Cases against Pfizer and your physician are based on two different sets of law. One is a product liability case against the manufacturer of a drug; the other is a medical malpractice case against a health care provider.
Legal rules governing product liability cases differ from those regulating ordinary injury liability cases. In ordinary cases, the injured person must prove that the defendant was negligent in some way as to cause the injury. For example, a physician failed to give the right dosage of medication. With a product liability case, the law is called strict liability, which means the injured person need not prove that the defendant was negligent at all! The injured consumer must, instead, show that the product was defective. Defenses to these claims, therefore will differ as well.
Pfizer’s Defense
Product liability, as said above, is generally considered a “strict liability” offense. Strict liability wrongs do not depend on the degree of carefulness by the defendant. Simply stated, a defendant is liable when it is shown that the product is somehow defective and unreasonably dangerous. It is irrelevant whether the manufacturer or supplier exercised great care. If there is a defect in the product that causes harm, the manufacturer or seller of the product will be liable for it. One defense Pfizer, cannot use is that the FDA gave its approval to this drug. In no way does that protect Pfizer from liability because as a government agency, the FDA is protected by governmental immunity.
In theory, there are no defenses to a strict liability claim. That said, the one that has come up with varying success in prescription drug cases, is the claim that the product was not defective, but that it was an “unavoidably unsafe product”. This means the product was carefully designed, properly manufactured, correctly marketed, but dangerous nonetheless, and may cause injury. It’s a product that, when made correctly, can never be made safe. Weapons makers have used this argument, as have tobacco companies. Courts generally look at four criteria in making that determination: the manner in which the product was prepared, the manner in which it was marketed, the utility of the product compared to the risk it poses and whether there are any alternatives to this product available.
If a mistake is made in the preparation while manufacturing the product and that mistake makes the product ineffective or dangerous, the product will not be found unavoidably unsafe. For example, if a baby stroller is made with wheel locks that don’t stay in place, and a stroller rolls, injuring the baby, the manufacturer cannot use “unavoidably unsafe” as a defense since they made a mistake in the manufacturing process. If a product is appropriately marketed, but directions accompanying the product are faulty, or the product is sold with inadequate warnings, it also may not be found unavoidably unsafe. Thus, if a prescription drug is marketed with no indication as to how it should be taken, or by whom it should be taken, it may not come within the unavoidably unsafe exception. For example, if the insert with a prescription does not tell you whether or not to take the medicine with food or on an empty stomach, and you later suffer an ulcer from having taken it without food, the manufacturer cannot use the unavoidably unsafe defense.
Similarly, if the drug is marketed with no warnings as to potential adverse reactions or contraindications, it may not be considered unavoidably unsafe. For example, if a drug is prescribed to a cardiac patient and no warning is given indicating that cardiac patients may suffer a heart attack from this drug, and such a warning is later added by the manufacturer, the manufacturer cannot use the defense that the medicine was unavoidably unsafe.
The third requirement is that the utility or usefulness of the product must outweigh its risk of danger. So, for example, if a drug cures a mild case of hiccups but causes death in half the people who use it, it may not qualify as unavoidably unsafe. It is worth noting that a product need not save lives to be considered useful. Products ranging from birth control medications to beauty products have been found to be sufficiently useful to warrant the risk associated with their use.
Lastly, there must not be any other way to fully achieve the intended purpose of the product. If there is an alternative product that would be as effective in accomplishing the purpose of the product, then it may not be unavoidably unsafe. In determining whether there is an alternative, courts have considered the risk avoided by the alternative, the financial cost of the alternative, the benefits of the alternative, and the relative safety of the alternative. In the case of the hiccup cure, a bottle of water would be a safe alternative product making the hiccup cure unlikely to qualify as an unavoidably unsafe product.
Will Bextra qualify as an unavoidably unsafe product? Will the alternatives be found to perform as well with a higher level of safety? Lawsuits will decide this issue over the next few years.
Physician’s Defense
Your physician will be sued for medical malpractice, not product liability.
Therefore, as indicated above, your lawyer will need to prove that your injury or illness was caused, at least in part, by your doctor’s negligence either in:
Prescribing the drug for you. For example, did he take your full medical history, ask what other drugs you are taking, ask about any conditions which could have made the drug more dangerous for you;
(2) Following up with your care once you were on the drug. This would include performing any necessary testing, asking questions about your symptoms, taking complaints of pain or other symptoms seriously and making further inquiry to see if the drug was causing the problem, etc.
The doctor’s defenses will likely follow along these lines:
•He did not deviate from the standard of care to which doctors are held;
•Even if he did deviate from the standard of care, that is not what caused your injuries;
•You were partially or entirely at fault yourself;
•It was solely the fault of the drug manufacturer.