Drugs and Medical Device Lawyers

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 What Are Considered Drugs and Medical Devices?

What is a Prescription Drug?

Prescription drugs are medications which cannot be legally purchased without a prescription from an authorized medical professional, including doctors or dentists. Prescription drugs differ from over-the-counter drugs, as over-the-counter drugs may be purchased without a prescription.

Prescription drugs are usually stronger, or more effective, and may have more side effects than over-the-counter drugs. Certain newer prescription drugs may also lack long-term testing and research, meaning that side effects may develop over time in some cases.

What is a Failure to Warn Regarding Defective Prescription Drugs?

There are two common legal theories which prescription drug lawyers typically use as a basis to sue manufacturers, defective product and failure to warn. A claim based on a defective product alleges that a manufacturer did not place a safe product into the stream of commerce and that product harmed the public.

A defective product is a product which either has a design flaw, for example, every single batch of the drugs made is defective or a manufacturing flaw, for example, only one batch of medication is defective. A claim based on a failure to warn alleges that a manufacturer knew of the dangers of the drug and sold the drug as it was without warning of its dangerous propensities.

Manufacturers are required to conduct years of research on a drug prior to obtaining approval from the FDA to sell it. During the research period, the manufacturer will test whether the drug is safe.

Depending upon how dangerous the drug may be, a manufacturer may or may not be permitted to sell it. If, however, a drug only has some semi-unsafe side effects, a manufacturer may still be permitted to sell the drug so long as they provide consumers with adequate warnings regarding the side effects and risks that the consumer will be taking.

It is important to note that there are some medical professionals, including doctors, pharmacists, and other professionals who may be held liable for malpractice in connection with prescriptions in some cases. An example of when this may occur would be if a doctor prescribed the wrong dosage of a drug or if they knowingly prescribed a drug which has been subjected to a drug recall.

What if I was Injured by a Drug or Medical Device?

If an individual is injured by a drug or a medical device, they should first determine what party is responsible for their injury. There are a number of parties that may be held liable for the injury, including:

  • The drug or device manufacturer;
  • The doctor who prescribed the drug or device; and
  • The pharmacist who sold the drug or device.

Each of these parties has obligations to patients under the law. The manufacturers of prescription drugs and medical devices have two basic obligations, which include:

  • Researching and understanding the following related to the drug or device:
    • The side effects;
    • The dangers; and
    • The risks of use; and
  • Informing the public regarding the following associated with the drug or device:
    • The side effects;
    • The dangers; and
    • The risks.

If a manufacturer fails to fulfill either of these duties, they may be held liable. The Food and Drug Administration (FDA) is responsible for evaluating drugs that manufacturers wish to put on the market.

Receiving FDA approval, however, does not mean that a drug is safe. In addition, it does not relieve the manufacturer from liability if a drug is later determined to be unsafe.

Doctors can also be held responsible for prescribing an unsafe drug or medical device. Doctors are obligated to inform their patients regarding the risks that are associated with the drugs or medical devices they prescribe.

If a doctor fails to tell a patient about a risk the doctor was aware of and that patient suffers an injury as a result of that risk, the doctor may be liable for the injury. Similarly, pharmacists may be held liable for issues caused by drugs.

A pharmacist may be held liable if they make a mistake filing a prescription. If the pharmacist provides the wrong drug and an individual suffers an injury as a result, that pharmacist may be held liable for those injuries.

What is Medical Product Liability?

Product liability claims are claims based upon defective, or faulty, products. The legal theory of product liability may be helpful when determining if a manufacturer can be held liable for permitting a defective medical product or device to be placed into the stream of commerce.

It is important to note that medical product liability claims are typically used for actual medical products or devices and not for medicinal or pharmaceutical-related claims, such as those for prescription drugs. There are, however, some cases where certain types of drugs may be included in a medical product liability claim.

As with all claims based on product liability, the defects in a medical product or device may fall into three categories:

  • Defective design;
  • Defective manufacturing; and
  • Defective warning labels.

Design defects occur when an entire product or device is faulty. This means that the device was never safe for consumer use and it should be re-designed in such a way that it is safe and complies with national health and safety standards.

Manufacturing defects may arise during the manufacturing process. This may occur when:

  • A manufacturer excludes a part from the device which makes it whole;
  • A manufacturer uses old or faulty parts to finish assembling a medical product; or
  • Some other issue which affects how the device is constructed.

Defective warning labels may refer to medical products or devices which lack sufficient instruction manuals, warning labels, or advertising which would notify the consumer regarding improper use or dangers which are associated with the particular medical device or product. These warnings can either be left out entirely or may just be deemed insufficient.

I Know Who Is Responsible for My Injury – What Should I Do Now?

Once an individual determines the party that is responsible for their injuries, they will likely have to file a lawsuit to recover damages for an injury caused by a defective drug or medical device.

  • If a manufacturer is responsible, an individual should file a product liability lawsuit against them. For example, filing a lawsuit against Bayer for manufacturing Essure or suing Roche for making Avastin;
  • If a physician is responsible, an individual should file a medical malpractice lawsuit against them; and
  • If the pharmacist is responsible, an individual can file a negligence lawsuit against the pharmacist and the pharmacy for their injuries.

Do I Need an Attorney to Help Me With My Drug or Medical Device Lawsuit?

A lawsuit which involves a drug or medical device may be very complex, especially due to their scientific nature. In addition to this, every state has different laws that govern drugs and medical devices.

It would be advisable to consult with a defective products lawyer to help you understand the value of your case and file a lawsuit on your behalf. It is important to consult with a lawyer as soon as possible following an injury to ensure that you do not miss the time window for filing your claim.


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