It’s not easy to sue Big Pharma. But, legal firm Baum Hedlund has been doing it for years. Unfortunately, as pharmaceutical deceit and side-effects grow, it’s getting exponentially more difficult. After all, using prescription drugs as prescribed is the top killer in the USA.
I reached out to attorney Michael Baum to get a behind-the-scenes look at how this growing monster is shielded from liability by our court system. Baum generously agreed to share his candid insights. If you or a loved one are taking prescription meds — make sure you read this interview closely.
Michael L. Baum
TPC #1: Does the court system protect the pharmaceutical industry from liability? If so, how?
Mr. Baum: Yes. The court system has made it very expensive for claims to be made against pharmaceutical companies for injuries. For instance, drug lawsuits require expert testimony from a person with a related PhD and/or MD level education. Otherwise, the case may be thrown out before going to trial.
This makes suing drug companies pricey because the experts charge high hourly rates to offset the “cost” of going up against the same entities that pay for grants, lucrative industry jobs and coveted academic positions.
Furthermore, many judges now have gate-keeping authority to reject cutting-edge science that goes against the status-quo — what the rest of the scientific community “believes.” Drug companies are able to foster “established beliefs” with hundreds of millions of dollars in marketing aimed at physicians, medical journals, academic opinion leaders, and professional organizations of scientists. Once those marketed messages become pervasive, use of the drug becomes the standard of care. So overcoming that impression is like convincing a court the emperor is not wearing new clothes, which can be very difficult.
TPC #2: What are the ramifications of this conflict, on the average U.S. citizen?
Mr. Baum: The expense itself can make bringing an individual case prohibitive. We now have to combine cases to spread the cost. Unfortunately, courts (and legislative actions) have whittled away using these class actions for drug injuries. They now say that each person’s damage is unique and not common across a class, even if they suffer the same injury, e.g. a heart attack.
Combining many claimants into lawsuits is still possible, but it requires enough similarly injured people to justify a consolidated action. Finding lawyers qualified and willing to take on the detailed investigation and pay out the expense of engaging experts is itself a big hurdle. Drug companies can afford to make lawsuits long and difficult, so financing such litigation with qualified, available lawyers can be a barrier to an average U.S. citizen pursuing a drug case.
There’s also the pill-popping culture that causes an additional barrier. Many injuries occur after a person has been prescribed a number of drugs. Separating out one drug’s effect from another adds another level of complication. Thus, many law firms and courts will reject cases unless it is clear that the likely culprit is one particular drug.
TPC #3: If a drug has been proven ineffective and dangerous in a court of law, why is it still on the market?
Mr. Baum: A court is not the FDA, so it does not have the power to recall a drug. An individual court finding that the drug was not effective and harmful to one person may not indicate that there are others that may benefit from the drug. So court cases are not used to dictate what can or can’t be on the market.
Most drugs are essentially dangerous chemicals that have benefits that outweigh their risks. If court trials show that a warning was not adequate, labeling can be modified to address that.
In the context of pediatric prescribing of an antidepressant like Paxil or Celexa, litigation showed that the drugs did not out-perform placebo. It also showed that they doubled the risk of suicidal behavior. Eventually, the FDA required a black box warning about the risks, but the marketing and clinical experience of the placebo effect convinced many doctors to keep prescribing them. Plus, the studies proven false in litigation don’t necessarily end up getting corrected or withdrawn.
One such infamous study, Paxil 329, is still published and cited by other studies in favor of the drug, despite widespread recognition that it was ghostwritten and contained false information. Again, the marketing created the impression of safety and efficacy. A counter-marketing campaign has not occurred to correct the mis-impressions created by the initial marketing and ghostwritten articles.
TPC #4: How do drug companies get away with false advertising? Has a pharmaceutical company ever been convicted in court for false advertising?
Mr. Baum: I guess the short answer is they get away with it until they get caught. Whistleblower cases and product liability lawsuits have exposed many fraudulent campaigns, resulting in large fines or verdicts. I think many of the methods used during the 90’s and up till recently (ghostwriting, bribing with dinners, entertainment tickets, trips, or opinion leader status) have been curtailed to some degree by such lawsuits.
As with many frauds, they are coated with some truth — they used self-funded and ghostwritten or controlled study results to promote benefits and minimize risks. Once published by cooperative journals, the studies can be circulated by sales representatives to physicians. It takes a while for the courts and scientific community to catch up with these tricks, if ever.
TPC #5: In your experiencing suing drug companies (whose dangerous drugs are APPROVED by the FDA) — would you say the FDA is doing its job at protecting patients?
Mr. Baum: There are some elements of the FDA that are trying to protect consumers. Other factions consider the pharmaceutical companies to be their “clients” since the FDA is partially funded by the companies through the Prescription Drug User Fee Act (PDUFA).
The volume of work the FDA must do to monitor the risks — with all the drugs already on the market, plus the drugs trying to get on the market — can result in subtle problems getting masked by “summaries” of data provided by the companies. In other words, an overworked FDA can end up simply relaying information spoon fed to them by Big Pharma. This is counter to what the FDA was set up for, which was to act as a non-biased third party to business interests.
TPC #6: Does a black box warning really have much influence over whether or not people choose to take the drug? (Does anyone even bother to READ those warnings?)
Mr. Baum: A black box warning is a good step in the right direction. But it may not be enough to overcome the misimpression created by the massive marketing campaigns that preceded the black box warnings. This is a clear case of Mark Twain’s observation, “It’s easier to fool people than to convince them that they have been fooled.”
TPC #7: Is the lack of sufficient warning on medications the biggest problem here? Or is it that drug makers are allowed to sell products that require such warnings in the first place?
Mr. Baum: Any medication may have risks that are worth taking for the needed benefits — antibiotics can prevent an infection from becoming fatal, but they adversely affect other useful bacteria in the gut. Adequate warnings with appropriate guidance make it possible for drugs with some harmful side effects to be used effectively and safely.
The problem I see is the excess influence of pharmaceutical money in the marketing, medical education, professional publications, public media direct-to-consumer advertising, political donations, and lobbyists. These have resulted in a system that enables drug dangers to go uncorrected too long at the expense of public health.
TPC #8: What do you personally believe needs to CHANGE about the pharmaceutical drug industry as a whole?
Mr. Baum: I think it would be useful to stop direct-to-consumer advertising. The current media are too dependent on Pharma marketing dollars. Therefore, they are unable and unwilling to critically analyze proclaimed benefits and potential harms of drugs. This has crushed unbiased reporting and journalism. Intrepid reporters’ stories can end up not getting aired to protect the advertising income.
Further, pharmaceutical companies should not be allowed to fund “educational” dinners, seminars, or continuing medical education on drugs they have a profit motive to positively influence.
Ghostwriting of clinical trial results needs to be exposed. The patient data from clinical trials (with patient identifying information protected) should be available so that scientists can see what actually happened, not just the spin that the pharmaceutical marketing departments were able to maneuver into print.
Lobbyist armies should be curtailed to prevent excessive legislative influence. Approval boards and advisory committees should not have members on the payroll of pharmaceutical companies, directly or indirectly. Company documents obtained in litigation should be more easily made public, especially when they don’t involve actual trade secrets and would affect public safety.
Author Shane Ellison was a chemist for the pharmaceutical industry. He left that career to pursue investigating and creating natural cures with his extensive knowledge of organic chemistry. Shane authored the book Over-The-Counter Natural Cures Expanded Edition . His website is The People’s Chemist.