Before a medication can be sold in the United States, the Food and Drug Administration (FDA) must review the medication and approve it for sale. Once the FDA's Center for Drug Evaluation and Research (CDER) approves the drug, it can be prescribed for the specified approved purposes. This process, however, does not guarantee that the drug is safe. In addition, drugs approved by the FDA are often times used for "off-label" purposes.
Since 2002, more than a dozen widely used prescription drugs have been withdrawn from the market for safety reasons. Nine of those recalled drugs were approved since 1993, when the Food and Drug Administration agreed to "fast-track" review and approval of more drugs.
Many of these drugs were approved without adequate testing, and have resulted in patients' injuries and deaths in Tucson, Yuma, AZ and throughout the country. Numerous medical devices have also been recalled after significant injuries to patients. This is one of the subjects our Yuma and Tucson defective medical device attorney Department at Shultz & Rollins are very educated on.
With the help of an experienced Tucson and Yuma, AZ defective medical device lawyer, individuals can bring claims against the manufacturer for injuries or death caused by drugs, medical devices and other pharmaceutical products. Manufacturers can be held liable based on theories of strict liability, negligence or for failing to warn about potentially dangerous side effects caused by prescription drugs, over-the-counter medicines, medical devices and herbal supplements.
Consumers trust drug and medical device manufacturers to produce safe and effective products. If a manufacturer acts negligently, its actions can result in serious medical complications for the consumers of their products.
Drug manufacturers are required to comprehensively test each product before seeking approval from the FDA. Additionally, each drug's label must disclose full information about the product's potential side effects. Failure to warn of the risk of serious side effects such as heart attacks and strokes is negligent and dangerous and a potential case for a defective medical device attorney in Tucson or Yuma.
Defective products are those that are not reasonably safe for their intended use. In other words, the product must be safe for all uses a reasonably prudent person might make of it, taking into consideration its characteristics, warnings and labels. As such, product designers and manufacturers are responsible for:
Manufacturers must design safe medical products. If a component of the product is inherently dangerous and cannot be resolved through design changes, the manufacturer must guard against those dangers. If this is not possible, they must warm and instruct users about the risks associated with the product. If these standards are not met, the retailer, distributor and manufacturer may all be held liable to injured consumers.
Defective pharmaceutical or medical device lawsuits are difficult, time-consuming and expensive. They require skilled Yuma and Tucson defective medical device lawyers with the experience and resources necessary to:
It is important to select a skilled defective medical device lawyer in Yuma, AZ and Tucson with experience in successfully handling complex cases against large companies and manufacturers, as the defendants in these cases often have access to significant resources and will vigorously defend themselves against such claims.
Drug companies hoping to sell their products in the United States cannot do so until the Food and Drug Administration (FDA) reviews the medication and approves it for sale.
The FDA does not guarantee the safety of drugs. Once the FDA approves a drug for a particular use, patients who are injured by that medication — whether it is used for its approved purpose or for some other reason (known as "off-label" use) — must look to the manufacturer if they are harmed or injured.
Manufacturers often contend that, because the FDA approved the medication, the manufacturer should not have to answer for any harm or injuries the medication caused.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) governs the regulation of dietary supplements. DSHEA also sets forth rules for making claims about products and information that must appear on labels.
Before Congress enacted DSHEA, dietary supplements were regulated by the Food and Drug Administration (FDA) as food. Under DSHEA, the manufacturer is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements are not reviewed by the FDA for safety and effectiveness before they are marketed.
The Dietary Supplement Health and Education Act defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.
DSHEA does require dietary supplement labels to have the ingredients listed on them. The information must include the name and quantity of each dietary ingredient or for proprietary blends, the total quantity of all dietary ingredients in the blend. The label must also state that the product is a "dietary supplement" and contain nutritional information. It must list dietary ingredients in "significant amounts" for which the FDA has established daily consumption recommendations and a list of ingredients with no daily intake recommendations.
Under Section 201 of the Food, Drug and Cosmetic Act, a medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Examples of medical devices include: breast and other cosmetic implants, orthopedic screws, hip implants, knee implants, defibrillators, heart valves and many other items.
The Center for Device and Radiological Health, a division of the Food and Drug Administration (FDA), is responsible for regulating medical devices and radiation-emitting products. The CDRH screens and approves medical devices.
Before granting approval to manufacturers to sell their new devices, CDRH scientists review the manufacturer's data from investigational studies to determine if the device does what it claims to do effectively without presenting any unreasonable risks to the patient.
Medical device recalls may occur for a number of reasons, including:
A company can also voluntarily recall a medical device or the FDA can require a company to recall a device.
If a particular medical device is recalled, it does not always mean that you must stop using the device. It could simply mean that the device needs to be checked or fixed. A recall can be a correction (which addresses a problem with a medical device in the place it is used or sold) or a removal (which addresses an issue with a device by removing it from the market or place it is used).
The following are examples of actions that are considered recalls:
is the most serious recall in which there is a reasonable chance that the product will cause serious health problems or death.
recalls are associated with a less serious risk than in a Class I recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.
recalls involve very little chance that using or being exposed to the device will cause health problems.
If the FDA approves a drug, it means that the FDA has determined that the drug's benefits outweigh its known risks. An FDA-approved drug is not necessarily safe for everyone.
The FDA reviews a manufacturer's research to determine whether the drug actually works and if it is safe for most people. Since some serious side effects are rare, they may not be discovered before the drug is approved.
The Center for Drug Evaluation and Research (CDER) – part of the Federal Drug Administration (FDA) – is responsible for examining the applications and then weighing the evidence submitted by drug manufacturers when they seek approval for a new drug.
CDER ensures that prescription and over-the-counter drugs, including biological therapeutics and generic, work correctly and that the health benefits outweigh known risks. For example, fluoride toothpaste, antiperspirants, dandruff shampoo and sunscreen are all considered “drugs.” However, CDER does not actually test the drugs when determining if the drug is safe for consumers.
The FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies so that the CDER can evaluate the data. The studies answer the question: "Does this drug work for the proposed use?" By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved.
DSHEA provides that various statements can be used on dietary supplement labels. Dietary supplements cannot contain claims about the use of the supplement to diagnose, prevent, mitigate, treat or cure a specific disease.
Under DSHEA, only drugs can "treat, prevent or cure" a medical condition. Instead, manufacturers of dietary supplements and herbal remedies can make health claims, nutrient-content claims and structure/function claims.
These terms are defined in DSHEA. The statute provides that if the manufacturer makes one of these permissible claims, it also must provide a disclaimer on the product label that advises the consumer that the FDA has not evaluated the truth of the claims.
Da Vinci Surgical Robots are used for surgical procedures instead of the surgeon’s hands. The advantages of using a mechanical arm can be less risk of a trembling human hand, a clear line of sight to a hard to reach operating area and less surgeon fatigue because they are in a seated position while operating. However, patient injuries are common and its estimated that more than 70 deaths have been caused by the Da Vinci Surgical Robots.
Problems with the Da Vinci Surgical Robot have included malfunctioning arms, system errors, video/imaging problems, unintended operation of instruments and electrical problems. When malfunctions occur with the Da Vinci Surgical Robot, the surgery must be converted to non-robotic techniques. Common patient injuries from the Da Vinci Surgical Robot include burns, cuts, damage to organs/tissue and even death.
An experienced defective medical device attorney in Yuma, AZ and Tucson, AZ can help you determine who is responsible for your injuries. In general, parties who may be liable can include the drug or medical device manufacturer, your treating physician or the pharmacy that dispensed the medication.
The parties responsible for causing the injuries can be required to pay damages. A seriously injured plaintiff may be entitled to recover:
If a person dies because of a defective product, the survivors may recover monetary damages for their economic losses. These may include lost financial support and funeral expenses, in addition to their emotional distress damages for loss of love, society and companionship.
Due to the complex issues involved in prescription drug and medical device claims, discussing your case with an experienced defective medical device attorney in Yuma or Tucson will ensure a thorough evaluation of your case.