Articles Posted in 510(k) Process

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Last week I wrote a timeline on the key events surrounding the failure of the Depuy ASR artificial hip. Today I want to take a similar look at the Depuy Pinnacle artificial hip. The Pinnacle was supposed to be the ASR’s more active and athletic brother. But it didn’t turn out that way.

1995: Study on Metal-on-Metal Hips Released

Study on Metal on Metal Artificial Hips
For all metal-on-metal artificial hips, we have to start with the central question: what did the manufacturer know, and when did the manufacturer know it? In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained that the performance of MoM hip implants was “unpredictable,” that the hips may work well for some time “before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics should have known about the metal-on-metal risk factors in 1995. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” That’s not good.

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Physiomesh Hernia Mesh
Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

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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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Even if you’ve never needed a surgical mesh implant, you’ve probably heard about a number of lawsuits due to problems patients are having with them. One type in particular has been the transvaginal mesh (TVM) implants in women. These TVM lawsuits are well underway, with tens of thousands of lawsuits currently pending. However, it appears another influx of lawsuits involving more surgical mesh implants are appearing on the horizon: surgical mesh used to treat hernias.

Treating Hernias with Surgical Mesh

First off, let’s briefly explain what a hernia is. A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it doesn’t belong. Depending on how bad the hernia is, surgery may be required to fix it.

Surgeon implanting surgical mesh to treat hernia Because hernias involve a hole in a muscle or other tissue, additional reinforcement is usually needed to close the opening and keep it from reopening. This is where surgical mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

Clinical studies have shown that using surgical mesh to treat hernias reduces the chances of the hernia returning. Each year hundreds of thousands of hernia surgeries are performed. Given their proven effectiveness, it’s no wonder that many of these surgeries use a surgical mesh. Unfortunately, a significant number of the meshes have serious flaws.

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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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Third Depuy Pinnacle Bellwether Trial
The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.

Third Depuy Pinnacle Bellwether Trial

Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.

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Transvaginal Mesh Appeal
I have written about the maddening ways a product liability case can go on (seemingly) forever. An injured person may wait years to get to a jury trial. And then, if the individual wins the trial and the jury awards a substantial amount of money for the plaintiff’s injuries, the product manufacturer will appeal. You can read about appeals here. But the appellate courts are not there solely to protect big business. When the injured person loses her jury trial, she also has the opportunity to appeal. Often this is more difficult for the individual than it is for the large corporation, which has much more money and time, but appeals courts are there, in theory, for all of us, the powerful and the less-powerful. A week ago, an injured woman won her appeal and was granted a second opportunity to try her transvaginal mesh (TVM) case against Boston Scientific Corporation, which she had lost in 2014.

Let’s back up.

Boston Scientific’s Pinnacle Pelvic Floor Repair Kit transvaginal mesh was implanted in Diane Albright in 2010 to treat her pelvic organ prolapse (POP). Rather than make her well, the TVM caused her many other problems and serious injuries. In 2012 Ms. Albright sued Boston Scientific Corporation in Massachusetts over its failure to warn of the risks of the Pinnacle mesh product, as well as the defective design of the mesh.

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Last week I wrote about the dreaded post-trial life of a product liability lawsuit. If an injured person wins the jury trial, and particularly if the jury awards a large amount of money, the plaintiff should expect to face an onslaught of post-trial motions and the inevitable appeal to the next highest appellate court.

That is exactly what happened in one of the first important Depuy ASR Hip trials in California.

The Jury Trial

Depuy ASR Jury TrialOn March 8, 2013, a jury in Los Angeles Superior Court awarded $8,338,236.12 for a man injured by the failure of the Depuy ASR Hip. Loren Kransky alleged that the Depuy ASR hip components were negligently designed, that the components had a design defect, and that Depuy failed to warn him and his doctors about the potential risks involved in implanting the device.

After a five-week trial in 2013, the jury in the California case awarded Mr. Kransky $338,236.12 in “economic damages” and $8,000,000.00 in “pain and suffering” damages. Jurors in the case found that the device was defective at the time of sale, and that it injured the plaintiff. The jury found in favor of Mr. Kransky and awarded damages for medical costs and for emotional suffering and distress.

The jury did not award punitive damages to Mr. Kransky. The jury did not find that Depuy acted with fraud or malice, which prevented an award of punitive damages. Which was good for Depuy, as Mr. Kransky’s legal team aggressively argued for punitive damages in amounts that could have exceeded $100,000,000.00.

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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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So maybe you’ve heard the news that Washington and California recently sued Johnson & Johnson for misrepresenting the safety of its transvaginal mesh (or “pelvic mesh”) products. I pulled the Washington lawsuit and read it. It is alarming. If Washington can prove the allegations in the complaint, it will be a damning indictment of Johnson & Johnson and the pelvic mesh industry generally.

The Washington Lawsuit

Washington State Transvaginal Mesh LawsuitStates can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.

Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.

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