Thursday, April 09, 2015

Why Pharmaceutical Companies are Protected from Liability - Why Obama and Congress Refuse to Fix the Law - Why You Stand Alone


Have you ever heard the phrase "stand alone"?  Well when it comes to the multi-billion dollar pharmaceutical field, everyone in America is standing alone, abandoned by your representatives in Congress and the Administration of President Obama.

If you should happen to have serious injury from taking FDA approved drugs, or even death, the Obama Administration, Congress, the Supreme Court, and the FDA, are your enemy.  They ignore the need to fix liability on behalf of the consumers, and have built a shield of protection around the billions of dollars taken from consumers by industry giants.

In case there is any confusion, pharmaceutical company revenues reached about $750 billion in 2014, and will exceed $1 trillion in just five years according to the FiercePharma web site.  Here are some revenue and lobbying charts showing the extent of political influence in politics in America.  Note how over the years both parties receive about the same amount of money.

Here is a good description of how the pharmaceutical companies got this multi-billion dollar shield of protection by the US government.  Obama and Congress can fix this regulatory quirk at any time but are they rushing to help the consumer by holding drug companies liable, of course not, and that means Democrats and Republicans alike.

Filing Dangerous Drug Lawsuits for Harmful Side Effects

If you've suffered a serious illness or injury from taking a dangerous drug, whether prescription or over-the-counter, you may be wondering what legal rights you have. Who do you file a drug lawsuit against? Common questions include:
  • Can I sue the pharmaceutical company who made the drug?
  • How about the U.S. Food and Drug Administration for approving it?
  • Is my doctor liable for prescribing the drug?
  • Does the pharmacy share any responsibility?
Let's discuss the options...

U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is "responsible for protecting the public health by regulating human and animal drugs, biologics (e.g. vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation."

Most people think the FDA approves all drugs on the market today, but that's not true. Some drugs are not subject to FDA approval (ex. "compounded" drugs), and others are only reviewed after they're put on the market. Read more about the FDA approval process here.

Since the FDA was created, thousands of dangerous drugs have entered the market and caused harmful side effects, including serious illnesses and wrongful deaths. While the FDA has become better at finding potentially dangerous drugs, many have slipped through their fingers and made it to market.

You might think that if the FDA approved a dangerous drug which caused you harm, you'd be able to sue the FDA for their negligence. Unfortunately, the FDA is a government agency, therefore it has sovereign immunity. Sovereign immunity is a legal privilege stating government agencies can't be sued (unless they allow it, which rarely occurs).

Pharmaceutical Drug Companies

Before 2013, drug companies could be sued if their drug caused serious adverse side effects, injury, illness, or death. They paid out hundreds of millions of dollars in drug lawsuit settlements and jury verdicts.

In 2013, the U.S. Supreme Court made a historical decision. In the case of Karen Bartlett vs. U.S. Merck and Co. and Mutual Pharmaceutical Company, the Supreme Court ruled that once the FDA approves a drug, individuals are prohibited from suing the drug's manufacturer, even if it's proven that the drug caused harm!

In the Bartlett case, the plaintiff took the drug Sulindac, which allegedly caused her to suffer gangrene in her right arm as a result of "toxic epidermal necrolysis." The Supreme Court ruled that, because the FDA approved the drug Sulindac, the manufacturer has immunity from private and class action lawsuits.

Basically, the ruling stated drug manufacturers have a right to rely on the FDA approval system, and once a drug is FDA approved, pharmaceutical companies can't be sued. Otherwise, the court said, why does the FDA exist at all?

What this means to you is, if you've suffered a serious side effect or illness from an FDA approved medication, you are barred from filing a lawsuit against the manufacturer. (Supreme Court rulings are rarely overturned, but in the future it may happen.)

Doctors and Pharmacists

While you may not be able to file a lawsuit against the FDA or a drug manufacturer, you can sue your doctor or pharmacy if they prescribed a dangerous drug which caused you harm.

Physician Liability
There's a difference between drug lawsuits and medical malpractice lawsuits. A lawsuit based on illness or injury caused by a doctor's negligence in prescribing medication, falls under the category of medical malpractice.

By law, doctors are held to a very high standard of care in the medical community. When a doctor deviates from the medical standard, and as result a patient is injured, the doctor is considered negligent, and therefore liable for any resulting injuries.

When a patient can prove a doctor's negligence was the direct cause of his injuries, the patient may be entitled to compensation for his or her damages. In extreme cases of negligence, an injured or deceased patient's family may be entitled to punitive damages.

Pharmacy Liability
Pharmacists have a legal duty of care when prescribing medications. They receive extensive training in pharmacology and must be familiar with every drug they dispense. This includes knowing about potentially harmful interactions between drugs when taken together.

It's up to the pharmacist and doctor to work together to make sure a prescribed drug will not injure the patient. In today's day and age however, communication between a doctor and pharmacist is often limited. The one who suffers most is the patient.

As a patient and customer, you have a right to rely on the expertise of your doctor, and the pharmacist who filled your prescription. When they fail to protect you from harm and you suffer injuries, you have a right to seek compensation.

Example: Doctor and Pharmacist Negligence
Vic was previously diagnosed with celiac disease, which means his body can't metabolize gluten. When gluten is introduced to someone with celiac disease, they can suffer nausea, vomiting, diarrhea, and even life-threatening intestinal damage.

Vic went to see Dr. Neglushent complaining of weakness and lethargy. Vic was very careful and lived a gluten-free lifestyle, and the doctor knew Vic suffered from celiac disease.

Dr. Neglushent prescribed the drug Palagluden. Vic asked Dr. Neglushent if Palagluden contained gluten, and was told it did not. When Vic went to pick up his prescription, he asked the pharmacist if Palagluden contained gluten, and was told no. There was also no indication on the pill bottle that the drug contained gluten.

After taking Palagluden for 3 months, Vic collapsed and was hospitalized due to a ruptured large intestine. It turned out the drug Palagluden in fact did contain large amounts of gluten, used as a binding agent.

Vic successfully sued Dr. Neglushent for medical malpractice and the pharmacy for negligence. In the lawsuit, the pharmacy blamed the doctor, and the doctor blamed the pharmacy. The court said both defendants knew, or should have known the drug Palagluden contained gluten, and ruled in Vic's favor.

The Role of Attorneys

Any kind of drug lawsuit requires professional legal representation. Doctors and pharmacies rarely admit to fault, and are often defended by large insurance companies with deep pockets. Only an experienced personal injury attorney has the skills to handle a case like this. An attorney can take depositions, subpoena records, hire expert witnesses, and more.

If you've suffered a serious side effect or illness due to a drug, seek the counsel of an attorney in your area as soon as possible. Save the pill bottle, your receipts, and your medical records (to verify the treatment you required as a result of the drug). Bring all your evidence with you when meeting with attorneys.

Case Study:

Dangerous Medication Interaction
Here we look at a case where the victim suffered harmful side effects from taking two drugs together. Although a doctor prescribed the medications, liability falls on the manufacturer because of inadequate warnings.

Media On Right And Left Ignore The Truth About Vaccines

Cliff Kincaid, February 5, 2015

They bash each other over vaccines, but ignore what's really at stake.

NBC accuses Republicans of accepting bad “science” on vaccines, while Fox News fires back, accusing liberals of spreading bad “science” on vaccines. Each side is trying to score partisan political points. The message from both sides is that vaccines are completely safe. But that message is absolutely and demonstrably false.

As I noted in a recent column, the National Vaccine Injury Compensation Program exists to compensate victims of vaccines. The latest Statistics Report shows nearly 4,000 claims were awarded financial damages.

Why do both sides of this “debate” pretend that vaccine-related injuries do not occur? Why not just report the facts? It doesn’t take a lot of work to dig them out.

Barbara Loe Fisher of the National Vaccine Information Center (NVIC) tells me that she has given more than 100 interviews in the last two weeks on the subject of the measles outbreak, but that the media simply will NOT report on the existence of this federal program and the implications for the subject of vaccine safety.

“Vaccines are the only pharmaceutical products that government mandates and completely indemnifies,” she notes. She is referring to federal legislation that takes legal responsibility for their actions away from the companies making the vaccines.

“I’ve been talking about it in every interview I do and I have been bringing it up. But whenever I talk about liability protection for the companies—that this is the only pharmaceutical product that is mandated by government and indemnified by government—they [the media] don’t want to talk about it,” she said.

Observers believe the glaring omission reflects the power of pharmaceutical companies or their advertising agencies in the major media. It is in the interest of these companies to make pariahs out of those favoring vaccine choice by playing down—or even suppressing—questions about vaccine safety.

Simply put, the evidence and history show that the vaccine makers have been given total liability protection for injuries and deaths caused by government-mandated vaccines. Vaccine safety is not “settled science,” as we have been hearing repeatedly in the media. To the contrary, for purposes of the law, vaccines are considered sometimes unsafe, even deadly.

The “Vaccine injury table” associated with the legislation includes a list of the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines.
But why is it so difficult for the media to report on the existence of these health problems?

The vaccines that are covered include:
  • diptheria and tetanus vaccines
  • pertussis vaccines
  • measles, mumps, and rubella vaccines
  • polio vaccines
  • hepatitis A vaccines
  • hepatitis B vaccines
  • Haemophilus influenza type b polysaccharide conjugate vaccines
  • varicella vaccines
  • rotavirus vaccines
  • pneumococcal conjugate vaccines
  • seasonal influenza vaccines
  • human papillomavirus vaccines
  • meningococcal vaccines
As I reported in my column, the one exception to this drumbeat of misleading and inaccurate coverage about “vaccine safety” is on the local level, where correspondent Michael Chen of ABC 10 News in San Diego, Calif., noted a case of a boy who suffered serious injuries, including fever, seizures, nervous tics, and autism, as a result of two vaccines. The mother, almost in tears as she described what happened to her son, was paid $55,000 in damages through the federal program. But the damage award didn’t cover the autism diagnosis. She said she wished she had more thoroughly researched the safety of vaccines.

The National Vaccine Injury Compensation Program grew out of the 1986 National Childhood Vaccine Injury Act. Fisher explains what happened: “The companies threatened Congress that they were going to leave the people without any childhood vaccines if they did not get liability protection. The companies wanted this liability protection and it was mainly for losses at that time for DPT and oral polio vaccine. MMR (Measles, Mumps, and Rubella) vaccine at that point was a relatively new combination vaccine.”

The DPT vaccine had been associated with brain inflammation and brain damage, while polio paralysis can be caused by the vaccine.

Fisher explains what the federal protection means for the companies: “Nobody who makes or profits from the sale of the vaccine, nobody who regulates the vaccine, who promotes the vaccine, who votes to mandate the vaccine—nobody is accountable or liable in a civil court of law in front of a jury of our peers when we get hurt because we’ve been told we have to take it, or when the vaccine fails to work.”

The compensation program, with total liability protection for injuries and deaths caused by government-mandated vaccines, was upheld by the Supreme Court in a 2011 case in which vaccines were acknowledged to be “unavoidably unsafe.”

My column actually underestimated the total financial damages paid through the program. The figure is actually $2.8 billion to the victims or the families of victims themselves.

Liberal and conservative media are trying to make political points over who’s right and wrong about vaccine safety. But Fisher says people who support her group and vaccine choice come from across the political spectrum and include Democrats, Republicans, libertarians, and independents. In the media, however, each side is trying to smear the other side, as if there is a partisan divide.

The coverage has led to cases of strange bedfellows, such as the George Soros-funded blog Think Progress running a story praising Megyn Kelly of Fox News under the headline, “Megyn Kelly Speaks Up For Mandatory Vaccination On Fox: ‘Some Things Do Require Big Brother.’”
Indeed, Kelly defended mandatory vaccines, saying, “…some things do require some involvement of Big Brother.”

What she and many others in the media have consistently ignored is the role of Big Brother in shielding the companies making the vaccines from the side effects of their products.

As I asked in my column: If there are no problems associated with vaccines, then why did Congress pass the National Childhood Vaccine Injury Act of 1986, which created a national Vaccine Injury Compensation Program?

The media on the left and right have no answer to this question. So they pretend there is no debate or dispute over the safety of vaccines. They simply point fingers about one side or the other being guilty of ignoring what they pretend is settled science.

The only thing “settled” about the science is that while vaccines work for a large majority of people, they can also cause serious health problems, even death, for some.

The commentators who ignore the truth are either lying or so utterly ignorant that they should not be in a position of offering “news” on a national basis. Whatever the case, the public is being denied the facts about decisions affecting the lives of their children. Fortunately, the public can go to sites like and the National Vaccine Information Center for information that is being denied to them.

A troubling aspect of the current debate is how people in the media act like experts on subjects that they know so little about. They seem to think that by huffing and puffing and sounding authoritative, they will be taken seriously. They have large staffs which seem incapable of making phone calls or doing elementary research.

If news organizations on the left and right can’t even dig out the facts in life-and-death matters involving children, then what can they be trusted to report accurately on?


No comments: