Articles Posted in Commentary

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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.”

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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?

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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.

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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).

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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.

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I get it.  When you get injured, you almost immediately begin to worry about money.  It is completely rational.  If my client is a car salesperson and has severe pain after standing for more than an hour, he may worry that his failed artificial hip surgery could cause him to lose his job.  If another client is a graphic designer, and a car crash results in a broken arm, the client may wonder how she will do her graphic design work at a computer or work space.  Beyond concerns about handling job duties, there will be immediate financial pressures.  I wrote about handling medical bills in a product liability case here. But there are of course other bills to be paid:  mortgage payments or rent, food, utilities, and other expenses of living.  It can seem overwhelming.

Try to Get Through This Difficult Period Without Obtaining Loans

Couple paying their bills during product liability case

I know, I know, easy for me to say. And frankly you are right. No one ever wakes up and says, “today is a great day for me to enter into a ruinous loan I will never be able to pay back.” I understand that most people attempt to exhaust every other funding source before looking for third-party funding during a desperate financial period.  But I am going to say it anyway: exhaust every other funding source before looking for third-party funding. Call your parents, your kids, your friends, anyone who might help you get through the difficult financial period you face when waiting for a product liability or other personal injury case to resolve.

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Abraham Lincoln had this to say about frivolous lawsuits: “Never stir up litigation.  A worse man can scarcely be found than one who does this.”  I agree.

I agree with Lincoln that we should never “stir up” litigation, for many reasons, the main one being that “creating” litigation is simply the wrong thing to do, it is harmful to the client, and it creates ill-will and distrust in the world and within the legal profession.  But I also agree with Lincoln for completely selfish reasons: it does not lead to good results and it can easily destroy a person’s law practice.  Reports of the filing of frivolous lawsuits are greatly exaggerated.

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