Articles Posted in Corporate Greed

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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

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Oxycontin is a deadly drug
Three years ago I wrote this column: My Challenge to Medical Device and Drug Companies: Put Me Out of Business! The point was straightforward: if companies would do the right thing, and properly test their medical devices, and carefully monitor the drugs they sell, and try to help patients instead of merely chasing profits, then I will stop being a product liability lawyer. Well, turns out my line of work may be safe for a long time. This week several executives from Insys Therapeutics were found guilty of racketeering. The jury found that these executives conspired to push sales of a deadly fentanyl drug, by increasing dosages and prescriptions. These guys are going to jail. And they should. The story that emerged from the two-month trial was hideous, and it proves yet again that without careful oversight companies will often harm public health in their pursuit of massive profits.

Before I bullet point some of the evidence developed at trial, start with this: the Centers for Disease Control estimates that well over 200,000 people have died from prescription opioids since 1996. Sit with that for a moment. More than 200,000 people have died from opioid overdoses. It is heart-wrenching. Now, add to this tragic statistic the narrative that several opioid companies, and not just Insys Therapeutics, pushed for more prescriptions and higher doses for decades, solely to increase sales and profits and employee bonuses.

Let’s take a look at the evidence from the Insys criminal trial:

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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.

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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.

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Prescription MedicationsI have to say, there are times I just don’t want to hear any more alarming news. But recently I stumbled upon a disturbing database of payments made by drug and medical device manufacturers to physicians. It can be horrifying to imagine that your doctor or surgeon is getting huge amounts of money from drug companies or device makers, for any reason.  Now imagine that the payments were hundreds of thousands of dollars, or millions. It just doesn’t pass the smell test. Think about it: if a surgeon gets $250,000.00 per year from a medical device manufacturer, do you think the surgeon is likely going to “choose” to implant devices made by the fee-paying medical device manufacturer?

ProPublica is the nonprofit organization who maintains the database. Recently nonprofit organization updated its database of doctors across the country who were paid by medical device manufacturers or drug makers in 2015. ProPublica also compiled statistics on the amount of money drug companies spent promoting certain prescription medications and medical devices. The numbers are staggering. Let’s take a look at a few of the prescription medications on ProPublica’s list that I’ve written about on this site:

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On July 1, 2016 a jury in Philadelphia sent a very loud and angry message to Johnson & Johnson. After a lengthy trial, the jury awarded a young boy who grew breasts after taking the drug Risperdal a staggering $70,000,000.00. This verdict is far and away the largest money judgment awarded (yet) to a victim of the drug Risperdal. As one of the attorneys representing the disfigured child stated, “this verdict is a game-changer.” I think he is right.

But let’s back up.

What is Risperdal?

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Genentech SettlementYou see ads for them all the time. Supplements, creams and pills that will help you lose weight, clear up your skin, improve your sex life or maybe do all of these things at the same time. Whether they’re in late night cable TV infomercials or spam email, you might think this kind of medical scam is perpetrated by small time operators making a fast buck. But scams can also be done by multi-billion dollar pharmaceutical companies (but in much more sophisticated ways), sometimes with potentially deadly results.

California based Genentech and its marketing partner OSI Pharmaceuticals will pay $67 million to settle claims that they misled doctors into prescribing a drug to lung cancer patients that the defendants knew would not work. Due to this highly corporate hucksterism some of these patients may have precious time robbed from them, dying earlier than they would have if they had taken more effective drugs. These allegations are in the settled lawsuit filed by a former Genentech employee. Federal prosecutors joined the lawsuit, reports the Los Angeles Times.

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Profits can lead corporations to take dangerous risks. In the medical device industry, it can mean that a company decides to rush a product onto market without proper clinical testing. Or it could mean the company goes too far in promoting a product for “off-label use.” Sometimes, the pursuit of corporate profits turns into a crime.

Acclarent Medical Device Criminal TrialThere is an unsettling criminal case being tried in Massachusetts federal court this week. Two executives of a company called Acclarent are being prosecuted for fraud in the marketing of a medical device known as “Stratus.” The Stratus was a device that was supposed to relieve symptoms of sinusitis using saline. It consisted of a tube with a balloon attached to a sharp pin. The device would be implanted in the patient’s sinus, where it would be left in place for two weeks. It was reported to work as similar devices which created space in the sinus area using saline, which allowed patients to breathe easier. But according to testimony in the criminal trial, Acclarent had other intentions for the Stratus. Instead of using saline, the Stratus was intended to deliver “Kenalog,” a steroid found in medications like Nasacourt.

But I should back up.

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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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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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