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Product liability claim for defective medical equipment

If you were injured or harmed by the use of a defective medical device in Los Angeles and you need to sue the manufacturer or any other person responsible for recovering damages, do not hesitate to contact our expert product liability and personal injury attorneys at Lluís Law. We have been dealing with this type of case for more than 50 years and helping victims obtain justice.

Medical devices are those products used by medical professionals for the treatment of patients with some type of disease. They serve for the diagnosis, prevention and treatment of various conditions and injuries. However, these devices sometimes fail and cause injuries to patients, unfortunately.

In such a situation, the patient has the right to file a product liability claim for defective medical equipment to obtain compensation.

There are numerous medical devices sold in the US market, which could at some point present a flaw in its design or operation and be the cause of damage to the health of patients. The most common are:

  • Hip ​​or knee prosthesis (replacements)
  • Breast implants
  • Heart pacemakers and valves
  • Heart stents
  • Defibrillators
  • Intrauterine devices, contraceptive implants
  • Heart valves

Medical devices are acquired by doctors’ offices, hospitals and clinics for the treatment of patients. Although it is assumed that before any of these devices are put on the market, they are subjected to strict quality tests, the fact is that sometimes they fail.

To approve the use of a medical product, the Food and Drug Administration (FDA) requires a series of very strict controls and tests of the product, precisely to ensure that it is safe and fulfills the function for which it was created. But not always all the products that are acquired have the same quality.

Patients harmed by the use of a defective medical device, have the right to file a claim or take a civil action against the manufacturer or any other person responsible, in order to recover damages.

Compensatory damages for the responsibility of the medical product

The medical expenses in general, both present and future, the expenses in medicines and transport to medical consultations paid by the pocket worker and the lost wages, are part of the recoverable damages in a case of responsibility of the medical product. Also, pain and suffering, specialized exams and rehabilitation therapies, among others.

When there is also intentional or deliberate damage on the part of the responsible person, in this case the doctor or the clinic, the claim for civil liability could include punitive damages. Punitive damages, also called exemplary damages, are those in which the defendant is sought to punish the defendant so that he reforms his behavior or succeeds in dissuading the accused and other persons from returning to commit a similar act.

Origin of faults in medical devices

The causes or origin of faults in medical devices can be found during:

  • The product design phase
  • The manufacturing phase of the product / device
  • The marketing or distribution phase

It can also be during the combination of two of these phases. The stages of development of a medical device range from the research and development of the product to its final distribution. After the research ends, it passes to the design and manufacturing department and, subsequently, various samples are processed and subjected to rigorous tests to ensure their usability, safety and compliance with functions.

In this last phase, the product must pass the tests of the FDA for then if receive the approval that will allow the manufacturer its marketing and distribution. That’s when it goes on the market and can be purchased by doctors, hospitals, clinics and any other medical provider. Despite all this process, some products are not suitable for use due to manufacturing defects.

Design flaws

These problems occur during the design stage of the product. The failure of the device does not necessarily mean that the product is harmful or dangerous to the health of the person who uses it. However, it can cause discomfort due to its size or because some of its parts do not fit well with the body of the person.

A product design defect can be the subject of a product liability claim when it causes direct harm to a person (for example, injury or acceleration of a disease).

In legal disputes over the design of a medical device, the court bases its decision on two tests or basic rules regarding whether the damage to the patient was directly caused by the defect in the product. These are:

1. The rule of consumer expectations

This rule establishes that the seller of a product is responsible if the product has a defect and is a dangerous unjustified for the consumer. During a trial, the jury can infer the existence of a defect in the product when it does not meet the reasonable expectations that consumers have.

Moreover, when it is not possible to present evidence to prove the manufacturing defect, the plaintiff can claim his right to recover damages by demonstrating that the product did not work according to “the reasonable expectations of the user”.

2. The equilibrium rule of the risk utility

Under this test the manufacturer is liable, if the probability of injury caused by the current design or product warning is much greater than the economic cost of an alternative reasonable design. To them we must add the decrease in utility as a consequence of the design modification.

In a trial, according to these rules, it is appropriate to establish sanctions for a design defect of the medical device when it is:

  • Very dangerous because of its design.
  • Predictably unsafe for the use that was created.

Devices for cardiovascular, gastroenterological and urological use, together with orthopedic devices are among the implants that have the highest number of withdrawals and demands in the United States market.

Manufacturing defects

Medical products (equipment and supplies) are generally manufactured by large global corporations. These processes are very delicate and involve specialized personnel who are in charge of setting up the machines and permanently assessing their optimum performance.

Manufacturing problems in the medical equipment and supplies industry are not frequent, but they occur, as in the pharmaceutical, automotive, chemical, etc. industries. For whatever reason, defects in materials, breakdowns in machinery, irregular manufacturing processes or human errors can result in a defective final product.

The biggest problem with defective medical products arises when the flaws are not visible but hidden. Then when they are acquired and used is when their failure is detected.

It must be borne in mind that in order to present a claim or demand for liability of the medical product, it is necessary to verify and demonstrate that the manufacturing defect of that product directly caused damage.

An example of this type of defective products can be breast implants with defects. Some women reject the breast implants placed on them or for some reason they break causing serious consequences for their health.

Common case One of the breast prostheses that Mary placed to increase the bust, after a while it burst causing severe damage and putting her health at serious risk, so she had to undergo surgery to remove and replace the defective implants.

The problem of defective implants was in the gel used by the manufacturer, which did not meet quality standards. By tearing the silicone material that contained the gel and spilling into Mary’s body, she suffered inflammation and severe pain and doctors warned about the danger of cancer.

Suffice it to recall the scandal that erupted in March 2010 around the world in the case of implants of defective breast prostheses manufactured by the French company PIP (Poly Implants Prothèses). The company had to withdraw its products from the market and it was sued by thousands of women who acquired this defective medical device.

Marketing flaws / warning flaws

After the design, manufacturing and testing stage, the commercialization phase begins. It is not enough with an impeccable design and manufacturing process, so that the use of a product can be dangerous. The potential damages that a product can cause range from injuries to death due to improper use (negligence).

When sellers do not sufficiently explain to buyers (doctors, health service providers) the proper use of a product with the potential to cause harm, it can be dangerous. It is assumed that the distributors of the medical device, are sufficiently trained on the correct use of the product and the existing risks for misuse.

When the correct use of a device is not fully explained and its contraindications are promptly described to medical providers, there is a risk that the product is not used improperly and causes harm to patients.

In this case, the failure to fully explain the correct use of the medical device could have been at the manufacturer (labeling) or at the distributor if it did not test and sufficiently explained its mode of use to the purchaser. This warning failure constitutes an obvious negligence that may be the subject of a lawsuit.

Demonstrate product responsibility

To demonstrate negligence in a product liability case for medical devices in a lawsuit against the manufacturer, the following legal elements must be proven:

  • That the manufacturer had the duty to take care of and avoid harming consumers.
  • That the manufacturer breached his duty by adopting negligent conduct / actions.
  • That negligence was the direct cause of the injuries.
  • When injured, the person suffered recoverable or compensable damages.

What does the specialist lawyer do in these cases?

Claims for product liability for defective medical equipment are among the most complex cases to handle in the legal system of California and the United States. The lawyer representing a victim of personal injury must be an experienced and trained professional.

Firstly because during the trial you will have to face very influential law firms serving very powerful pharmaceutical corporations and secondly because demonstrating the negligence of the manufacturer of the medical device is not an easy task.

The manufacturer will hardly admit his fault, because in doing so he will have to withdraw from the market thousands of similar products, allegedly defective as well. In addition to the damage that this causes to your image and the associated market loss.

If you or a loved one were injured by a medical device, you can count on Lluís Law’s law firm. Our expert lawyers in medical device and personal injury liability can help you with your claim or claim for damages. Do not hesitate to contact us for a free consultation. Our telephone number is (213) 320-0777.

Address: 205 South Broadway, Suite 1000 Los Angeles, CA 90012. Tel: (213) 687-4412 Fax: (213) 687-3441.

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