A metal-on-metal hip is an artificial joint in which a metal ball moves against a metal socket. The Food and Drug Administration (FDA) says metal debris can cause damage to bone or tissue around “some implants.” If your doctor has diagnosed metallosis or tissue damage, or has told you the hip needs revision surgery, the question is whether the implant is what caused that harm.

What Changed at the FDA in 2016?

In February 2016, the FDA published a final order requiring premarket approval for metal-on-metal total hip implants. Premarket approval is the agency’s most stringent device application, and it rests on scientific evidence of safety and effectiveness. The requirement for filing took effect that May.

As of a page dated 2019, the FDA said no approved metal-on-metal total hip replacement was marketed in the US, and it listed two approved resurfacing devices. That order isn’t a finding that any particular hip was defective. It tells you how the rules changed, and your own implant still has to be identified and examined on its own facts.

When the Hip Went In Years Ago

Timing can be the hardest part of an older hip case. Under Ind. Code § 34-20-3-1, a product liability action must be commenced within two years after it accrues or within ten years after the product was delivered to the initial user or consumer. A special provision applies when a claim accrues at least eight but less than ten years after delivery.

The ten-year measure runs from delivery, not from manufacture and not from the day you first felt pain. Indiana’s Supreme Court has upheld it as constitutional. That matters for hips implanted long before symptoms appear, so the implant date should be pinned down early. Our guide to defective medical device claims in Indiana explains how those dates work together.

What Records Tend to Decide These Cases

A metal hip claim usually depends on paperwork as much as on the medicine. The records below can help show what was implanted, what happened to it, and why it came out.

• The implant log. Hospital operative records often show the maker, model and lot numbers of each component.
• Blood and imaging results. Your doctors may have ordered tests or scans that track the problem over time.
• Revision surgery notes. A surgeon may describe the tissue and the condition of the parts found during the second operation.
• The removed parts. If the implant comes out, ask early whether it can be kept and stored rather than discarded.

Other explanations will usually be raised, including surgical placement, infection and ordinary wear. For a broader look at how Indiana treats these claims, see our Indiana product liability page, and our short overview of defective medical devices lists other implants that raise similar questions.

Transvaginal mesh is surgical mesh placed through the vagina, most often discussed for repairing pelvic organ prolapse (POP), where pelvic organs slip out of position. Women who live with chronic pain, an organ perforation or another lasting complication after mesh surgery may want to know whether the product played a part. The answer starts with which mesh you received and what it was implanted to treat.

Is Your Mesh the Kind the 2019 Order Covered?

On April 16, 2019, the Food and Drug Administration (FDA) ordered all manufacturers of surgical mesh intended for transvaginal repair of POP to stop selling and distributing their products immediately. The products it named were Boston Scientific Uphold Lite and Xenform and Coloplast Direct Fix Anterior. The FDA had reclassified POP mesh as class III, its highest-risk device group, in 2016.

The order has limits that are easy to miss. It doesn’t cover mesh placed through the abdomen for POP, and it doesn’t cover slings used for stress incontinence. Two women can both say they have “vaginal mesh” and have products with very different regulatory histories, so your operative report should be read closely.

A Stop-Sale Order Is Not a Verdict

The FDA found that the manufacturers had not demonstrated a reasonable assurance of safety and effectiveness. That is a statement about the evidence they submitted. It isn’t a finding that a particular patient’s mesh was defective, or that it caused a particular injury.

So the order can be useful background without proving your case. You would still need medical evidence tying your symptoms to the mesh, and a surgeon who removed or examined it may be an important witness. Any mesh taken out in surgery should be kept if at all possible.

Why “Reasonable Care” Matters for a Design Claim

Many people assume a harmful product makes the company automatically liable. Indiana doesn’t work that way for design claims. Under Ind. Code § 34-20-2-2, a person claiming a design defect must establish that the manufacturer or seller failed to exercise reasonable care under the circumstances in designing the product.

Put simply, a mesh case about the design looks at the company’s conduct as well as the product. What did it test, what did it know, and what did it do with that knowledge? Internal testing records and design choices can matter a great deal here. Our Indiana product liability page covers how these claims fit under the Product Liability Act.

Some complications may also raise questions about the surgery itself. A claim against a doctor is a separate kind of case, and our medical malpractice page explains that route. The guide to defective medical device claims sets out the first evidence to gather.

Hernia mesh is implanted material that surgeons use to reinforce a weak spot in the abdominal wall or groin. These cases involve infections and painful complications after repair, including the Physiomesh product. The difficulty is separating a product problem from risks that come with hernia surgery in general.

Pain After Repair: The FDA’s Two-Sided Picture

The Food and Drug Administration (FDA) says the most common adverse events for all hernia repair include pain, infection, recurrence and adhesion, which is scar-like tissue joining surfaces that should stay apart. For repair with mesh, it reports additional events, including migration or shrinkage of the mesh itself.

The agency also says the literature shows a reduced likelihood of recurrence with mesh. Both points matter. A manufacturer will likely argue that your pain or infection is a known risk of the operation, so the medical evidence needs to point at the mesh specifically.

Cleared or Approved: Which Road Did Your Device Take?

Most people use “FDA approved” for every device, but the two main pathways are different. A 510(k) is a premarket submission showing a device is substantially equivalent to one already legally on the market, and the FDA clears it rather than approving it. Premarket approval is a separate and more stringent application based on scientific evidence of safety and effectiveness.

The pathway can shape what a lawsuit may argue, for any device and not only mesh. Which route a particular product took has to be checked for that product.

• Premarket approval. In Riegel v. Medtronic (2008), the US Supreme Court held that federal law bars common-law claims challenging the safety or effectiveness of a device marketed in a form that received premarket approval. Claims premised on a violation of FDA rules are a different matter.
• 510(k) clearance. In Medtronic v. Lohr (1996), the Court held that negligent design claims about a device cleared through that process were not pre-empted, which means federal law did not block them.

What the Record Shows on Physiomesh

The FDA recall database holds a Class 2 entry for PhysioMesh products handled by a third party, EXP Pharmaceutical Services. The recall arose because EXP had not registered as a device establishment. It wasn’t about a safety defect in the mesh, so that entry can’t carry a claim about how the product performed in your body.

A Physiomesh claim would therefore rest on your own records and on evidence about the product. Your operative report should show which mesh was used, and any later repair may show what happened to it. The Indiana guide to defective medical device claims covers those first steps, and our product liability page explains how the Indiana statute applies.

Pacemakers and implantable cardioverter defibrillators (ICDs) are devices placed in the chest to monitor the heart and respond when its rhythm goes wrong. These cases involve electrical failures and other malfunctions in a device a patient depends on. Food and Drug Administration (FDA) records show that the word “recall” can describe very different problems in this field.

Three Recall Records, Three Different Problems

• Medtronic, 2023. The FDA identified as Class I, which it calls the most serious type of recall, a recall of ICDs and related cardiac resynchronization devices with a glassed feedthrough. It said they may deliver low or no energy output when high voltage therapy is needed.
• Medtronic, 2021. The FDA’s database lists a Class 1 recall of Evera and Visia ICDs for a shortened interval between the replacement alert and end of service. The record says a small percentage of devices from a well-defined subset may be affected.
• Abbott, 2017. An FDA safety communication described a firmware update for cybersecurity vulnerabilities in pacemakers formerly sold by St. Jude Medical. The recall record lists this as Class 2.

These records concern batteries, circuitry and software in different ways. Your own claim depends on whether your model was covered and whether it actually misbehaved.

Your Device Was on a List. Did It Fail?

A recall notice doesn’t establish that your device failed or that it hurt you. The 2023 action was programming guidance, and the notice said not to replace devices prophylactically for that issue. If a surgery was performed anyway, the reason for it will need a close look.

Stored device data can be valuable because these implants may log events and therapy delivered. Ask your cardiology team to keep those interrogation reports, along with the serial number and any removed device. Those records may show what the device did on the day that matters.

Does Meeting Federal Standards Protect the Maker?

Indiana gives manufacturers a head start on this point. Under Ind. Code § 34-20-5-1, there is a rebuttable presumption that a product wasn’t defective and that the maker wasn’t negligent if it conformed to the state of the art or complied with applicable government codes, standards or regulations. Rebuttable means the presumption can be overcome with evidence. It isn’t a complete bar.

For FDA-regulated products, expect that presumption to come up, alongside any federal limit that may apply to the device. The evidence needed to answer it goes to what the company knew and did before the sale. Our guide to Indiana medical device claims explains why an FDA report is a lead rather than proof.

If a device problem contributed to a death, the family’s claim raises separate questions covered on our wrongful death page. Questions about whether a cardiologist should have responded sooner belong on our medical malpractice page.

This category covers Zimmer and Biomet knee, shoulder and hip implants that appear to have failed sooner than a patient was led to expect. An early failure doesn’t explain itself. The cause may lie in the implant, in the instructions that came with it, in the operation, or in something about the patient.

Why Indiana Readers Know These Names

Zimmer and Biomet were separate companies based in Warsaw, Indiana, before they combined under the Zimmer Biomet name. For an older implant, that history matters in a practical way. Your records may show one brand, and the correct company has to be identified for the product you actually received.

Reading the Durom Cup Recall Closely

The Food and Drug Administration (FDA) database records a 2008 Class 2 recall of the Zimmer Durom Cup, a hip component. The stated reason was that instructions for use and surgical technique were inadequate, and Zimmer suspended US marketing pending user training and revised instructions.

That reason deserves careful reading. It concerns what surgeons were told, and it isn’t a finding that the cup itself was defective. It also covers one product. It says nothing about Biomet implants or about Zimmer knees and shoulders, each of which would need its own evidence.

Hardware, Surgeon or Both?

Because a joint implant passes through a surgeon’s hands, the companies in these cases often point elsewhere. Indiana allows that. A defendant may raise a nonparty defense, claiming your harm was caused in full or in part by someone who isn’t in the lawsuit (Ind. Code § 34-51-2-14). The defendant has to plead and prove that defense.

Fault then gets divided by percentage. Under Ind. Code § 34-20-7-1, each defendant in a product case is liable only for its own share and can’t be held jointly liable for another’s share. In practice, any percentage placed on someone who isn’t paying may come out of your recovery, so who is named in the case can matter a great deal.

• Instructions. What did the maker tell surgeons about technique, and when did that change?
• Components. Which parts were used together, and were they meant to be?
• Surgery. Do imaging and operative notes show correct placement?
• Patient factors. Is there any history that could explain loosening or fracture?

If the surgery itself is in question, that part of the case runs under a separate process described on our medical malpractice page. Our guide to defective medical device claims in Indiana covers who may be responsible and how long-implanted devices are treated, and our Indiana product liability page sets out the statute.

Insulin pumps and pain pumps deliver medicine into the body over time, without a person giving each dose. These cases involve a pump that may have delivered the wrong amount, or a drug delivered somewhere it may not belong. Beyond that, the two products raise quite different questions, and the Food and Drug Administration (FDA) records on them say different things.

Insulin Pumps and a Wireless Weak Point

An FDA safety communication dated June 27, 2019 said certain Medtronic MiniMed insulin pumps have potential cybersecurity risks. It said an unauthorized person “could potentially connect wirelessly” to change settings, and that Medtronic was recalling affected pumps and providing alternatives. The recall record is Class 2.

That was a warning about something that could happen, not a report that it had. It doesn’t show that any pump delivered a wrong dose because of it. If your blood sugar swung dangerously while you were using a pump, the evidence will more likely come from the pump’s own history, your glucose readings and your hospital records.

Pain Pumps Left to Drip Into a Joint

A pain pump can be used after surgery to feed a local anesthetic through a small catheter. In November 2009, the FDA reported reviewing cases of chondrolysis, a loss of joint cartilage, after continuous infusions of these drugs directly into a joint. It required label warnings and said that neither local anesthetics nor infusion devices were approved for that use.

The FDA also said it is “not known which specific factor or combination of factors contributed.” So the record supports asking questions, but it doesn’t settle what caused a given patient’s cartilage loss. Where the catheter was placed will likely be a central fact, and the operative report is the place to find it.

One Injury, Two Products: Who Made What?

These claims often involve a device and a drug that came from different companies. That raises a threshold issue, because Indiana limits strict liability to manufacturers (Ind. Code § 34-20-2-3). The statute’s definition of manufacturer reaches those who design, assemble or produce a product or a component, and a seller with actual knowledge of a defect can also fall within it.

• The pump maker. What did its instructions and promotion say about where the device could go?
• The drug maker. What did the label say at the time of your surgery?
• The supplier. Was it simply a seller, or did it have knowledge or control that changes its role?
• The care team. How was the pump programmed, placed and monitored?

If a dosing problem traces back to how staff programmed a pump, the case may be about care rather than the product, and our medical malpractice page covers that path. For the product side, our Indiana product liability page and the guide to defective medical device claims give the wider picture. Keep the pump, its supplies and any lot numbers.

Dialysis cleans a patient’s blood when the kidneys can no longer do that work, using machines, filters and chemical solutions at every session. These cases involve treatment complications that may trace back to one of those products. They are unusual because the patient rarely handles or even sees what is being used, and the clinic stands between the maker and the person hurt.

The GranuFlo Recall, Explained

The Food and Drug Administration (FDA) classified a recall of GranuFlo powder acid concentrate as Class 1. The firm started it on March 29, 2012, citing a risk of alkalosis with acetate-containing dialysis acid concentrates. Alkalosis means the blood has become too alkaline. A related record covers NaturaLyte liquid.

The word “recall” needs explaining here. The firm’s action was a prescribing information letter, so this didn’t mean all product was pulled from clinics. The recall was terminated on July 20, 2017.

Other dialysis products, including a machine or a filter, would each need their own evidence of what went wrong.

Could the Maker Say It Told the Clinic Enough?

This is a defense worth understanding, because dialysis products are sold to trained professionals. Indiana courts have said a manufacturer may have no duty to warn where the dangers are already known to the user, or where it sells to a knowledgeable intermediary. The Indiana Supreme Court has described this as a defense whose merits can be a fact question, so a maker doesn’t escape automatically.

Warnings still have to be reasonable. Under Ind. Code § 34-20-4-2, a product can be defective if the seller fails to give reasonable warnings of danger or reasonably complete instructions when reasonable diligence could have made them available. The real issue may be what the clinic was told, when, and whether it was enough to change how care was delivered.

Records That Live at the Clinic

A dialysis patient’s best evidence usually sits in someone else’s filing cabinet. Requests should go out early, since the details can change from one session to the next.

• Treatment run sheets. These may record the products, settings and readings for each session.
• Lab work. Blood results around the event may show what changed and when.
• Physician orders. The prescription shows what the doctor directed for your treatment.
• Clinic notices. Any letters received from a supplier can show what staff knew.

Where a clinic’s own care is the concern, the claim may run through a different process, explained on our medical malpractice page. If a patient died, our wrongful death page explains how Indiana treats those claims. The guide to Indiana device claims covers the wider steps.

Bone graft products are used in spine and neck surgery to help bones fuse together. Some use a lab-made protein called recombinant human bone morphogenetic protein (rhBMP) rather than bone taken from the patient. These cases usually arise when serious complications follow surgery, and they turn on what product was used, where it was placed and what anyone was told.

The FDA’s 2008 Notice on the Neck

On July 1, 2008, the Food and Drug Administration (FDA) issued a public health notification about reports of life-threatening complications with rhBMP used in the cervical spine, meaning the neck. It said “these products are not approved by FDA for this use.” The notice concerned rhBMP products generally, and it named rhBMP-2 contained in InFuse Bone Graft when describing approved uses.

The FDA also said the mechanism of action is unknown. The notice is a report of what the agency was seeing, and it isn’t a finding that any product was defective. It reaches a specific use, so a graft placed elsewhere in the spine stands on different ground.

A Use the Label Didn’t Cover

Surgeons may make their own judgments about how to use a product, and that choice alone doesn’t answer whether anyone did wrong. Still, it changes the questions in a case. Did the maker promote that use, or warn against it? Did the surgeon know about the notice, and were you told?

The manufacturer may respond that the surgeon chose this path, and it can try to assign fault to someone outside the lawsuit. Your operative report and consent forms may show who decided what, and both are worth getting early.

What Should Surgeons Have Been Told?

Against the maker, the main question is usually about information. Under Ind. Code § 34-20-2-2, a warning claim requires proof that the maker failed to exercise reasonable care in providing its warnings or instructions. Dates matter, since a surgery before the 2008 notice and a surgery after it raise different questions about what was known.

The guide to defective medical device claims covers the first evidence to gather, and our Indiana product liability page explains the statute. A claim against the surgeon or hospital is a separate case that generally has to go through a medical review panel first.

Telling a Graft Problem From a Spine Problem

Neck and back surgery carries risks of its own, and the underlying condition can also worsen over time. Expect a close comparison of your symptoms before the operation with those afterward. Swelling or breathing trouble soon after surgery, nerve symptoms and repeat operations should all be documented in detail, because the timing can matter to any medical opinion on cause.

SGLT2 inhibitors are type 2 diabetes medicines, and Invokana, whose active ingredient is canagliflozin, is among the best known. Claims about this class have centered on kidney injury and amputations. The Food and Drug Administration (FDA) record on those subjects is more specific than that summary, and it doesn’t apply evenly to every drug in the class.

Match the Warning to the Drug

That history cuts both ways. There is an FDA conclusion on amputation for canagliflozin, but it doesn’t extend to the whole class, and the agency later revised how it described the risk. A claim therefore depends on which drug you took, and when you took it compared with the label in force.

Was Your Doctor the One Who Needed the Warning?

Prescription drug cases in Indiana often run into the learned intermediary doctrine. In plain terms, that means a drug maker may be able to meet its duty by warning the prescribing doctor, who can weigh the drug’s risks for a particular patient. The rule comes from Indiana Court of Appeals decisions, starting with Ortho Pharmaceutical Corp. v. Chapman (1979). A search found no Indiana Supreme Court decision adopting it.

So your doctor may become a central witness. What did the label say when the prescription was written, and would a stronger warning have changed the prescription? Those answers can matter as much as the medical evidence. See our Indiana product liability page for how warning claims fit within the statute.

Sorting the Medicine From the Diabetes

Diabetes can itself affect the kidneys, the legs and the feet, so a maker is likely to say the disease caused your harm. That makes medical history especially important in these claims. Foot wounds, circulation problems and earlier kidney test results will likely all be reviewed.

• Pharmacy records. They show the exact drug, the dose and the dates.
• Kidney tests. Results before and during treatment can show any change.
• Foot and vascular care. Those notes may show what came before an amputation.

If a provider’s care is part of the concern, our medical malpractice page explains that separate route.

Low testosterone drugs are prescription products used to raise testosterone levels. Older descriptions tied them to heart attacks and strokes, but the Food and Drug Administration (FDA) has changed its position since then. A claim today has to deal with the whole timeline, not just the part that was in the news years ago.

How the FDA’s View Moved Between 2015 and 2025

On March 3, 2015, the FDA cautioned that the benefit and safety of testosterone had not been established for low testosterone levels due to aging. It required labeling about a possible increased risk of heart attack and stroke. “Possible” was the agency’s word, and it wasn’t a conclusion that the drugs cause those events.

On February 28, 2025, the FDA recommended removing Boxed Warning language on increased adverse cardiovascular outcomes for all testosterone products. That followed a large study called the TRAVERSE trial, along with blood pressure studies. The agency required blood pressure warnings instead, saying results “confirmed an increase in blood pressure with use of all” tested products.

So the 2015 language can’t be presented as the current view. The live safety subject in the FDA record is now blood pressure, not a settled finding about heart attacks and strokes.

What Did the Warning Need to Say at the Time?

Indiana measures a product’s condition when it was conveyed, meaning when it left the seller. A product can be defective if the seller fails to give reasonable warnings of danger when reasonable diligence could have made them available (Ind. Code § 34-20-4-2). Because this is a warning claim, you must also establish that the maker failed to exercise reasonable care.

Those rules make dates important. The fair question may be what the company knew or could have learned during the years you were using the drug, rather than what the label says now. A later change could help or hurt, depending on when you were treated and what you claim the label left out.

The Reason for Treatment Counts

The reason for treatment can be an important fact here. The 2015 caution focused on low testosterone due to aging, so a man treated for ordinary aging stands in a different position from one treated for a diagnosed condition. Your chart and your lab results should show which applies, and they may show what your doctor discussed with you.

Any claim would also need medical evidence specific to you. Past heart conditions, blood pressure history, smoking and family history are likely to be reviewed, since each can offer another explanation for a heart attack or stroke. Pharmacy records can establish the product, dose and dates of use.

Our Indiana product liability page explains how these standards fit together. If the concern is whether a provider prescribed or monitored the drug properly, see our medical malpractice page. If someone died, our wrongful death page has more.

Prilosec, Prevacid and Nexium are proton pump inhibitors (PPIs), a group of medicines that lower stomach acid. These drugs are often discussed in connection with chronic kidney disease, but the label warnings discussed here describe something else: inflammation of the kidney that comes on as an acute illness. That gap between the chronic and the acute shapes any claim here.

Acute Inflammation Versus Lasting Disease

The 2022 Prilosec label warns of acute tubulointerstitial nephritis, saying it “has been observed in patients taking PPIs and may occur at any point during PPI therapy.” A Nexium label with a December 2014 change added Acute Interstitial Nephritis. For suspected cases, the Prilosec label tells prescribers to discontinue the drug and evaluate the patient.

We can’t point to a Food and Drug Administration (FDA) warning about chronic kidney disease, and the 2022 Prilosec label has no such warning section. If you have that diagnosis, the label won’t answer the question for you. Whether these are the current labels, and what Prevacid’s label says, would also need checking.

Showing the Drug Caused This Injury

Being on the drug and then getting sick isn’t proof of cause. The Indiana Supreme Court made that plain in Kovach v. Caligor Midwest (2009), a case about medicine cups. Summary judgment went to the cup makers because none of the claimed defects could have caused an overdose of the size found.

That case involved a very different product, but its lesson carries over. Even in a failure-to-warn claim, you generally must connect the alleged problem to what actually happened to you. For a kidney injury, that connection may depend on several kinds of proof.

• Timing. When did you start the drug, and when did kidney symptoms or abnormal labs first appear?
• The diagnosis. Which condition do your nephrologist’s records name, and how was it established?
• Other causes. High blood pressure, diabetes and other medicines may all be considered.
• The response. Did anyone stop the drug, and what happened to your kidney function afterward?

A Label That Tells Doctors to Stop

The instruction to discontinue and evaluate gives this category a wrinkle. A maker may argue the label told doctors what to do, so your chart should show whether anyone acted on it. If the concern is that a doctor kept you on the drug after signs of kidney trouble, see our medical malpractice page.

These products have also been sold without a prescription, so keep receipts or other proof of store purchases along with pharmacy records. Our Indiana product liability page explains how warning claims work under the statute.

Zantac is a brand of ranitidine, a heartburn and stomach acid medicine once sold by prescription and over the counter. The Food and Drug Administration (FDA) asked manufacturers on April 1, 2020 to withdraw all ranitidine drugs from the market immediately because of a contaminant called NDMA. The FDA calls NDMA “a probable human carcinogen,” and that careful wording matters.

What the Agency Said, and What It Stopped Short Of

The FDA didn’t say Zantac causes cancer. It also said it “didn’t observe unacceptable levels of NDMA in many of the samples.” The withdrawal was a request, so “banned” is the wrong word for it.

The agency’s concern was tied to storage, because it said NDMA levels increase with storage. That offers a possible reason the problem could vary from one package to another. It also means a single test of one sample may not tell you much about the pills someone actually took years earlier.

Proving Which Product You Took

Ranitidine claims can fall apart on basic proof of use. Over-the-counter purchases often leave no pharmacy record, and many people switched between brand and store versions without thinking about it. Identification may need to be pieced together from several sources.

• Pharmacy and insurance records. These can document prescription use and the maker of each fill.
• Medical charts. Doctors often list over-the-counter medicines at each visit.
• Store loyalty and card records. Some retailers keep purchase history that may reach back years.
• Family and caregiver accounts. People close to you may recall what was in the medicine cabinet.

Identification matters because Indiana’s Product Liability Act claims run against the manufacturer or seller of the product that caused the harm (Ind. Code § 34-20-1-1). The store version and the name brand may have come from different companies.

A Store-Shelf Medicine With No Doctor in Between

Over-the-counter use changes the warning question. Indiana’s learned intermediary rule is about warnings given to a prescribing doctor, and no doctor stood between the maker and a box picked off a shelf. For those purchases, the package itself is the warning you had.

The harder question is what a maker knew about NDMA and when. If the danger arises in storage, what did the company know about how the drug held up over time? Any failure to warn claim must still show a failure of reasonable care, and it must rest on evidence tying your diagnosis to the drug. That medical link is likely to be the most contested part of any case, and expert opinion would probably be needed.

Our Indiana product liability page covers those standards in more depth. If a cancer took someone’s life, our wrongful death page explains how those claims differ.

Lipitor and other statins are cholesterol-lowering drugs that many people take for years. If you were told you have muscle damage or diabetes while on one, the questions are whether the drug is responsible and whether you and your doctor were adequately warned. The Food and Drug Administration (FDA) record on statins is narrower than that description, and it comes with an important qualifier.

What the 2012 Label Changes Covered

On February 28, 2012, the FDA approved label changes for statins. They added information on generally non-serious and reversible cognitive effects, and on increased blood sugar and HbA1c levels. HbA1c is a blood test that reflects average blood sugar over recent months.

Higher blood sugar readings aren’t the same thing as a diabetes diagnosis, and this entry doesn’t address muscle damage. The FDA also said it “continues to believe that the cardiovascular benefits of statins outweigh these small” risks. A maker can be expected to rely on that statement, and a claim has to work around it.

Brand or Generic: The Name on the Bottle Can Decide It

Federal pre-emption, meaning federal law overriding a state claim, treats brand and generic drugs differently. Most long-term statin users have taken a generic at some point, so this may be the first thing to check.

• Brand-name drugs. In Wyeth v. Levine (2009), the US Supreme Court held federal law didn’t pre-empt a state claim that a brand-name drug’s label lacked an adequate warning.
• Generic warning claims. In PLIVA v. Mensing (2011), the Court held failure-to-warn claims against generic makers pre-empted, because federal law required their labels to match the brand-name label.
• Generic design claims. In Mutual Pharmaceutical v. Bartlett (2013), the Court held design-defect claims that turn on the adequacy of a drug’s warnings pre-empted. That was a generic drug case, and the holding is limited to those warning-based claims.

So two people with the same injury might face very different outcomes, depending only on what the pharmacy dispensed. Your pharmacy records can show the maker of each fill.

Brand-Name Makers Have an Argument of Their Own

Yes. Wyeth has a limit: “clear evidence” that the FDA would not have approved the label change. In Merck Sharp & Dohme v. Albrecht (2019), the Court held that a judge, not a jury, decides that question. The company must show it fully informed the FDA of the justifications for the warning, and that the FDA said it wouldn’t approve it.

Under Indiana law, a warning claim still requires proof that the maker failed to exercise reasonable care. Our Indiana product liability page explains that standard. If the worry is that a provider ignored rising blood sugar or new symptoms, our medical malpractice page covers that separate path.

Zofran is a brand of ondansetron, a medicine used against nausea. Its Food and Drug Administration (FDA) label lists prevention of nausea and vomiting from chemotherapy, radiotherapy and surgery as its indications, and it doesn’t list morning sickness. Claims in this area come from families who ask whether the drug played a part in a birth defect after it was prescribed during pregnancy.

What the Pregnancy Section Actually Says

The label, in a version revised in October 2021, says available studies have “important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy.” In plain terms, the research can’t answer the question either way. The label uses the phrase “inconsistent findings,” and it reports one Medicaid group study with a finding on oral clefts after oral use.

It also says postmarketing data, meaning information gathered after a drug is sold, haven’t identified a drug-associated risk of miscarriage or adverse maternal outcomes. None of this is an FDA finding of harm. A statement that Zofran causes birth defects would go further than the record does, and any claim would need its own scientific support.

A Prescription for Something Not on the Label

A condition missing from the label doesn’t by itself answer whether a prescription was proper. Doctors have long had to make judgment calls about nausea during pregnancy, and the treating doctor’s reasoning is likely to come up. A claim would look at what the maker told prescribers, and whether anything it said or left out affected the decision.

Warnings are measured against reasonable care under Indiana law, so timing matters here too. The record of what was known when the prescription was written could differ from the 2021 label. Older labels and your obstetric chart would both be important to review.

When the Injured Person Is a Child

Many Indiana families assume a child’s claim can wait until the child grows up. That is risky with a product claim. The Product Liability Act says its time limits apply to all persons “regardless of minority or legal disability” (Ind. Code § 34-20-3-1). The extra time the general disability rule gives minors doesn’t help here.

So a family shouldn’t count on a child’s age to extend a claim about a medicine taken during pregnancy. Parents who have questions may want them reviewed early, even if a diagnosis is recent. Records to gather include pregnancy charts, pharmacy fills, and the child’s treatment records and any genetic testing.

Our Indiana product liability page explains how these claims work. If the concern is the prescribing decision itself, our medical malpractice page covers that separate path, and our post on prescription and medication mistakes gives examples of how these errors happen.

Talcum powder is a personal-care product made from talc, a mined mineral. These cases rest on two related concerns: that some talc may contain asbestos, and that long-term use may be connected to cancer. The Food and Drug Administration (FDA) position on both is more guarded than most headlines suggest.

Where the FDA Stands on Talc and Asbestos

The FDA says asbestos “is a known carcinogen when inhaled.” On talc itself, it says studies “have not conclusively demonstrated” a link between genital talc use and ovarian cancer. Those are two different statements about two different exposures, and a claim needs to be clear about which one applies.

The rulemaking record is unsettled as well. Under a 2022 law known as MoCRA, the FDA proposed a rule in December 2024 on testing talc-containing cosmetics for asbestos. It withdrew that proposal on November 28, 2025, and said it will issue a new one. No final FDA talc rule was found, and the agency’s page lists its yearly testing results through 2023.

Can You Show What Was in the Container?

The source of the talc may be the hardest fact to prove. A claim based on asbestos would need evidence that the product you used contained it. Testing of some containers, at some time, doesn’t automatically say anything about the one on your shelf. Old containers, if you still have them, should be saved and left unopened.

• Product history. Which brands did you use, and over what years?
• Manner of use. Was it applied to the body, or inhaled regularly at home or at work?
• The diagnosis. Pathology reports may show the type of cancer and how it was identified.
• Other exposures. Past jobs, military service or family history will usually be examined.

Why Indiana’s Asbestos Rule May Not Reach This Case

Indiana has a special rule for some asbestos claims, under which a personal injury claim accrues when the injured person knows of an asbestos related disease or injury (Ind. Code § 34-20-3-2). It sounds like a natural fit, but it applies only against those who mined and sold commercial asbestos and certain bankruptcy-related funds. A consumer powder maker may fall outside it, so the general product liability time limits may control.

That is a point for a lawyer to work through early, since a cancer can appear long after use has stopped. A claim about a warning on the label also calls for proof that the maker failed to use reasonable care, based on what it knew or should have known while you were buying the product.

Our Indiana product liability page explains the standards in more detail. If a cancer proved fatal, our wrongful death page describes how those claims are brought in Indiana.

OxyContin and other opioids are prescription painkillers that carry serious risks of misuse and abuse. Cases here involve people who were prescribed these drugs and developed addiction or suffered an overdose, including families who lost someone. They ask whether the warnings, the prescribing or both fell short, and they raise hard questions about the patient’s own conduct.

How the FDA’s Warnings Have Shifted Since 2001

The Food and Drug Administration (FDA) timeline gives a useful outline of what prescribers were being told, and when. Where a claim sits on that timeline may shape what a maker should have said.

• 2001. The FDA added a Boxed Warning to OxyContin.
• 2010. It approved a new formulation of OxyContin.
• 2016. It required a new class boxed warning on immediate-release opioids about serious risks of misuse and abuse.
• July 31, 2025. It issued safety labeling changes emphasizing the risks of long-term opioid use, and it approved the label updates that December.

The FDA also maintains a safety program for outpatient opioid analgesics called a Risk Evaluation and Mitigation Strategy (REMS). Its page says the program does not require prescribers to take its education. So a warning’s existence doesn’t prove your doctor saw or absorbed it.

Will Your Own Use Be Held Against You?

Probably, in some form. Indiana compares the fault of everyone involved in a product claim (Ind. Code § 34-20-8-1). Your recovery is reduced by your share, and under Ind. Code § 34-51-2-6 you are barred if your fault is greater than the fault of all others combined, meaning more than 50%.

A defendant can also raise specific defenses. These include using a product with knowledge of a defect and its danger, and misuse that the seller could not reasonably have expected. The defendant carries the burden on those defenses. Taking a drug exactly as prescribed is very different from taking it in another way, so the prescribing history matters a great deal.

Pharmacy records and the state’s prescription monitoring data, if available, can show what was filled and when. Addiction treatment records and the prescriber’s chart can fill in the rest.

When the Conduct Goes Beyond Carelessness

Some claims allege a company or prescriber did more than make a mistake. Punitive damages require clear and convincing evidence, and they are capped at the greater of three times compensatory damages or $50,000 (Ind. Code § 34-51-3-4). Most of any award goes to the state, and wrongful death claims have limits of their own. Our explainer on Indiana punitive damages covers the details.

Where the concern is a doctor’s prescribing, see our post on prescription and medication mistakes and our medical malpractice page. Families who lost someone can find more on our wrongful death page.