Houston Harris County Medical Device Lawyer | Houston Defective Medical Device Attorney | Houston Product Liability Law Firms

Products Liability applies not only to everyday household items or dangerous drugs, but also to many medical devices that fail to perform as they should. It is not surprising that medical devices themselves can hurt you. If you were hurt by a defective drug or defective medical product, call a Houston Defective Drug Lawyer.

Defective pacemakers cause deaths every year in cities like HoustonMedical devices encompass a broad range of equipment that Houston residents use.  For example, medical devices could include complicated machines that are ONLY to be used by trained professionals in the medical industry, or they could be other, less intense mechanisms such as everyday items like denture cream or blood testing equipment.  Regardless of what a medical device is used for, there are two things you can always be sure of: 1) the device is intended and expected to improve your health, and 2) the device is never expected to cause you serious injury or death.

Unfortunately, many times, these devices will lead to unforeseen consequences.  If you have experienced an unsafe medical device, it is always advisable to seek the advice of an experienced Houston Texas Products liability or Houston Texas medical device lawyer for assistance.

There is a serious cause for concern when it comes to the safety of medical devices in the 21st century.  Perhaps this is because there have been so many product recalls in the past decade.  In the first half of 2010 alone, twenty-one (21) medical devices were recalled by the U.S. Food and Drug Administration (FDA).  The reason the FDA recalled so many medical devices was because they were noted to present a risk of serious injury or death to the party who used them.  The 21 product recalls were more than double the number of recalls for medical devices in the first half of 2009.

What is the FDA approval process?

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating corporations who manufacture, repackage, relabel, and/or import medical devices sold in the United States.  The FDA approval process occurs toward the end of the drug development process. This means that the drug manufacturer has already invested a lot of money before the FDA ever sees the potential drug and, if it is not approved, the manufacturer will lose a significant amount of money. These companies are for profit companies and they will do almost anything to get their drugs approved. Finally, the FDA, like all governmental units, is always under-funded. Thus, the FDA actually looks to the drug manufacturing companies to provide money and research assistance to reach its conclusion on the safety of the drug. This poses a very real conflict of interest that can ultimately prove harmful, even lethal for Houston consumers of medical devices.

For a medical device to be marketed to consumers, it must first be approved by a division of the FDA known as the Center for Devices and Radiological Health (CDRH). This agency is responsible for testing and approving every medical device to ensure that it will be safe and effective for consumers to use. The FDA may request a voluntary recall by the manufacturer or issue one itself if the device is found to be unreasonably dangerous or defective; however, as with dangerous drugs, many devices are introduced into the market that end up causing excruciating pain and suffering, or even death, to consumers.

Medical devices are divided in to three categories.  These categories are titled Class I, II, and III. The reason for three classes is because FDA regulatory control increases from Class I to Class III. For example, most Class I medical devices are exempt from the FDA approval process called Premarket Notification 510(k).  Additionally, most Class II devices will require Premarket Notification 510(k).  Finally, most Class III devices require Premarket Approval.  To learn more about the approval process for medical devices in Houston, Harris County, Texas and throughout the rest of the United States, please contact a Houston Products Liability attorney for assistance.  These attorneys are experienced in all aspects of products liability and medical device recall law and will be happy to assist you.

What are the regulatory requirements for manufacturers of medical devices?

As stated, premarket notification is one of the stages in the FDA approval process. This is just one of many stages. The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

Establishment Registration, Medical Device Listing, Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), Investigational Device Exemption (IDE) for Clinical Studies, Quality System (QS) Regulation, Labeling Requirements, and Medical Device Reporting (MDR)

What Manufacturers of medical devices are required to list their device with the FDA?

Most manufacturers must list their devices with the FDA. The companies that are required to list their devices include: manufacturers, contract manufacturers that commecially distribute the device, contract sterilizers that commercially distribute the device, repackagers and relabelers, specification developers, reprocessors single-use devices, remanufacturer, manufacturers of accessories and components sold directly to the end user, U.S. manufacturers of "export only" devices, and Medical Device Listing.

Who files Houston, Texas drug injury lawsuits and handles medical device cases?

Houston and Harris County drug injury lawsuits and medical device cases are brought by persons when a dangerous drug or medical device causes them injury. Usually, the product is known to be potentially dangerous and is sold without a proper warning to the consumer. It does not matter if the medical device is recommended by a doctor, or purchased in a local Houston area drugstore. If you or a loved one has suffered injury and you believe that a dangerous drug or medical device is to blame, contact a Houston medical device recall attorney today.

Additionally, in Texas, the spouse of a person injured by a dangerous drug or medical device may bring a loss of consortium claim for any damages to their marital relationship resulting from the dangerous drug or device. A loss of consortium claim encompasses a broad spectrum of damages, including loss of love, affection, support, companionship and sexual relations. Spouses may also wish to speak with a Houston drug recall lawyer if their loved one was injured or died as the result of a dangerous drug or device. If you are unsure if a medical device has been recalled, you mat research the device on the FDA Medical Device Recall Web Site.

If you would like to report a problem regarding an FDA-regulated product or device directly to the FDA, please visit and follow the reporting procedure at the FDA website. Also make sure to contact an experienced Houston drug injury attorney regarding your legal rights.

What are the duties of a medical device manufacturer or pharmaceutical company regarding the safety of their products?

Defective hips, defective knees and other Houston product liability casesThe obligation of a drug manufacturer is to make a safe product. This includes the obligation to design, manufacture, inspect, and label a drug or medical device product appropriately. They must provide patients and physicians complete safety information about their product. If a drug manufacturer fails to warn the public about any serious side effects associated with taking its drugs and the drug is responsible for causing you harm, then the company can be held liable for medical expenses, therapy and treatment, lost income, and non-economic damages, such as pain and suffering.

If you or a loved one experienced a serious side effect as a result of an unreasonably dangerous drug or medical device, you are entitled to compensation from the manufacturer. Contact a local Houston products liability attorney today.




The following dangerous or defective medical devices are also responsible for Houston injuries and deaths:

Guidant Curlin Painsmart Pump Charit
Medtronic Pacemakers Zimmer Durom Cup Hip Implant
Calaxo Screw Implantable Cardioverter Defibrillators (ICDs) Stryker CMF Custom Cranial Implant Kits
ObTape Sling Contaminated Heparin Syringes DePuy ASR Hip Implants
Duragesic Patch Shoulder Pain Management Pump Zimmer Hip Replacements
Inbone Total Ankle Shelhigh Medical Device Seizure Forteo starter kits containing Triad Group alcohol prep pads

The above table is by no means exclusive. If you or a family member has suffered a serious reaction or death due to a dangerous drug or medical device, you might be entitled to compensation from the company that markets and manufactures the drug. Contact a Houston drug recall attorney or Harris County drug recall attorney today to help you protect your rights. To see the most recent FDA medical Devices recalled, follow the FDA Recall feed

Drug related injuries are caused by:


  1. Medical devices sold without warnings as to the hazards;
  2. Medical devices sold with side effects; and
  3. Medical devices sold that tend to cause long term use, or withdrawal symptoms

Types of Drug Labels and Black Box Warnings

A black box warning is a type of warning that appears on the package insert for prescription drugs and medical devices that may cause serious adverse effects. It means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The FDA can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires. These so-called black box warnings have even been placed on anti-depressants for children, since an alarming number of children have committed suicide while taking anti-depressants.

Also, the FDA has supplied guidance on what should be included as to drug reactions, and how adverse reactions should be presented in drug warnings. A Houston, Texas drug recall lawyer can advise you on whether a proper warning is present on a drug you have taken and whether you may have a claim against the manufacturer.

See below for more information on Houston, Texas class action lawsuits and multi-district litigation suits involving dangerous drugs and medical devices. Houston drug recall attorneys are some of the best in the nation and are able to bring multi-district or class action lawsuits in defective drugs cases. Click here to read the Texas Products Liability Statute.


Houston Drug Class Actions

Houston Drug Class Actions are seen very rarely after a series of Texas Supreme Court rulings that placed obstacles in the way of certifying and winning a dangerous drug class action lawsuit. Additionally, the Texas Legislature adopted Chapter 26 of the Civil Practice & Remedies Code, which also places obstacles on the formation, or certification, of class actions. Finally, even the U.S. Congress, under President Bush, addressed class actions under the Class Action Fairness Act of 2005, which severely tightened the availability of national class action lawsuits. However, in certain cases, a judge may certify a class action lawsuit, and this happens occasionally with defective drug lawsuits. If you believe a defective drug has injured you, contact a Houston drug recall attorney today.

Multi-District Litigation (MDL) Drug Lawsuits

If an MDL has been formed pertaining to a drug that you took and from which you may have suffered adverse effects, it is essential that you retain a lawyer that actively practices in Federal Court and is familiar with the very specialized practice in MDL. Houston products liability attorneys are experienced in handling MDL and complex class actions lawsuits.

Who may be Liable for a Drug Injury or Medical Device Injury?

The designer, manufacturer, and others involved in the chain of commerce, including the distribution of the products that caused the injury or illness, can be held responsible or liable for injuries and illnesses caused by the defective drug or medical device product. Houston drug injury lawyers will identify and pursue your claims against all potentially liable parties to recover your damages and losses.

Steps to make a claim for Houston defective drug injuries & Houston defective medical device injuries:

1. You must be able to prove that you took the drug or used the medical device. If it was purchased over-the-counter, then a receipt or a credit card statement would do. Sometimes it can take years to discover that a medication or a medical device could be dangerous or otherwise defective, and this typically occurs after several people have already suffered debilitating injuries or wrongful death due to their use of the product. Obviously, if it was a prescription medication, proving that you took it is much simpler, but you should always do your best to document and record all pertinent evidence relating to your use of the drug and the effects that you suffered as a result;
   2. You need to show that the drug or medical device caused a physical injury or illness (including psychological and/or mental illness) as the result of a defect in the medication or device, or its labeling;
   3. If you or a loved one has been injured or has fallen ill due to what you believe is a defective drug product or device, do not delay in seeking immediate medical attention, as prompt diagnosis and treatment may help to avoid irreparable damage. It is also important to take immediate legal action, as restrictive Statutes of Limitations can prevent you from collecting the compensation to which you are entitled. Successful defective drug litigation sends a clear message to the pharmaceutical industry about accountability and consumer safety. For more information, contact one of the skilled Houston defective drug litigation attorneys listed at the top of this page.

How can a Houston Drug Recall Attorney or Houston Defective Medical Device Attorney help you?

An experienced lawyer can help you recover the money you deserve. Texas law limits the amount of time you have to file a lawsuit under something known as a Statute of Limitations. After the applicable time period has passed, you may be legally barred from exercising your rights. In Texas, the limitations period is two (2) years from the date that the cause of action accrues, which is usually the time of injury. If you or a loved one has experienced a severe adverse reaction to a prescription or over-the-counter drug, or to a medical device, it is in your best interest to contact a Houston personal injury attorney who will fight to get you the compensation and settlement you deserve. Contact one of the attorneys listed at the top of this page for a free consultation regarding your injury before Texas' two-year limitations period expires and your right to financial compensation has been forfeited!

Successful medical device litigation sends a clear message to the pharmaceutical industry about accountability and consumer safety.  A qualified defective drug lawyer can uncover all of your legal rights and discuss your litigation options with you, including you may file your lawsuit and claims.


11th Civil District Court
Harris County Civil Courthouse
201 Caroline Street, 9th Floor
Houston, TX 77002
(713) 368-6020
55th Civil District Court
Harris County Civil Courthouse
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Houston, TX 77002
(713) 368-6055
61st Civil District Court
Harris County Civil Courthouse
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Houston, TX 77002
80th Civil District Court
Harris County Civil Courthouse
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Houston, TX 77002
(713) 368-6100
125th Civil District Court
Harris County Civil Courthouse
201 Caroline Street, 10th Floor
Houston, TX 77002
(713) 368-6141
127th Civil District Court
Harris County Civil Courthouse
201 Caroline Street, 10th Floor
Houston, TX 77002
(713) 368-6161
129th Civil District Court
Harris County Civil Courthouse
201 Caroline Street, 10th Floor
Houston, TX 77002
(713) 368-6180
133rd Civil District Court
Harris County Civil Courthouse
201 Caroline Street, 11th Floor
Houston, TX 77002
(713) 368-6200


Acuity Hospital of Houston
2001 Hermann Drive
Houston, TX 77004
Memorial Hermann Hospital
6411 Fannin Street
Houston, TX 77030-1501
CHRISTUS St. John Hospital
18300 St. John Drive
Houston, TX 77058
Methodist Willowbrook Hospital
18220 Tomball Parkway
Houston, TX 77070
Cypress Fairbanks Medical Center Hospital
10655 Steepletop Drive
Houston, TX 77065
Michael E. DeBakey VA Medical Center
2002 Holcombe Boulevard
Houston, TX 77030
Houston Northwest Medical Center
710 FM 1960, West
Houston, TX 77090
Lyndon B. Johnson General Hospital
5656 Kelley
Houston, TX 77026
(713) 566-5100

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