So What’s the Difference?

Medical malpractice is the legal term for a doctor who has been negligent. This means that the doctor failed to perform the surgery with an expected degree of care and competence. In a phrase, the doctor simply screwed up the surgery. For a plaintiff to win a medical malpractice claim, he or she must show that the doctor failed to perform his duties with a normal “standard of care” typical of similarly situated doctors. This means that surgeons in small towns will be judged against similar doctors in similar towns, while doctors from major research hospitals in big cities will be judged against their similarly situated peers, and of course will be held to a higher standard. The bottom line is this: medical malpractice is the failure to provide competent medical care, causing the patient unexpected injury.

Please understand that medical malpractice is not limited to surgeons: hospitals, nurses, and other medical care providers can be liable for malpractice. For example, a nursing staff may fail to do the proper count of “sharps” in a surgery and leave a surgical needle inside the patient’s body. That’s a bad thing, potentially very harmful, and certainly malpractice.

Product liability is an area of tort law where a person is injured by a defective product. Virtually any kind of product can harm us: a car, a heating pad, an artificial hip. On this site I focus on two kinds of product failures: medical devices and prescription drugs, two products which can cause serious injury when they turn out to be defective.

A defective product is one that has a substantial flaw or imperfection. The defective characteristic could be a design flaw, or a manufacturing defect, or even a missing or inadequate warning (for example, “do not take this mix this medication with alcohol”). A defective product becomes a product liability case when the defect causes injury to the consumer. To use an example from this site, when a metal-on-metal (MoM) artificial hip causes metal shavings to leach into the body, and the blood metal levels become dangerously high, the product is defective and has caused injury, and the patient should have the right to bring a lawsuit against the manufacturer.

In many cases it is not always simple to sort out whether the injury was caused by the defective product or by negligent surgical technique.

And here’s another problem: in many of these cases, when the case is grinding forward, the separate defendants will point fingers at each other. The surgeon will insist he performed the surgery correctly, but that the defective product (a defect of which he was unaware) was the cause of the injury. The product manufacturer will state that the product is fine, but the surgeon was a hack and did not understand the correct implantation technique. (In fact, Smith & Nephew may be suggesting this defense in the Birmingham Hip Resurfacing (BHR) litigation, which you can read about here and here.) Still, a good lawyer can figure it out.

Can’t It Be Both?

Yes. You can certainly be the victim of a defective product and negligent medical care. But it’s often like threading a needle. To win such a case, you will need to prove that your injuries were caused by the failure of a defective product and by negligent surgical technique. So sticking with the MoM artificial hip example, let’s say you were injured following hip replacement surgery. In the months that followed your cobalt and chromium metal levels shot up, but you also developed a painful infection near the surgical site. An investigation revealed the hospital was flagged for inadequate sterilization practices, leading to an outbreak of dangerous infection. In that case, the plaintiff-patient can rightly bring claims both for the defective product and for medical malpractice.

Unfortunately, it is rarely simple to identify two separate injuries from two separately identifiable acts of negligence in a single surgery. In most cases, it is one or the other: the surgeon implanted a faulty device, or the surgeon implanted a non-defective medical device, but put it in upside down.

Either way, you need a good lawyer to help you find the answers.

Without question, the Zimmer NexGen Knee MDL is not going all that well for plaintiffs lately. The first bellwether trial ended in a defense verdict in favor of Zimmer. Then Judge Rebecca Pallmeyer issued a Lone Pine Order which imposed a heavier burden on plaintiffs to avoid dismissal of their cases. That Order requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its continued place in the litigation. These requirements include a showing of (1) evidence of loosening of the artificial knee, (2) evidence of knee flexion of 120 degrees, (3) other detailed designations of injury and product failure. You can read more about the Lone Pine Order here.

Then, on October 21, 2016, Judge Pallmeyer ruled that the second bellwether case did not warrant a jury trial. In her Order, she granted summary judgment for Zimmer. You can read about that court decision here, but in a nutshell, Judge Pallmeyer simply rejected the validity of the plaintiff’s key expert witness. She concluded that Dr. Joseph Fetto failed to refer to scientific literature or to “give any explanation for why the implant design, and asymmetric loading generally, causes . . . loosening.” (Order, p. 12) She wrote at length about the reasons why Dr. Fetto’s testimony is unreliable, ultimately concluding that Dr. Fetto has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) Without a reliable expert witness, a plaintiff cannot win a product liability case.

The Judge’s Order was a sledgehammer, but . . .

It’s Not All Bad News

It’s quite awful to select a bellwether case, prepare it for trial, and then, days before jury selection, the judge grants summary judgment on all claims in favor of defendants. After years of litigation, the plaintiff, who was clearly injured, was out of court without compensation. Still, there is reason to believe that future cases may have different results. Judge Pallmeyer admitted as much in the last section of her 43-page order, titled “Potential Differences Between Joas’s Case and Others in the MDL.” Let’s examine a few keys statements in the part of her Order (the italicized statements below were written by Judge Pallmeyer):

more Other Cases Should Fare Better Although the first bellwether case in this MDL proceeded to trial, this second one terminates at the summary judgment stage. There are a number of significant differences, however, between Joas’s case and Batty that explain the different outcomes in the two cases, and differences between Joas’s case and future bellwether cases are likely to allow those cases, like Batty, to go before a jury as well.

First, Batty was the plaintiff in the first bellwether case; Joas was the plaintiff in the second bellwether case. Both plaintiffs lost their cases, but Batty survived summary judgment and was granted a jury trial. The statement above is a clear signal from the judge overseeing the Zimmer NexGen MDL that she expects other cases will have better evidence of causation between the injuries and the failure of the artificial knee components than did Joas. Because other cases appear stronger than the second bellwether case, Judge Pallmeyer expects future cases to survive summary judgment and reach a jury. This is good news.

Strong Expert Witness Necessary to Establish Causation of Injury

Unlike this case, the specific causation theory in Batty did not rely on a differential etiology. Instead, there was significant radiographic evidence that appeared to link Ms. Batty’s injury with the plaintiffs’ general causation theories. Proving causation via differential etiology in a case like this may be difficult because of the many possible causes of aseptic loosening that would have to be ruled out. But a properly applied differential etiology, with consistent standards for ruling causes in and out, may well provide an adequate specific causation opinion.

Differential etiology tries to establish a particular medical condition (or disease) from several other conditions that present similar clinical features. Doctors use differential etiology to diagnose one disease or condition from another. Judge notes here that differential diagnosis is not the strongest approach to proving causation in the knee failure litigation, although it may work with “consistent standards for ruling causes in and out.”

Wisconsin Design Defect Law Was Challenging This case also differs from Batty, and possibly from other cases, in that Wisconsin law requires a proposed safer alternative design as an element of a design defect claim. In states where there is no such requirement, a design defect case may be easier to make.

In federal court, the law of the state where the case is originally filed governs the case. Wisconsin law was applied in the second bellwether case, because that is where the case was originally filed. Wisconsin law has an added element to establish a “design defect” of a medical device. Essentially, the plaintiff must show that an alternative design would have been safer. This is a higher burden of proof for design defect claims than many other states have.

Femoral Loosening Easier to Establish Also unlike in Batty, only Joas’s tibial implant exhibited loosening. A causal link between the implant’s design and femoral loosening, as in Batty, may be easier to establish.

If your case involves medical evidence of tibial loosening only, you may have trouble proving your case, as did Mr. Joas in the second bellwether case. The judge signals here that she is looking for cases which include evidence of femoral loosening.

Implant Surgeon Must Read the Product Package Inserts And finally, unlike in this case, there was evidence in Batty that the plaintiff’s implanting surgeon had read the device’s package insert and had relied upon information from Zimmer in selecting the device and warning his patients. Under such circumstances, a failure-to-warn claim becomes much more tenable.

This statement sets out the obvious threshold for winning a “failure to warn” claim. In a failure to warn claim, the plaintiff argues that the manufacturer knew about the dangers posed by the product, had a duty to warn patients about those dangers, and were negligent about their duty in such a manner that the patient was hurt by the product.

In the second bellwether case, the plaintiff’s expert admitted he did not read the package insert for the Zimmer NexGen knee components. The defendants reasonably argued that they did all they could do: they drafted an insert with warnings about the device, but the implanting surgeon (the “learned intermediary”) failed to read the warnings. This is a key reason Mr. Joas lost his failure to warn claim.

So if you are a plaintiff, I see grounds for optimism in this Order. The Zimmer NexGen MDL is far from over.

Approximately 250,000 people have an IVC filter implanted each year. Each time it captures a blood clot and prevents it from moving into the heart or lungs, it is a great thing. Unfortunately, IVC filters often cause other health problems, sometimes as serious as the conditions they were designed to prevent. I wrote about the problems the IVC filter is causing many patients here.

Two corporations manufacture most of the IVC filters on the market: C.R. Bard, Inc. and Cook Medical, Inc. Lawsuits have been filed over Bard’s Recovery, G2, and G2 Express IVC filters. Lawsuits have also been filed over Cook’s Gunther Tulip and Celect IVC filters. Hundreds of people have been injured by these IVC filters. Try not to be one of them.

If you have an IVC filter implanted in your body, you must stay on high alert. I suggest taking the following actions if you have an IVC filter implant:

1. Watch the Calendar. Doctors sometimes recommend implantation of a “retrievable” IVC filter to capture a pulmonary embolism, which is a blood clot that has broken loose from one of the deep veins in the legs and which can travel to the heart and lungs, causing serious health problems. An embolism can form in the veins of patients following surgery (embolism can form in the body for other reasons too). Doctors can sometimes stop the formation of a blood clot through the administration of blood thinning drugs, but not all people can handle blood thinners. In those cases, doctors may recommend implantation of an IVC filter to serve as a kind of catcher’s mitt to capture the blood clot as it travels up the inferior vena cava (the large vein carrying blood from the body to the heart) toward the lungs and heart. The thing is, retrievable IVC filters are not meant to be permanent, and doctors recommend removal of the device as soon as the threat of embolism has passed, and almost always less than two months after implantation. So if you have a retrievable IVC filter implanted, don’t rely on your surgeon’s office to remind you to return and have it surgically removed. Remember the date of implantation, and talk to your doctor regularly about the appropriate time to remove it. The sooner the better.

2.GetIt Out. This is not always easy. In fact studies have shown that the IVC filter often cannot be surgically removed from the body. The IVC filter can migrate or travel within the inferior vena cava and often cannot be successfully removed. In other cases, surgeons have removed IVC filters with one or many spikes missing, which means those spikes are still in your body, floating somewhere in your blood vessels, lungs, or heart. The IVC filters can also rotate or turn, making them useless for capturing blood clots but also causing complications inside the blood vessel. If your surgeon can retrieve it—and retrieve it quickly after implantation—get it out of your body.

3.Maintain Steady Communication With Your Doctor. If you believe your IVC filter may be moving or causing you problems, your first priority is to get it out and get back to good health. So call your surgeon’s office regularly and remind them of the IVC filter and alert them to any new symptoms. If it turns out the IVC filter has migrated or broken in pieces, you will want to have that information as soon as possible and you may need to schedule emergency surgery. But again, you need a good doctor on alert to help you analyze your medical situation.

4.Start a Symptoms/Pain Journal

. For a failed IVC filter, this symptoms journal may extend for just a few days or even a few hours, but the more information you can write down the better. It is simple enough: When you first begin to notice any sensations or pains which seem abnormal or unexpected, write down a brief description of the pains on a piece of paper (or a notes app on your smart phone). The more detail the better—note the kind of pain you feel, the location, and any other descriptions. This journal may provide important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A pain/symptoms/well-being journal can provide valuable information to an attorney putting together the best case for you in the event you have a viable claim against a manufacturer for a failed IVC filter.

5. Keep Records of Expenses and Missed Work Time. Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your surgery, recovery, rehabilitation, medications, etc. Manufacturers of defective products may be obligated to pay the out-of-pocket expenses to a victim of a failed IVC filter. Also, keep detailed records of all time missed from your employment, including sick days which you were forced to use, and days out of work for which you lost compensation. Make notes for each day missed from work, and why you missed work (e.g., “Missed work June 23-30 due to IVC filter removal surgery at X hospital, recovery at home.”). Keep a file with any documentation you receive from your surgeons, cardiologist, or your primary care doctor, your pharmacist, and any other professionals who participated in your surgery or follow-up care.

6. Do Some Research. Start with the U.S. Food and Drug Administration website (https://www.fda.gov/MedicalDevices/), a federal government website which provides timely information on the latest recalls or problems associated with medical devices such as IVC filters. Also, you may want to review the court website associated with the IVC filter device you have implanted. I also (cautiously) recommend going to established news outlets, such as The Wall Street Journal, The New York Times, The Washington Post, and other reliable publications.

7. Find a Good Lawyer. Many attorneys advertise but don’t litigate or even represent the people to whom they are marketing their legal services, and other attorneys throw up a laundry list of practice areas in which they claim expertise. You will want to find an experienced attorney who practices plaintiff-side product liability and personal injury law. Take your time with this important decision.

Note: I am not a doctor. Always consult a trusted doctor with any questions related to your health. I am, however, an attorney. If you have legal questions, call me: (919) 830-5602.