A recent study commissioned by the Association of Personal Injury Lawyers (APIL), a plaintiff lawyers group, demonstrated that the success rate of legally aided claims against drug companies in Britain is zero. This perfect batting average was mainta

The only beneficiaries thus far of the estimated £30 million of public money paid out in legal aid on this action alone have been the claimants’ lawyers and expert witnesses.

In America, where it’s always assumed to be far easier to sue anybody, drug companies oftentimes prevail. Thirty-six sets of parents took Merrell Dow Pharmaceuticals to court over birth defects of their children allegedly caused by the anti-nausea drug Bendectin taken during pregnancy. Even with the emotive ingredient of deformed children, and the spectre of another potential thalidomide, 34 of the 36 cases recently lost.

Together, these facts raise serious questions about the entire process of using the courts to claim for damage caused by a drug.

It’s important to keep in mind that the purpose of a trial is to determine not the truth about a given event, but which side has the more convincing evidence. The burden of proof rests with you, if you’re the one suing, to prove both fault and causation. The rules which determine these issues have evolved over centuries. They were never intended to address the complexities of modern medicine in the legal arena. However, the lawyer and the court have no option but to grapple with these difficulties, applying ancient legal concepts to scientific evidence.

For the lawyer causation is deterministic; once proven to a required standard it is then deemed to be a factual certainty. Even in multiple-plaintiff claims each plaintiff must show that the drug in question definitely was responsible for the damage suffered.

For the scientist, causation is biostatistical, probabilistic and expressed according to confidence limits and significance levels (ie, the probability of chance). This is because of the biological variation between you and me. Biological studies have to be conducted on large populations to eliminate individual variation. Simply put, while scientists live in a world of endless shades of grey, the universe to a lawyer is solidly black or white.

Unfortunately, it is not uncommon for specialist lawyers to confuse the legal concept of “standard of proof” with the biostatistical concept of “probability of chance”. Scientific evidence can merely attempt to answer the question “can agent X cause this condition?” rather than “did agent X cause this condition?”

If your injury is highly specific, extremely rare and known to be a side effect of a drug, then you have a possibility of meeting the standard of proof.

However, as happened in the tranquillizer cases, if you are claiming that the drug caused common conditions like anxiety and sleeplessness the very conditions for which you took the drug in the first place the chances of your succeeding are very slim indeed.

In America, certain cases have run aground because the same difficulty of proving causation. This is what ultimately damaged the cases over Bendectin; apparently, in more than 30 published studies of some 130,000 people, none had found that Bendectin could cause birth defects.

Suing your doctor instead of the manufacturer is unlikely to provide a successful strategy since you’re still up against the problem of proving individual causation. The exception is if he misdiagnosed you or gave you the wrong treatment, in which case you can mount a negligence case-provided of course you can prove the damage you suffered was caused by the treatment.

Until the legal process can accommodate an approach which straddles both science and law, the prospects of success for plaintiffs in this sort of litigation appear remote.

The US doctrine of “market share” is one way forward for certain cases. In English law the plaintiff can’t sue unless he can identify the defendant. This requirement can be difficult where several manufacturers produce the same drug. In the US, if a plaintiff is unsure of the manufacturer of a particular drug but can prove it caused damage, all the manufacturers of that drug may be made to pay compensation in proportion to their market share.

With the decision on Daubert vs Dow Merrill, one of the Bendectin cases, the US Supreme Court has attempted to elucidate the sort of scientific evidence admissible in such cases. Individual states have attempted to define standard medical practice for given conditions, the better to rule on negligence.

It may well be that in the end, the courtroom will not be the right forum for resolving such disputes. Again, in the States, mediation and arbitration are more developed; manufacturers are more likely to award compensation or set aside compensation schemes from company profits for individuals suffering side effects if they can avoid admitting general liability with the endless future litigation that would invite.

Following the debacle of the benzodiazepine litigation the Legal Aid Board itself gave a nod in that direction by asking for the creation of investigative tribunals: “There ought to be consideration given to alternatives to the courts.”

!AAnthony Barton

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Written by What Doctors Don't Tell You

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