The FDA 510(k) System Overhaul -Process For Medical Device Approval: Is this a win for Big Pharma?

 

IS BIG PHARMA LOBBYING DICTATING FEDERAL REGULATORY POLICY IN WASHINGTON D.C. NOW?

By Mark A. York (December 5, 2018)

 

 

 

 

 

 

 

Official FDA announcement: FDA changes 510(k) program for approval and review of medical devices Nov. 26, 2018

(MASS TORT NEXUS MEDIA) On November 26, 2018 the FDA announced an overhaul of the 510(k) system that is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize the manufacturers and their devices that are based on older products.

The FDA is supposed to protect the interests of the general public and ensure that new devices, as well as existing ones are functioning as designed. More often that is not the case, as the FDA either fails to review medical device failures or simply ignores them.

The FDA has a reporting and tracking database that permits the public to review and see what devices are unsafe or causing adverse events, see FDA Medical Device Adverse Event Report Database.

Now there seems to be an effort by the FDA to pull back on the reporting functions in their official oversight duties. This includes the reporting requirements for problematic medical devices.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

For the FDA Medical Device Reporting Program (MDR): FDA.gov/MedicalDevices/Safety/ReportaProblem

BIG PHARMA LOBBYING INFLUENCE

Pharmaceutical companies and medical device makers, collectively Big Pharma, spend far more than any other industry to influence politicians. Big Pharma has poured close to $2.5 billion into lobbying and funding members of Congress over the past decade.

Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152 million on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the single largest beneficiary, with donations from the industry totaling $228,670.

Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its report findings on November 26, 2018.

The new FDA rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly 9 out of 10 device categories, a recent review found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.

As part of the worldwide scrutiny of medical devices and at times, the  affiliated dangers, a massive investigation known as “The Implant Files” was undertaken by a group of journalists around the world.  Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete

ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored. This included an analysis of more than 8 million device-related health records, including death and injury reports and recalls.

The Implant Files review encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.

Like the rest of Big Pharma, the medical device manufacturers have created an intricate web of corporate and political influence including at the Federal Drug Administration, where the FDA is charged with oversight of medical devices.

The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the pharmaceutical and medical device industry, which is a massive global business that has existed for years with minimal international scrutiny.

A recent analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.

BUYING A PRESENCE IN WASHINGTON

The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.

But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.

Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.

There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.

The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress and target agencies and offices across the executive branches in D.C., from the FDA to the Center for Medicare and Medicaid and the National Security Council.

Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.

With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.

An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma-pharmaceuticals, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year, more than six times as much as the device industry, according to a Statista market analysis.

The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.

Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.

“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”

Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.

Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.

Three companies that spent the most on lobbying in the past five years were  ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”

Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.

In a statement, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”

OBAMA – TRUMP COMPARISON

During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.

Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.

Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.

“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.

During Obama’s final year in office, the FDA banned its first device in more than 30 years, a type of surgical glove and proposed a ban on a home shock collar for behavior modification. That ban is still pending.

The industry successfully pushed for changes in a proposed regulation on unique device identifiers, the identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.

“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”

President Trump vowed to cut regulations across the government by 75 percent when he came into office.

In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. In its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.

“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that the industry gets FDA to agree to and that they’re paying for.”

If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.

“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.

The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”

The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination, and including device identifier codes in insurance claims forms.

MAKING FDA APPROVAL EASIER FOR BIG PHARMA

The changes to how adverse events are reported was seen as an overwhelming industry success.

The FDA database in which surgical complications are entered is known as the Manufacturer and User Facility Device Experience Database (MAUDE), which includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.

Despite its size, it’s widely accepted that the database is only a rather limited record of the full scale of medical device complications and adverse events.

The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.

“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Patients are able to report adverse events to the database themselves, but few know to do so. Companies are required to report the events, once they are notified., which they don’t always do. The FDA said thirty-three percent (33%)  of all FDA warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.

The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.

Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.

“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”

In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.

“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”

In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”

In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”

But Redberg, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.

“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”

How these changes are affecting medical care in the US, and more importantly the publics right to be informed of adverse events and problems with medical devices, their approval process and who’s lobbying who and for what in the FDA should be open and transparent.  

(Certain images and text excerpts in this article were reprinted from third party media sources)

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DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics,  a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

 DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip  trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

 They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

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NJ Designates State Lawsuits over Stryker LFIT V40 Femoral Heads as Multicounty Litigation

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head

New Jersey’s chief justice on May 16 assigned state lawsuits over the Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads into a multicounty litigation docket.

The court assigned the artificial hip cases to Judge Rachelle Harz of the Bergen County Superior Court, In Re:  Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, No. 624, N.J. Superior Court in Bergen County, NJ.

Separately, 36 federal LFIT cases were centralized in April into MDL 2768 in US District Court for the District of Massachusetts.

Chief Justice Judge Harz issued an initial case management order on May 22.  The first trial conference is set for June 21. The multicounty litigation was sought by 25 plaintiffs.

Motion follows recall

The Stryker LFIT was voluntarily recalled in August by Howmedica Osteonics Inc. when some taper locks failed. Plaintiffs allege that the part can fret and corrode, releasing metal particles and posing a risk of metallosis, necrosis, osteolysis and higher levels of cobalt and chromium in the bloodstream.

Howmedica opposed consolidation, saying existing cases are being effectively coordinated by Judge Harz.  It suggested that if cases are consolidated, they be limited to cases involving the recalled LFIT V40 femoral heads that show taper lock failure.

The motion was filed by plaintiff attorney Ellen Relkin of Weitz & Luxenberg in New York.

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Federal MDL Created for Stryker LFIT Anatomic CoCR V40 Prosthetic Hip

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head

The Judicial Panel on Multidistrict Litigation (JPMDL) created the new MDL No. 2768 to hear products liability litigation involving the Stryker-branded LFIT Anatomic CoCR V40 femoral heads, a prosthetic hip replacement device.

US District Judge Indira Talwani in Boston will oversee a total of 33 cases from 17 district courts, with at least eight groups competing plaintiffs’ counsel involved, in In re: Stryker LFIT V40 Femoral Head Products Liability Litigation. Defendant HowmedicaOsteonics Corp. of Mahwah, NJ, unsuccessfully opposed centralization and wanted the cases heard in New Jersey or New York federal court.

All the lawsuits involve common factual questions about alleged defects in Howmedica’s Stryker-branded LFIT Anatomic CoCr V40 femoral heads. The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA.

42,519 defective hips

Howmedica recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Potential hazards listed in the recall notice included excessive metal debris, disassociation of the head from the stem/failure, trunnion fracture, and corrosion at the femoral head and stem junction.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The plaintiffs’ claims focus on the performance of the LFIT V40 cobalt-chromium device, in particular the alleged propensity of the device to cause corrosion at the taper junction when paired with femoral stems made from different alloys (such as Howmedica’s proprietary TMZF, which is an alloy of titanium, molybdenum, zirconium and iron). This corrosion allegedly leads to failure of the implant or other serious health consequences and necessitates surgery to remove and replace the implants.

In addition to the specific causes of the failure of each plaintiff’s device, the cases have common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the LFIT V40 cobalt-chromium femoral head. “We note, though, that the transferee judge might find it useful, for example, to establish different tracks for the different femoral stems that can be mated with the LFIT device,” the JPMDL said.

New Jersey plaintiffs

A different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.

Separately, Stryker is the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersey State Court.

 

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New Group of Plaintiffs Seek Stryker LFIT Hip MDL in New Jersey State Court

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head Device

As the federal courts weigh creating an MDL for litigation involving the Stryker LFIT V40 Hip Device, a different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

  • The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.
  • The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, requesting MDL No. 2768 be created in federal court in Massachusetts. The Judicial Panel on Multidistrict Litigation (JPMDL) will hear this motion on March 30 in Phoenix, AZ.

Separately, Stryker is the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersy State Court.

Defective hips

Defendant Stryker Howmedica Osteonics Corp. of Mahwah, NJ, recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The LFIT femoral head has been marketed fo ruse with a variety of femoral stems. Some medical literature says the problem arises when stems made of titanium or TMZF titanium alloy are combined with cobalt-chromium alloy femoral head and taper devices.

The problem involves fretting and corrosion in the junction where the femoral head connects to the femoral stem. Corrosion at this junction has led to the systematic release of metal particles into the surrounding tissue and bone, putting patients are risk of toxic metallosis, tissue death, bone death and elevated levels of cobalt and chromium in the blood.

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery.

Furthermore, excessive corrosion at the head-neck junction causes the femoral head to break off the from neck, become loose in the body, and depart from the acetabular cup where it is supported to move.

Revision surgery

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery. Many of the New Jersey cases involve patients who have needed revision surgery.

All the cases allege design defect, failure to warn, breach of warranty and manufacturing defect.

Judge Harz is presiding over the LFIT litigation, as well as the Stryker Rejuvenate and ABG II litigation, which involves similar issues.  “It is both logical and fair to the litigants for these cases to remain in Bergen County before Judge Harz,” attorney Relkin argues. She speculates that if a federal MDL were created in New Jersey, then “seamless coordination could occur between the federal MDL and state MCL litigation.”

The New Jersey Multicounty Litigation Center centralizes litigation over Accutane, Benicar, Talcum Powder, Stryker Hip/ABG II, DePuy ASR Hip Implant, Mirena, Pelvic Mesh, Stryker Implant, Yaz/Yasmin/Ocella, Asbestos, AlloDerm, Fosamax, Levaquin, Propecia, Reglan and Risperdal / Seroquel / Zyprexa.

A global settlement was announced December 19, 2015 regarding the Stryker Hip/ABG II litigation.

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New MDLs Requested for Farxiga, Mirena, Hip Implants and Sorin 3T Heater

farxiga320x320The US Judicial Panel on Multidistrict Litigation (JPMDL) will hear argument on March 30 on whether to create new multi-district litigation docket (MDL) No. 2776 for Farxiga and Xigudo diabetes medicines.

Oral argument is scheduled starting in the morning at the US Courthouse in Phoenix, Arizona. In addition, oral arguments will be held to create the following MDLs:

Ketoacidosis and kidney failure

Plaintiff’s attorney Holly Dolejsi of Robins Kaplan L.L.P. in Minneapolis moved to transfer currently filed Faxiga and Xigduo cases to either the Southern District of New York before Judge Lorna G. Schofield, the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel, who all have Farxiga cases assigned to them.

The motion involves 18 pending cases in 6 district courts, with 13 of the 18 filed in New York. The Defendants The Defendants in these cases are Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB, and AstraZeneca PLC.

As a result of ingesting Farxiga, the plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories. On January 8, 2014, the FDA approved Farxiga for use in

On January 8, 2014, the FDA approved Farxiga for use in treatment of type 2 diabetics.2 Farxiga is a part of the gliflozin drug class. The gliflozin class is referred to generally as SGLT2 (short for “Sodium Glucose Cotransporter 2”) inhibitors. Xigduo XR was (dapagliflozin combined with metformin) designed and made by the same defendants as Farxiga, and is an extension of the Farxiga product line. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

FDA safety warning

On December 4, 2015 the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis-related to SGLT2 inhibitors. The FDA noted adverse event reports “include only reports submitted to FDA, so there are likely additional cases about which we are unaware.”

The same safety communication also warned of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis). In light of the data disclosed in the December 4, 2015 safety communication, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis. On June 14, 2016, the FDA issued a safety announcement which advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

While a cross-motion to include Farxiga cases with Invokana MDL No. 2750 was raised, considered and ultimately denied by the Panel following the hearing in Charlotte, North Carolina, that request was opposed by both the Invokana Plaintiffs’ counsel and Defendants who claimed that the litigations were sufficiently different such that a joint SGLT2 MDL was improvident.

A total of 100 lawsuits have been filed in the MDL since the courts created it in December.

 

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Plaintiff Seeks MDL for Stryker LFIT V40 Hip Device

LFIT V40 Femoral Head
Stryker LFIT V40 Anatomic Femoral Head device

A Massachusetts hip replacement patient has requested that the Judicial Panel on Multidistrict Litigation (JPMDL) consolidate litigation against Stryker Orthopaedics over its defective LFIT V40 Anatomic Femoral Head devices, of which more than 100,000 units have been implanted into patients.

The new wave of litigation arises after Stryker Corporation issued an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

At the moment, six product liability actions over the LFIT device are pending in three jurisdictions, prosecuted by at least 10 different law firms. Plaintiff attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, proposed that new MDL. No 2768 be located in federal court in Massachusetts before Judge Joseph L. Tauro, Judge Patti B. Saris, Judge Richard Saylor or Judge Indira Talwani.

The JPMDL has created MDLs in the court in Boston for litigation over GranuFlo/NaturaLyte, Zofran, Nexium, Neurontin, Celexa and Lexapro.

1,800 lawsuits

Stryker is already the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersy State Court.

The prosthetic hip used in a total hip arthroplasty, more commonly known as total hip replacement, generally consists of several components – a femoral stem, a femoral head or ball, and an acetabular cup with liner. The Stryker LFIT V 40 Anatomic Femoral Head represents one part of a hip prosthesis and can be used across many hip replacement femoral hip stems manufactured and marketed by Stryker.

Stryker explains in its marketing materials that the “LFIT Anatomic CoCr Femoral Heads are compatible with Accolade TMZF, Secur-Fit Max, Citation TMZF, Hipstar, and most commercially available Stryker femoral hip stems.”

During hip replacement surgery, the femoral head is impacted onto the taper, in this case a V 40 taper, where it is supposed to lock in place. The failure of that taper lock causes excessive movement between the femoral head and the stem and ultimately leads to product failure.

On August 29, 2016, Stryker sent an “Urgent Medical Device Recall Notification” letter to surgeons that implanted or reported problems with certain Stryker LFIT V40 femoral heads manufactured prior to 2011. The letter explained that Stryker had received a higher than expected number of complaints involving taper lock failure of the recalled femoral heads.

In the letter, Stryker outlined the failure of the Stryker LFIT V40 femoral head and enumerated the reported problems associated with the device:

  • Dislocation of the femoral head from the hip stem
  • Hip stem fractures
  • Excessive metallic corrosion leading to cobalt and/ or chromium poisoning
  • Insufficient range of motion
  • Loss of implant/bone fixation strength
  • Excessive wear debris
  • Noise

Simultaneously, the Canadian public health agency issued a recall concerning the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert regarding the same devices.

The plaintiffs contend that Stryker knew for years that the LFIT V 40 femoral heads were defective and dangerous but instead chose to downplay the risk of using such device and failed to properly warn the hundreds of physicians implanting these devices

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Stryker Hip Settlement Extended to Cover 2014 to 2016

Stryker Rejuvenate Hip-Replacement-5US District Judge Donovan W. Frank in pretrial order No. 36 expanded a 2014 settlement program for US patients who underwent surgery to replace their metal-on-metal Stryker Rejuvenate Modular-Neck hip stem or their ABGII Modular-Neck hip stem up to Dec. 19, 2016.

The judge is overseeing 1,800 lawsuits in Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL 2441 in Minneapolis, MN.

“In order for this Court, the cooperating New Jersey Multicounty Litigation (Master Docket No. BER-L-936-13), and any other cooperating courts to manage this litigation, as well as to assist the parties to effectuate the provisions of the private Settlement Agreement, it is necessary to continue to identify and update all remaining, unresolved filed and unfiled claims,” the judge said.

No dollar value was placed on the expanded settlement. Stryker said it expects most payments to be made by the end of 2017. About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement.

$1 billion settlement

Stryker recalled the Rejuvenate and ABGII hips in 2012.  Plaintiffs allege that the metal-on-metal design of the hip joint components caused premature failure and resulted in metal debris causing pain, infection, tissue and bone death and difficult revision surgery.

The parties reached a $1 billion settlement in 2014. Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery,  dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization.

Plaintiffs’ lead counsel are Peter J. Flowers of Meyers & Flower in Chicago; Annesley H. DeGaris of the DeGaris Law Group in Birmingham, Ala.; Wendy Fleischman of Lieff, Cabraser, Heimann & Bernstein in New York; Ben W. Gordon Jr. of Levin Papantonio in Pensacola, Fla.; Eric Kennedy of Weisman, Kennedy & Berris in Cleveland; Genevieve M. Zimmerman of Meshbesher & Spence in Minneapolis; and Charles S. Zimmerman of Zimmerman Reed in Minneapolis.

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Stryker Expands $1 Billion Defective Hip Settlement to Hundreds of New Claimants

Stryker Rejuvenate Hip-Replacement-5Expanding a $1 billion settlement struck two years ago, Stryker Corp. and Howmedica Osteonics Corp. have agreed to compensate hundreds of additional claimants who had defective metal hips implanted and removed from Nov. 2014 to Dec. 19, 2016.

  • Stryker now faces 1,794 product liability cases consolidated into MDL 2441 before US District Judge Donovan W. Frank concerning its Rejuvenate and ABG II Hip Implant Products.
  • Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

$300,000 base settlement

Eligible claimants will receive a base award of $300,000 for each revised hip. Unrepresented claimants are eligible for 71% of the base award, or $213,000. Reductions will be made for obesity, smoking and age, according to the settlement. Settlements may be increased up to $550,000 under an enhanced benefit program, for re-revision surgery, related additional surgery,  dislocation of the femoral head of the hip, infections, inability to lift the front part of the foot, and pulmonary embolism or deep vein thrombosis during hospitalization,

The MDL Plaintiffs’ committee, chaired by Peter J. Flowers of Meyers & Flowers of Chicago, reached a new settlement agreement in ongoing litigation against Stryker and Howmedica over the defective Stryker Modular Rejuvenate and ABG II Femoral Hip Implants. This new settlement encompasses patients who had the hip replacement system implanted and then removed after November 2014.

About 20,000 people were implanted in the US with the Rejuvenate and ABG II hip replacement. The settlement, much like the historic, unlimited compensation fund of more than $1 billion in restitution established in late 2014, is once again an unlimited fund for this new set of plaintiffs injured by these metal-on-metal hip replacement devices.

The global settlement includes plaintiffs from across the U.S. who underwent painful revision surgeries since the fall of 2014 to remove the defective devices regardless of if they filed a case in state or federal court. Settlement payments are expected to be distributed starting in 2017.

“This settlement is the latest chapter in the ongoing litigation against Stryker and Howmedica for the extensive, at-times crippling injuries of our clients, many of whom have experienced life-altering pain and disabilities due to these hip devices,” said Flowers. “Our continuing and tireless negotiations bring a degree of relief to these clients as well as hope to future victims of defective devices.”

Victims step forward in 2010

Flowers has spent decades litigating cases against Stryker and similar device manufacturers for their defective medical products. In 2010, he began to hear from victims of hip replacement injuries that echoed past metal-on-metal friction cases he dealt with in the Depuy Orthopedics of Johnson & Johnson recall lawsuits.

Stryker issued recalls for its Modular Rejuvenate and ABG II Femoral Hip Implants in July 2012 when he was already representing many clients who had been injured by these devices, even while the company continued to sell them.

The Stryker hip replacement devices had four components: the femoral stem, modular neck, ball and an acetabular cup. Once implanted, the metal components began to wear causing friction and metal shards to release toxins into the bloodstream.

During a hip replacement, the device stem is implanted in the femur bone. When the device fails or needs to be removed, the femur bone often has to be fractured, resulting in mobility issues that can last for six to eight months as well as painful side effects and extensive periods of rehabilitation.

“The ripple effect that has been seen year after year from these defective hip replacement devices is truly outrageous,” said Flowers. “When medical device makers put profit before patient safety, we all suffer. There are devastating consequences to the victim, their family, and community as well as the overall economy and the government, which is why protecting these injured parties is so essential.”

 

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Stryker Must Pay $7.6M for Defective Knee Replacements

Unicompartmental knee prosthesis
Unicompartmental knee prosthesis

Stryker Corporation, notorious for its defective hip implants, must also pay a $7.6 million product liability settlement for its artificial knee joint called the Duracon Unicompartmental Knee (or “Uni-Knee”) according to the Sixth US Circuit Court of Appeals.

The ruling ended 15 years of litigation in which Stryker tried to get its excess liability insurance carrier, TIG Insurance Company, to pay for the settlement of 70 product-liability claims dating back to 2000. Stryker v. National Union Fire Insurance Company of Pittsburgh, PA and TIG Insurance Company, Nos. 15-1657/1664 (decided Nov. 18, 2016).

Stryker currently faces 1,772 product liability cases consolidated into MDL 2441 before US District Judge Donovan W. Frank concerning its Rejuvenate and ABG II Hip Implant Products.

Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

Defective knee replacements

There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)

  • More than 7 million people in the U.S. have had a knee or hip replacement surgery
  • Hip and knee devices account for more than 85% of the joint reconstruction and replacement market
  • Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices

In the late 1990s, Stryker purchased a subsidiary of Pfizer, Inc. that made and sold the Duracon Unicompartmental Knee, which turned out to be defective. They were sterilized using gamma rays, which caused ultra-high molecular-weight polyethylene in the artificial knees to degrade and, if implanted past their five-year shelf life, potentially fail. Due to an inventory oversight, a number of expired Uni-Knees were sold to hospitals and implanted in patients.

Two policies, effective during the year 2000, were relevant: a “commercial umbrella” policy, issued by XL, and an “excess liability” policy, issued by TIG. The umbrella policy covered any “batch” of losses that Stryker became “legally obligated to pay by reason of liability imposed by law or assumed by the [i]nsured . . . because of [b]odily [i]njury.” That policy was limited to $15 million, after a $2 million self-insured retention.

The TIG excess liability policy kicked in after the umbrella policy was fully “exhausted,” and extended to Stryker’s “ultimate net loss . . . in excess of all underlying insurance” up to $25 million.

XL covered Stryker’s losses, but did so in non-chronological order: XL paid out the larger Pfizer judgment first, exhausted the limits of its coverage, and left Stryker’s individual product-liability claims on the table.

No written consent

Stryker sued TIG in the Western District of Michigan in 2013, seeking to recover the remaining $7.6 million paid to settle its direct product-liability claims. TIG disputed its coverage obligation, raising a defense that was “unique to [its] policy.” Stryker, 681 F.3d at 825 & n.4. In TIG’s view, the direct Uni-Knee claims did not constitute “ultimate net loss” because Stryker failed to obtain “written consent” at the time the settlements were made.

Stryker claimed that the policy, as applied to the idiosyncratic facts of this case, was latently ambiguous: because XL satisfied the Pfizer judgment first (and exhausted its policy), Stryker was forced to present its direct settlements to TIG years after they were made. Relying on the testimony of TIG’s former claims adjusters and underwriters, Stryker argued that the excess-liability policy did not actually require “consent to the Uni-Knee settlements when they were made.”

The Sixth Circuit disagreed, saying “Because Stryker did not satisfy the consent requirement, its direct settlements cannot constitute ultimate net loss, and there is no coverage under the policy.”

 

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