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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C. R. Bard, Inc., Hit With Multimillion Dollar IVC Filter Jury Verdict in Arizona Federal Court

Plaintiff Wins the First Bellwether Trial in Bard IVC Filters Products Liability Litigation MDL 2641

By Mark A. York (March 30, 2018)

Bard G2 Inferior Vena Cava Filter

 

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  A Phoenix federal jury awarded $2 million in compensatory damages on Friday to plaintiff Sherr-Una Booker, in the first bellwether trial against IVC filter maker Bard, Inc. and affiliate company Bard Peripheral Vascular, Inc. finding that the clot-stopping vein filter known as a G2 model IVC filter, (an Inferior Vena Cava filter) manufactured by Bard broke apart in her body, and returned a verdict citing that the device maker was responsible for 80 percent of the harm. They also said that Bard is liable for punitive damages in addition to the $2 million in actual damages award, with the hearing on punitive damages taking place right after the initial verdict announcement.

The punitive damages phase of the first bellwether over the IVC device began immediately after the early Friday verdict in the Sherr-Una Booker v. C.R. Bard, Inc et al, Case No. 16-CV-0474-PHX-DCG litigation, US District Court of Arizona in front of Judge David G. Campbell.  The Booker trial is the first “bellwether trial” in the more than 3,500 other IVC filter lawsuits pending in the Bard IVC Filters Litigation MDL 2641, before Judge Campbell. The verdict came fairly quickly after just six-and-a-half hours of deliberations that started Thursday. The jury said Bard was not liable for strict liability, which will probably be appealed by Ms. Bookers counsel. We will update this article with the results of the punitive damage hearing as soon as they become available.

BARD IVC FILTER PROBLEMS

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of over 3,500 injury claims in the Bard IVC Filters Products Liability Litigation MDL 2641 currently pending before the court in the District of Arizona. The thousands of lawsuits  filed against the two Bard companies claim they concealed dangerous side effects associated with their retrievable IVC filters – including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures – and failed to warn doctors and patients about these risks. In addition to the Bard MDL 2641 cases, there is other litigation against smaller IVC manufacturers, Cordis Corporation Rex Medical, Argon Medical, and B. Braun who are all facing  IVC lawsuits in state and federal courts across the country.

BARD FAILURE TO WARN

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

Additional research has shown in the last 30 years an estimated 30,000 IVC filters have been implanted. But it wasn’t until 2010, after they’d received thousands of adverse event reports, that the FDA finally issued a warning citing the risk of retrievable filter injuries. It took another four years for the FDA to strengthen the warning when in 2014 they implored doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.

BARD KNEW OF DANGERS

In 2015 after the FDA issued the second IVC warning, a bombshell media report claimed C.R. Bard continued to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death. The report went on to link at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters. The investigative report also uncovered that IVC devices made by C.R. Bard and Cook Medical had been linked to hundreds of adverse event reports where they punctured the vena cava, tilted out of position or migrated or broke apart and caused metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.

With 3,500 additional cases remaining the the Bard IVC Filter litigation docket, it seems that the Bard entities may need to prepare for a long and protracted legal fight, unless they determine settlement discussions are the best legal strategy to prevent future plaintiff wins.

 

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WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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3,700 IVC Filter Lawsuits Filed Against Bard and Cook Medical

Bard G2 Express IVC Filter
Bard G2 Express IVC Filter

Cook Medical, Inc. and C.R. Bard, Inc. continue to face mounting lawsuits over their retrievable IVC filters, with 3,769 cases filed against the companies in two federal MDLs.

Cook Medical is a defendant in at least 1,918 product liability claims involving its Gunther Tulip and Celect IVC filter blood clot filters. IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation is pending before US District Chief Judge Richard L. Young in MDL 2570 in the Southern District of Indiana.

In March 2017, Judge Young ordered both sides to appear at three hearings with a proposed settlement framework.

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of 1,851 injury claims. IN RE: Bard IVC Filters Products Liability Litigation is pending before US District Judge David G. Campbell in MDL 2641 in the District of Arizona.

On March 21, 2017, Judge Campbell appointed the Plaintiffs’ Co-Lead/Liaison Counsel and State/Federal Liaison Counsel:

  • Ramon R. Lopez, Lopez McHugh, LLP, Newport Beach, CA.
  • Mark S. O’Connor, Gallagher & Kennedy, PA, Phoenix, AZ.

Failure to Warn

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

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Australian Survey Finds that 58% were Injured by Pelvic Mesh Implant

HIC CEO, Danny Vadasz
HIC CEO, Danny Vadasz says “This is a significant public health problem which has been grossly underestimated — in terms of numbers of women as well as the severity of resultant health problems.”

Problems caused by transvaginal mesh have been grossly under-estimated, according to a new survey by an Australian Health Issue Center.

  • Of these, a shocking 58% say they have been adversely impacted, citing problems such as chronic incontinence, abdominal pain, and pain during intercourse. Sadly, for a quarter of these women, the impact of the implants has led to a breakdown of their marriages or personal relationships.
  • Just 38% of the respondents believe they made an informed choice to have the procedure.
  • Of the women who sought remedial medical help, slightly over 10% reported this made things better while 40% reported it made no difference and 11%, that it made matters worse.
  • The remaining 39% were told that nothing could be done for them.

In just three weeks, 1,250 women completed the online Facebook survey targeting the thousands of women nationwide who have undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse.

In the US, there are 80,000 lawsuits against the manufacturers or transvaginal mesh in eight MDLS:

A catastrophic failure

Commenting on the overwhelming response to the survey, HIC CEO, Danny Vadasz, says he has no idea ‘how much of the iceberg has been revealed’ so far but believes there could be considerably more given that HIC is currently averaging over 100 survey responses per day.

“Even if we were to receive no further responses, I think we have already demonstrated that this is a significant public health problem which has been grossly under-estimated — in terms of numbers of women as well as the severity of resultant health problems.

HIC is a not for profit consumer health advocate based in Victoria, Australia, which encourages better health outcomes by encouraging consumers to become involved in their own health care and ensuring the health system is responsive to their needs.

“What we are seeing is a catastrophic failure at all levels of the health system to protect the well-being of thousands of women – the lack of due diligence by the TGA in approving the device given the risks; culpability of manufacturers who despite plenty of evidence of adverse reactions overseas, continue marketing their products; the government which does not have a central register of how many procedures have occurred and how many products have been sold and finally, those surgeons who continue to practise the procedure without informing their patients of the risks and the irreversibility of the implant.

“Clearly a lot of questions need to be asked!”

Vadasz says while transvaginal mesh has been seen by the medical fraternity as having ‘revolutionised’ surgical options for women with stress urinary incontinence and pelvic organ prolapse, the collateral damage for women when it goes wrong, is just too high. “We are calling for the classification of mesh to treat either of the conditions to be upgraded to a higher risk status so the patient consent process reflects the consequences when there are complications.”

Unaware that mesh caused injuries

Despite the number of women coming forward, Vadasz believes that the problem will continue to go underreported given that many women do not associate their symptoms with their mesh implants. On top of this, many have been told by doctors there is no causal relationship.

“This has been borne out by the significant number of survey respondents who told us they were unaware that the pain and problems they had suffered for many years could be linked to their mesh implant. Some have cried at the realization with one woman declaring, ‘Now I know I’m not crazy’.”

Here are some of the more harrowing comments on the HIC Facebook page:

“My specialist told me it was all in my head. He got angry with me and said: “I suggest you stop focussing on the vagina, and get on with your life” in a dismissive and irritated tone. Doctors I have seen since have not been forthcoming on what they can see, it is like they are trying to protect the medical fraternity by not telling me fully what is going on or helping me fine treatment.”

“I was told the mesh cannot be removed. I had complications from the moment I came out of theater. I needed a complete reconstruction but was refused and offered the TVT as part of a study or to put up with consequences of a grossly oversized baby that was a face presentation and a complete episiotomy after he became stuck. I now suffer urge incontinence and a partial vaginal prolapse. I wish I’d never had the TVT done!”

 Vadasz is calling on women who have had an implant (or believe they may have) to complete the HIC survey: https://www.facebook.com/pg/UnderstandingPelvicMesh/about/

About the survey

The Health Issues Centre is one of several organizations invited to give input into the senate inquiry into the extent and impact of Transvaginal Mesh Implants (TVM) across Australia. Currently there is little information about the number of women who have undertaken the procedure and less about those who have suffered from side-effects. In order to understand the size of the problem and gain insight into the impact on these women, the consumer health advocacy conducted a highly targeted nationwide survey.

Using the center’s Facebook page to create interest and an online survey, the survey targeted 14,000 women nationally. The questions are as follows:

·       Have you undergone a transvaginal mesh, tape or sling implant as treatment for urinary incontinence or pelvic organ prolapse?

·       Do you continue to have undiagnosed symptoms of chronic abdominal pain or urinary incontinence?

·       Do you feel you were fully informed before agreeing to the procedure?

·       Did the procedure satisfactorily resolve your health concerns?

·       Could you specify any adverse impacts you may have experienced?

·       How would you rate this adverse impact – discomforting, severe, debilitating, unendurable, none of these.

·       Have you sought medical assistance to rectify the problem?

·       Did your doctor/specialist confirm a causal relationship between your symptoms and the mesh implant?

·       If you were offered remedial treatment, did it change your condition?

While launched only three weeks ago, 20,000 have engaged with the survey and 1,250 surveys have been completed. Over 14,000 people have viewed the Facebook video.

 

 

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Bard Seeks Summary Judgment in IVC Filter MDL with Novel Preemption Argument

Bard IVC filter
IVC filters cause injuries from migration downward and upward. The IVC Filters can also tilt or shift, making them almost impossible to remove.

In a gambit to dismiss 1,700 lawsuits against its IVC filter, CR Bard is pressing a novel argument that the FDA’s quickie 510(k) approval process has become more rigorous, thus entitling it to a ruling that the plaintiffs’ state-law claims are preempted by federal law.

The argument is a stretch because courts have often declined to hold claims preempted where medical devices were cleared under the shortcut 510(k) process, as opposed to the more rigorous premarket approval (PMA) process.

All of Bard’s IVC filters involved in MDL 2641 – the Recovery, G2, G2, Express, G2 X, EclipseTM, Meridian, and Denali Filters — got approval via the lenient 510(k) process. The case is IN RE: Bard IVC Filters Products Liability Litigation, Case No. 2:15-MD-02641-DGC before US District Judge David G. Campbell in Arizona.

Changed greatly?

Bard argues in its summary judgment motion that the plaintiff’s master long and short form complaints, asserting state-law claims, are expressly and impliedly preempted by federal law.

FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

“The 510(k) program has changed greatly since Lohr (Medtronic v. Lohr, 518 U.S. 470 (1996),” Bard argues. “In 1990, Congress dramatically altered the 510(k) process in section 12 of the SMDA (Safe Medical Devices Act). The language expressly linked FDA substantial findings to “safety” and “efficacy”/”effectiveness”:

[T]he term “substantially equivalent” or “substantial equivalence” means . . . that the device . . . (ii)(1) has different technological characteristics and the information submitted . . . contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device.

Bard says that in its 510(k) approvals:

  • The FDA required compliance with special controls.
  • FDA required Bard to conduct clinical studies of its filters.
  • FDA required additional testing, labeling, and other information during its review.

“These device-specific guidances are intended to address specific risks or issues related to specific devices or device types, and where, as here, FDA has required manufacturers to follow them, they become device-specific federal requirements entitled to preemptive effect,” Bard asserts.

Bard quotes an FDA  2010 Working Report, saying that “the 510(k) program has changed significantly since its inception…. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.”

Similar argument failed

A similar argument failed in a motion for summary judgment by Janssen in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. In that case, US District Judge Eldon Fallon ruled:

“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.

The judge added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”

Plaintiffs argue that IVC filters cause injuries as follows:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

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Federal Court to Select Pool of Bellwether Cases in Bair Hugger MDL

bair-hugger-infectionUS District Judge Joan N. Ericksen said she will randomly select 150 cases for bellwether trials from the 809 actions filed in In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666 in Minnesota.

Pretrial Order No. 15, issued on November 16, states that the cases will be designated on Dec. 23 from those that were filed in, removed to, or transferred to MDL No. 15-2666 (JNE/FLN) on or before Dec. 19, 2016.

After the parties submit relevant characteristics or categories to be considered, they will each select 16 cases from the pool of 150 for consideration for bellwether trials. Cases can be drawn from those filed in Ramsey County, Minnesota state court.

Deep joint infections

Bellwether nominations must be made by Jan. 20, 2017. Between then are March 1, 2017 the parties may conduct case-specific discovery, including collecting records from third parties. By March 1 the court will select up to eight of the Bair Hugger lawsuits for the final trial pool, with the first trial commencing on Nov. 6.

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. During an operation, a portable heater/blower takes in and warms ambient air, which is then gently forced through a flexible plastic hose into a single-use, disposable blanket.

Plaintiffs include patients who developed hip and knee infections following joint replacement surgery that involved use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

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More than 1,000 Product Liability Lawsuits Filed Against Bard Meridian IVC Filter

Virginia Bard Meridian IVC Filter LawsuitMore than 1,000 actions have been filed against C.R. Bard, Inc. about its defective Meridian IVC Filter in litigation consolidated in Arizona federal court before US District Judge David G. Campbell.  The C.R. Bard IVC Filter Litigation MDL 2641 was created on August 17, 2015.

The latest case is filed by Aleasia J. P., a woman from Virginia who was implanted with the C.R. Bard Meridian® Vena Cava Filter on October 12, 2012 at a hospital in Virginia. The action was filed on November 8, 2016 in the U.S. District Court for the District of Arizona, Case No. 2:16-cv-03871.

Knew device was defective

Bard no longer manufactures or sells the Meridian in the United States. Product liability and injury lawsuits filed against Bard, Cordis and other retrievable IVC filter makers allege that these companies knew or should have known that the devices were defective because:

  • The defendants failed to conduct proper testing, including human clinical testing, to determine how the devices actually functioned in the body.
  • Published medical studies have found many complications including fracture, device migration, perforation of the vena cava wall, organ penetration, and increased risk for venous thrombosis.
  • The defendants misrepresented the risks with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.

Meridian is a temporary filter that consists of 12 needle-like legs arranged in a cone-shape around a central hook. It is implanted in a major blood vessel called the inferior vena cava (IVC) to catch blood clots and prevent pulmonary embolisms

Meridian was approved by the FDA in 2011 with a 510(k) application, which means it did not go through clinical trials because it was “equivalent” to several other IVC filters made by C.R. Bard. Unfortunately, these other filters have been linked to serious risks.

Meridian is similar to the Recovery, which was introduced in 2003 and withdrawn in the market in 2005. In 2012, a study of 363 patients estimated that 40% would fracture within 5.5 years. See Class Action Charges Company Lied to Cover Up Defective Bard IVC Filter

Meridian is also very similar to the G2, which C.R. Bard introduced in 2005 to replace the Recovery. In June 2014, a study of 829 patients implanted with the G2 estimated that 38% would fracture within 5 years, with the risk increasing over time.

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New Research: IVC Filters Don’t Save Lives in Trauma Patients

Bard Denali IVC Filter
Bard Denali IVC Filter

New research in JAMA Surgery concludes that IVC filters don’t save lives in trauma patients, who are at increased risk of bleeding and thrombosis, and the devices should not be placed in trauma patients in an effort to decrease all-cause mortality.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis. The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the study concludes.

See Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality by Shayna Sarosiek, MD, Denis Rybin, PhD, Janice Weinberg, ScD, Peter A. Burke, MD, George Kasotakis, MD, and J. Mark Sloan, MD.

Should not be placed in trauma patients

“The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place,” the researchers said. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

“Overall, these data indicate that IVC filters should not be placed in trauma patients in an effort to decrease all-cause mortality.”

Litigation against the makers of IVC filters is one of the largest mass torts today. “All these products are defective,” Mass Tort Consultant John Ray said, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

  • There are 886 cases in Bard IVC Filter Litigation in MDL 2641 before Judge David G. Campbell in US District Court in Arizona.
  • There are 993 cases in Cook Medical IVC Filter Litigation in MDL 2570 before Chief Judge Richard L. Young in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark.
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

Venous thromboembolism is a significant cause of death in the United States. Approximately 900,000 patients per year have a clinically significant deep vein thrombosis or pulmonary embolism. Since the invention of the permanent percutaneous IVC filter in 1973 and the retrievable IVC filter in the 1990s, its use has become a standard part of treatment for select patients with acute lower-extremity venous thrombosis who cannot receive anticoagulation.

 

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Bard Can Look Into Plaintiffs’ Communications With FDA Regarding IVC Filters

Bard Denali IVC Filter
Bard Denali IVC Filter

US District Judge David G. Campbell overseeing the C.R. Bard IVC filter multidistrict litigation ruled on Sept. 6 that the company can conduct discovery into the plaintiffs’ alleged efforts to influence the Food and Drug Administration.

But the company cannot inquire into the plaintiffs’ communications with NBC Nightly News or third-party litigation funding. The case is In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641 in Arizona.

Bard said in its motion that it wants to discover any role plaintiffs or their counsel had with the FDA that may have biased the agency, that may reflect improper motivation for the letters and that signals that the letters lack “trustworthiness” for admissibility.

Bard also said five NBC Nightly News stories about Bard’s IVC filters have become the “focal point” for the plaintiffs and they have interviewed Bard witnesses after their appearance in the stories. Bard said the plaintiffs’ communications with NBC could have biased the stories and are thus relevant to Bard’s defense.

No Work Product Protection

Judge Campbell ordered the plaintiffs to respond to interrogatories about their contact with the FDA. He said the requests are relevant to the defense and “proportional to the needs of the case.”

“Plaintiffs have placed and will continue to place much emphasis on the FDA letters, and information regarding Plaintiffs’ role in securing those letters or otherwise influencing the FDA’s actions is plainly relevant to the defense,” the judge wrote.

The plaintiffs argued that the FDA information would be hearsay, but the judge said “information need not be admissible in evidence to be discoverable under Federal Rule of Civil Procedure 26(b)(1).”

“Plaintiffs claim that their communications with the FDA are protected work product because they reveal mental impressions and strategies of counsel, but courts have widely held that communications with government regulators that might prompt government action that could prove beneficial in private litigation waive any work product protection,” the judge said.

As to discovery into the NBC stories, Judge Campbell denied the motion because the plaintiffs assured the court that the stories will not be used at trial.

There are 810 cases in the MDL.

For recent news developments, read:

Proof! C. R. Bard, Inc. has been Settling IVC Filter Cases

IVC Filter Cases Settling Quietly as Litigation Grows

 

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