What is a Defective Drug?

In society today we like to make fun of side effects. We watch drug commercials on television about pharmaceuticals with various functions and there is a deluge of side effects listed in quick succession somewhere in the commercial ranging from dry mouth to death. That’s right, even if a defective drug has a chance of killing the patient they will still advertise it and, worse yet, healthcare professionals will still prescribe it. It seems crazy, but true.

Patients can try to consult their physicians about any drug approved by the Food and Drug Administration (FDA) and get a whole book of literature regarding their physiological effects both beneficial and detrimental.

Once the patient has slogged through the confusing language of the literature and gotten the layman’s explanation from their doctor, they weigh the options and usually just end up taking the pill anyway because notion of a profit over patient system is generally too much for any decent person to fathom.

This sad truth is aired out in courtrooms across the nation every year as patients find that the drug they took actually made their ailment more severe or caused a new, more critical ailment to crop up. Whether the case settled out of court or is taken to trial, thousands of victims are fighting giant global pharmaceutical conglomerates who have figured out that they can factor lawsuits into the cost of a defective drug and still come out with billions.

What is a defective drug?

A defective drug in its simplest form is a drug who’s health risks outweigh the benefits. But there are many different circumstances in which a drug can be defective.

Ways drugs can be defective are:

Manufacturing – Drugs and their packaging are manufactured all over the world with different standards and the standards of the drug factory may not correspond with that of the package manufacturer. An example of this was in 2011 when Johnson & Johnson and their Children’s Tylenol line of cough syrups were found to have foreign debris (dust, plastic and metal shards, etc) and in some cases a rare infectious bacteria on their product produced in their facility in Porto Rico.

Dosage – A consistent dosage in a drug is incredibly important. The reason for this is that reactions to the drug is on a patient-by-patient basis and some smaller, more frail, or older patients might have to strictly regulate their dosage. If the pill’s dosage is inconsistent it could have serious consequences. GlaxoSmithKlien, the manufacturer of Paxil found this out in 2010 when they were fined $750 million for inconsistent doses in their antidepressant drug after their lack of regulation was exposed by a whistle-blower.

Labeling – The labeling of drugs is very serious. There is regular labeling and then there is “black box labeling” imposed by the FDA. This is when patients need to be especially concerned about certain risks of a particular drug. Many drugs have this imposed on them and it should be closely observed. An example of this is Pfizer and the embattled antidepressant Zoloft, which was recently ordered to change their packing over the “suicideality” side effect after adolescent patients were found to have potentially fatal thoughts of suicide due to the drug.

Side Effect Discovery – Side effect discovery after the introduction of the drug onto the market is very common. This is generally due to the fact that many drugs are rushed to market without the proper amount of testing. An example of this Merck’s painkiller Vioxx, which studies found caused thousands of heart attacks prompting the largest drug lawsuit to date with a total cost of almost $5 billion dollars for Merck.

Selective Testing – Selective testing is suspected to be an epidemic in the pharmaceutical industry where they have many different studies of their drugs going on at the same time, then pick and choose the studies that best suit their needs. They then present these findings for the FDA to review for approval. This could ignore or gloss over what could potentially be a serious side effect. An example of this is what happened with another Glaxo drug Avandia, where there is speculation that the company knew about the heart attack risk of the drug prior to bringing it to market.

Sponsored Testing – There are many (in fact most) studies that are sponsored in part or directly by the drug manufacturer to the lab or study group. Proportionately these studies result in stellar results for the drug. Avandia is another good example of this as they presented evidence that the drug had little to no connection to heart attacks as evidence from the Journal of American Medical Association, FDA, and a US Senate committee all revealed otherwise.

Off label selling – Off label selling is when a drug rep or company touts benefits of a drug outside of its normal FDA approved functions. This is another epidemic behavior amongst pharmaceutical companies that persists today even though it elicits millions of dollars of fines from FDA regulators every year. A prime example of this is Bayer’s top-selling birth control drug Ocella. It was up-sold to both healthcare professionals as everything from preventing the symptoms of premenstrual syndrome to treating acne. Neither of these functions had been tested or been approved by the FDA.

Advertising – The commercials and ads that companies push out to the public can be just as detrimental. Though a laundry list of side effects can (and must) be named, the advertisement through the wording, images, and other aesthetic elements can deceive the potential recipient into something that the drug is not. This behavior caused Bayer to pull their ad over their next generation birth control drug YAZ after the images of off label benefits not approved by the FDA were flashed across the screen written on balloons as the serious and potentially deadly side effects were quickly rattled off.

Defective Drug Attorneys

As you can see, the simplest definition of a defective drug is far too elementary of an explanation because most drugs stay on the market even after they have been found to be highly detrimental to a large portion of their patients. “Regulation over recall” is the FDA’s preferred method. How can this possibly be when protecting the public is supposed to be their priority? Because 80% of their funding comes from the drug companies themselves rather than from the public sector. That funding keeps the agency so small that it is seriously limited in its ability to legitimately regulate an industry with seemingly limitless resources.

That is why lawsuits are so incredibly important in order to protect the rights of the patient. In a system that is proportionally balanced toward profit over the patient, the only weapon victims have is to use their legal right to seek justice.

Phillips Law Firm is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. If you or a loved one have experienced serious injury or death due to a defective drug, call us today for a free consultation and to find out your legal rights.