Jury Orders J&J Pay $1 Billion for Pinnacle Hip Implants


A Texas jury last week awarded more than $30 million in damages and more than $1 billion in punitive damages to six plaintiffs who sued Johnson & Johnson for defective metal-on-metal hips made by its DePuy unit. It’s the third largest jury award in 2016.

J&J will almost certainly appeal the size of the verdict as well as other legal decisions made in the case.  This is the third verdict on liability for Pinnacle hip implants.  J&J won the first trial.  The jury in the second trial found for the plaintiffs in the amount of $502 million, but the judge reduced the award for the five patients to $150 million.

There has been a substantial amount of litigation over defects with metal-on-metal hip implants over the past few years.  The most recent implants to have problems arise were from certain Stryker hip implants.

New Warnings of Stryker Hip Failures with LFIT Component

X-ray scan of hip joints

A study in the Journal of Bone and Joint Surgery last month identified five cases of catastrophic trunnion dissociation in Stryker Accolade TMZ Femoral Hip Stems. What does that mean in lay terms? It means that the hip implant device fails painfully in a small percentage of patients with certain risk factors approximately 7 to 7.5 years after surgery. And the $1.4 billion settlement for patients with defective Stryker hip implants following hip replacement surgery may not be the end of the lawsuits for the company.

Further information now available from Australia suggests the problem is with Stryker’s LFIT Anatomic CoCR V40 femoral head which was a component of Stryker Accolade TMZF, Accolade 2, Meridian and Citation hip implants.

If you experience hip implant failure or crippling pain with one of these Stryker hips, particularly if it includes the LFIT Anatomic CoCR V40 femoral head, you may be entitled to compensation through a personal injury lawsuit. Our Philadelphia trial lawyers are prepared to review your medical records, evaluate your options with you, and file a lawsuit to recover compensation, if necessary. If you suffer a metal-on-metal hip implant failure, call 1-800-590-4116 to speak to Jim McEldrew or one of our other attorneys.

About the Metal-on-Metal Hip Implant Defects

Stryker is a manufacturer of hip replacement systems. Several models of Stryker hip implants have already been in litigation over patient injuries for a few years. These patients have reported debilitating pain, crippling tissue and muscle damage, and premature failure of their hip replacement.

Metal-on-metal hip implants like these have experienced failures across several manufacturers. In addition to the Stryker implants, the other potentially problematic devices include the Zimmer Durom Cup, Wright Profemur-Z hip system, the DePuy ASR and certain DePuy Pinnacle metal implants.

The new Stryker Hip Implant

The Accolade TMZ Femoral Hips at issue in the study were available for use from 2001 to 2011. In the patients experiencing failure, the adverse event was clustered around 7 to 7.5 years after surgery. It is believed that severe corrosion led to the dissociation of the femoral head from the trunnion (trunnionosis). In addition to the five patients identified, the journal article mentions two previously known cases of catastrophic trunnion dissociation in total hip arthroplasty.

Patient Characteristics

The journal article suggests that there may be other patients who have not come forward yet or who have not experienced this problem yet but will in the future. The typical patient who might suffer this problem after modular total hip arthroplasty is male, taller than 5 ft 10 inch and weighing greater than 180 pounds. It is estimated that this demographic puts greater load on the femoral head-trunnion interface. The patient group explored had cobalt-chromium alloy femoral heads combined with a titanium trunnion.

Update: The Australia Stryker LFIT

Australia has issued a hazard alert for certain femoral heads used in hip replacement surgeries.  Specifically, a range of LFIT Anatomic CoCR V40 femoral heads manufactured by Stryker before 2011.  Australia, in consultation with Stryker Orthopaedics, expressed concerns about a higher than expected incidence of taper lock failures.

The taper lock connects the femoral head to the femoral neck.  If it fails, a patient can experience broken bones, joint instability, pain, inflammation, loss of mobility, leg length discrepancy and the need for revision surgery.

The impacted component was used in the Stryker Accolade TMZF, Accolade 2, Meridian and Citation hip implants.  The Australian alert urged orthopedic surgeons to monitor patients with the component at issue for fractured hip stem trunnion, increased metallic debris, bone fixation strength, and disassociation of the femoral head from the hip stem.

Some legal commentary in the United States is already suggesting that a recall by Stryker is imminent.  Stryker has already recalled other lines of its metal-on-metal hip implants due to complaints of inflammation, metal poisoning, inflammation and organ damage.  Stryker is expected to pay out more than $1 billion total to plaintiffs in the previous litigation.

The Stryker Hip Implant Lawsuits

Stryker previously recalled its Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012. It also recalled the Accolade TMZF Plus Hip Stem for packaging and manufacturing errors in 2012 and 2013. The defective metal-on-metal hip devices resulted in the implant loosening for some patients and toxic metals release into their bodies. Stryker has been in litigation with these patients over the past few years. The lawsuits allege that the company inadequately tested the products and failed to warn patients and doctors about the risk of side effects. Stryker previously agreed to pay at least $1 billion to settle these lawsuits.

About McEldrew Young

Jim McEldrew and Eric Young engage in litigation against large pharmaceutical and medical device manufacturers on behalf of patients and whistleblowers. If you have been injured by a defective drug, medical device or other form of medical malpractice, please call 1-215-545-800 to speak to Jim McEldrew concerning your legal rights.

Big Award for Compliance Whistleblower in Record Kickback Case


Earlier this week, medical device manufacturer Olympus agreed to pay the largest ever civil False Claims Act settlement by a medical device manufacturer to resolve a lawsuit over violations of the federal anti-kickback statute. In addition to the record $310.8 million, they also agreed to pay $312.4 million in criminal penalties. A reward of around $51 million will go the whistleblower in the case.

Kickbacks are probably the hottest area in False Claims Act litigation right now. Referrals for medical treatment paid for by government healthcare programs rewarded by anything of value are prohibited by the Anti-Kickback Statute (AKS) and the Stark Law. The Stark Law applies to physicians. The AKS is a criminal statute that applies broadly. Both laws contain numerous exceptions or safe harbors to permit conduct deemed acceptable in the health care industry.

Violations of these two laws bring on liability under the False Claims Act. The False Claims Act provides for statutory monetary penalties for each false claim and treble damages to the federal government as compensation for the misconduct. As violations of these laws increase the costs on Medicare/Medicaid while encouraging physicians and other treatment providers to make treatment decisions based not on the best interest of the patient but the potential financial benefit.

The whistleblower award comes at a time when many compliance professionals have been expressing concern about the potential for increased liability. Over the past few years, there have been fines to compliance officers by both the SEC and FinCEN over their role in corporate misconduct. The DOJ announcement of increased pursuit of individual liability has no doubt also stoked these fears.

The debate over personal liability for failed compliance really hasn’t touched on the possibility of the individual to become a whistleblower. But it does happen from time to time. Two out of the SEC Whistleblower awards have already gone to individuals in an audit or compliance function. A hospital compliance officer and physician services director reporting kickbacks at her hospital received $20 million last year for a lawsuit which began in 2009. Although there are sometimes special rules for compliance officers in order to earn a reward or prove retaliation, reporting violations externally when internal efforts have failed is still an option for them.

While recognizing that the decision to blow the whistle is a tough one, it is a solution for compliance employees with concerns that they will be charged because of institutional resistance to cleaning up the corporate misconduct.  The False Claims Act offers rewards of between 15 and 30 percent of the government’s recovery in order to encourage individuals to report fraud.  But for the compliance officer simply trying to do the right thing, it remains an option when the corporation resists their efforts.  Our False Claims Act attorneys can assist you – contact us for a free, confidential initial legal consultation.

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Four Settlements for Justice Dept as Health Care Companies Seek to Avoid Coal for Christmas


It must be the last weekend before Christmas because health care companies are looking to resolve government investigations into their wrongdoing before we leap into the new year!  In the last two days, we’ve now seen four multi-million dollar settlement announcements in False Claims Act cases.

A pharmaceutical company settled allegations that it billed federal healthcare programs for chewable fluoride tablets which contained less than half of the amount of fluoride ion contained on its label, causing children to receive less fluoride than recommended by the American Dental Association guidelines. The company stopped selling the tablets when the government started investigating and will now be $39 million to the federal government and various states under the federal and state False Claims Acts. The whistleblower will receive $4.71 million.

A cancer care service paid nearly $20 million to resolve allegations it billed Medicare and Tricare for unnecessary urine tests to detect genetic abnormalities consistent with bladder cancer. The government alleged that the laboratory tests for fluorescence in situ hybridization. The whistleblower, a medical assistant that formerly worked at the company, will receive $3.2 million from the recovery.

Another large group of hospitals agreed to pay a total of $28 million to resolve allegations that they performed kyphoplasty as an inpatient procedure in order to increase their billings rather than perform it as a less costly outpatient procedure. Kyphoplasty is a minimally-invasive procedure treating certain spinal fractures resulting from osteoporosis. The government has now reached settlements with over 130 hospitals and the medical device company responsible for the procedure. It previously paid $75 million to settle allegations it counseled hospital providers to perform the procedures on an inpatient basis.

A splint supplier has agreed to pay just over $10 million to resolve allegations of improperly billing Medicare for splint reimbursement when the government was already paying a bundled fee to the skilled nursing facility for their treatment. The defendants misrepresented the patients were in their homes rather than in a SNF.

The False Claims Act rewards whistleblowers who come forward with evidence of fraudulent billing of Medicare and Medicaid, as well as other government programs, with 15 to 30 percent of the government’s recovery.  If you have evidence of a company engaged in wrongdoing similar to one of the above examples, please call our whistleblower attorneys at 1-800-590-4116 for a free, confidential legal consultation.

Congrats to all of the whistleblowers and their counsel in these cases!

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Watch for Medical Malpractice Among Health Tech Hazards in 2016


Over the past few years, our personal injury lawyers have been representing more clients in cases of defective or improperly used medical devices. Although part of this may be due to an expansion of our interests in this area, health technology is a growing part of the practice of medicine and this no doubt has something to do with the fact that we are seeing more defective products in potential medical malpractice cases.

ECRI Institute published a Top 10 list of Health Technology Hazards for 2016 today. Because of our work representing clients, we are already intimately familiar with the top danger cited, which is “Inadequate Cleaning of Flexible Endosocopes before disinfection can Spread Deadly Pathogens”.

In the medical community, the device described above is a duodenoscope. It is used to perform an ERCP Procedure. In the beginning of the year, patient deaths believed to be caused because of design changes that made it difficult to adequately clean the devices before re-use were publicized by hospitals across the country.

We thought that highlighting the rest of the list would be of interest to the health care professionals that read our blog. We expect that we will definitely see cases in 2016 and beyond from the problems identified on this list:

2. Missed Alarms

Patients may not get treatment for dangerous conditions either because the medical device does not detect a condition warranting an alarm or the medical professionals fail to notice the alarm.

3. Opioid-Induced Respiratory Depression

Patients on postoperative drugs such as morphine or fentanyl are at risk of anoxic brain injury or death if oxygenation and ventilation are not adequately monitored every few hours for opioid-induced respiratory depression. The condition may occur because of a medication error, receipt of another drug or comorbidities that compromise their respiratory system. Nevertheless, it should be caught by medical professionals.

4. Telemetry Monitoring

Medical professionals may fail to properly monitor technology designed to increase the number of patients they can assist. In telemetry, patient conditions are automatically communicated remotely to a place for patient monitoring. However, the lack of in person contact and increased workloads could mean that problems are missed.

5. Inadequate Training

ECRI Institute estimates roughly 70% of accidents related to medical devices involve user error or poor technique. Better training concerning new operating room technologies could alleviate many of the errors that lead to complications and additional injuries.

6. Integration of Health IT

Medical errors can result if a new health IT (HIT) system isn’t properly and carefully integrated into the process already used in workflow. ECRI identified missed information, input errors such as the mistaken use of default values, and workarounds as potential problems that can lead to patient harm in treatment.

7. Unsafe Injection Practices

The list identified the transmission of bacterial infections and bloodborne viruses through the reuse of needles, sharing of insulin pens or single dose drug vials.

8. Gamma Camera Failures

There have been more than 40 safety recalls of gamma cameras filed with the FDA in a 2 year period. If the device experiences a mechanical failure, its heavy components can rotate into or fall on a patient.

9. Ventilator-Induced Lung Injuries

Inappropriate ventilation of intensive care patients can lead to preventable deaths from lung injuries. Advanced ventilators and lung-protective strategies can be used to prevent harm, but some professionals do not use these techniques or have access to devices with the latest capabilities.

10. USB Misuse

Medical devices contain USB ports that can cause the device to malfunction or reboot if unauthorized devices are plugged into them. For example, it was discovered last year that an anesthesia delivery system could have a life threatening failure if a USB device was plugged in while it was running. The FDA recall identified recharging a cell phone as a possible cause of the malfunctioning software.

We hope that medical professionals quickly figure out how to avoid and minimize these mistakes so that patients do not need to seek out the services of our medical malpractice lawyers. However, we know that this is not always an easy task. For a free consultation concerning medical malpractice related to a medical device, please call 1-800-590-4116 to speak to one of our attorneys.

Massive Implantable Defibrillator Settlement under False Claims Act Approaches


The Department of Justice is reportedly nearing settlements with hundreds of hospitals over their fraudulent billing of Medicare for defibrillators. Medicare covered the $40,000+ defibrillators for the primary prevention of arrhythmia unless they were implanted within 90 days of bypass surgery or 40 days of a heart attack. Doctors implanted the medical devices in patients and then fraudulently billed Medicare in spite of the guidelines.

This is expected to be the largest settlement in terms of the number of hospitals and the amount for a group of hospitals. In 2013, 55 hospitals settled a national investigation for $34 million into the use of cement in fractured vertebrae, a procedure known as kyphoplasty. The government is reportedly using data mining techniques this time around to assist them in their investigation.

The cardiac investigation dates back to at least 2012, when Modern Healthcare reported that the Justice Department was simultaneously emailing hundreds of hospitals with questionnaires concerning their use of the devices. At that time, Modern Healthcare obtained a document from the DOJ called the “Medical Review Guidelines/Resolution model”. It divided the possible scenarios for hospital billing of patients into categories which included those covered by the National Coverage Determination and/or excluded from the investigation, that the government had used its discretion to determine it would not bring enforcement (referred to as buckets), and those which would be included in an enforcement action.

The enforcement action(s) included certain coding errors, patients who were previously qualified but did not have an implantation until they were not within the coverage window, and those where it was not medically indicated. The calculation identified that the hospitals would be charged for the difference between the code they used and the correct code, as well as a per hospital multiplier of damages based on a variety of factors including knowledge, compliance efforts and patient harm.

At least six healthcare systems have already publicly reported the amount of their settlements to shareholders. Tenet announced a settlement of $12.1 million and HCA indicated their number was $15.8 million.

It will be interesting to see how the credit for this victory is shared. It seems likely that there are a number of whistleblowers out there, insiders who reported their hospital to the federal government through a qui tam lawsuit and may be in line for a reward as part of the settlement. The False Claims Act requires the DOJ to pay eligible relators between 15 and 25 percent of the award (in cases like this one where the government has not declined to intervene in the case). However, there are various rules such as the first to file rule and public disclosure which could limit those payments.

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Drug and Medical Device Companies Pay Doctors $6.49 Billion in 2014


1,444 companies paid 1,100 teaching hospitals and 607,000 physicians nearly $6.5 billion in 2014. It is the first full year of data concerning the financial ties between doctors and the pharmaceutical companies and medical device manufacturers that are paying them. The data counts the value of meals as well as payments for speeches, consulting and research.

Pfizer is believed to have made the most payments with $234 million in research payments and general outlays of $53.3 million.  Some companies like Johnson & Johnson and Merck reported payments from several different entities.

The data comes from the release of the second annual Open Payments report by the Centers for Medicare and Medicaid Services today. Last year, CMS released information for payments from August 1 until December 31, 2013. Physicians and teaching hospitals received $3.43 billion in payments during the last 5 months in 2013.

The release of this information was authorized by the Affordable Care Act in 2010. The provision, called the Sunshine Act, requires manufactures to disclose their payments to physicians and teaching hospitals. The effort is to bring transparency, or sunshine, to the ties that might impact a doctor’s prescribing decisions and inform their patients of them.

As we represent several health care whistleblowers in False Claims Act litigation that has been unsealed, and have seen several other settled and currently pending cases, we know that drug and device companies do cross the bounds when marketing their products. The allegations we have seen allege that payments for speaker programs were in effect kickbacks in violation of the Anti-Kickback Statute and the Stark Law. Many of these payments were for “sham” speak programs that had few or no attendees as well as little, if any, educational value. Companies were also expressly tying the participation of physicians in their speaking programs, for which they receive compensation, to the amount of product that they prescribed.

Patients should be aware of these tactics of marketing medical products, check the data and speak to their physician about their medications.

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DOJ Fines Medical Device Companies $100+ Million in 2014


An annual report by the Departments of Justice and Health and Human Services identified more than $100 million in fines issued against medical device companies in 2014, according to FierceMedicalDevices. The total includes fines against Carefusion for off-label marketing, Boston Scientific’s Guidant for defective cardiology devices, Medtronic for kickbacks to doctors for pacemakers and Abbott Labs for encouraging the submission of false claims for surgeries to Medicare.

The False Claims Act is one of the primary tools in the government’s arsenal to fight fraud by medical device manufacturers. It has helped the government recover billions of dollars lost to fraud over the past 25 years. It also authorizes the Department of Justice to pay rewards of between 15 and 30 percent of the government’s recovery to whistleblowers who file a qui tam lawsuit and provide evidence of health care fraud.

In other news, recalls of medical devices have fallen by more than 50% in the first quarter of 2015 compared to Q4 2014, when there was a record 968, according to analysis by Regulatory Affairs Professional Society covered by FierceMedicalDevices. The 426 recalls was the second lowest total from the FDA’s data, which includes information going back to 2013. It reversed a trend of gains in three straight quarters.

The total number of devices recalled is not reflected in this information, however. It only measures the number of different models recalled. One model number recall could implicate hundreds or thousands of different devices.

The fall in recalls comes at the same time that medical device manufacturer Olympus has been caught up in the controversy over contaminated duodenoscopes leading to CRE superbug infections. The spread of deadly infections linked to the device and its decision not to seek FDA clearance when it sealed the elevator wire channel has already resulted in patient lawsuits seeking compensation for damages. Our law firm is investigating patient claims of infections caused by these devices.

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