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From Alex Winslow, Texas Watch, Consumer Protection, Corporate accountability, Citizen Advocacy

Over the last decade, Texas Governor Rick Perry has presided over a series of radical legislative proposals that, under the guise of so-called tort reform, reward those who needlessly endanger our communities at the expense of families and small business owners. The Texas Watch Foundation’s latest report, Tort Reform in Texas: Implementing the Corporate Immunity Agenda, details the impact these restrictions have had on the rights of patients, families, workers, homeowners, senior citizens, policyholders, and small business owners.

Beginning with the dramatic, sweeping changes in 2003 that severely restricted the rights of patients and nursing home residents, as well as the crony capitalism behind the creation of the Texas Residential Construction Commission, and ending with the so-called œloser pays proposals of 2011, the last decade has been marked by a series of dangerous restrictions on bedrock legal and constitutional protections.

Today, Texas is place that would be unrecognizable to the framers of our state and federal constitutions who believed the right to a trial by jury was fundamental.

You can read this report at www.texaswatch.org.

FACT #1: BAILEY & GALYEN receives 30 40 calls each month from potential new clients wanting to sue an emergency room doctor and hospital for their negligence.

FACT #2: Most of those potential new cases do actually involve clear negligence by the emergency room doctor and hospital.

FACT #3: Even with clear negligence by the emergency room doctor and hospital, you cannot pursue or file that case because the emergency room doctor and hospital are protected by Texas law.

The Texas legislature in 2007 amended the laws that deal with medical malpractice cases. Texas Civil Practice and Remedies Code Sec. 74.151, entitled Liability For Emergency Care, now states that a person who in good faith administers emergency care is not liable in civil damages for an act performed during the emergency unless the act is wilfully or wantonly negligent. The legislature has raised the level of proof required to file a lawsuit to the highest possible degree of negligence: Wilfull or wanton negligence, which means the medical error must have been intentional. That’s right. To hold the emergency room doctor and/or the emergency room staff accountable for any serious injury or death, you must be able to show that the treatment or lack of treatment by emergency room doctor and/or the emergency room staff totally disregarded or was totally indifferent to the known consequences which the patient suffered. It requires proof of actual or deliberate intention to harm the patient, or at a minimum an absolute and complete indifference to or conscious disregard for the patient’™s safety. That standard is insurmountable, and it slams shut the courthouse door on the innocent victims.

Not being able to file a civil suit when a loved one has suffered serious complications, injuries or death from emergency room errors is a hard pill to swallow. How did this happen, you might ask? It is the result of the collision between political agenda of tort reform and patient safety where political agenda won.

The problem is that tort reform advocates never believe that they will be the innocent victim of emergency room medical malpractice. Further, they all believe that if they are, their claim will be meritorious and different from all those frivolous medical malpractice claims they heard so much about from tort reform advocates. The fact is that emergency room medical malpractice happens very frequently, and those who thought they would never find themselves in the innocent victim’™s shoes and who supported the popular political agenda of tort reform do not like not being unable to hold accountable those responsible for these serious injuries and deaths. Put another way, Texas law gives emergency room physicians and hospitals absolute and complete immunity.

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.

HOT COFFEE examines the dangers of so-called tort reform and its threat to our civil justice system. Using the now-infamous legal battle over a spilled cup of McDonald’s coffee as a springboard, the film follows four people whose lives have been affected by their inability to access the courts, and examines the role of corporations and a complicit media in promoting tort reform.
Is Justice Being Served?

“Seinfeld mocked it. Letterman ranked it in his top ten list”. And more than fifteen years later, its infamy continues. Everyone knows the McDonald’s coffee case. It has been routinely cited as an example of how citizens have taken advantage of America’s legal system, but is that a fair rendition of the facts? Hot Coffee reveals what really happened to Stella Liebeck, the Albuquerque woman who spilled coffee on herself and sued McDonald’s, while exploring how and why the case garnered so much media attention, who funded the effort and to what end. After seeing this film, you will decide who really profited from spilling hot coffee.

Product liability cases are filed against drug companies to recover compensation for serious injuries and damages from dangerous prescription drugs. These lawsuits are based on the inadequacy of the written warnings (also referred to as the label or package insert) that come with the drug to warn the patient and prescribing physician of its risks and serious side effects. The lawsuits are premised on the principle that the drug companies have the duty not to injure the patient. Drug companies fulfill that duty when their drug’s warnings disclose all of the drug’s risks and serious side effects. Only then can the patient exercise their absolute right to know all of the risks and serious side effects of a drug before they take a drug. When the drug companies fail to fulfill that duty and serious injuries and harm result, the drug company must be held responsible and accountable.

Notice that I said the drug company must be held responsible and accountable. That litigation may or may not involve the doctor who prescribed the dangerous drug. At Bailey & Galyen, litigation against the drug companies rarely if ever involves the prescribing doctor. Prescribing doctors are not sued because they only know what the drug companies tell them. Fact is that the prescribing doctors know little more about a drugs risks and serious side effects than that, and the information they do have is solely from the drug company’s written warnings. So, if the warnings are inadequate, in all likelihood so is the doctor’s knowledge of the drugs risks and serious side effects. That effectively makes both the doctors as well as their patients the victims when their patients experience serious side effects that the drug company did not adequately warn about. To add insult to injury, when a lawsuit is filed the drug companies deny any responsibility of wrongdoing and blame both the injured patient and the prescribing doctor for the patients’™ injuries and damages. Here is an example of that language which drug companies regularly include in their defensive pleadings:

When the drug company takes the prescribing doctor’s deposition with hopes to prove that the doctor would not have done anything differently no matter what was in it’s warnings and not matter what the prescribing doctor knew, it is important to be clearly point out and emphasized to the prescribing doctor that his patient did not sue or make any allegations against him in the case against the drug company. The prescribing doctor must be shown in the drug company’s pleadings filed in the lawsuit the allegations against the prescribing doctor, stating that the prescribing doctor is responsible and at fault for his patient’s injuries and damages.

The drug companies further contend:
1. even if armed with this knowledge, it wouldn’t matter because the prescribing doctor already knew everything that a supposedly adequate warning would have contained;
2. that the prescribing doctor didn’t read the warnings and therefore a different warning wouldn’™t have changed the doctor’s decision to prescribe that drug for the patient; and
3. that even if at the time the prescribing doctor prescribed this dangerous drug to the patient he knew everything then that he has since learned about this drug, he still would have treated the plaintiff the very same way (by prescribing the drug).

To justify this position, the drug companies use the statistics of how many patients might experience a drug’s serious side effects. Drug companies take the callous position that all drugs have side effects, and it is acceptable if 1 in 10,000 patients experience a serious side effect from their drug because 9,999 people didn’t.

Putting the blame on another in a lawsuit is called alleging an affirmative defense. The affirmative defense states that if the drug company did something wrong (which it denies it did), someone else actually caused the patient’s injuries and damages. The drug company’s affirmative defense alleges that its warnings were accurate and complete and the prescribing doctor caused the patient’s injuries because the drug company passed on to the prescribing doctor all of the information that it had about the drug’™s risks and serious side effects, and it was the prescribing doctor’s responsibility to then pass that information on to the patient. That works fine if the drug company did make accurate and complete disclosure of all the drug’s risks and serious side effects in its warnings. In that event, the prescribing doctor would have been fully aware of the same and could have passed those warnings on to the patient. Most often however, that is not the case: The prescribing doctor knows only what they read in the drug company’s warnings.

The fact of the matter is that a prescribing doctor’s learning about a drug’™s risks and serious side effects does change his prescribing practices accordingly: It does affect which patients he prescribes the drug for, what doses he prescribes, what directions he gives for taking the drug, and the risk/benefit discussion the prescribing doctor has with the patient before prescribing the drug. It does change the patient’s decision whether or not to take the drug when the patient is aware of and weighs all known risks against the touted benefits of the drug.

The problem is multifold:
1. The FDA approves prescription drugs solely on the information it is provided by the drug company. The FDA does no testing; it is understaffed and underfunded. The FDA relies on the drug companies to test drugs for safety or effectiveness. If the drug company does not adequately test for safety or effectiveness and does not disclose all study results to the FDA, and the FDA approves the drug, it has done so on inaccurate and incomplete information.
2. The drug company warnings only include that which the FDA makes it include based on what the drug company tells it about the drug’s safety and effectiveness. If the drug company does not disclose all known risks and side effects to the FDA, the warnings will be inaccurate and incomplete
3. The drug company’s incentive is not to make accurate and complete disclosure of all known risks and serious side effects to the FDA and in its drug’s label. The reason: Doctors will be hesitant to prescribe it and patients will be hesitant to take it, and that reduction in prescriptions being written equates to a drop in the drug company’s revenue.

The solution is having the ability to hold the drug companies responsible and make them accountable for their failing to fulfill their duty to the patient to protect them from known risks and serious injuries.