H Law GroupPersonal Injury

Product Liability

Medication should come with the truth about its risks

Most drug cases are not about a medication that failed to work. They are about a serious risk the manufacturer knew of and left off the label.

About dangerous drugs claims

A drug claim in California can rest on a manufacturing defect (contamination, a degraded compound or an out-of-specification lot) or on a failure to warn, which is the most common theory. Failure-to-warn litigation asks whether the labeling, the prescribing information and the company’s communications to physicians adequately conveyed a risk the manufacturer knew or should have known about.

We look at drugs associated with undisclosed cancer risk, liver and kidney injury, cardiac events, severe skin reactions such as Stevens-Johnson syndrome, birth defects from use in pregnancy, dependency and withdrawal that was minimized in marketing, and dangerous interactions omitted from the label. Contamination cases, including nitrosamine impurities and compounding-pharmacy sterility failures, are handled as manufacturing defect claims.

Who can be held responsible depends on what was taken and who made it, and the analysis differs between brand-name and generic products because of how federal labeling law applies. We work that out at the outset so a client understands early who the realistic defendants are.

Common injuries

Injuries we see most often in these cases. Every claim is different, and this list is not exhaustive.

  • Cancer diagnoses linked to long-term exposure or contamination
  • Acute liver failure and kidney injury requiring transplant or dialysis
  • Heart attack, stroke, arrhythmia and blood clots
  • Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Birth defects and developmental injuries following use in pregnancy
  • Dependency, severe withdrawal and psychiatric injury

Who can be held liable

Responsibility often extends well beyond the most obvious company. We look at every party in the chain.

  • The pharmaceutical manufacturer that developed and labeled the drug
  • A contract manufacturer or active-ingredient supplier responsible for contamination
  • A compounding pharmacy that prepared a non-sterile or misdosed preparation
  • A distributor or repackager in the chain of commerce
  • A marketer that promoted an unapproved use while downplaying known risks

Evidence that matters

What we work to preserve and obtain early, because this proof tends to disappear with time.

  • Pharmacy dispensing records, lot numbers and the original packaging or bottle
  • Complete medical records establishing diagnosis, timing and differential causes
  • The drug’s label history, including every revision and added warning
  • FDA adverse event reports, warning letters, recalls and advisory committee materials
  • Internal clinical trial data, safety signals and pharmacovigilance records

Do not wait on the deadline

California generally allows two years to bring a personal injury or product liability claim under Code of Civil Procedure § 335.1, and two years from the date of death in a wrongful death case. Shorter deadlines apply when a government entity is involved, and deadlines can be extended for injured children. Exceptions are fact-specific. Talk to us before you assume anything about your own timeline.

Answers

Dangerous Drugs: common questions

Usually not. A physician who relied on a label that omitted a known risk is generally not the target of a failure-to-warn claim. The manufacturer that wrote the label is. If the facts also suggest a provider deviated from the standard of care, we will tell you and evaluate that separately.

Injured by dangerous drugs? Let us review it at no cost.

A conversation costs you nothing and there is no obligation. No fee unless we recover compensation for you. In some matters a client may still be responsible for case costs and expenses, and we will explain exactly how that works before you decide to hire us.

What compensation may be available

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