Medical Devices and Pharmaceuticals

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Since 2002 more than a dozen widely used prescription drugs have been withdrawn from the market for safety reasons.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. Numerous medical devices have also been recalled after significant injuries to patients.

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 negligence and dangerous.

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.

A defective product is one that is not reasonably safe for its intended use. An intended use of a product includes all those uses a reasonably prudent person might make of the product, bearing in mind its characteristics, warnings and labels.

Practically speaking, this means that product designers and manufacturers have a duty to sell safe products, provide adequate warning labels and repair components they know are defective or dangerous.

The manufacturer has a duty to design a safe product. If the product has an inherent danger that cannot be taken care of by design then the manufacturer must guard against those dangers. If the dangers cannot be limited by design or guarded against then the manufacturer must warn and instruct users of those dangers.

Depending upon the circumstances, the retailer, distributor and manufacturer of the defective product may all be liable to injured consumers if they fail to meet these standards.

A defective pharmaceutical or medical device lawsuit is difficult, time-consuming and expensive. It requires experienced product liability lawyers with sufficient resources to conduct extensive investigations, collect evidence, talk with witnesses and employees, obtain company records and hire experts in order to properly evaluate and prove product defects. This is especially true since the defendants in these cases are often large companies with significant resources and will vigorously defend against such claims.

Drug and Medical Device Information

The Role of the FDA in Drug Approvals
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 FDA's Role in Dietary Supplement Regulation
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 do not need approval from FDA 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 vitamin,
  • a mineral,
  • an herb or other botanical,
  • an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or
  • a concentrate, metabolite, constituent, extract.

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.

DESHA 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.

If you feel that your injury or the death of loved one is due to a prescription drug or a dietary supplement, you may have a personal injury, product liability or wrongful death claim. There are mandatory time limits in which lawsuits must be filed or you may forever lose your right to make a claim. Contact the experienced lawyers Shultz & Rollins, Ltd.

Medical Devices
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 Role of the FDA
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 see if the device does what it claims to do effectively and the device does not present any unreasonable risks to the patient.

Medical Device Recalls
Recalls may occur for a number of reasons:

  • When a medical device is defective;
  • When it could cause a health risk; or
  • When it is both defective and a health risk.

A company can 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 just 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 issues with a device by removing it from the market or place it is used).

The following are examples of actions that are considered recalls:

  • inspecting the device for problems;
  • fixing the device;
  • making adjustments to the device;
  • changing the label on the device;
  • destroying the device;
  • notifying patients of a problem; and
  • monitoring patients for health problems.

There are three classes of recalls. Class I is the most serious recall in which there is a reasonable chance that the product will cause serious health problems or death. In a Class II recall there is 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. In a Class III recall there is little chance that using or being exposed to the device will cause health problems.

If you feel that your injury or the death of a family member is due to a faulty medical device or prescription drug, you may be entitled to file a personal injury, product liability or wrongful death claim. There are mandatory time limits in which lawsuits must be filed or you may forever lose your right to make a claim.

To schedule a free confidential consultation and preliminary case evaluation to see if your case is appropriate for our firm to handle call us.

Frequently Asked Questions

If the FDA approved the drug for use in humans, doesn't that mean it is safe?
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.

What does the FDA do to ensure public safety?
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, both brand name and generic, work correctly and that the health benefits outweigh known risks. However, CDER does not actually test the drugs when determining if the drug is safe for consumers.

Does the FDA test drugs?
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.

What claims that can be made on dietary supplement labels?
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.

What is a defective medical device?
Guidant Corp. maker of the Guidant Defibrillator, advised physicians that nine pacemaker models made from 1997 to 2000 might need to be replaced. An estimated 28,000 of the pacemakers remain implanted in patients worldwide, with about 18,000 in U.S. patients. Guidant indicated that a component in the pacemakers had degraded and could cause a malfunction. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

Who is liable for harm suffered from prescription drugs or a medical device?
The parties who may be liable can include the drug or medical device manufacturer, your treating physician or the pharmacy that dispensed the medication.

What damages can be recovered in a defective pharmaceutical or medical device action for personal injuries or death?
The parties responsible for causing the injuries can be required to pay damages. A seriously injured plaintiff may be entitled to recover:
Medical expenses (past and future)
Loss of income (past and future)
Loss of earning capacity
Past and future pain, suffering and emotional distress
Loss of consortium
and, depending upon the circumstances, punitive damages.
If a person dies because of a defective product, the survivors may recover monetary damages for their economic losses such as lost financial support and funeral expenses in addition to their emotional distress damages for loss of love, society and companionship.

If I have a medical device or prescription drug claim, do I need a lawyer?
Due to the complex issues involved in prescription drug or medical device claims, discussing your case with an attorney who is experienced in the area ensures a thorough evaluation of your case.


Food and Drug Administration
The Center for Device and Radiological Health
Learn About FDA Recalls

To schedule a free confidential consultation and preliminary case evaluation to see if your case is appropriate for our firm to handle call us

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