From an external perspective, it may seem simple to file a lawsuit against a pharmaceutical company. An individual consumes a drug, experiences a severe injury, and then takes legal action against the drug manufacturer. However, the legal framework surrounding these lawsuits is designed in a manner that actually makes it challenging to win such cases – not because the injuries are not legitimate, but because the law establishes certain bottlenecks that essentially eliminate claims before they have the opportunity to be presented to a jury. It is important to be aware of these bottlenecks if you are considering whether to take a case to court, or if you are questioning why so few individuals who file lawsuits against pharmaceutical companies receive compensation.
Why “FDA approved” isn’t the defense manufacturers think it is
Drug companies often rely heavily on FDA approval to indicate the safety of a drug. Their lawyers see the regulatory clearance as an institutional protection – if the agency evaluated it and authorized it for marketing, why would a plaintiff have any issue?
The problem is that approval is a single point in time. It represents what the manufacturer presented throughout the clinical trial process, not what the drug accomplishes over years of post-approval use.
Plaintiffs overcome the regulatory shield by demonstrating that the manufacturer concealed information from the regulators, failed to revise its warning label after postmarket adverse events were reported to the FDA Adverse Event Reporting System (FAERS), or had actual knowledge of the risk through its pharmacovigilance system and failed to act. It isn’t the approval, but the conduct around it.
The specific causation problem is where most cases die
Did the drug cause the harm, and did it cause this plaintiff’s harm? Defense attorneys capitalize on that gap between questions to protect their clients. If a plaintiff has a pre-existing condition that could independently explain the injury, the drug was incidental. If they were taking other medications at the time, those were the real cause. Lifestyle factors shoulder the blame. Medical history is unearthed in search of other possible causes. The defense’s goal is to present so many possible alternative causes that a jury couldn’t say with certainty that the drug was the specific culprit.
To win on specific causation, you need to be able to roll out expert witnesses – epidemiologists, toxicologists, and more – who can eliminate each potential cause one by one and then statistically link the injury to the drug. That is almost as scientifically exacting a proof as the tort law’s “more likely than not.” It’s expensive, it’s time-consuming, and it’s where under-resourced plaintiffs tend to get wobbly and fall short.
Navigating these complex legal doctrines requires a dangerous drug lawsuit attorney with the resources to essentially go to war with the multi-billion-dollar defense arm of a pharmaceutical company on the terms of their choosing. That means having the experts who can meet Daubert standards for their research and methodology, the scrubbed and audited records, house-to-house pretrial scrutiny, and the sheer bodies in the office to make it all happen on your end.
The generic drug loophole is a genuine structural problem
Most patients can’t even tell you what version of a drug they were prescribed. They remember the name of the drug. But whether they were dispensed the brand-name formulation or a generic equivalent becomes a crucial factual predicate to a lawsuit.
Because generic versions are so much cheaper, if not required by an ill-informed or under-informed doctor, consumer’s pharmacies will automatically fill the prescription with the generic equivalent. And, by and large, that’s all they stock.
Following the Supreme Court’s decision in PLIVA, INC. v. Mensing, there was a virtual complete bar to failure to warn claims against the generic manufacturer. It makes sense in simple terms. The federal law requires the generic manufacturer to simply copy whatever the most current warnings are from the brand-name manufacturer. The generic manufacturer has no ability to unilaterally enhance that warning or update that warning. Thus, they cannot be held liable for failing to do something that the law prohibited them from doing.
The result is that plaintiffs who ingested the generic version of a harmful drug are left without an economically viable failure-to-warn claim against the manufacturer of the generic equivalent. They might have a claim against the original brand-name company, but most plaintiffs cannot prevail in that circumstance either, since proving such a case when they ingested someone else’s product is complex enough to lead to the outright dismissal of many claims.
Surviving Daubert is a case within the case
Even before a pharma lawsuit ever comes close to going to a jury, defendants will challenge the plaintiff’s experts. The Daubert standard compels judges to serve as gatekeepers, determining whether an expert’s approach – and not just the expert’s opinion – is scientifically valid and applicable.
This sets the stage for a pretrial fight that can be just as exhausting and time-consuming as the trial itself. Defense counsel will undermine the statistical methods that underlie the epidemiologic research. They will call into question whether the animal research is indicative of human response – and whether the expert opinion is nothing more than potential speculation. If the plaintiff’s key expert flakes out under Daubert, the whole case on causation comes crashing down.
Crafting Daubert-armored expert testimony means lining up the right experts from the get-go – rather than trying to retrofit a case after the challenges have been made.
How MDLs actually work
Most legal actions against drug companies don’t happen as standalone court cases. Rather, they’re combined with thousands of similar lawsuits from around the United States in something called Multi-District Litigation. This pools all the cases together for pretrial proceedings in front of a single federal judge.
MDLs can go on for a long time. A few cases, called “bellwethers,” go to trial before any of the other lawsuits. The verdicts in those early trials help shape the outline of a settlement between defendants and plaintiffs for the rest of the people in the lawsuit. So, whether or not you win your case often depends largely on how a handful of strangers fared in the courtroom.
Again, this has been set up as a kind of solution to the problem of large-scale litigation. But it does mean that patients need to grasp that they’re not entering a lawsuit so much as a multi-year, thousands-strong, mini class-action of which their name will be at the top of the list.
