Product Liability Lawyers in Maryland for Defective Product, Drug and Medical Device Injuries

The Law Offices of Alex Poberesky, P.A. represents Maryland consumers who were hurt by a defective or dangerous product, from a household appliance to a prescription drug, and the responsible party can range from a manufacturer to a distributor or seller.

Pharmaceutical and medical device injuries often raise issues a broken appliance never will, including an FDA regulatory history and, in some cases, a drug or device that was used off-label, which can be relevant to a claim depending on the facts.

Alex Poberesky can review your injury and help you understand whether a claim may be available. Call (410) 834-4292 for a free consultation to discuss your options.

What is Pharmaceutical Drug Liability?

Pharmaceutical product liability claims involve injuries allegedly caused by a defective or dangerous prescription or over-the-counter drug. Depending on the circumstances, a claim may involve a manufacturing defect, defective design, inadequate warnings, or other conduct that may make a manufacturer or another responsible party legally liable. FDA approval does not automatically prevent a product liability claim, but the effect of FDA approval and the specific facts of the injury must be evaluated in each case.

The makers of pharmaceutical drugs have an obligation to evaluate all of the drugs and medicines that they sell to consumers before they put them on the market through approved testing mandated by the U.S. Food and Drug Administration (FDA). However, it should be noted that even if a drug is approved and subsequently licensed by the FDA, this has no effect on a manufacturer’s liability. A manufacturer can still be held liable for any injury that a consumer may experience from using the medication in question.

Off-Label Drug and Mdedical Device Injury Claims

A prescription drug or medical device may sometimes be used for a purpose that differs from the indication described in its FDA-approved or cleared labeling. This is commonly referred to as off-label use. For prescription drugs, physicians may prescribe an approved medication for a use that is not specifically listed on its FDA-approved label. Medical devices may also be used outside their cleared or approved indications, depending on the circumstances.

Off-label use is not automatically illegal, and it is not automatically evidence that a drug or device is defective. Physicians are generally permitted to make off-label treatment decisions as part of the practice of medicine.

Whether an injury involving off-label use raises a legal issue depends on the specific product, how it was used, what warnings accompanied it, and the conduct of the manufacturer or other parties. Depending on those facts, an off-label injury may raise questions of product liability, failure to warn, or negligence. Alex Poberesky can review the facts of an off-label drug or medical device injury and help you understand whether it may support a claim.

Pharmaceutical Product Liability Claims in Maryland

Pharmaceutical liability claims can involve a drug’s design, manufacturing process, warnings, or known risks. FDA approval does not automatically prevent a manufacturer from being held liable when a drug causes an injury under circumstances recognized by Maryland law.

The Learned Intermediary Rule and a Drug Maker’s Duty to Warn

Maryland recognizes the learned intermediary rule for prescription drugs. Under the doctrine, a prescription drug manufacturer generally has a duty to provide adequate warnings about known risks to the prescribing physician or other appropriate health care professional rather than directly to the patient. Whether the doctrine applies in a particular case depends on the facts, including the product involved and the warnings provided.

Medical Device Product Liability Claims in Maryland

Medical devices such as joint replacements, cardiac devices, and surgical mesh can be the subject of a claim when a design flaw, a manufacturing defect, or an inadequate warning caused an injury. FDA clearance or approval does not automatically establish that a device is safe, and it does not automatically prevent a claim.

Consumer Product Liability Claims in Maryland

Not every claim involves a drug or a medical device. Household products, children’s products, appliances, tools, and electronics can cause a serious injury when they are defectively designed, manufactured, or labeled, and the same defect and warning principles apply.

Who May Be Responsible for a Defective Product Injury

More than one party can potentially be responsible, depending on the product and the facts, including the manufacturer, a distributor, a supplier, the seller, or a pharmaceutical or medical device company. Not every party in that chain is automatically liable; responsibility depends on Maryland law and what each party knew or should have known.

Evidence That Can Support a Maryland Product Liability Claim

The following can help establish a product liability claim, though not every case requires every type of evidence:

• The product itself, along with its packaging, labeling, instructions, and warnings

• Purchase and medical records

• Photographs and video of the product and the injury

• Product manuals and communications concerning the product

• Expert analysis and documentation of the injury and its treatment

In a pharmaceutical or medical device case, medical records and product-specific documentation, such as a device’s model and lot number, are often particularly important.

Compensation for a Maryland Product Liability Injury

Depending on the nature of the injury and the legal claims available, compensation may include:

• Medical expenses and ongoing medical treatment

• Lost income and diminished future earning capacity

• Pain and suffering

• Other losses permitted under Maryland law

The damages available in a product liability case depend on the facts, the severity of the injury, and the legal claims that can be established. No particular settlement or recovery can be guaranteed.

How a Maryland Product Liability Lawyer Investigates Your Claim

Product liability cases usually require more investigation than a typical injury claim. That process can include:

• Reviewing the circumstances of the injury and identifying the product and its manufacturer

• Preserving the product and related evidence before it is lost or discarded

• Reviewing warnings, instructions, and medical records to investigate a possible design or manufacturing defect

• Consulting experts and evaluating the manufacturer’s conduct to assess which legal claims may be available

• Handling insurer communications and preparing for litigation when a case does not resolve through negotiation

Personal Injury Experience Behind Every Maryland Product Liability Claim

The Law Offices of Alex Poberesky, P.A. has more than 26 years of experience representing individuals and families across Maryland, Virginia, and the District of Columbia in personal injury cases, including product liability and medical malpractice. That background carries over to the complex injury and causation issues that pharmaceutical and medical device cases often raise, along with experience negotiating with insurers and preparing a case for litigation when a fair settlement is not offered. Case evaluations are free.

What Turns an Off-Label Injury Into a Possible Legal Claim

In order for a product’s liability claim to stand up in court, there are four particularly important elements that must be proven. They are as follows:

• The product itself was defective when it left the control of the manufacturer. For example, the manufacturer is not held responsible for a product being defective if the cause of the defect was due to shipping after leaving the manufacturing area.

• The product is proven to be unreasonably dangerous to the consumer. This means that the dangers posed by the product cannot reasonably be assumed when using it. For example, when you use a knife, there is a reasonable expectation that if it is used incorrectly, you may cut yourself and sustain an injury.

• The product’s defects are what caused the victim to have injuries. Your attorney must prove that your injury was directly caused by the defective product. Additionally, they must demonstrate that you used the product in accordance with prescribed safety measures.

• There were no conditions that occurred to cause the product to have a change in its condition prior to reaching the consumer.

There are many legal issues that can make product liability law difficult to understand. Our skilled product liability attorneys can assist you in determining if your potential case meets the criteria as described.

Frequently Asked Questions About Maryland Product Liability Claims

Do I have a case if I used the drug or device exactly as prescribed and still got hurt?

You may. A drug or device can still cause a legally significant injury even when used exactly as prescribed, if a design defect, manufacturing problem, or inadequate warning was involved.

My doctor used a device or prescribed a drug off-label without telling me. Does that affect my options?

It can. What you were told about an off-label use and its risks can be relevant to a failure to warn or informed consent issue, though an attorney would need to review your records to evaluate this.

Do I still have a claim if I no longer have the product that injured me?

It is still worth discussing with a lawyer. Medical records, purchase records, photographs, and other documentation can support a claim even when the product itself is no longer available.

Does FDA approval or clearance mean a drug or medical device is legally safe from a claim?

No. FDA approval or clearance does not guarantee safety and does not automatically prevent a claim; a manufacturer can still be held responsible depending on the facts.

How long do I have to file a product liability claim in Maryland?

Maryland generally has a three-year statute of limitations for many personal injury claims, but the deadline can depend on the legal theory involved and the circumstances of the injury. Certain claims may be subject to different limitation or repose rules. Because missing a filing deadline can prevent recovery, it’s important to have an attorney review the timing of your potential claim promptly.

Can I still pursue a claim if the product was recalled after my injury?

A recall is not required to bring a claim, and a later recall does not by itself prove it caused your injury, though it can be relevant evidence.

If a defective or dangerous product, drug, or medical device injured you or a family member in Maryland, including an injury involving an off-label use, call the Law Offices of Alex Poberesky, P.A. at (410) 834-4292 for a free, no-obligation consultation to discuss what happened and your possible legal options.