Texas Personal Injury: Fight Defective Medical Devices

Understanding Defective Medical Device Claims in Texas

A medical device can be defective due to a flawed design, a manufacturing error, or inadequate warnings or instructions. In Texas, these claims often proceed under strict products liability and negligence. Depending on the facts, you may assert design-defect, manufacturing-defect, marketing (warning) defect, breach of warranty, and negligence claims. For design-defect claims, Texas law requires proof that a safer alternative design existed and that the defect was a producing cause of the injury. See Tex. Civ. Prac. & Rem. Code § 82.005; see also Ford Motor Co. v. Ledesma, 242 S.W.3d 32 (Tex. 2007) (producing cause standard).

Common Types of Device Defects

• Design defects: The device’s overall blueprint is unreasonably dangerous compared to a safer, feasible alternative (§ 82.005).
• Manufacturing defects: A particular unit or lot deviates from specifications or the intended design.
• Warning/marketing defects: Inadequate instructions or risk disclosures that fail to inform physicians and patients of known or reasonably knowable dangers; in prescription contexts, Texas generally applies the learned intermediary doctrine (duty to warn runs to the prescribing physician). See Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012).

Evidence That Strengthens Your Case

Successful cases are evidence-driven. Useful proof can include: device identification (model, lot/serial numbers), operative and hospital records, explant and pathology reports, treating physician notes, imaging, photographs of the device or injury, adverse event reports, communications from the manufacturer, sales representative notes, and FDA materials such as recall notices or safety communications. Preserve the device if it is explanted and request proper chain-of-custody procedures. See FDA resources on recalls and MedWatch reporting.

Recalls, FDA Oversight, and Preemption

FDA clearance or approval does not automatically shield manufacturers from Texas liability. However, federal preemption may bar some state-law claims for certain devices. For Class III devices with Premarket Approval (PMA), state requirements that are “different from, or in addition to” federal requirements are generally preempted, but parallel claims premised on violations of federal duties may proceed. See Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); cf. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (limited preemption for 510(k) devices); see also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) and Fifth Circuit applications recognizing parallel-claim pathways, e.g., Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011). FDA recalls, safety communications, and adverse event data can be persuasive evidence but are not, by themselves, dispositive of liability.

Who May Be Liable

Potential defendants can include the device manufacturer, component suppliers, distributors, and in some instances entities involved in reprocessing or repackaging. Health care providers may be implicated in limited scenarios, usually under medical negligence standards rather than product defect, depending on the facts.

Damages You May Recover

In a successful Texas product liability or negligence action, recoverable damages may include medical expenses, lost wages or earning capacity, pain and suffering, mental anguish, disfigurement or physical impairment, and, when warranted, exemplary (punitive) damages subject to statutory limits. See Tex. Civ. Prac. & Rem. Code § 41.008. Families may pursue wrongful death and survival claims if a defect causes a fatal injury. Damages limits can vary based on the type of defendant (e.g., health care providers may be subject to caps under Chapter 74).

Texas-Specific Considerations

• Design-defect burden: Plaintiffs must prove a safer alternative design and producing cause (§ 82.005).
• Proportionate responsibility: Fault may be apportioned among multiple actors. See Chapter 33.
• Learned intermediary doctrine: For prescription drugs and medical devices, the duty to warn generally runs to the prescribing physician. See Centocor, 372 S.W.3d at 166-70.
• Caps and limits: Exemplary damages are capped in most cases (§ 41.008). Health care liability claims against providers may have non-economic damage caps (§ 74.301). Case-specific analysis is required.

How Long You Have to File

Strict deadlines apply. Many Texas personal injury and product liability claims have a two-year statute of limitations (§ 16.003), and product cases are also subject to a 15-year statute of repose in most instances (§ 16.012), with limited exceptions. The specific timetable can vary based on the injury, discovery, warranties, and the identity of defendants. Act promptly to avoid missing your filing window.

Practical Next Steps if You Suspect a Defective Device

• Seek medical care and follow your physician’s advice.
• Preserve the device and packaging when possible; request that any explanted device be retained with proper chain of custody.
• Keep a record of symptoms, missed work, and out-of-pocket expenses.
• Save all instructions, warranty materials, and communications from the manufacturer or provider.
• Report adverse events to your provider and consider filing with FDA MedWatch.
• Speak with Texas counsel experienced in medical device litigation promptly to evaluate your rights.

Why Legal Representation Matters

Defective device cases are complex, often involving technical experts, federal regulatory issues, and extensive discovery against well-resourced manufacturers. An attorney can preserve evidence, engage the right experts, navigate preemption defenses, comply with Texas pleading standards, and pursue full compensation.

Ready to talk? Contact our Texas product liability team for a free, confidential consultation.

FAQ

Does an FDA recall guarantee I win my case?

No. Recalls and safety communications can support your claim but are not conclusive proof of liability. You must still prove defect, causation, and damages under Texas law.

What if my device had FDA PMA approval?

Some claims may be preempted for PMA devices, but parallel claims based on violations of federal requirements may proceed. A Texas attorney can evaluate which claims are viable.

Should I sue the doctor or the manufacturer?

Most defective device claims target manufacturers and distributors. Claims against providers are fact-specific and typically arise under medical negligence standards.

How long do I have to file?

Many claims must be filed within two years, and most product claims face a 15-year repose period, with exceptions. Deadlines vary; act quickly to protect your rights.

What is a safer alternative design?

It is a feasible, safer design that would have significantly reduced the risk without substantially impairing the device’s utility. Texas law requires this showing for design-defect claims.

Can I bring a claim if the device was used off-label?

Possibly. Off-label use does not automatically bar recovery, but it can affect warnings, causation, and responsibility. Case facts matter.

Do I need to report my injury to the FDA?

You are not required to, but filing a MedWatch report can help document the event. Talk to your attorney before submitting public reports.

What damages can I recover?

Medical bills, lost wages, pain and suffering, and in some cases punitive damages, subject to Texas statutory limits.

Will a class action cover my claim?

Many device cases proceed as individual lawsuits or in multidistrict litigation rather than class actions. Counsel can advise on the best forum.

How much will this cost?

Many firms handle these cases on contingency, meaning you pay fees only if they recover money for you. Discuss terms during your consultation.

Sources

• Tex. Civ. Prac. & Rem. Code ch. 82 (Products Liability)
• Tex. Civ. Prac. & Rem. Code ch. 33 (Proportionate Responsibility)
• Tex. Civ. Prac. & Rem. Code § 41.008 (Exemplary damages cap)
• Tex. Civ. Prac. & Rem. Code § 74.301 (Health care liability non-economic caps)
• Tex. Civ. Prac. & Rem. Code § 16.003 (Limitations) and § 16.012 (Products liability statute of repose)
• Ford Motor Co. v. Ledesma, 242 S.W.3d 32 (Tex. 2007)
• Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012)
• Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
• Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
• Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)
• Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011)
• FDA: Recalls, Market Withdrawals, and Safety Alerts
• FDA MedWatch: Safety Information and Adverse Event Reporting

Disclaimer

This blog post is for general informational purposes only and is not legal advice. Laws change and outcomes depend on specific facts. Reading this post does not create an attorney-client relationship. Consult a licensed Texas attorney about your situation.