, in some instances, retain them is an aspect of this field.
Pharmacodynamics deals with how drugs attach to a receptor or enzyme. Because a cell only contains a defined number of receptors to which a drug can bind you must know the number of these that are able to bind. The drug must attach to the right receptor. The drug serves as the key to unlock the receptor in order for the drug to then do its work.
When the drug opens that lock (receptor) it may have a good or 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 causing hair growth. So today Rogaine is sold as a hair growth drug and not as a drug for high blood pressure.
Drug makers prepare what are called package inserts that go with their products. The info 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 licenses drugs and devices. However 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 be a bonus to makers. Makers cannot promote off label usage. However they do some times turn a blind eye to this off label use. Call, or contact us for a free consult.
If off label usage has caused injury to a client, then the claim against the doctor may be a straight medical malpractice claim. It is based upon the usage of the product. In the alternative it may also be based upon a failure to obtain informed consent. That is, the fact that the intended use of this product varies from the actual use may be malpractice. The fact that it is being used for a purpose not approved by the FDA is info the patient has a right to know. The failure to provide that to the patient may be malpractice. How strong that claim is may be a function of how far the doctor has strayed from the FDA approved usage.
So if the off-label use simply consists of a higher dosage that may not be of import. In contrast if the drug has been prescribed for a problem not listed, that may be proof of fault on the part of the doctor. Where the injury to the patient is a side effect that was warned about by the manufacturer but not disclosed by the doctor, then that may be a strong informed consent claim. In contrast the mere listing of this side effect by the maker may establish causation.
Tainted steroids from a compounding pharmacy in Mass. infected hundreds of pain medicine patients. The tainted drug was methyl-prednisolone acetate. This is a pain drug injected into the spinal canal. It became tainted with a fungus that is the cause of a very rare form of meningitis. This illness was tricky because the symptoms tended to be slow in coming on. The early symptoms are easily confused with the flu. In addition the symptoms include being sensitive to light, stiff neck, weakness or numbness and slurred speech. However the fungus infects the brain and requires months of care in order to cure.
The outfit that prepared the compound was what is called a compounding pharmacy located in Framingham, Mass. These outfits are ones that custom make drugs for individual patients.
Of 56,000 community pharmacies across the country 7,500 are considered to be compounding pharmacies. In this instance, the large volume of doses that were being prepared raised questions as to whether it is really a pharmacy or a drug maker. The pharmacies themselves are controlled by the State although the FDA claims oversight of drug compounding.
Drug injury from these types of outfits is alarming. The fungus that tainted this drug caused a number of incidents of meningitis. Some resulted in death. The drug that the fungus was in is a very potent long acting steroid that was used to relieve inflammation and pain in people with ruptured discs. In addition it treats certain types of arthritis.
The FDA had been uncertain to whether it had the power to control these outfits since most of them are Mom and Pop outfits that prepare special drugs for special patients. However this outfit had gone far beyond that. It was preparing large batches of drugs for distributors.
The FDA has been on notice for many years of problems with these outfits. 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. These included tainting and incorrect strengths. These outfits have been copying drugs and thereby acting as makers. They are not allowed to act in that fashion. The whole idea was to allow these groups to act as Mom and Pop stores to avoid the redtape of larger firms. Call, or contact us for a free consult.
Following the money is a poignant concept. This is true with big Pharma and doctors. Tracking where the money comes from and where it goes to tells you who “owns” who.
There is a great deal of money that flows between Pharma and doctors. What Pharma does is to offer doctors money rewards to prescribe their drugs. In addition they ask doctors to take part in speakers’ bureaus and sign off on articles that are ghost written by someone else.
Dr. Jerome Kassirer, in a June 2012 article in Trial Magazine, reported on this. 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.
One thing that concerned Dr. Kassirer is this issue of ghost writing. It exists not only in regards to journal articles but also in clinical trials. Such a trial consists of a drug being tested by a group of doctors to see what effects it may have. As a result the ghost writing of these trials calls into question the the conclusions reported.
Dr. Kassirer also reported that there is a very cozy fit between medical device makers and doctors. The device makers supply a great deal of funding for meetings and education.
Within Obamacare there is a sunshine rule that requires pharma to report any doctor who is making more than a small amount of money from them. In addition they must publish this info on a website that is available to the public. These websites have a way of becoming difficult to identify.
In 2007 surveys that were done among doctors who belonged to the AMA it was reported that a large fraction of them had taken something from industry. 16% were receiving money for services on speaker’s bureaus. 18% were receiving money for consulting.
Most doctors are beyond reproach when it comes to conflicts involving the care of their patients. However a doctor who attends a meeting in Hawaii that is paid for by pharma may well be inclined to prescribe that companies’ drugs in the future. In other words that impact is what pharma is buying. Call, or contact us for a free consult.
Doctor speaking fees paid by Merck during the year 2010 totalled $20.4 million. They were paid that sum to discuss and, in effect, promote Merck’s products. To the extent that medical malpractice cases deal with pharmaceutical or medical device issues it is worthwhile to explore this.
Merck had disclosed that for the second half of 2009 they had paid $9.4 million to nearly 1700 doctors to promote their products and to discuss health care topics. Merck is not alone.
These numbers show the bias that many doctors may have in terms of drugs, devices and treatment.
This raises the question of what does the patient do. Some issues that you may want to research or ask your doctor about are the following:
Drug errors are on the rise according to the Agency for Healthcare Research and Quality. This is the lead U.S. agency charged with improving quality, safety and efficiency of health care for all Americans. They report that in 2008 1.9 million people became ill or were injured from drugs. This includes side effects, being given the wrong type or dose or because they took the wrong type or dose. The report does not state whether the errors were made at the prescriber level, the dispensing level or the consumer level. Noteworthy that the substances most often found at the center of the presumed error were steroids, pain relievers, blood thinners and heart and blood pressure drugs. medications.
Noteworthy that many of these errors could be avoided. Better exchange of info between the doctor and the patient and better access to info on-line could reduce errors.
On September 10th,2013 the FDA announced that it was requiring increased warnings on labels relating to certain pain killers. The focus is on OxyContin and oxycodone. These new rules will apply to other pain killers known as opioids. Enhanced warnings are to combat increased abuse.
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 treat every adult in the United States with 5 mgs of hydrocodone every four hours for a month.
So this increased labeling will apply to all delayed release and long acting opioid painkillers. In the past these were given to patients with short term pain. Over the past decade the use of pain killers has exploded and now their use is common for things such as back pain to arthritis.
A study reported in a Washington Post article of September 11, 2013 notes that about 2 million in the U.S. are misusing painkillers. Those are numbers that far exceed those who are addicted to cocaine or heroin.
The new warnings will alert patients and doctors that these drugs should be used only by patients for whom other treatment is not working. Call, or contact us for a free consult.
The FDA will require that drug makers conduct more studies and trials to further state the risks of these pain killers. In addition the FDA will require new warnings as to use by pregnant women. Chronic use can cause withdrawal symptoms in a newborn.
Vaccine maker’s immunity was affirmed in February 2011 in the case of Bruesewitz v. Wyeth where the Supreme Court dealt with the issue of whether U.S. law protects pharma from lawsuits by parents who claim that vaccines have harmed their children. The Court sided with pharma. The Court stated that Congress found that making pharma immune was needed to insure that vaccines remain open to all. In other words the National Childhood Vaccine Injury Act of 1986, according to the Court, leaves complex judgments about vaccine design to the FDA and to the National Vaccine Program rather than to juries.
This tendency to find pharma immune is no surprise.
In this case, Hannah Bruesewitz began to have seizures as an infant after receiving the DPT vaccine made by Wyeth. The vaccine court ruled that Hannah had not proved that the vaccine harmed her.
The Court ruled that no vaccine maker could be made to pay for death or injury from side effects where the vaccine was properly prepared and had proper directions and warnings.
In addition failure to warn claims involving generic drugs took a hit on June 23, 2011 with the decision of Pliva, Inc. v. Mensing from the U.S. Supreme Court. The Court diluted the Wyeth decision by ruling that makers of generic drugs cannot be sued for failure to warn because such claims are preempted by U.S. law. However in Wyeth the Court held that drug makers could be sued for failure to warn in state court on the theory that the FDA approval process does not preclude pharma from giving better warnings than what are required.
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. Therefore failure to warn claims against makers of generic drugs were preempted by federal law.
This decision affecting drug injury law is especially troubling in light of the fact that 75% of all prescriptions are filled with generic drugs.
This case creates different standards between the two forms. As a result this creates a motive for makers to push more generic drugs than brand name drugs and thereby decrease their risk.
See the pages on Wikipedia for more info.
If you have been injured as a result 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 consult regarding your drug injury claim in Northern Virginia, Maryland, and Washington, DC.