Not every birth injury is caused by a doctor or a nurse. Sometimes the device fails, the infusion pump delivers the wrong dose, the catheter breaks off, or the medication carries undisclosed risks. Our M.D./J.D. medical-legal team builds layered cases that hold doctors, hospitals, AND manufacturers accountable — recovering from every responsible party.
The Alvarez Law Firm's catastrophic birth injury practice covers more than doctors and nurses. We also represent families harmed by defective medical devices and pharmaceuticals used during pregnancy, labor, or the newborn period. A traditional malpractice firm may overlook the product side of a case. We do not — because the manufacturer's liability is often as large as the hospital's, and missing it leaves money on the table.
A product liability claim can be brought on several legal theories. Defective design means the product is unreasonably dangerous as conceived. Defective manufacturing means an individual unit was made incorrectly. Failure to warn means the manufacturer did not adequately inform physicians and patients about risks it knew or should have known. Strict liability, recognized in many states, allows recovery without proving fault when a product is defective and causes injury.
Many birth injury cases are best understood as layered claims: hospital and provider negligence on one side, manufacturer responsibility on the other, sometimes joined with multidistrict litigation already underway against the same defendant. We build every case to recover from each responsible party.
The most common categories of defective birth products we evaluate.
Monitors that lose signal, fail to alert clinicians to deteriorating tracings, or produce inaccurate readings can give false reassurance during labor. When a monitor failure contributes to a missed Category III tracing, the manufacturer may share responsibility for the injury.
FDA has issued recalls on vacuum extractor models for design defects, pressure regulation failures, and detachment problems. Devices like the Kiwi OmniCup and certain Mityvac models have appeared in adverse event reports linked to subgaleal hemorrhage and intracranial bleeds.
Manufacturing defects in forceps blades, locking mechanisms, or shanks can cause unexpected slippage or misapplication, leading to skull fractures, facial nerve damage, and intracranial injury.
A defective infusion pump that delivers oxytocin (Pitocin) at the wrong rate can cause uterine tachysystole, which compresses placental blood flow and starves the baby of oxygen. Programming defects and free-flow failures have been the subject of FDA action.
Epidural catheters that sheared or broke off in the spine, defective epidural kits, and contaminated injectable medications have caused maternal injuries that in turn affected the delivery course and the newborn.
Multidistrict litigation involves several prescription products used during pregnancy. Each case is evaluated under its own science and regulatory history. We are careful to distinguish well-supported claims from speculation, and we work with toxicology and developmental neurology experts to assess causation.
Phototherapy lights used to treat newborn jaundice must deliver the correct wavelength and intensity. A defective unit that under-delivers therapy can lead to untreated hyperbilirubinemia and kernicterus — permanent brain injury.
Pulse oximeters and oxygen delivery equipment in the NICU must perform accurately. When inaccurate readings contribute to oxygen toxicity, retinopathy of prematurity, or hypoxic events, the device manufacturer may share liability.
Bag-valve-mask devices, endotracheal tubes, and laryngoscopes used in newborn resuscitation must function reliably. A device failure during resuscitation can extend the period of oxygen deprivation and worsen outcomes.
Layered claims demand layered investigation. Here is how our team works.
Herb identifies what role a product played in the injury. The medical record. The device's lot and serial numbers. The hospital's biomedical engineering records. The manufacturer's complaint history. The FDA recall and MedWatch databases. Every detail that ties the product to the harm.
Biomedical engineering experts for device design and performance. Pharmacology and toxicology experts for drug cases. Maternal-fetal medicine and neonatology for the medical standard. Pediatric neuroradiology for injury timing. Life care planners and economists for damages.
The manufacturer. The hospital that purchased and maintained the device. The biomedical engineering team responsible for inspection. The physicians who used a recalled device or prescribed a drug without adequate warnings. We name everyone whose conduct contributed to the harm.
Alex Alvarez is a Board Certified Civil Trial Lawyer (NBTA). When a case fits into an existing multidistrict litigation, we file accordingly. When it does not, we build the case for individual trial. Either way, defendants know we are prepared to do the work.
Product liability cases against medical device and pharmaceutical manufacturers can recover damages similar to medical malpractice cases — with one important addition: corporate misconduct often supports punitive damages. The damages picture typically includes:
Manufacturer defendants typically carry substantial commercial general liability and excess insurance coverage, and large device makers also have significant corporate assets to satisfy judgments. When the product liability claim is layered with a malpractice claim against the hospital and providers, the total available recovery can be significantly larger than from any single defendant.
We build every case around a detailed life care plan and an economist's calculation of the lifetime impact, and we evaluate every available defendant for the largest possible recovery for your family.
The medical record almost always identifies the equipment used by manufacturer, model, and often serial number. The pharmacy record documents every medication administered. Once we obtain your records, we cross-reference them with FDA recall databases, MedWatch reports, and manufacturer complaint histories to identify any device or drug that may have contributed to the injury.
It can. A recall, particularly a Class I recall (which addresses a reasonable probability of serious adverse health consequences), is strong evidence that the manufacturer knew or should have known the product was dangerous. We assess every applicable recall and adverse event report as part of building the case.
A multidistrict litigation (MDL) is a federal procedure that consolidates similar product liability claims from across the country before a single judge for pretrial purposes. Several pregnancy- and birth-related products have active MDLs at any given time. If your case fits the MDL criteria, joining it can be procedurally efficient and powerful. If it does not, we pursue an individual claim. Either way, we evaluate the strongest path for your family.
Statutes of limitations for product liability vary by state, and the rules can be different from those that apply to medical malpractice. Some states use a discovery rule. Most states extend the filing window for injuries to minors. The most important step is to call us so we can evaluate your case under the deadlines that apply.
Nothing upfront. The Alvarez Law Firm handles every product liability birth injury case on a contingency fee basis. No Fees Unless We Recover Money for You. The case review itself is free and confidential.
Herb Borroto, M.D., J.D., will personally review the medical record and identify what role a device or drug may have played in your baby's injury. No cost. No obligation. Just an honest read on every recovery path available to your family.
