The safety of Zantac®, a popular medication used to treat heartburn and acid reflux, has come under scrutiny. Consumer groups and a number of lawsuits allege that Zantac® or "ranitidine"—which is referred to as the generic counterpart to or active ingredient in Zantac®—contains dangerous levels of N-nitrosodimethylamine (NDMA), a known carcinogen. As companies recall the drug, pharmacies like CVS pull it from shelves, and the U.S. Food and Drug Administration investigates, it's important for consumers to understand the legal issues at play.
Mere use of Zantac® is not usually enough of a legal basis for the filing of a civil lawsuit against a pharmaceutical company like GlaxoSmithKline, Novartis, or Sanofi (all of which manufacture Zantac and other ranitidine products). The combination of having used the medication and experiencing related health problems, however, can lead to a viable lawsuit. And If you think you're experiencing health problems related to the safety of Zantac® or any other ranitidine product, a clear medical diagnosis is typically crucial to showing that you're entitled to financial compensation.
In any personal injury or product liability case, including lawsuits over the safety of medications like Zantac®, the specifics of the plaintiff’s health problems are critical. They shape the value of the case, making an accurate diagnosis essential.
Diagnosis goes straight to the nature and extent of the plaintiff’s losses ("damages" in legalese). A Zantac® case almost always includes both "economic" damages (covering the cost of medical treatment, lost income, and other quantifiable losses) and "non-economic" damages (applying to pain and suffering, loss of enjoyment of life, and similar, more subjective consequences of the plaintiff's health problems). (Learn more about damages in an injury case.)
When faced with a lawsuit over the safety of a drug, pharmaceutical companies typically argue that the plaintiff doesn't actually have any health problems linked to use of the drug, or that the plaintiff’s condition is attributable to some other cause. That’s part of why diagnosis is so important to any case—an undiagnosed condition or an inaccurate diagnosis makes it much easier for the defense to argue that the plaintiff hasn’t proven that the claimed harm came from use of the product.
Laws called "statutes of limitations" set time limits on the right to file a lawsuit. Since health problems linked to ranitidine can progress gradually, it's not always clear when the plaintiff's "injury" actually occurred for purposes of the filing deadline.
In some states (like California), the date the person knew (or should have known in the eyes of the law) that their injuries were related to a defective product is typically the start of the statutory time period. In Zantac® cases, this could be the date on which the plaintiff was diagnosed with a form of cancer (or some other specific condition). But other factors can influence when the statute of limitations "clock" is said to start. In some jurisdictions, that the plaintiff became or should have become aware of the injury is what matters, not their potential or actual knowledge of the cause of that harm. Product manufacturers have also been known to argue that the onset of symptoms (not necessarily a clear diagnosis) is enough to start the statute of limitations "clock" in certain cases, and some courts have agreed.
Bottom line: If you wait too long to file your lawsuit, you might be barred from pursuing a civil case over Zantac®. An extension of the deadline might be possible, but you should consult a lawyer as soon as you begin to think about whether you have a viable case.
Many states have a specific statute of limitations for product liability lawsuits, while in other jurisdictions the limitations period for general personal injury lawsuits will apply. Either way, the filing deadline in most states ranges from one to six years for a lawsuit over health problems caused by Zantac®. For details on how the statute of limitations affects your situation, talk to a lawyer.
Most lawyers will not start a lawsuit over the safety of Zantac® until they have confirmed that a possible client has developed a form of cancer or some other specific health problem that could be linked to use of the medication. (Learn more about why a lawyer might turn down your injury case.)
Some attorneys will arrange for a health assessment for potential clients whose medical history includes use of ranitidine. Other times attorneys will order medical records from the potential client’s doctor or hospital and send the material to medical experts for evaluation of the nature and extent of the injuries.
If your doctor does not think you have a health issue related to your use of Zantac®, but a lawyer's medical expert thinks you do, you can take the expert’s report to your own doctor for a follow-up exam, or seek a second opinion from a different doctor.
A lawyer who has decided to take your case will determine which defendant(s) to sue and then file a "complaint" in court. The complaint is the legal document that starts the lawsuit and asks for damages from the defendant. (Note that a lawsuit doesn't always need to be filed; any product liability lawsuit can settle out of court, at any time. See the timeline of a typical personal injury claim.)
Next, the case moves into the "discovery" phase, when both sides gather evidence. Your lawyer might need to order additional medical documentation for retained experts to review. Your lawyer's medical experts might also examine you.
Defendants are usually entitled to see whatever medical information the plaintiff’s lawyer has that’s relevant to the case. If you have a case, your lawyer will probably need to provide the defense with a list of facilities where you've been examined or treated. The plaintiff’s lawyer usually hands over this kind of information as "answers to interrogatories," part of the discovery phase.
When the defense attorneys decide they want to look at specific medical records the plaintiff’s lawyer hasn’t already provided, the plaintiff often has to give authorization allowing the release of further medical information. Because of privacy regulations, each authorization must be specific to the facility, so the plaintiff might have to sign a lot of forms.
Sometimes the defense asks for medical information by issuing a subpoena to a facility. If they take this route, they have to notify the plaintiff’s attorney. If the request is for something inappropriate or irrelevant, the attorney can try to block the subpoena or review records first to protect the plaintiff’s privacy.
Normally, the defense can also have its own medical expert examine the plaintiff. This step is called an "independent medical examination." The plaintiff’s attorney helps arrange such an exam and should protect the client from any improprieties, such as medical tests that aren’t related to the plaintiff’s claims.
If you have a ranitidine case, and it gets to the point of a deposition (or even trial), the defense will ask you about your health, your diagnosis, and your treatment. Sometimes plaintiffs’ deposition (and trial) answers differ from their written answers to interrogatories because of a mistake in memory. These small discrepancies are normal and extremely unlikely to affect the plaintiff’s case. If you have a case, you don't need to prove that your diagnosis is correct or even understand the medical details; expert witnesses will weigh in on those subjects.
If you’re considering filing a lawsuit over Zantac® or ranitidine, you should consult an attorney as soon as reasonably possible. An experienced lawyer will be able to explain the law as it applies to your situation.