Articles Posted in Commentary

Published on:

Johnson & Johnson has 100,000 pending product lawsuits
Most of us pay our bills on time. If we break a neighbor’s rake, we promptly purchase a replacement. If our child dumps fruit punch on a friend’s carpet, we pay to have it cleaned. In fact, we don’t really think about these unwritten rules often; it’s just the right thing to do, so most of us do it instinctually: if we cause damage, we pay for the damage. But too often companies refuse to pay fair settlements to resolve product failure cases, even in the face of a mountain of evidence that (1) the product clearly failed and (2) the failure physically injured the person. For example, let’s say a sixty-eight year old retired schoolteacher learns her metal-on-metal artificial hip implant has failed; her doctor tells her that, in addition to the pain she feels in her hip and leg, she now suffers from dangerously high cobalt and chromium levels (a condition called “metallosis”). Thousands of other injured people have similar claims, but the manufacturer of the failed hip product simply won’t pay. Why not?

Well, I can’t know all the reasons, but let’s look at a few theories:

Companies Don’t Like to Pay Settlements

Published on:

Harmful Medical Devices on HBO's Last Week Tonight with John Oliver

I’ve been writing about dangerous medical devices on this site for four years. Over that time I’ve reached thousands and thousands of people injured by these harmful implanted medical products. John Oliver, host of Last Week Tonight, picked up the subject this week, and I am grateful to him and to HBO because he reached more people in twenty minutes than I have in four years. I want more people to get the word out about the serious problems with medical devices rushed to market and “cleared” through the 510(k) loophole because it’s a public health crisis. Too many companies are pushing too many untested medical devices to market, and the FDA is not doing enough to protect the public from these devices. John Oliver talks about all of this on the latest episode of his show. It’s funny (and profane), but he lays out accurately the way massive profits have driven companies to push harmful medical devices on to an unsuspecting public. You can check it out at the link below:

Warning: This is HBO. Oliver speaks freely: the language is salty and the subject matter adult. Companies and people other than me own the content linked above. The show is the property of HBO and whoever owns HBO. Neither HBO nor John Oliver has any affiliation with my website.

 

Published on:

Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long and cost too much money. In fact, preliminary studies showed problems with the device, and the company believes extensive clinical testing may reveal more problems, further slowing its path to the market (and to big profits). Instead, the company seeks fast-track approval of the device. The company argues that because the device looks similar to a device already on the market, it should be allowed to sell the new device without extensive testing. This process is known as the 510(k) pathway, and I’ve written about it a ton on this site, including last week. In the application the company reassures the FDA: “and don’t worry, we will keep an eye on the device and the patients who receive the device and if problems arise down the road we will let you know.”

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.

Plaintiffs' Lawyers Are Consumer Protection Heroes
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.

Published on:

Unhappy client waiting to hear from her lawyer
This is the question I get most often from people who have hired a lawyer but are not happy with the legal representation. Above almost everything else, good communication is the key to a healthy attorney-client relationship. I try not to be the kind of lawyer who doesn’t return phone calls. I don’t want any of my clients talking to another lawyer about me. And I understand: every client deserves to be updated regularly on his or her case.

Let’s look at some reasons why your lawyer may not be returning your calls:

  • Your lawyer is doing lawyer things.
Published on:

Some drug companies pay doctors, who then prescribe the company's drugsYou scratch my back, I’ll scratch yours. Favors are often exchanged among friends and family. But what most people don’t know, or don’t want to know, is that questionable “favors” are also exchanged in professional and business relationships. Over the years, there have been reports that favors, or benefits, are too often exchanged between drug manufacturers and doctors and hospitals who prescribe medicines.

Recent studies have explored this relationship and compared data to see if drug makers are, effectively, paying doctors to prescribe their medications.

In 2010, the Affordable Care Act included a section called the Physician Payment Sunshine Act. This Act requires drug and device manufacturers to report any and all payments made to physicians and hospitals. Since 2013, 40.74 million records have been published and $24.92 billion dollars have been given to doctors and hospitals from drug and device manufacturers. The Sunshine Act has been successful at exposing these payments.

Published on:

Drug TestingDr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription medications. According to Matthew Herper in Forbes magazine, Dr. Califf believes “the way forward requires putting science above politics and focusing on creating new ways to prove medicines help patients without causing undue side effects. Throwing out the standards that made the U.S. a global hotspot for medical innovation is not an option.”

Dr. Califf offered remarkable insight on the high failure rate of clinically-tested medications, as well as the urgent need for medications to do no harm:

FDA Approved Drugs“The most recent empirical data that we have at the FDA is that approximately 92% of drugs that go into human testing don’t make it to market because they have unacceptable toxicity, they actually don’t work for the intended purpose, or they can’t be manufactured at scale safely. Of the 92% of drugs that don’t make it to market, “100% had a lot of really smart people who thought they were going to work. If you were just going to start guessing about drugs you would do a lot of harm, because most of them would do more harm than good.”

Published on:

Calls From Pro Se PlaintiffsNow and then I get calls from people who are representing themselves in product liability litigation. (An individual who represents himself in litigation is called a pro se litigant.) Usually these callers have worked their cases to a point and have questions. Sometimes the questions are rather modest: “I’ve been offered this amount of money to settle? Is that fair?” Other times the questions are ominous: “The judge now says I need an expert witness. What is an expert witness?” The first question is a mere judgment call. Is $150,000.00 enough to compensate you for the pain and suffering of a failed artificial hip? That is mostly for the injured person to decide (though lawyers have plenty of insight into the value of such a claim). The second question poses a serious threat to your case. If an expert witness is required to prove your case, and you don’t have an expert witness (or worse, you don’t even know what an expert witness is) your lawsuit will be lost. And quickly. (You can read about expert witnesses here.)

I get the impulse to “do it yourself.” Prior to attending law school, I sued my landlord in small claims court for the return of my security deposit (I won). I also tried to replace the steering box in my 1974 Ford Bronco (that didn’t turn out so well).

These phone calls from pro se litigants are often interesting. Plainly some people have developed a distrust of lawyers. For others, the thought of paying legal fees for a good attorney seems unpleasant and undesirable, even overwhelming. Some may be trying to litigate their claim “on the cheap.” But the real question is: does it work? Can a person represent himself or herself successfully in a product liability injury case?

Continue reading →

Published on:

supermoon-724384_1920-287x300If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21st Century Cures Act: The Good

The 21st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

Published on:

I see this on many lawyers’ websites or print advertisements: Free Consultation! It sounds great. Something is free! It’s a free con-sul-TA-tion, from an actual lawyer (although this last part is often not true; instead you likely get an “intake specialist,” a person gently trained to take down your story and type it up, usually for a paralegal to read). The “free consultation” is not all it’s cracked up to be.

The Free Consultation Has Very Limited Value

Free Attorney ConsultationLet’s start with the hourly-rate case. If the legal representation will ultimately be subject to an hourly fee payment arrangement, this “free consultation” will not likely save you much or any money. First, some lawyers allow thirty minutes “free” and then announce, “if we go further I’ll need to charge you my hourly rate.” But even if the attorney sits patiently and listens carefully to you explain your case for forty-five minutes or an hour, it is unlikely the attorney will be able to give you sound legal advice at that point. Quite simply, a legal dispute is complex (otherwise you could have handled it yourself). Even a basic breach of contract action will usually have two conflicting stories, and behind those stories will sit documents: agreements, letters, invoices, emails, texts, witness statements, all of which must be reviewed carefully and analyzed. So a one-hour consultation usually gives the attorney a surface understanding of your issues. Imagine if a doctor offered a “free consultation,” and after a twenty-minute visit announced, “I understand completely. We must perform surgery and remove one part of your lung.” It doesn’t work that way. Instead, the doctor listens to your story (and charges an office visit fee), then orders the appropriate tests (more fees), and finally makes a decision on proper treatment (again, more fees).

Continue reading →

Published on:

Corporate Responsibility For Medical Devices and Drugs

I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an act of violence and malfeasance. I am convinced there are two sides to every story (even if, often, one side of the story is weaker).

Medical Devices and Drugs Have Saved Many Lives

So it is with my law practice. I do not believe major companies are evil, that they are out to hurt people, that all the conspiracy theories are true. I am convinced the life-cycle of a medical device or drug begins with a beautiful idea: to develop a product that will save lives, that will make people more active, that will help people and not hurt them. In fact, virtually all medical devices or drugs are first developed by one or a few smart people attempting a solution to a pressing health problem.

And these medical devices and drugs have saved lives. And as a society we have to create an environment where doctors and scientists and corporations have the freedom and the opportunity to build new medical devices and new drugs to solve vexing health problems.

Continue reading →