The Meyerson Law Firm Wins Appeal on Medical Device

Texas Tort Reforms Don’t Bar Medical Device Claims

Law360, Dallas (November 13, 2015, 5:00 PM ET) — In a case of first impression, a Texas appeals court on Friday said personal injury claims against the manufacturer of a medical device accused of promoting off-label uses with kickbacks to doctors aren’t subject to the same requirements Texas imposes on health care liability claims.

The Third Court of Appeals in Austin said manufacturer Verticor Ltd. can’t avoid a patient’s claim the company solicited a doctor to do an off-label surgery implanting Verticor’s Eclipse Sphere device into his spine to treat a herniated disc. Verticor had argued plaintiff Michael Wood’s claims triggered tort reform measures that require expert reports and impose damages caps on lawsuits designated as health care liability claims, and that his case against the company should have been dismissed when he didn’t meet those requirements.

The court said there is no bright-line rule that product manufacturers can never be considered health care providers under the Texas Medical Liability Act but that reality is more complicated than the diametrically opposed all-or-nothing arguments made by the parties. Texas law doesn’t categorically exclude medical device manufacturers from being considered health care providers, but the mere manufacture and sale of a medical device also does not ipso facto constitute the provision of health care under the act, the court held.

But because Verticor didn’t show evidence it had any involvement in Wood’s care or treatment, or was licensed to be involved in his care or treatment beyond manufacturing the Eclipse Shield that was used, the company was not entitled to the protections the TMLA gives to health care providers, the court held.

“Without more, Verticor has not raised a fact issue, let alone demonstrated conclusively, that it is a ‘health care provider’ under the TMLA,” the court said.

Wood sued both Verticor and surgeon James Hansen for damages after complications arose following the implantation of the Eclipse Sphere. Wood alleged Hansen acted with professional negligence and gross negligence in performing what he says was an off-label and experimental procedure for which he did not obtain Wood’s informed consent — and he filed expert reports supporting his health care liability claim against Hansen.

Wood also alleged both defendants engaged in a fraudulent scheme in which Verticor paid Hansen kickbacks to induce his off-label uses of the device. Wood said the Eclipse Sphere was approved by the Food and Drug Administration solely for use in lumbar intervertebral fusion procedures and was never intended for “motion-sparing, nonfusion” procedures like the one performed on him, and that Verticor didn’t disclose the FDA warning adequately.

He sought damages based on theories of strict product liability for marketing defect, negligent marketing of the device and breach of the implied warranty of merchantability, according to the opinion.

“Defendants like Verticor keep pushing the boundaries on the tort reform laws to shield their unscrupulous actions,” Jeff Meyerson of The Meyerson Law Firm PC, an attorney for Wood, said on Friday. “We are glad the court made a well-reasoned decision and we can finally proceed to trial.”

Meyerson said Verticor “shouldn’t take up the court’s time with further appeals” because the ruling draws a clear line.

“While we respect the court of appeals opinion, it’s clear they missed the point, and we are looking at an appeal to the Supreme Court of Texas,” David Chamberlain of Chamberlain McHaney, who represents Verticor, said on Friday.

Verticor is represented by David Chamberlain, Cathy Kyle and David Campbell of Chamberlain McHaney.

Wood is represented by Jeff Meyerson and Mark McLean of The Meyerson Law Firm PC.

The case is Verticor Ltd. v. Wood, case number 03-14-00277-CV, in the Texas Court of Appeals for the Third District.

–Editing by Aaron Pelc.

Defective Medical Devices – How to Recover for Injuries and Costs

All medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval, 1) pre-market approval (PMA), and 2) 510(k).  With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product.  However, with a 510(k) clearance, the manufacturer must merely show that the device has been approved by another manufacturer and is substantially similar.  Surprisingly, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients.

The significance is that a PMA approval provides certain protections to a manufacturer that a 510(k) clearance does not.  Our firm has successfully litigated against device manufacturers with both types of approvals.  These devices include spine stimulators, neuro-monitoring devices, and spinal fusion medical devices.  In our investigations for clients, we have also uncovered kick-back schemes which involve doctors being paid to use certain devices.  Patients are never informed of this lucrative scheme which can conflict with what is best for the patient.

Medical device litigation is complicated and dynamic with various courts around the country setting different rules and laws.   Causes of action can include negligent manufacturing, design defects, failure to warn, and breach of warranty.  Various statutes of limitations apply, some as short as one year.  With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast.    If you have concerns that your medical device is not functioning or may have caused you injury, call us immediately for a free consultation.

We are currently actively investigating and litigating regarding the Medtronic RestoreSensor spine stimulator.  Patients have reported issues which include a short battery life, spontaneously turning on, and injuries from the device being removed.

Medtronic SynchroMed II Implantable Infusion Pumps

If you or someone you know has a Medtronic implantable medicine pump, it is important to know about a recent Complaint Filed by the U.S. Attorney’s Office in regards to manufacturing problems. This injunction filed April 27, 2015 against Medtronic and its CEO, seeks to prevent them from selling SynchroMeds that have been adulterated and to force them to improve the quality of their manufacturing methods. It describes numerous violations of the quality system regulations at Medtronic Neuro and states that many of the violations related directly to the manufacture of the SynchroMed II implantable infusion pump.  The complaint references four inspections where the FDA observed and documented violations.

If your SynchroMed pump is not functioning correctly or if you had your implant removed due to problems, please call or email our office to see if you can recover damages.

The Meyerson Law Firm, P.C.   (512) 330-9001

Suit Filed Against St. Jude Medical

The Meyerson Law Firm has filed suit against St. Jude Medical in regards to claims of manufacturing and warranty defects with its Eon Mini stimulator.  Not to be confused with St. Jude Children’s Hospital, St. Jude Medical is a for profit company that sells various medical devices throughout the world.  There have been recalls and numerous complaints regarding its Eon Mini stimulator, including that it causes burning sensations while charging, it delivers painful jolts, and its battery depletes too quickly.  Removing the devices can be medically risky and permanent scar tissue can build up near the spine where the leads were implanted.

Button Battery from Vizio Remote Causes Severe Injury to Toddler

Last year a one year old in Austin, Texas accessed a coin shaped “button” battery from a Vizio stereo bar remote control and ingested it.  The battery lodged in his esophagus and the electric current created a caustic agent that burned his throat tissue.  This serious condition put him in the hospital for what is now months of operations, treatment and observation.  The Meyerson Law Firm has filed suit in San Diego Federal Court alleging a dangerous design defect in the remote.

The Meyerson Law Firm urges everyone to look through their remotes and ensure that any which use button or coin shaped batteries are secured with child safe mechanisms.  If you know of anyone whose child has been injured by a similar occurrence, please have them call The Meyerson Law Firm for a free consultation.

Nuvasive, Inc. Blames Doctor in Case Involving NVM5 Neuromonitor

On February 28, 2012, our client Edith went in for surgery where the doctor used the NVM5 neuromonitor manufactured by Nuvasive, Inc.  In the middle of the surgery, the orthopedic doctor aborted the procedure.  Nuvasive admitted in emails to the doctor that their product did not work properly during the procedure and explained what they would do to prevent problems in the future.  The patient incurred damage to her lumbar plexus which affected her ability to walk.  Nuvasive now blames the doctor for the injury to the patient.  The case is set for trial in the U.S. District Court, Western District of Texas in October of 2014.

Warning on Specialty Compounding

FDA Alert – Specialty Compounding Products

Friday, August 9th the US Food and Drug Administration (FDA) sent out an alert informing health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX. Bacterial infections had been potentially associated with contaminated calcium gluconate infusions produced by the company. FDA had received reports of 15 adverse events experienced by patients in two hospitals; the patients had developed bacterial bloodstream infections caused by Rhodococcus equi, an organism commonly found in dry soil. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent withRhodococcus species.

As of Monday, August 11th the FDA announced nationwide voluntary recall of all products for sterile use from Specialty Compounding. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.

According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.

Please call The Meyerson Law Firm today to discuss any case.  512-330-9001

The Meyerson Law Firm Brings Claims Against Prosecutor

Attorney: Two injured in crash with Travis Co. prosecutor

Attorney: Two injured in crash with Travis Co. prosecutor photo
Brandon Grunewald

By Ciara O’Rourke

American-Statesman Staff

Attorneys representing two women who were in the car that police say was rear-ended Sunday by an intoxicated Travis County prosecutor said Thursday that they were injured in the crash.

The driver suffered a concussion and one of two passengers the Meyerson Law Firm is representing has complained of pain, the attorneys said.

The women, the attorneys said, also say that Travis County Assistant District Attorney Brandon Grunewald accused them of causing the collision and tried to convince them not to call police.

The claim comes after Travis County District Attorney Rosemary Lehmberg issued a statement about the crash Tuesday, saying that “currently there are no injuries reported from the collision.”

“They were injured,” attorney Jeff Meyerson said. “It wasn’t a love tap.”

Authorities say Grunewald, 33, rear-ended his Land Rover into a Mini Cooper that was stopped along the southbound service road of MoPac Boulevard (Loop 1) near Barton Skyway in Southwest Austin. He was booked into the Travis County Jail shortly after the wreck, which occurred around 3:30 p.m., and was released several hours later, jail records show.

Grunewald was charged with driving while intoxicated, nearly four months to the day after Lehmberg was arrested for the same offense.

She pleaded guilty and was sentenced to 45 days in jail, though she was released in about half that time for good behavior.

She said Tuesday that her office does not typically fire employees for a first-time DWI offense and that she was going to wait until all the facts were known before making any decisions about Grunewald’s employment.

“We have to look closely at each case separately because each case is different,” she said in a phone interview. “We look at the offense, criminal history, performance issues.”

Meyerson said his firm hasn’t filed a lawsuit on the women’s behalf and that there’s no need to file a suit at this time because there doesn’t appear to be a liability dispute.

The Meyerson Law Firm represents injured victim of Travis County prosecutor

Travis County prosecutor charged with DWI

Involved in wreck, refused breath test, police say

AUSTIN (KXAN) – A prosecutor with the Travis County District Attorney’s Office was charged with driving while intoxicated after being involved in a traffic wreck over the weekend.

According to an arrest warrant affidavit released Monday, Brandon Grunewald, 33, was in a collision Sunday afternoon on the southbound MoPac Boulevard service road near Barton Skyway, Grunewald was driving a 2008 Land Rover. The other driver was in a Mini Cooper.

Grunewald ran into the back of the Mini Cooper when it came to a stop, the affidavit said.

The officer who responded reported that Grunewald appeared to have bloodshot, watery eyes and smelled of alcohol, the affidavit said. He also had difficulty with his balance and appeared confused, the document said.

Grunewald refused to take a breath test or to perform field-sobriety exercises, the document said.

Grunewald was booked into jail and posted bail, which was set at $3,500. He was ordered to install an ignition lock on his vehicle that detects alcohol on the breath.

Grunewald’s attorney, Brian Roark told KXAN News that his client made a mistake that he’s sorry about.


Recall of St. Jude Eon Mini Spine Stimulators


St. Jude Medical has recalled certain models of Eon and Eon Mini implantable pulse generators (IPGs).  IPGs are battery powered devices that are implanted into a patient’s spinal area and provide stimulation in order to reduce chronic pain.

IPGs require the implanted internal battery to be recharged.  However, these devices suffer from significant problems.  In certain models, the battery fails which then prevents the device from providing pain relief.  In other cases, IPGs have severely burned patients while recharging the battery. Once a problem is detected, the devices must be surgically removed from the spinal area, subjecting the patient to a host of other risks and problems such as infection, pain and scarring.

St. Jude Medical (which is sometimes confused with St. Jude’s Children’s Hospital) has announced that the battery failure problems stem from weld failures within the internal batteries of the units, sometimes allowing fluid to spill out. The battery is fully contained in the titanium shell of the unit, however, and is not at risk of leaking into the body.

If you are having problems with your St. Jude Stimulator, please contact us to discuss how our firm can help you.