Your Rights When Defective Drugs or Medical Devices Cause Harm

Defective Drug & Medical Device Lawyers Who Take On Big Pharma — And Win

If you’ve been seriously injured by a recalled drug, defective medical implant, or dangerous pharmaceutical product, you’re facing multinational corporations with unlimited resources to defend themselves. But you have rights, and LKSA has the elite trial experience and financial resources to fight for you and win.

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If a Drug or Medical Device Has Harmed You: What You Need to Know Right Now

You trusted your doctor. You trusted the medication or medical device they prescribed. You trusted that the pharmaceutical company or device manufacturer tested their product thoroughly and warned you of all the risks.

That trust was broken.

Every year, thousands of Americans suffer catastrophic injuries or lose their lives because drug companies and device manufacturers:

  • Rush products to market without adequate testing
  • Hide known dangers from doctors and patients
  • Exploit regulatory loopholes to avoid safety reviews
  • Put profits ahead of patient safety
  • Fail to warn about severe, life-threatening side effects

If you’ve been harmed, you’re not alone. And you’re not powerless.

At Lewis, Kullman, Sterbcow & Abramson, LLC, we’ve spent decades taking on the biggest pharmaceutical companies and medical device manufacturers in the world. We’ve secured millions for clients who suffered permanent injuries from defective products. We know how these companies operate, how they hide evidence, and how to hold them accountable.

But these cases are complex, expensive, and require immediate action to preserve evidence and protect your rights.

If you or a loved one has been injured by a drug or medical device, contact us today for a free consultation. We’ll review your case, explain your rights in plain language, and fight to get you the compensation you deserve.

Quick Facts: Defective Drug & Medical Device Claims

What qualifies as a defective drug or device?

  • Prescription medications with hidden or undisclosed side effects
  • Over-the-counter drugs that cause serious injuries
  • Medical implants that fail, break or cause complications
  • Surgical devices with design or manufacturing defects
  • FDA-recalled products still in use when you were injured

Common injuries we handle:

  • Metal-on-metal hip replacements requiring revision surgery
  • Hernia mesh causing chronic pain and infection
  • Transvaginal mesh/pelvic slings causing tissue damage
  • Blood thinners causing uncontrolled bleeding or death
  • Diabetes drugs linked to cancer
  • Antidepressants causing suicide or violent behavior
  • Heart devices causing infections or failure
  • Spinal implants causing paralysis or nerve damage

Who can be held liable?

  • Drug manufacturers (pharmaceutical companies)
  • Medical device manufacturers
  • Component part manufacturers
  • Distributors and suppliers
  • Sometimes hospitals or doctors (if they knew of dangers)

What you can recover:

  • Past and future medical expenses
  • Lost wages and earning capacity
  • Pain and suffering
  • Disability and loss of quality of life
  • Wrongful death damages (for families)
  • Punitive damages (to punish reckless conduct)

Time limits:

  • Varies by state and type of claim
  • Discovery rule may extend deadlines in some cases
  • Evidence disappears fast — contact a lawyer immediately

How Dangerous Products Make It to Market (And Why You’re at Risk)

Most people assume that if a drug or medical device is on the market, it’s been thoroughly tested and proven safe by the FDA.

That assumption is wrong, and it’s getting people killed.

The FDA Approval Process: Not As Safe As You Think

For new drugs:

  • FDA approval requires clinical trials, but trials are often short-term (months or a few years)
  • Long-term side effects may not appear until millions of people use the drug
  • Drug companies fund their own safety studies (conflict of interest)
  • Negative study results are sometimes hidden or minimized
  • Post-market surveillance through FDA MedWatch is weak — dangerous drugs stay on the market for years

For medical devices:

  • Many devices NEVER go through full FDA approval
  • Instead, they use the 510(k) “clearance” process — a dangerous loophole
  • If a device is “substantially equivalent” to a device already on the market, it can be fast-tracked
  • This means a new device can be approved based on an old device that was also never fully tested

The Dangerous 510(k) Loophole

Here’s how dangerous this is:

Example: Metal-on-Metal Hip Implants

  1. Original hip implant approved decades ago with minimal testing
  2. New metal-on-metal hip design claimed to be “substantially equivalent”
  3. FDA clears it through 510(k) process WITHOUT rigorous safety testing
  4. Thousands of patients receive the implant
  5. Patients suffer metal poisoning, tissue death, need revision surgeries
  6. Only then does FDA investigate and recall the device

By the time the recall happens, thousands of people have already been harmed.

Read our detailed legal breakdown of the dangerous FDA 510(k) clearance process and why ‘cleared’ doesn’t mean ‘safe.’

Why Companies Hide Known Dangers

Pharmaceutical and medical device companies are businesses driven by profit. When they discover their product causes serious harm, they face a choice:

Option A: Do the right thing

  • Pull the product from the market
  • Warn doctors and patients immediately
  • Issue recalls
  • Redesign the product
  • Cost: Millions in lost revenue

Option B: Hide the danger

  • Bury negative study results
  • Minimize warnings to doctors
  • Continue selling the product
  • Fight lawsuits individually
  • Benefit: Billions in continued profits

Too often, they choose Option B.

Internal company documents revealed in litigation have shown:

  • Companies knew their products were dangerous years before recalls
  • Safety concerns were dismissed by executives focused on profits
  • Whistleblowers were silenced or fired
  • Studies showing dangers were never published
  • Marketing materials downplayed serious risks

This is why you need lawyers who know how to find this evidence and use it against them.

The Three Types of Product Defects (And How We Prove Them)

To win a defective drug or device case, we must prove the product was defective in one of three ways:

1. Design Defects: Dangerous From the Start

What this means: The product was inherently dangerous, even when manufactured perfectly and used as intended, because of how it was designed.

Examples:

  • Metal-on-metal hip implants that inevitably shed metal particles
  • Pelvic mesh made from materials that degrade in the human body
  • Blood thinners designed without reversal agents

How we prove it:

  • Expert testimony from biomedical engineers showing safer alternative designs existed
  • Scientific studies demonstrating the fundamental flaw in the design
  • Evidence the manufacturer knew of design problems but released the product anyway

2. Manufacturing Defects: Something Went Wrong in Production

What this means: The design was safe, but something went wrong during manufacturing, making this particular batch or unit dangerous.

Examples:

  • Contaminated medication batches
  • Surgical mesh with manufacturing flaws causing premature failure
  • Implants with microscopic cracks from production errors

How we prove it:

  • Expert analysis of the specific product that harmed you
  • Manufacturing records showing quality control failures
  • Evidence of other injuries from the same batch/lot number
  • FDA inspection reports showing facility violations

3. Failure to Warn (Marketing Defects): Hidden Dangers

What this means: The product may work as designed, but the manufacturer failed to adequately warn doctors and patients about known risks and side effects.

This is the most common type of defect in pharmaceutical cases.

Examples:

  • Antidepressants increasing suicide risk in young adults — inadequate warnings
  • Blood thinners causing uncontrolled bleeding — downplayed risks
  • Hip implants causing metal poisoning — failure to warn about metallosis

How we prove it:

  • Internal company documents showing they KNEW about the dangers
  • Clinical trial data buried or unpublished
  • Comparison to warnings in other countries (often more honest)
  • Expert testimony about what warnings SHOULD have been given
  • Evidence the company marketed the drug for uses not approved by FDA

📚 Helpful Resources for Drug & Device Safety Information

If you want to research your medication or medical device, these official government resources provide safety information:

FDA Resources:

Medical Information:

  • MedlinePlus – Trusted drug and device information from National Library of Medicine
  • PubMed – Medical research and scientific studies

Consumer Protection:

Important Note: While these resources help you understand your device or medication, they don’t replace the need for experienced legal representation. If you’ve been injured, contact LKSA for a free case evaluation to protect your rights.

How We Build Winning Cases Against Big Pharma

Defective drug and device cases require extraordinary resources and expertise:

Investigation & Expert Development

We retain world-class medical specialists, biomechanical engineers, FDA regulatory experts, pharmacologists, and economic analysts to prove your case. Expert costs alone can exceed $150,000-300,000 per case.

Document Discovery

We fight to obtain internal company emails, unpublished clinical trial data, FDA correspondence, and marketing materials, often reviewing millions of pages to find the smoking gun documents proving the company knew about the dangers.

Scientific Case Building

Our experts conduct independent testing, analyze your medical records in detail, and create comprehensive reports and demonstrative exhibits for trial.

Trial Preparation

We prepare every case as if it will go to trial, taking depositions of company executives, preparing your testimony, and developing powerful visual presentations. Most cases settle only because we’re fully prepared to win at trial.

Total investment required: $500,000 to $2,000,000+ per case

You pay nothing unless we win. If we lose, we absorb all costs. Most law firms cannot afford to finance cases like this; LKSA can and does.

Why Individual Cases vs. Multi-District Litigation (MDL) Matters

When a drug or device harms hundreds or thousands of people, federal courts often consolidate cases into Multi-District Litigation (MDL).

What Is MDL?

MDL consolidates similar cases for pretrial proceedings:

  • All cases transferred to one federal judge
  • Discovery is coordinated (avoids duplicating work)
  • Bellwether trials test legal theories and jury reactions
  • Most cases settle based on bellwether results

Major MDLs we’ve participated in:

  • DePuy ASR Hip MDL
  • Zimmer Durom Cup MDL
  • Biomet M2a Magnum MDL
  • Transvaginal mesh MDLs
  • Various pharmaceutical MDLs

Advantages of MDL:

  • Shared discovery costs (reduced expense)
  • Access to documents obtained by thousands of lawyers
  • Coordination with top trial lawyers nationwide
  • Faster resolution than individual litigation
  • Settlement structure based on injury severity

Disadvantages of MDL:

  • Your case becomes one of thousands
  • Settlement amounts may be formulaic
  • Less individual attention to your unique damages
  • Timeline controlled by the MDL schedule, not your needs

When Individual Litigation Is Better:

Your case may be better filed individually if:

  • Your injuries are more severe than typical MDL cases
  • You suffered unique complications
  • You want to go to trial (not settle)
  • MDL has already settled and you weren’t included
  • Your case involves a smaller number of victims (no MDL formed)

LKSA has experience in both MDL and individual complex litigation. We’ll advise you which path provides maximum recovery for your specific situation.

Real Clients, Real Results: How We’ve Held Manufacturers Accountable

Due to confidentiality agreements, we cannot disclose specific settlement amounts or client names. However, we can share the types of victories we’ve achieved:

Metal-on-Metal Hip Cases

Client situation: Multiple clients suffering metallosis, pseudotumors, severe pain, requiring revision surgeries

What we proved:

  • Manufacturer knew metal debris was toxic
  • Alternative designs existed and were safer
  • Company prioritized profits over patient safety
  • Inadequate warnings to surgeons

Result: Significant settlements for medical expenses, revision surgery costs, pain and suffering, and future medical monitoring

Dangerous Antidepressant Cases

Client situation: Families who lost loved ones to suicide after taking SSRIs; inadequate warnings about suicide risk in young adults

What we proved:

  • Clinical trials showed increased suicide risk
  • Company buried negative data
  • Marketing materials downplayed warnings
  • FDA was misled about safety profile

Result: Wrongful death settlements recognizing the devastating loss and company’s failure to warn

Defective Spinal Device Cases

Client situation: Clients suffering paralysis from devices used to treat herniated discs

What we proved:

  • Device had design flaws causing migration
  • Manufacturer knew of failures in similar patients
  • Surgeons were not adequately trained
  • Warnings were insufficient

Result: Substantial compensation for permanent disability, lifetime medical care, lost earning capacity

Children’s Medication Cases

Client situation: Child suffered permanent brain damage (Reye’s Syndrome) after aspirin ingestion

What we proved:

  • Aspirin risks in children were known
  • Warnings were inadequate for parents
  • Safer alternatives existed
  • Company continued marketing to parents despite risks

Result: Settlement covering lifetime care needs for brain-damaged child

Blindness from Prescription Drugs

Client situation: Permanent blindness resulting from side effects of dangerous medication

What we proved:

  • Vision loss was known complication
  • Monitoring protocols were inadequate
  • Warnings to doctors were insufficient
  • Earlier detection could have prevented blindness

Result: Compensation for permanent disability, lost income, pain and suffering

Common Defenses Drug Companies Use (And How We Counter Them)

Defense #1: “The Patient Was Already Sick”

What they argue: “Your pre-existing condition caused your problems, not our product.”

How we counter:

  • Medical records showing you were healthy before the drug/device
  • Expert testimony proving timeline of injury matches product use
  • Differential diagnosis ruling out other causes
  • Similar injuries in other patients using the same product

Defense #2: “The Doctor Made the Mistake”

What they argue: “The surgeon implanted it wrong. The doctor prescribed it incorrectly. This isn’t our fault.”

How we counter:

  • Surgical technique was standard and appropriate
  • Doctor followed all manufacturer instructions
  • The product failed despite proper use
  • Multiple doctors had same problems with the product
  • We may sue both the manufacturer AND negligent doctors if applicable

Defense #3: “We Provided Adequate Warnings”

What they argue: “We warned doctors about the risks. It’s in the package insert.”

How we counter:

  • Package insert warnings were buried in technical jargon
  • More prominent warnings existed in other countries
  • Internal documents show they knew warnings were inadequate
  • Sales reps minimized risks when marketing to doctors
  • Warnings were added only after injuries occurred

Defense #4: “The FDA Approved It”

What they argue: “This product went through FDA approval. We followed all regulations.”

How we counter:

  • FDA approval doesn’t make manufacturers immune from liability
  • They misled FDA during approval process
  • They hid safety data from FDA
  • 510(k) clearance is NOT the same as approval
  • Post-market surveillance showed problems FDA didn’t anticipate

Defense #5: “You Signed a Consent Form”

What they argue: “The patient signed consent acknowledging the risks.”

How we counter:

  • Consent forms don’t waive rights for defective products
  • Doctor couldn’t warn about risks the manufacturer hid
  • General consent doesn’t cover specific manufacturing defects
  • Consent under false pretenses isn’t valid
  • You can’t consent to unknown dangers

Defense #6: “Your Injuries Aren’t That Bad”

What they argue: “You’re exaggerating. You can still work. Your life isn’t ruined.”

How we counter:

  • Independent medical examinations
  • Life care planning showing lifetime costs
  • Testimony from your family about changed quality of life
  • Economic experts calculating true lost earning capacity
  • Before/after comparisons of your life

Warning Signs: When Should You Contact a Lawyer?

Contact a defective drug or device attorney immediately if:

For Medical Devices:

  • You’ve had revision surgery to remove/replace a failed implant
  • Your device has been recalled by the FDA
  • You’re experiencing complications your doctor says are “unusual” or “not expected”
  • You have chronic pain or infections since receiving the implant
  • Your doctor recommends removing the device due to failure
  • You’ve seen news reports about your specific device
  • Multiple people with your same implant have had problems

For Prescription Drugs:

  • You developed a serious medical condition after starting a new medication
  • The drug has been recalled or had a black box warning added
  • Your doctor says your condition is a “rare side effect” of the drug
  • You’ve seen ads for lawsuits involving your medication
  • You suffered an injury the drug was supposed to prevent
  • The medication was prescribed “off-label” (for unapproved use)
  • You or a loved one had suicidal thoughts or behavior after starting psychiatric medication

For All Cases:

  • Your injury happened within months/years of starting the drug or receiving the device
  • Your doctor seems surprised by your complications
  • You’ve been told “this doesn’t usually happen”
  • The manufacturer has contacted you about the product
  • You’re facing additional surgeries to correct the problem
  • Your quality of life has been permanently affected

Don’t wait for a recall announcement. Companies often know about problems years before they issue recalls.

Common Questions About Drug & Device Cases

This requires medical investigation:

Our process:

  1. Review your complete medical history
  2. Establish timeline of drug/device use and injury onset
  3. Consult with medical experts
  4. Search for similar injuries in other patients
  5. Review clinical trial data and adverse event reports

We can usually tell within 2-4 weeks if you have a viable case.

Doctors often don’t want to admit a product they recommended harmed you.

Reasons doctors may deny causation:

  • They don’t want to feel responsible for your injury
  • They’re not up-to-date on latest safety information
  • They have relationships with pharmaceutical sales reps
  • They’re afraid of being sued themselves

Our independent medical experts provide unbiased analysis.

Yes, in most cases.

Consent forms don’t protect manufacturers from:

  • Design defects they knew about
  • Manufacturing flaws
  • Failure to warn about known dangers
  • Fraud or intentional concealment

You can’t consent to risks the manufacturer hid from your doctor.

FDA approval doesn’t prevent lawsuits.

You can still sue because:

  • FDA approval is based on limited data
  • Long-term risks may not be known at approval
  • Companies sometimes hide safety data from FDA
  • 510(k) clearance is not the same as approval
  • Post-market problems emerge after approval

FDA approval is a minimum standard, not a liability shield.

Timeline varies significantly:

Individual cases: 2-4 years on average MDL cases: 3-7 years (some longer)

Factors affecting timeline:

  • Complexity of medical issues
  • Number of defendants
  • Whether it’s MDL or individual litigation
  • Court scheduling
  • Settlement negotiations

We keep you informed every step of the way.

Every case is different, but we consider:

Economic damages:

  • Past medical expenses
  • Future medical care and monitoring
  • Lost wages
  • Lost earning capacity
  • Cost of revision surgeries

Non-economic damages:

  • Pain and suffering
  • Emotional distress
  • Loss of enjoyment of life
  • Disability and disfigurement
  • Loss of consortium (for spouses)

Punitive damages (in some cases):

  • To punish reckless conduct
  • To deter future misconduct
  • Typically multiples of compensatory damages

Settlements we’ve achieved range from hundreds of thousands to millions, depending on injury severity.

Most cases settle before trial, but we prepare every case as if it will go to trial.

Why this matters:

  • Defendants only offer fair settlements if they fear trial
  • Our trial reputation forces better offers
  • We’ve tried complex pharmaceutical cases successfully
  • You always have final decision on whether to settle or try the case

We’ll advise you on settlement vs. trial, but the decision is always yours.

You can afford us.

We work on contingency fee:

  • No upfront costs
  • No hourly fees
  • No out-of-pocket expenses
  • We advance all case costs (experts, investigation, court fees)
  • We only get paid if we win
  • Our fee is a percentage of your recovery
  • If we lose, you owe us nothing

Defective drug and device cases cost hundreds of thousands to litigate. We shoulder this burden so you don’t have to.

You may still have a claim.

Key questions:

  • When did the company first know about the dangers?
  • Did they delay the recall to maximize profits?
  • Were you injured during the delay?

Internal documents often show companies knew about problems months or years before issuing recalls.

Drug and device cases are usually NOT class actions, they’re MDLs (Multi-District Litigation).

Key differences:

Class action:

  • One settlement for entire class
  • Divided among all members
  • You have little control over case
  • Usually small individual recoveries

MDL:

  • Individual cases coordinated for efficiency
  • Your settlement based on YOUR specific injuries
  • You maintain more control
  • Can result in much larger individual recoveries

LKSA has extensive MDL experience and will maximize your individual recovery.

Act Now: Time Limits Apply to Product Liability Claims

Statutes of limitations vary by state and case type:

General rules:

  • Louisiana: 1 year from discovery of injury (some exceptions)
  • Federal MDLs: May have different deadlines
  • Discovery rule: Clock starts when you knew or should have known the product caused your injury

BUT many cases have shorter deadlines than you think:

  • Evidence disappears over time
  • Witnesses’ memories fade
  • Medical records become harder to obtain
  • Companies destroy documents after certain periods
  • MDL settlement windows close

If you suspect a drug or device harmed you, contact us immediately for a free case evaluation.

What Makes LKSA Different in Defective Drug & Device Cases

Taking on pharmaceutical giants and medical device manufacturers requires more than just legal knowledge, it requires resources, expertise and trial experience that most firms simply don’t have.

New Orleans injury attorney

What Sets LKSA Apart:

✓ 40+ Years of Complex Product Litigation Experience
✓ Proven Track Record in High-Stakes Cases
✓ Elite Network of Expert Witnesses
✓ Financial Resources to Take on Big Pharma
✓ Trial Experience That Forces Settlements
✓ MDL Leadership Experience
✓ Compassionate Client Service

Most personal injury firms cannot handle these cases. Big Pharma knows this and uses it against injured patients.

You need a firm with:

  • The financial resources to invest hundreds of thousands in your case
  • The expert network to prove complex medical causation
  • The trial experience to take on multinational corporations
  • The track record of winning against pharmaceutical giants

Lewis, Kullman, Sterbcow & Abramson, LLC has all of this, and 40+ years of results to prove it.

Don’t Let Big Pharma Get Away With It. Fight Back with LKSA.

Pharmaceutical companies and device manufacturers have unlimited resources to defend themselves. Contact us today for a free consultation. No fees unless we win.

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