So the FDA gives the multi-billion dollar corporation 510(k) approval to sell the device. In the first year the company sells one billion dollars’ worth of the device. In the second year it sells $1.5 billion in new devices, but it also begins to receive an alarming number of “adverse event” reports. This means patients are reporting problems and injuries after receiving the device. The company undertakes an internal study but does not report its findings to the FDA. In the third year it sells even more devices, but by now hundreds of adverse reports are rolling in. The injuries finally get the attention of the FDA, and the company reluctantly hands over its data on the many serious injuries caused by the new device.

In the fourth year a woman with the implanted device is forced to undergo “revision surgery” to remove the device, and her recovery is lengthy and painful. She calls me and tells me her story. It is awful. She was once a competitive tennis player, but now she walks with a cane. She hasn’t played tennis in two years. She had to take time away from her job. Even with decent health insurance she has thousands of dollars in out-of-pocket medical bills related to the failure of the device.

I take her case. I file a lawsuit in the new “multidistrict litigation” organized to handle the hundreds of cases involving injuries from this new medical device. I move the case along, handle the discovery and make sure my client’s case complies with all Case Management Orders from the MDL judge. Eventually we secure a good settlement for my client.

Later, at a press conference, a spokesperson for the corporation breezily refers to lawyers as ambulance chasers.

So after that narrative of events, I am the ambulance chaser?

As John McEnroe might scream, “you cannot be serious!”

I understand in this age of constant spin, the primary defense to a bad act is to attack. We see it in business; we see it in politics. We see it so often on social media it seems social media was invented for the purpose. And it is very frustrating. But that’s why it is vitally important not to let agents of spin control how you understand any subject. If a corporation can manipulate you into considering whether I am an “ambulance chaser,” it does not have to defend itself for introducing a harmful medical device into the marketplace, seriously hurting thousands of people.

Fighting spin is necessary to appreciate the excellent work so many plaintiffs’ lawyers are doing for injured people across the country.

There is no doubt there are unscrupulous lawyers out there. Some are opportunistic. A few lawyers wade into a new area of law simply because it appears profitable. Some lawyers produce ridiculous and creepy television commercials. A few may even hand out business cards at hospitals like Danny DeVito did in The Rainmaker. I understand that. And I don’t like it. It hurts all lawyers when a few lawyers do incompetent work or play fast and loose with ethics rules.

But the large majority of plaintiffs’ lawyers are doing good work for their clients. And in a world where the 510(k) fast-track approval pathway exists, it is critically important that good plaintiffs’ lawyers keep holding companies accountable for selling flawed, defective medical devices. In fact, it is one of the only defenses a patient has against unscrupulous device manufacturers.

So if an “ambulance chaser” is considered this way, then count me as a proud ambulance chaser. Because taken in this context, ambulance chasers are consumer protection heroes.

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad as the free speech rights individuals have) and there’s a tension between what the FDA wants companies to say, what these companies want to say, and what the courts say the companies can say.

The agency in late August published a notice of public hearing and request for comments concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016 in Silver Spring, Maryland, and in case you want to present information you must register by October 19. You could also send in written comments by January 9.

more Off-Label Drug Use

These are very hot button topics. Manufacturers can’t market their products for purposes that are not approved by the FDA (such as if a drug is approved to treat lung cancer only it can’t be marketed to treat malaria), but once approved by the FDA a physician can prescribe it for off label uses. There have been court rulings stating manufacturers can talk truthfully about unapproved uses of their products to physicians. It’s a fine line, and it can easily be abused.

To be approved for a particular use a drug manufacturer must go through a long and expensive process to show the FDA the drug is safe and effective. The danger to patients is that if they take a drug for an unapproved use it may not be safe or effective. It may be a waste of money, it may harm them directly, or the time wasted taking this ineffective drug may allow the disease or condition to worsen, possibly making treatment more difficult or impossible.

On the flip side patients may be suffering from a disease or condition that may be very difficult to treat or is untreatable. A drug approved for one purpose may show promise in clinical trials to battle this hard-to-treat or impossible-to-treat disease. Instead of potentially waiting years for formal approval, these patients may be able to benefit in the present instead of waiting to use it in the future (if they live that long).

FDA Public Hearing

The FDA poses a number of questions on which it would like input from a number of interested parties including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics generally cover:

• How off-label communications impact public health,
• How changes in the health care system result in data on new uses of approved products,
• How to preserve incentives for manufacturers to seek approval for new uses,
• Standards for truthful and non-misleading information provided by manufacturers,
• What the FDA should consider when it monitors and enforces the law on off-label communications by manufacturers, and
• Changes FDA should consider to regulations covering manufacturers’ communications about their products.

Can Congress Help?

Add Congress to the mix. In May the House Committee on Energy and Commerce sent a letter to Health and Human Services Secretary Sylvia Burwell:

• Showing concern that FDA hadn’t clarified its position on permissible manufacturer communications about uses of drugs and devices beyond their approved labeling; and
• Voicing displeasure that HHS apparently was stopping the FDA from issuing guidance or new regulations after a number of court victories for companies and individuals prosecuted for off-label communications about drug and medical devices.

First Amendment commercial speech protections have been interpreted by the courts to allow manufacturers’ truthful and non-misleading speech concerning their products even if that speech includes uses of their products that have not been approved by the FDA. Companies and groups impacted by the issue have encouraged FDA to issue new guidance or change its regulations so its oversight and enforcement actions reflect these court decisions. This announcement and these public hearings are a possible step in that direction.

California is a beautiful, diverse state. It has everything from wide, sandy beaches to snow-capped mountains, deserts, thick forests, wide open spaces and massive cities. It also has laws and a court system that’s seen as friendly to those injured by prescription medications. And after a recent court decision, more people in other states may be heading there to try their product liability cases.

The California Supreme Court issued a decision in August which may encourage people harmed by prescription medications and medical devices from all over the country to file legal actions in the state. At issue is whether the state’s court system has jurisdiction over legal claims by people who’ve never been in California. In cases involving the drug Plavix, the answer was yes.

The eight lawsuits in question have 86 California residents and 592 people from 33 other states as plaintiffs. The defendant, Bristol-Myers Squibb, sought the dismissal of the claims by the 592 non-Californian plaintiffs.

Jurisdiction: The Power of a State to Hear a Legal Dispute

The question facing the court was whether state courts have jurisdiction over legal claims involving these plaintiffs. A key element to any civil case is whether the court has jurisdiction over the parties, whether it has the power to make decisions affecting those involved. The court decided that while the defendant’s “home” was not California, it also concluded that,

• Because of its “extensive contacts with California, encompassing extensive marketing and distribution of Plavix, hundreds of millions of dollars of revenue from Plavix sales, a relationship with a California distributor, substantial research and development facilities, and hundreds of California employees,”
• Jurisdiction over the non-California plaintiffs in state court was appropriate and consistent with Constitutional due process protections because these out of state claims arise from the same alleged conduct and actions which are the basis of those by the California plaintiffs.

The U.S. Constitution requires that government can’t take away property (such as a court ordering Bristol-Myers Squibb to pay plaintiffs’ damages) without due process of law. The defendant argued that having to litigate cases in California which originated in a number of other states is unconstitutional.

Why Do Plaintiffs Prefer California?

Why would 592 people from around the country want their Plavix legal claims litigated in a state where they may have never set foot?

• California state courts have a reputation as being more open to those suing drug makers.
• California’s consumer protection act offers better protections than other state laws.
• These are high stakes lawsuits and plaintiffs may be willing to put up with some practical inconveniences to benefit from any advantages they can get.

Defendant Prefers Other States

The defendant not only would prefer cases in states where plaintiffs would have a harder time proving their cases due to less favorable laws but there would also be practical advantages for Bristol-Myers Squibb:

• Having all these cases in one place saves resources for plaintiffs and their attorneys.
• If multiple cases are heard all over the country the Defendant may be better able to leverage its greater resources to be in a stronger position to defend itself and pressure plaintiffs into agreeing to a lower settlement.

This could be a win-win for plaintiffs. They may not only enjoy a better chance of winning their cases, or favorably settling them, but also take some time to visit California’s many famous sites. After a court room win plaintiffs (and their attorneys) could see Big Sur, Ghirardelli Square or do a tour of Hollywood.

Plavix is a blood thinning drug used prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. People who have taken the drug have alleged that Plavix has caused internal bleeding, heart attack, stroke, and cerebral hemorrhaging. Lawsuits allege that Bristol-Myers Squibb failed to warn patients and their doctors about the risks of taking the drug.

In March 2016 five people injured by the Depuy Pinnacle metal-on-metal artificial hip scored a huge courtroom victory. In that case a Texas jury awarded five plaintiffs $502,043,908.00 for injuries suffered by the failure of the Depuy Pinnacle hip. That figure was divided in different ways to the five injured people. Of that amount, $360,000,000.00 was awarded by the jury for punitive damages. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not adequately warn patients and their doctors of the risks. Like I said, this was a huge win. Unfortunately, the punitive damages award did not last long.

Judge Forced to Reduce Punitive Damages Award

Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. Judge Kinkeade, who is the federal judge presiding over the Depuy Pinnacle multi-district litigation (MDL), stated that he was bound by a Texas statute which puts a limit or “cap” on the amount of punitive damages a jury can award. Thus, Judge Kinkeade was required by law to reduce the punitive damages award, which a jury of twelve individuals, after a 42 day trial, thought was appropriate.

Thank You, Tort Reform! more

This Texas statute, like many across the country, was enacted in the great tort reform push of the last few decades. Legislators, often pressed by the insurance and big business lobbies, wrote statutes that put caps on the amount of punitive damages that a court could award, no matter what the jury thought was proper and necessary. In Texas, the limit on the amount of punitive damages that can be awarded “may not exceed an amount of two times the amount of economic damages; plus an amount equal to any noneconomic damages found by the jury, not to exceed $750,000; or $200,000, whichever is greater.” So the statute benchmarks punitive damages on the amount of other money damages awarded by the to the injured person. Never mind the fact that the intent of punitive damages is not to compensate the injured person but to send a loud message to the bad acting defendant. Legislatures have essentially said to juries: “we’ll let you know how loud your message can be to a defendant who injures one of our citizens.”

In North Carolina, where I live, there is a similar cap on punitive damage awards. N.C. Gen. Stat. § 1D-25(b) states that punitive damages “shall not exceed three times the amount of compensatory damages or two hundred fifty thousand dollars ($250,000.00), whichever is greater.” I can tell you that this statute has had a chilling effect on injury cases in North Carolina.

So What’s Next in Texas?

Judge Kinkeade reduced the $360,000,000.00 punitive damages award to $9,646,256.00. The five injured persons now have a verdict, after the operation of the Texas statute, of $151,646,256.00, down from the original jury verdict of $502,043,908.00. As astonishing as the original jury verdict was when it was announced in March, this reduction is almost equally stunning. Admittedly this jury verdict still represents a very large award and a big success for the plaintiffs. But the attack on the jury’s verdict is not over. Despite winning a $350,000,000.00 reduction in the jury award, Depuy and Johnson & Johnson immediately filed an appeal in the case, arguing that mistakes were made at the trial level and that the entire award should be voided and a new trial granted. Appeals like this one will take many months to resolve.

Thousands of Depuy Pinnacle Cases Remain

Depuy stopped selling the Pinnacle in 2013. Remember that—unlike the Depuy ASR hip—the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. Depuy still takes the position that the Pinnacle is different and safer than the ASR hip components. But this latest jury verdict makes it harder for J&J to advance that narrative.

The Depuy Pinnacle system was allegedly designed to provide better range of motion for a more active group of patients undergoing hip replacement surgery. One of the major complaints from injured patients is that the metal components grind and release metal particles into the body and blood of the patient. Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).”

The next “bellwether” Depuy Pinnacle case is scheduled to go to trial in September 2016.

The Takeaway

Punitive damages awards play a vital role in consumer protection. If companies do not fear large punitive damages awards, or even the freedom and power of juries, they will be less likely to take adequate precautions to protect the public. And as we’ve seen again and again, companies often rush products to market which they believe will make them great profits. The 510(k) process is one of these shortcuts that have caused unnecessary injuries from many flawed consumer products. Tort reform advocates speak of the protections of business and the money these statutes will save companies and insurance companies. But these legislative limitations come at a cost, and in my view will lead to more careless behavior from profit-first corporations.

In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas).