Why Suing Big Pharma Isn’t Changing Anything

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You could say this has been a bad year for Big Pharma as lawsuits over injuries caused by dangerous drugs and medical devices keep pouring in all over the country. Yet, nothing seems to really change, does it? The suits keep coming and so do the “new and improved” drugs and devices that only generate further suits. It may seem to be a bad year for Big Pharma, but is it really? Read on to learn why suing Big Pharma isn’t changing anything.

There are lawsuits over Zoloft (birth defects when taken by pregnant women), Xarelto & Pradaxa (uncontrollable, often fatal, bleeding events), testosterone (increased risk of strokes and heart attacks), Actos (risk of bladder cancer) and many, many more. One would think that Big Pharma would clean up its act. After all, these suits are expensive!

• Paxil’s manufacturer paid $3B in fines due to illegally promoting the drug for use with children and teens, despite clinical proof that it not only doesn’t work, but also increases the risk of suicidal thoughts.
• Actos’ manufacturer coughed up $2.34B in settlements.
• Pfizer continues to pay to defend against Zoloft suits.
• Bayer and Johnson & Johnson are paying to defend against Xarelto suits.

That’s recent information. The last few years have been costly to Big Pharma, too:

• 2012: Bayer settles for $110M over claims that the oral contraceptive, Yasmin, caused fatal blood clots.
• 2010: Avandia’s manufacturer pays $460M to settle 10,000 suits claiming its diabetes drug increased heart attack risks.
• 2008: Vioxx’ manufacturer settles claims that its painkiller caused strokes and heart attacks for $4.85B.

Despite these incredibly expensive suits and settlements, these same drugs rake in billions of dollars in sales for their makers. None of these things seem to work to convince the industry to straighten up and fly right. There are reasons for that and they’re somewhat surprising.

Settlements

We’ve been conditioned to think that big settlements effect change, yet this is a fallacy. Settlements actually have a protective effect on the issue at hand. When a plaintiff settles, there is no big, public trial at which all of Big Pharma’s dirty little secrets are exposed. In fact, some settlements even come complete with “gag orders” stating that the parties involved are not to publicly discuss the case.

As long as the profits are larger than the settlement payouts, Big Pharma is willing to take the financial hit. This is not conducive to changing the industry’s behavior. Instead, settlements become one more cost of doing business, much the same way that recall campaigns are for the auto industry.

SCOTUS Turns a Blind Eye

Sadly, the solution is not merely convincing plaintiffs to stop settling. We’ve seen cases taken to trial this year that resulted in victories for Big Pharma. The biggest example is the second Zoloft trial, which Pfizer actually won despite internal evidence that supported the case.

Back in 2013, the SCOTUS issued a ruling that stated, “If the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.” The other thing this ruling did was to exempt U.S. generic manufacturers from liability for drug side effects. Generics comprise roughly 80% of the U.S. pharmaceutical market.

FDA Puts Innovation Ahead of Safety

Congress has put four programs into effect since the 90s that expedite the approval process for “new, exceptional” drugs. The goal is to get FDA approval as quickly as possible so that these “better” drugs can save more patients. Unfortunately, this comes with a price: the data used to fast track these drugs comes from preliminary research that is often substandard.

The sad truth is that these programs have missed their marks. While more new drugs are hitting the market faster than ever before, studies suggest that they really aren’t all that “innovative and exceptional.” Researchers from both Brigham and Women’s Hospital and Harvard Medical School found that, of the drugs hitting the market since the mid-90s, about “85 to 90 percent… don’t offer any clinical advantages for users.” In fact, many of these innovations are duplicates – under a different name – for drugs already available.

The scariest part is that it often takes months, even years, for some of the damaging side effects to become known. In the meantime, patients are using these products under the assumption that they passed rigorous testing and are completely safe.

As you can see, it’s going to take a lot more than lawsuits to change Big Pharma. We need new and better legislation and policies covering drug approval, as well as a more realistic ruling from the SCOTUS. Whether we’ll get any of that is unclear at the moment.

Filed under: General Problems