The Food and Drug Administration (FDA) does a good job of policing the drug companies and protecting the public health in the United States. It assures the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation. It is responsible for product approvals, over-the-counter and prescription drug labeling and drug manufacturing standards.

In Europe, however, this job is performed by the European Medicines Agency (EMA). The EMA’s responsibility spans a decentralized, European Union, spanning over a European medicines network of 40 plus national regulatory authorities. It has to be an onerous task to police over 40 national regulatory authorities. However, the EMA is not as effective as the FDA. Drug companies in that European Union commit bad acts because they know they can get away with it.

Case in point is the October 23, 2012 news that the EMA is investigating allegations that Roche failed to comply with its EMA imposed obligations to monitor the science and adverse event reporting activities to detect, assess, understand and prevent patient injuries from adverse effects of its European manufactured and distributed drugs. These allegations came from the 2012 inspection of the UK Medicines and Healthcare products Regulatory Agency (MHRA), which showed several deficiencies in the safety reporting systems at Roche Registration LTD. It showed that Roche had not evaluated information it had received to determine whether or not the same constituted adverse reactions which would need to be reported to the competent authorities in the EU. Roche callously put patient care and safety in the back seat of the profit mobile.

We are not talking about a few reports that Roche did not have time to follow up on. At the time of the inspection, Roche identified some 80,000 reports that had not been evaluated to determine whether or not they should be reported as suspected adverse reactions. More astounding is that these reports included 15,161 reports of patient deaths.

For the worldwide pharmaceutical companies, Europe is the old west’s Hole-in-the Wall where they hide out from the law.



On August 30, 2012, the FDA issued a Safety Announcement that recommended that Revatio, a drug used to treat pulmonary arterial hypertension (PAH) or high pressure in the blood vessels leading to the lungs, not be prescribed for children between the ages of 1 and 17. Revatio may not sound familiar, nor will its chemical name, Sildenafil. However, everyone will recognize Sildenafil when told it is also marketed as VIAGRA. Both Revatio and VIAGRA are prescribed for the FDA approved treatment of erectile dysfunction (inability to get or maintain an erection) in men. As if this reason alone is not reason enough not to prescribe Revatio for children with pulmonary arterial hypertension, it is now known that giving Sildenafil to children significantly increases the potential risk of death.

Now known only because the FDA learned of this increased risk from a 16 week study of 234 patients with PAH who ranged in age from 1 year old to 17 years old. This study was designed to see if Revatio increased the exercise capacity of these young patients. As referenced above, it did not result in a statistically significant improvement in exercise capacity in those patients. Put another way, being absolutely no benefit of this therapy, the risk outweighed the benefit. Further, the higher the dose the more increased the risk, and the lower the dose the less effective the therapy.

Again, the study found absolutely no benefit of this therapy for children 17 years of age and younger. So why prescribe such a dangerous drug to a child? Doctors have been prescribing it as an off label use since its FDA approval on June 3, 2005. Off label means that the use is not approved by the FDA. The prescribing physicians learned of the off label use by the PFIZER drug reps who positioned the drug for that off label use. Positioned is the word used by PFIZER and all other drug companies who encourage doctors to prescribe it for non-approved uses because promoting and marketing for off label use is illegal.

One dares to think what other problems might occur when children 17 years of age and younger are given a drug to treat erectile dysfunction, but it gives a pretty good idea of why Revatio’s use for children under the age of 17 who have pulmonary arterial hypertension is not FDA approved.



The worldwide drug giant, Bayer, did it again. About 3 years ago, Bayer was caught hiding scientific studies regarding Trasylol from the FDA, physicians and patients. Bayer casually downplayed the significance of that criminal act by attributing it to regrettable human error. Now, and only because of the litigation over one of Bayer’s Yas and Yasmin birth control drugs causing serious blood clot injuries and deaths, it has been discovered that Bayer again withheld important safety information from the FDA.

Two recently published scientific studies found that women taking birth control pills like Yas and Yasmin that contain drospirenone are more likely to develop blood clots than those who take birth control medication that don’t have it. Evidently, Bayer neglected to disclose this increased risk to the FDA during the approval process for Yas and Yasmin.

In the federal court Multi District Litigation (MDL) case in Illinois, Former FDA Commissioner David Kessler wrote an expert report wherein he stated that Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present.

Commissioner Kessler further stated that Bayer engaged in extensive off-label promotion of Yasmin and Yas for unapproved uses, in violation of FDA regulations, to increase sales. That off-label promotion unnecessarily increases the risk of thromboembolic events in patients because there are better, safer FDA approved alternatives for those unapproved uses.

Here is a summary of what happened. Based on adverse event reports received by the FDA in 2003 which included six deaths, the FDA told Bayer then that a labeling change for venous thromboembolisms, or blood clots, was being considered. Commissioner Kessler determined that Bayer omitted data from a post-marketing surveillance study that was submitted to the FDA in 2004, and later failed to disclose blood clot risk into to the FDA, doctors and the public in 2008 and 2010.

Commissioner Kessler wrote in his report that serious adverse events observed in a clinical study should have been reported to the FDA prior to approval of Yasmin, but that Bayer chose not to do so. The FDA requested a proposed change to the warning label to indicate an increased risk, but Bayer did not provide the FDA with any proposed changes. Bayer knew, based on its own analysis, that Yasmin had an increase in the US reporting rate of various side effects, notably blood clots, compared to other contraceptives, but the drug maker omitted this info from its analysis that it presented to the FDA. Commissioner Kessler stated that: In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made. These facts would impact the Agency’s risk-benefit equation about the drug and whether it could be approved.

Bayer not only withheld this information from the FDA but has fought hard to keep it a secret from doctors and patients. The sheer gravity of Bayer’s conduct requires that Bayer be held accountable for the countless serious injuries and deaths caused by its corporate greed. You see, if doctors and patients knew of this increased risk, the doctors would write less prescriptions and Bayer would not make as much money. Bayer likely justified its 2003 actions because there were only 6 reported deaths and all drugs have side effects.

As with all pharmaceutical litigation, the question is what did Bayer know and when did Bayer know it. Full and complete disclosure of all known risks associated with a drug is absolutely required in the approval process. Once approved and on the market, Yas and Yasmin’s labels and warnings have to be updated when any new information is received regarding an increased risk of serious injury or death. Withholding information from the FDA during or post approval process is not an error, and it is not simply human error. It is an intentional act that is based in Bayer’s corporate culture of putting profits over people.



The US Supreme Court correctly held in its 2010 decision in Wyeth v Levine that state tort laws do not conflict with federal law and can be used to hold the pharmaceutical manufacturers accountable for the serious injuries and damages caused by their dangerous drugs. The legalese for the legal issue made the basis of that decision is preemption: Are claims brought on state tort laws inconsistent with and therefore preempted by federal law. The Court recognized that the FDA could not possibly shoulder all of the responsibility for determining the safety of a prescription drug during the new drug approval process. It further recognized that tort laws were not inconsistent with the federal laws and regulations that the FDA operates under, and those laws play a very important role in determining the safety and effectiveness of dangerous drugs that the FDA approves. After all, the only information the FDA has to make that decision comes from the drug’s manufacturer. No comfort level, there.

In June, 2011, the same US Supreme Court in Pliva Inc. v. Mensing held just the opposite for the manufacturers of the generic forms of these dangerous drugs. The Court found that state tort claims are inconsistent with and are preempted by federal law and are not permitted. This ruling is significant for a number of reasons. First, the company that develops and obtains FDA approval to market a drug (called the innovator) maintains that exclusive right for a ten year period. That ten year period can be extended under certain circumstances. After that ten year period and/or any extended periods run, the exclusivity is lost. Other drug companies can manufacturer and market the innovator’s exact same drug under its own name. These identical drugs are called generics. Second, the generic manufacturers do not have the same duties that the innovator has in the new drug approval process to test generics for safety and effectiveness and for full, complete and accurate disclosure of all know risks of serious side effects associated with that drug; this is the sole responsibility of the innovator. Third, if the innovator’s label for the drug is inadequate and incomplete, the generics label will be inadequate and incomplete. Fourth, if your physician prescribes a generic form of a drug, or worse yet if your insurance company will only approve and pay for a prescription filled with the generic form, and you suffer a serious injuries and damages from that drug, you will not be able to file suit to seek compensation against the generic manufacturer.

Since the innovator obtained FDA approval and is responsible for the drug label’s full, complete and accurate disclosure of all know risks of serious side effects, it appears that the patient may be able to bring suit against the innovator even though the patient ingested the generic and not the original form of the dangerous drug. The pharmacy, pharmacist, insurance company, and physicians are also left exposed by this ruling for their part in the patient’s injuries and damages. Prior to the Mensing decision, Bailey & Galyen did not included pharmacies, pharmacists, insurance companies, and physicians in cases filed against the drug companies for serious injuries and damages. The Supreme Court’s decision now forces us to include them in the lawsuit.

While the ruling is consistent with Levine, its disservice is that it leaves the generic manufacturers untouched and unaccountable for serious injuries caused by their dangerous drugs. It puts the consumer between the proverbial rock and a hard place, with the fox guarding the hen house.