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“The learned intermediary doctrine is itself an exception to the manufacturer’s traditional duty to warn consumers directly of the risks associated with any product.”  (source)

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It’s called the “learned intermediary doctrine,” and it’s important to drug manufactures because it allows them to avoid warning consumers directly about their products when it comes to the risks associated with their use. Instead, these warnings are (supposedly) given to the physician, who lends their trust over to the corporation in the hopes that they are disclosing all information, who in turn is then responsible (the doctor) for relaying these risks to their patient. It takes all responsibility and liability (regarding risks associated with pharmaceutical products like vaccines and prescription drugs) away from the drug manufacturer, and places it solely on the physician.

“Thus, prescription drug manufacturers’ duty to warn consumers flows through the patients’ prescribing physicians, not directly to consumers.” (source)

This is a scary thought, given the fact that the education doctors receive regarding all medicines comes directly from the drug manufactures themselves. Most of the time, doctors are educated on how the drug works to heal the patient and what biological processes take place with regards to the disease. In their own practices, some doctors accept the drugs without ever questioning their validity, giving complete trust over to the the pharmaceutical companies. Many doctors often assume that these drugs have passed through government safety checks by, for example, the Food and Drug Administration. It is still not properly acknowledged that pharmaceutical companies have a hand in dictating governmental policy, or that there are monetary incentives offered for dishonesty, especially when it comes to the health industry.

This is not just conspiracy theory, there are countless examples that clearly show why we cannot trust pharmaceutical companies to properly relay information regarding the risks associated with their products to doctors or to people who use their products and don’t require a doctor’s visit. I am talking about scientific fraud.

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine” (considered to be one of the most prestigious peer-reviewed medical journals in the world). – Dr Marcia Angell, Physician, Author, Former Editor in Chief of the NEJM (source)

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Documents obtained by Lucija Tomljenovic, PhD, from the Neural Dynamics Research Group in the Department of Ophthalmology and Visual Sciences at the University of British Columbia,ddd reveal that vaccine manufacturers, pharmaceutical companies, and health authorities have known about multiple dangers associated with vaccines but chose to withhold them from the public. This is scientific fraud, and suggests that this practice continues today. (source)

This is no secret. The list literally goes on and on, with many examples to choose from. And again, the law states that relaying the risks associated with these drugs are the doctors’ responsibility.

“For prescription drug manufacturers, the rationale behind the doctrine is based largely on the fact that prescription drugs’ actions are complex and the prescribing physician is the one best able to determine the drug’s potential benefits and risks for a particular patient.” Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 191 (Tex. 2004) (stating that the doctrine is based on the idea “that it is better for the patient for the warning to come from his or her physician”); Restatement (Third) of Torts: Prods. Liab. § 6(d)(1) cmt. b (1998) (“The rationale supporting this ‘learned intermediary’ rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy.’)” (source)

There are also exceptions to this law, where pharmaceutical companies provide health products directly to the consumer. In this case, they do not have to go through a physician. Examples include contraceptive pills, vaccines, and more.

“Modern realities have rendered the learned intermediary doctrine obsolete because its application allows pharmaceutical manufacturers to escape their traditional duty to warn at the expense of consumer health and well-being.” (source)

One example is the polio vaccine, where a (1968) court held that manufacturers of the polio vaccine had an obligation to warn patients directly of the fatal risks that are associated with vaccination. This is a great example where there was little to no physician supervision (still common today) when it comes to mass immunization clinics. In this case, the learned intermediary doctrine was inapplicable to drugs being directly marketed to consumers. Reasons include:

  • Informed consent requires a patient-based decision rather than the paternalistic approach of a bygone era
  • Many of the drugs marketed directly to consumers are lifestyle drugs that are not medically necessary, so it is not the physician weighing the risks and benefits but rather the patients
  • Drug manufacturers are already spending billions on advertising to consumers, so it is clear that they have effective means of communicating with consumers.

Why Are Pharmaceutical Companies Above The Law? Why Are They Constantly Exempt From Any Wrongdoing? 

What we are looking at here are measures put in place that completely protect pharmaceutical companies. Another great example is The National Childhood Vaccine Injury Act.

The mid-1970’s saw an increased focus on personal health, and accordingly, more people became concerned about vaccine safety. Several lawsuits were filed against vaccine manufacturers and healthcare providers by people who believed they had been injured by vaccines, and the evidence presented in court was good enough to win.

As a result, this act was developed to protect any pharmaceutical company, doctor, or medical association from any “fault.” It’s not about pointing fingers, many people really do believe that every vaccine is fine to inject into somebody. Instead of suing the vaccine manufacturer directly, parents have to undergo complex legal proceedings, asking the government to admit that the vaccine was responsible for their child’s injury and asking for compensation for the child’s care.

Pharmaceutical companies are exempt from participating in these proceedings, and tax payers are the ones who pay for all the vaccine-related damages, of which there have been many. Below is a great video explaining the process in detail. You can learn more about that here.

Again, ask yourself – why are so many laws, mandates, and programs put in place to completely protect pharmaceutical companies from any wrongdoing whatsoever? Think about that for a moment.

Sources:

http://www.burgsimpson.com/pdf/AbarayKernArticle.pdf

http://apps.americanbar.org/litigation/committees/products/articles/summer2013-0713-inside-learned-intermediary-doctrine.html

https://mckinneylaw.iu.edu/ilr/pdf/vol40p397.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964337/

http://nsnbc.me/wp-content/uploads/2013/05/BSEM-2011.pdf


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