As an orthopedic surgeon, I’m often called to serve as an expert witness in personal injury and malpractice litigation. Over the last 40 years, I’ve given hundreds of depositions and appeared in court on numerous occasions. During that time, I’ve learned the importance of knowing what you’re saying and being sure you’ve got the facts, and the science, to back you up.

There’s something called a Daubert challenge that every expert witness must be aware of and ready to defend. The term comes from a case in 1993, Daubert v. Merrell Dow Pharmaceuticals, which was decided by The Supreme Court. The case concerned the drug Bendectin, commonly used to ease morning sickness during pregnancy. Epidemiological studies consistently found no association, let alone causation, between the drug and birth defects. Yet plaintiffs in one case consulted with a cadre of experts who sliced and diced existing data to conclude otherwise. Their findings were never published in a peer-reviewed journal.

Robert P. Charrow, writing in The Wall Street Journal, tells us the court, adhering to a federal statute, instructed federal trial judges to act as gatekeepers by permitting testimony about scientific opinions only if it amounted to “good science,” developed in accordance with the scientific method. Such opinions, the justices added, must also “fit” the issue before the court. If a case were about whether a drug caused a disease in humans, its effect on animals likely wouldn’t suffice. The high court instructed the lower court to consider the propriety of the plaintiff’s expert testimony in light of its opinion.

When the lower court reconsidered the evidence in light of Daubert, it held that reanalyzing existing data for litigation and failing to publish such analysis in a peer-reviewed journal fails to ensure its reliability and isn’t consistent with the scientific method. Most states have adopted this approach.

Requiring a judge to act as a gatekeeper ensures that testimony is scientifically sound. It likewise ensures that judges follow the same rules when evaluating scientific evidence. Daubert doesn’t require that every expert have the same opinion—it simply ensures that judges will maintain guardrails. As in baseball, abiding by the same rules ensures that if a player hits a ball into the bleachers behind home plate, every umpire would call it a foul. The rules make the game, much as the scientific method makes science.

This brings us to the current situation where two mass products liability cases – in Florida federal court and Delaware state court – have had two different outcomes. Both cases concern the drug ranitidine, the active ingredient in the heartburn medication Zantac and its generic counterparts. Thousands of plaintiffs claim the drug caused them to develop at least one of several types of cancer. Both courts consider Daubert controlling precedent. Both analyses therefore should have been nearly identical. In practice, however, they were diametrically opposed.

Mr. Charrow tells us in a December 2022 opinion, federal judge Robin Rosenberg of Florida examined the plaintiffs’ expert opinions, which claimed that Zantac and other ranitidine-based drugs caused cancer because their active ingredient can degrade into the carcinogen NDMA, which is also found in smoked meats.

Yet to prove that claim, one must demonstrate the drug exhibits consistent positive associations with certain cancers across a series of human studies. No such relationship existed. The human studies didn’t show a consistent statistically significant and valid association between ranitidine use and cancer, let alone causation. Based on these, along with another study from the Food and Drug Administration, the agency and its European counterpart concluded that ranitidine poses no risk of cancer. The judge followed these assessments and excluded the plaintiffs’ expert testimony.

The Delaware court on May 31 reached the opposite conclusion in In re Zantac (Ranitidine) Litigation. Judge Vivian L. Medinilla’s opinion discounted epidemiology studies and the FDA’s conclusions. She relied instead on studies of NDMA—the chemical, not the drug—which showed a positive association between certain workers’ exposure to NDMA and cancer.

The FDA’s fellow public-health agency, the Agency for Toxic Substances and Disease Registry, reviewed at least one of these same studies and decided it couldn’t draw the same dispositive conclusions from it. Its limitations, the agency noted,“make it difficult to establish clear associations between NDMA exposure and mortality from specific cancers.” The studied workers were exposed to scores of carcinogens, which made linking cancer to one chemical scientifically impossible.

Mr. Charrow responds, “Yet these expert decisions didn’t trouble Judge Medinilla. In her view, the jury could second-guess federal agencies, as well as those who conducted the independent epidemiology studies, so long as other experts disagreed. The court effectively put a foul ball into play.”

Clearly, the Delaware judge is not following the science. The Daubert decision was supposed to make this impossible.  It is the judge’s responsibility to keep the expert witnesses in line and prevent unproven scientific theory from deciding cases.

I’ve never had a Daubert challenge to my testimony in 40 years. But if I ever start testifying based on my theories, and not the proven science, I should.

People are having knee and hip joint replacements at younger ages. In the past, doctors usually recommended putting off joint replacement surgery until patients were in their  sixties or seventies, but that seems to be changing.

Alex Janin, writing in The Wall Street Journal, tells us the average life expectancy is ticking up and the average age of joint replacement surgery is going down. He says many Americans are no longer willing to sacrifice decades doing their favorite activities, such as skiing, hiking or playing pickleball, to sit in pain, according to doctors.

Certain intense, high-impact fitness activities can increase the chances of injury and arthritis—leading to more procedures. “In the past, people would just say, ‘I don’t run, I have bad knees,’” says Dr. Ran Schwarzkopf, an orthopedic surgeon at NYU Langone. Now, he says, “they’re not willing to accept limitations that arthritis gives.”

The other reason younger people are getting replacements is the growing prevalence of obesity in the U.S. More than 40% of U.S. adults have obesity, the Centers for Disease Control and Prevention says, up from roughly 30% in 1999. Excess weight puts more pressure on the joints—roughly 4 pounds for each additional pound of body weight—leading more patients to need replacements earlier in life.

For patients ages 45 to 64, there was a 211% increase in inpatient hip replacements and a 240% increase in inpatient knee replacements between 2000 and 2017, according to data from the U.S. Department of Health and Human Services’s Agency for Healthcare Research and Quality. (Records after 2017 are less accurate due to changes in Medicare coding.) There was also an increase in joint replacements for patients ages 65 to 84, but the rise wasn’t as steep.

This tracking doesn’t include the growing share of replacements that are outpatient surgeries, which allow patients to go home the same day as their procedure. More than a million hip and knee replacement surgeries are performed in the U.S. every year.

“Back in the day, patients were told they had to wait until they were 70 or 80 to undergo this procedure because implants did not last long enough,” says Dr. Antonia Chen, an orthopedic surgeon at Brigham and Women’s Hospital. “Now, implants last 20, 25 or 30 years, and quality of life means a lot more.” Chen estimates that patients under 65 account for roughly 50% of her practice now, up from roughly 30% in 2014.

All this sounds great but there is another side to this story. Many surgeons still recommend minimizing or altogether avoiding running and other high-impact exercises after surgery, because it can put extra pressure on the prosthetics. Our joints are like tires; the more weight the tire carries, the quicker it wears out. These procedures are largely elective, and surgeons caution they still shouldn’t be considered preventive. They carry risks including infection, dislocation or joint instability.

As an orthopedic surgeon myself, I can tell you it’s more complicated than it seems. I once performed a total knee replacement on a 33-year-old man, but he would have been in a wheelchair otherwise. I wasn’t trying to get him back to running marathons! Anyone can undergo a total joint replacement at an early age and improve their level of function. But the real test is how long before you have to repeat that procedure because the artificial joint has worn out, or more commonly, has become loose.

If a person in their forties has a knee or hip replacement, and lives a normal life expectancy, it is almost guaranteed they will have to have that joint replaced a second, or even a third time. And if obesity is their problem, those repeat joint replacements will happen even more frequently. While this is certainly possible, the incidence of complications with repeat replacements goes up significantly. I doubt the surgeons doing many procedures in patients under the age of sixty-five are being fully candid about the drawbacks of repeat total joint replacements. No improvements in the materials used or the surgical techniques employed can change that reality.

The latest news in the financial world is “price controls.” This approach to economics was put forth by the Biden Administration two years ago with the Inflation Reduction Act (IRA), a misnomer for legislation that only added to our inflation problem. The intent of this legislation was to reduce prices on prescription drugs.

It makes good political sense to tell seniors you’re going to lower the price of their prescription drugs. What you won’t tell them, however, is this same move will reduce the development of new medicines.

The Wall Street Journal editorial board tells us Charles River Laboratories, a top research contractor that helps drug makers with clinical trials, warned in its quarterly earnings report that pharmaceutical companies are slashing research and development owing to the IRA’s drug price controls.

“There are profound cuts” at pharmaceutical companies that reflect a “rapid deterioration” of their business, CEO James Foster said. He added: “A lot of these decisions have been taken relatively recently and probably more to come and haven’t been taken yet.” Might drug makers be hedging their investments because Democrats look more likely to hold the White House?

WSJ explains: “The IRA let Medicare “negotiate” prices for 10 to 20 drugs a year and a total of 60 by 2029. Negotiate is a euphemism for extortion: Drug makers that don’t participate or reject the government’s price face a daily excise tax that starts at 186% and climbs to 1,900% of a drug’s daily revenue.”

The law also requires manufacturers to pay the government rebates on medicines sold to Medicare if they raise prices more than the rate of inflation, and puts them on the hook for more of the entitlement’s Part D costs. Democrats used the resulting estimated “savings” of some $160 billion to pay for the green new deal.

WSJ says, “But subsidized solar panels won’t help if you get sick. The inevitable, albeit invisible, result of Democrats’ raid on pharmaceutical companies will be fewer new medicines.”

Roche CEO Thomas Schinecker said last summer that “we have decided that we are not going to do certain trials, or that we are not going to do a merger or acquisition or licensing [deal] because it is becoming financially not viable.” Astra-Zeneca also warned that it might delay launching some cancer medicines because of the IRA.

Some 90% of drug candidates fail in clinical trials, and manufacturers sometimes never recoup their investment on even those that are approved. They use profits from their few commercial successes to finance research and development into new medicines and to compensate investors. The IRA threatens this risk-reward model.

Despite these obvious drawbacks of price controls on the manufacture of prescription drugs, Democratic presidential nominee Kamala Harris has just announced she will pursue price controls on food and groceries as a “solution” to our inflation problem. Just as it has reduced the supply of new medicines when used in the IRA, this use of price controls will inevitably lead to fewer supplies of food and groceries.

Here is what the WSJ editors have to say about that:

“Fixing prices is a recipe for shortages, as controls would discourage grocery suppliers. Voilà, empty store shelves. Price controls have led to shortages everywhere they’ve been tried, from Moscow to Caracas. The last American President to impose wage and price controls was Richard Nixon in the early 1970s. He had to stage a humiliating retreat amid shortages and market dislocations, and prices immediately soared when controls were lifted. If Ms. Harris really believes in this price-fixing, she lacks the most basic understanding of economics. If she is merely floating it to be able to get “price gouging” into a speech, her cynicism is also telling.”