North Carolina Product Liability Lawyer Blog

Seven Actions You Should Take If You Have An IVC Filter Implant

Published on: June 23, 2016 | By Clay Hodges

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:

Judge Denies Motion to Delay Depuy Pinnacle Hip Trials

Published on: June 20, 2016 | By Clay Hodges

They say justice delayed is justice denied. Apparently Judge Kinkeade in the Depuy Pinnacle Artificial Hip MDL thinks so. On June 10, 2016, Judge Kinkeade denied Depuy’s motion to delay all future trials until the company completes its appeal of a massive $500 million jury verdict.

Depuy Orthopaedics and its parent company Johnson & Johnson filed their “motion to stay” on May 24, 2016. They asked the court to delay all further trials in the Depuy Pinnacle MDL until an appellate court rules on their appellate issues. (It is very common for a company in any case to appeal a trial verdict when the jury awards significant damages to the plaintiffs.) Depuy claimed there were significant errors made at the trial. Depuy also argued that the decision in the appeal could have “far-reaching implications” on how future Pinnacle cases are tried. Defendants claimed the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

Judge Kinkeade, who presides over the Depuy Pinnacle MDL in Dallas, Texas, denied the motion to stay the trials. In his order Judge Kinkeade selected seven bellwether cases to be tried beginning September 6, 2016. You can read that Order here.

The Criminal Pursuit of Profit: Device Company Execs Accused of Fraud

Published on: June 15, 2016 | By Clay Hodges

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.

There 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.

Depuy ASR Hip Failure: Nine-Year Window For Revision Surgery

Published on: June 10, 2016 | By Clay Hodges

Many people still have the Depuy ASR hip components implanted in their bodies. I get calls from them. Some have elevated metal levels in their blood; others are telling me about pain in the hip area, popping sounds, and other problems. They are preparing to schedule revision surgery, and they want to know if they may qualify for compensation based on the settlements that have been reached with Depuy, Inc. and Johnson & Johnson, the parent company.

These are good questions. I want to make sure you are aware of a nine-year window for undergoing revision surgery.

Two Settlement Agreements So Far

As I have explained in this blog, there have been two Depuy ASR settlement agreements, mostly identical in material terms. The major difference is that the first settlement agreement covered those who had undergone revision surgery prior to August 31, 2013. The second settlement covered those people who had revision surgery between August 31, 2013 and January 31, 2015.

Depuy Pinnacle Artificial Hip Litigation: Defendants Seek Delay of New Trials

Published on: June 8, 2016 | By Clay Hodges

A request by Depuy Orthopaedics Inc. to delay more trials concerning its Depuy Pinnacle hip implants is pending in the federal court in charge of thousands of cases against the company. The request came from Depuy on May 24. Depuy asks the Court to hold off on further trials until an appeal of one large case tried in March is resolved. That case, which I wrote about here and here, resulted in a stunning $502 million verdict for five people injured by the defective artificial hip components. So Depuy is plainly motivated to delay, if not overturn, the award. If the request is granted it will take much longer for other plaintiffs to have their cases tried, as complex appeals like this one can take years to resolve. As the saying goes, justice delayed is justice denied. I hope federal judge Ed Kinkeade in Texas denies Depuy’s motion. These remaining cases deserve their day in court.

Depuy and the other defendants claim their planned appeal could have “far-reaching implications” on how future cases are tried. Defendants claim the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

Transvaginal Mesh: Chilling Allegations in State Lawsuits Against Johnson & Johnson

Published on: June 2, 2016 | By Clay Hodges

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

States 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.

Zofran Lawsuits: Use During Pregnancy Alleged to Cause Birth Defects

Published on: May 27, 2016 | By Clay Hodges

Pregnancy brings with it many physical challenges, including nausea and vomiting which impact about 80% of pregnant women. It can range from being a minor issue to a potentially serious health risk, depending on the severity of the nausea and health of the mother. The drug Zofran is designed to limit nausea but it was not approved for use by pregnant women and it may cause birth defects. Although medical causation is not settled on the issue, many women who took Zofran during pregnancy gave birth to children with birth defects. Because of that potential link hundreds of lawsuits have been brought against the maker of Zofran, seeking compensation for the harm possibly done by the drug.

Intended Uses

Zofran (or ondansetron hydrochloride) helps prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that can trigger nausea and vomiting. It was originally designed to help cancer patients dealing with the side effects of chemotherapy but is also approved by the Food and Drug Administration (FDA) for those suffering nausea due to radiation therapy, anesthesia and surgery.

My Depuy ASR Hip Is Still Implanted: Do I Have a Claim for Compensation?

Published on: May 24, 2016 | By Clay Hodges

I have been getting a few calls recently from people who still have the Depuy ASR hip implanted in one or both hips. They are asking the right questions: Are the metal levels in my blood too high? How will metallosis affect my long-term health? Will the component slip on me now and cause all kinds of new pain? Should I schedule surgery and have the Depuy ASR components removed? Plainly, these are questions for a doctor, not a lawyer. I can’t answer any questions specific to your health. Eventually, however, these callers ask an intriguing question: I have the Depuy ASR hip implanted in my body and I have not yet scheduled revision surgery: Do I have a valid claim against Depuy and Johnson & Johnson? It’s a good question.

People with Depuy ASR hip components implanted in their bodies who did not undergo revision surgery did not “qualify” for the two settlements that have been reached in the Depuy ASR multidistrict litigation (DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation, MDL 2197). But this does not mean they are not injured or that they do not have a valid claim. All it means is that they did not qualify to participate in the settlement based on the timelines in the settlement agreements. Let’s take a step back.

Cook IVC Filter Litigation: “Discovery” Allowed on Cook’s Failure to Report Risks

Published on: May 19, 2016 | By Clay Hodges

In every lawsuit the court issues key rulings which will impact the outcome of the case. By “court” I mean the presiding judge. Some court decisions end the lawsuit (e.g., a judge granting a defendant’s summary judgment motion). Some decisions kick a leg of the stool out from under one party (granting a motion to exclude one side’s key expert witness). As I have written about in this blog, a judge has great power and influence over every court case. One decision has the power to make or break the lawsuit.

Recently, in the Cook IVC filter multidistrict litigation, a federal judge has refused to bar discovery involving an allegation that Cook failed to report to the FDA bad results with the Cook IVC filters.

What Is Discovery?

After a lawsuit is filed, the defendants have the chance to “answer” the complaint (“yes, we admit that happened” or “no, we deny the truth of that statement”). After these “pleadings” are filed, the parties engage in formal discovery. In civil litigation, discovery is the exchange of documents and information between the parties. It is required by the Rules of Civil Procedure. It goes like this: one side will write out questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. From there, the parties can build their cases for trial.

Cook IVC Filter: Injuring Patients, Lawsuits Mounting

Published on: May 17, 2016 | By Clay Hodges

When medical devices work as intended they are wonderful things. They can extend lives and improve the quality of life for patients and ease the stress on patients’ families. When they don’t work as intended medical devices can do more harm than good, possibly killing the patient. One example is the Cook IVC filter.

What is an IVC Filter?

The inferior vena cava (or IVC) is a large vein carrying blood from the lower and middle body into the heart where the blood is pumped into the lungs in order to have oxygen added to it. An IVC filter is a device that’s surgically implanted into the IVC just below the kidneys in cases where there is fear a blood clot from the legs (deep vein thrombosis) may travel from the body into the heart or lungs (pulmonary embolism). If that happens the results can be a serious, if not fatal, injury for the patient.

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★★★★★

I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.

Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.

We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.