BAYER Essure sterilization device: FAILED globally.

Bayer to phase out Essure birth control device in U.S.

Tina Bellon

NEW YORK (Reuters) - Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States, citing a decline in sales of the implantable device that made the business no longer sustainable.

The decision followed an announcement by the company in September 2017 that it would discontinue the sale of the contentious sterilization device in all countries outside the United States.

Bayer said in a statement that the decision was not related to safety concerns. The company, based in Leverkusen, Germany, is facing some 16,000 U.S. lawsuits over Essure, and it said it was expecting more.

“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research,” Bayer said.

It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers.

Essure will be gradually phased out and U.S. sales halted by the end of this year. Doctors will be able to perform Essure procedures until the end of next year when they will be asked to return unused devices.

FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure’s safety, and added, “We expect Bayer to meet its postmarket obligations concerning this device.”

Early in 2016, the FDA put its strongest safety warning label on the device after thousands of complaints and asked the drugmaker to conduct a post-market study.

The agency said it received nearly 12,000 reports in 2017 related to Essure.

Bayer said extensive research by the company and independent medical researchers showed Essure was safe.

Women have claimed in lawsuits that Essure, which is implanted in a woman’s fallopian tubes to permanently block the passage of eggs to the uterus, could pierce the tubes, and that metal parts of the device could become dislodged and migrate to other parts of the body, causing pain, injuries and severe bleeding.

They also claimed that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.

Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn sellers, doctors and regulators.

Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons.

Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.

The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and “inaccurate and misleading publicity about the device.”

Reporting by Tina Bellon; Editing by Clive McKeef, Toni Reinhold

Unethical Lawyers Exploiting Pelvic Surgical Mesh-Harmed Women

Exposing the underbelly of mass torts litigation

By Alison Frankel May 24, 2016 (FiDA Blog)

(Reuters) – On Monday, Harris County Judge Jeff Shadwick of Houston agreed to stay most discovery in a Vietnamese seafood industry worker’s fraud and conspiracy case against two noted Texas plaintiffs’ lawyers, Robert Hilliard of Hilliard Munoz Gonzales and John Cracken of the Cracken Law Firm.

That’s a shame. The worker, represented by the Tammy Tran Law Firm, alleges that Hilliard and Cracken secretly put up a combined $10 million to fund another Texas plaintiffs’ lawyer, Mikal Watts, when Watts hired investigators to drum up client leads after the 2010 BP Deepwater Horizon oil spill. Watts eventually brought claims against BP on behalf of about 40,000 seafood workers – almost all of whom turned out to be phantom clients. The workers either didn’t exist (one, famously, was actually a dog) or hadn’t authorized Watts’ firm to represent them.

Watts and several other people, including the investigators who supposedly fabricated his client list, have been indicted for attempting to defraud BP and the courts. They are scheduled for trial in July in federal court in Gulfport, Mississippi. Watts, who will be acting as his own defense counsel at the trial, has denied he or anyone else from his office knew their BP docket was a sham. “Generally, in mass tort cases, lawyers representing thousands of clients do not personally meet with, investigate and sign up the case of each individual client,” Watts and his former criminal defense lawyer said in a statement last October. “In the BP oil spill matter, the Watts firm clients were processed by an outside field team.”

The government’s indictment alleges that the outside field team was funded by two other lawyers who wanted a piece of the Watts docket. One invested $3.1 million, the other $7.8 million that was, in turn, supplied by a Texas businessman who regarded the BP litigation as an investment opportunity.

The indictment does not name the lawyers who funded Watts’ client expedition, but Tammy Tran, who represents workers who claim Watts misappropriated their identities, told me in March that she learned the lawyers’ identities from a criminal defense lawyer involved in the Watts prosecution. At the time, lead counsel for Hilliard and Cracken, Richard Mithoff of the Mithoff Law Firm, refused to confirm that his clients funded Watts.

It is now beyond dispute, though, that the two lawyers were somehow involved with Watts. Their motion to stay Tran’s civil suit discloses that Cracken and Hilliard will be called to testify this summer at Watts’ criminal trial. The stay motion uses the passive locution that the lawyers “have been notified” so it’s not clear whether Cracken and Hilliard will be witnesses for the government or for Watts at the Watts trial in Mississippi.

Cracken and Hilliard persuaded the judge in the Houston civil suit to delay most discovery until after he rules on a motion by Cracken and Hilliard to move the case to their home turf in Corpus Christi, Texas. For now, the Vietnamese workers who want to blame Cracken and Hilliard for supposedly enabling Watts’ misuse of their identities will have to wait to find out if evidence backs their accusations.

Why do I say that’s a shame? Because the civil case has the potential to expose the usually unseen mechanics of investing in mass tort litigation. At Watts’ criminal trial, the main event will be the extent to which he and his firm knew their docket was full of ghost claims. Cracken, Hilliard and their alleged investment in Watts’ BP claims will be, at most, a side issue.

But I’ve become increasingly convinced that mass tort litigation funding is profoundly influencing big personal injury cases. Look at the litigation over pelvic mesh, the biggest case – in terms of the raw number of plaintiffs – since asbestos. As my colleague Jessica Dye and I have been reporting for several months, the mesh litigation attracted all kinds of non-lawyer marketers, doctors and funders who saw an entrepreneurial opportunity in claims by women allegedly injured by the devices. Most recently, we reported that one mesh defendant is now claiming it has evidence of a sweeping conspiracy to lure women into needless surgery so that litigation funders could realize bigger returns when their cases settled.

And it’s not just humongous cases like the BP oil spill and the pelvic mesh litigation that have become investment vehicles. Take a look at an article that ran Tuesday in Investment News, discussing platforms for hedge funds and even individual investors to inject capital into personal injury suits. As plaintiffs’ lawyers themselves, Cracken and Hilliard were early to understand the potential upside from investing in Watts’ BP claims (assuming, of course, that they are indeed the unnamed lawyers in the BP indictment). But lots of non-lawyers have now seen the same light.

Maybe outside funding of personal injury claims is a good thing. The vast majority of people who are injured by, say, drugs and medical devices do not bring claims. Proponents of litigation funding argue that additional capital will enable more plaintiffs with legitimate injuries to become aware of litigation and find lawyers to prosecute their cases. Opponents say, of course, that outside money will lead to unfounded claims and further attenuate the relationship between lawyers and their clients. This is a hugely important discussion, especially with nearly 40 percent of all civil litigation in federal court taking place in multidistrict cases in which individual clients have little control over events.

The Houston litigation against Cracken and Hilliard might have added to our understanding of mass torts funding, but not without discovery. Too bad.

For more of my posts, please go to WestlawNext Practitioner Insights

Follow me on Twitter  @AlisonFrankel

http://blogs.reuters.com/alison-frankel/2016/05/24/exposing-the-underbelly-of-mass-torts-litigation/

Perverse Incentives: 10 Times More Likely To Need 'Revision' Surgery: Bayer Essure Study

Higher risk of surgery seen with Bayer Essure contraceptive -study

BY BILL BERKROT

Oct 13, 2015 

Women implanted with Bayer AG's Essure permanent contraception device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, a study published on Tuesday found.

The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as an alternative to surgical sterilization and acquired by Bayer in 2013. It has faced recent scrutiny from U.S. health regulators following numerous patient complaints and calls for its withdrawal from the market.

By one year after the initial procedure, 2.4 percent of Essure patients had required follow-up surgery compared with 0.2 percent of those who underwent the minimally-invasive tube tying procedure, laparoscopic sterilization, researchers found. That translates to about 21 additional surgeries per 1,000 patients receiving Essure, they said.

"Small risk in large numbers of patients translates into large numbers," said study leader Dr. Art Sedrakyan, professor of healthcare policy and research at Weill Cornell Medicine in New York.

"In some instances, these re-operations are quite major surgeries" including hysterectomies, he added.

The study, which analyzed coding data on medical records of some 52,000 women from outpatient ambulatory surgical centers in New York state between 2005 and 2013, was published in the British Medical Journal.

If the New York data were to be extrapolated to Essure use throughout the United States, you come up with about 150,000 patients getting this type of additional surgery, Sedrakyan said.

Both methods of contraception were equally effective, with about a 1 percent risk of unintended pregnancies.

Bayer, in a statement, defended the safety and efficacy of its device and cited limitations of the study, including that it was "based on a single database of one U.S. state" and unclear if it included patients who had Essure implantation in doctors' offices.

Bayer estimates there are about 750,000 women using Essure worldwide, about 70 percent of them in the United States.

Essure consists of two small nickel-titanium coils inserted into the fallopian tubes. Scar tissue forming around the device prevents pregnancy.

Personal injury lawsuits filed against Bayer have claimed the implant led to allergic reactions to nickel, severe pelvic pain, and surgeries to stabilize or remove the device after it shifted. More than 5,000 adverse events have been reported to the U.S. Food and Drug Administration, though it is not always clear what role Essure played in any event.

The FDA last month convened an advisory panel to mull the benefits and risks of Essure, and discuss whether it should face restrictions or label changes. The agency, calling it a high priority issue, said it will review the study findings, its panel's recommendations and public comments "to determine what future actions may be appropriate" regarding Essure. (Reporting by Bill Berkrot; Editing by Andrew Hay)

http://reut.rs/1La54Jv

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.

UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye

(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.

The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.

The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.

Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.

Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.

Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."

Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.

Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.

Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)

http://www.reuters.com/article/2015/03/05/johnson-johnson-mesh-verdict-idUSL1N0W728U20150305

Merck "settlement" is an affront to all!

Merck to pay $100 million in NuvaRingcontraceptive settlement

Fri Feb 7, 2014 11:53am EST

(Reuters) - Merck & Co said on Friday it will pay $100 million to resolve all U.S. product liability lawsuits alleging it downplayed serious health risks involving its NuvaRing intrauterine contraceptive device.

The product, which contains the hormones estrogen and progestin commonly found in birth control bills, is associated with an increased risk of developing blood clots that can cause heart attacks, strokes or sudden deaths. Available to women in the United States since 2001, NuvaRing is one of several contraceptive products linked to this higher risk.

Merck, the second-biggest U.S. drugmaker, denied any fault under the agreement, which must be accepted by 95 percent of about 3,800 eligible patients involved in lawsuits pending in federal and state courts.

A lawyer for the plaintiffs, Roger Denton of Schlichter, Bogard and Denton, said the settlement, reached after nearly a year of negotiations, is "an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of Nuvaring."

Under the settlement, Merck would pay a fraction of what at least one company has paid in a similar settlement.

German drugmaker Bayer AG said last year it had paid nearly $1.6 billion to settle thousands of lawsuits involving accusations that its Yaz and Yazmin birth control pills caused blood clots that led to strokes and heart attacks.

Merck shares were up 1 percent at $54.32 on the New York Stock Exchange, in line with a 1.2-percent advance in the ARCA Pharmaceutical Index of large U.S. and European drugmakers.

(Reporting by Ransdell Pierson; Additional reporting by Jessica Dye; Editing by Jeffrey Benkoe and Bernadette Baum)

meredithd wrote:

The article states “NuvaRing intrauterine contraceptive device”. NuvaRing is an intravaginal contraceptive device, not an intrauterine device.

Here's $200k! (Only requirement: live with pain of a faulty hip the rest of your life.)

Biomet reaches $56 million settlement over faultyhip replacements

Mon Feb 3, 2014 11:30pm EST

(Reuters) - U.S. medical device maker Biomet Inc will pay at least $56 million to settle a multi-district lawsuit relating to defective metal hip replacements, a court filing showed, ending a protracted legal tussle.

The litigation involves Biomet's metal-on-metal hip replacement device known as M2a Magnum. Hundreds of plaintiffs claimed in various courts across the country that the hip device led to injuries.

The lawsuits were combined and jointly heard at the federal court of Indiana, the state where Biomet is headquartered. The multi-district litigation began in 2012.

As part of the settlement, Biomet will deposit $50 million into an escrow account and another $6 million into an attorney fee fund, the filing showed.

The agreement with the plaintiffs shall extend to all pending cases, and any future lawsuit filed in a federal court on or before April 15, 2014.

Plaintiffs who have received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was rectified more than 180 days after it was implanted shall receive a base award of $200,000.

Biomet, however, maintains that the injuries, losses and damages were not due to its hip implants.

"Plaintiffs and Biomet are mindful of the uncertainties engendered by litigation and are desirous of settling and compromising their differences by entering into this settlement agreement," Judge Robert Miller wrote in his order.

Biomet said in a statement late on Monday that it is pleased to reach a settlement and resolve the lawsuits.

The case is Biomet M2A Magnum Hip Implant Products Liability Litigation (MDL 2391), Case No. 12-02391, U.S. District Court, Northern District of Indiana.

(Reporting by Sakthi Prasad in Bangalore; Editing by Supriya Kurane)

http://www.reuters.com/article/2014/02/04/us-biomet-settlement-idUSBREA1305Y20140204

Gender targeting by (sometimes criminal) medical device industry? Breast implants, birth control, transvaginal surgical mesh?

Maker of faulty French breast implants given fouryears in jail

BY JEAN-FRANCOIS ROSNOBLET AND ALEXANDRIA SAGE

MARSEILLE/PARIS Tue Dec 10, 2013 8:00am EST Reuters FiDA highlight

(Reuters) - The founder of a French breast implant company was sentenced to four years in prison on Tuesday for hiding the true nature of the sub-standard silicone used in implants sold to 300,000 women around the world.

Jean-Claude Mas, 74, founder and long-time chief executive of Poly Implant Prothese (PIP), was prosecuted after a worldwide panic in 2011 when France recommended that women with such implants should have them removed due to an abnormally high rupture rate.

Worries about the implants launched a flurry of international lawsuits and prompted calls for Europe to toughen controls on medical devices and fix its fractured oversight system.

Once the third-largest global supplier of breast implants, the company was shut in 2010 and its implants ordered off the market after inspectors pursuing a tip-off discovered vats of industrial-grade silicone outside the PIP factory in the southern town of La-Seyne-sur-Mer.

A Marseille criminal court also ordered Mas, who had been pursued for aggravated fraud, to pay a 75,000-euro ($103,000) fine. His lawyer, Yves Haddad, said he would appeal.

Four other executives, including the chief financial officer, were sentenced to between one-and-a-half and three years in prison, some of it suspended, and fined.

"It's a strong signal. This decision is what victims were waiting for," said one of their lawyers, Philippe Courtois.

The president of a PIP victims group, Alexandra Blachere, called it a "symbolic sentence" that challenged any prejudice that there was "a ditzy bimbo behind every pair of silicone breasts."

The two-month trial in April and May was held in an exhibition center to accommodate the 7,400 civil plaintiffs and 300 lawyers. Jeers from the crowd greeted Mas' appearance in the makeshift courtroom.

For less serious felonies in France, the criminal court hands down a sentence without pronouncing a guilty or not guilty verdict, which is implicit.

HIDDEN EVIDENCE

Mas admitted using silicone created by trial and error that was never approved by regulators and which cost a seventh of the price of silicone approved for use in medical devices.

He has insisted the gel he had relied on since the founding of the company in 1991 was non-toxic and has said women who complain about their PIP implants are "fragile people, or people who are doing it for the money."

A police investigation revealed a sophisticated fraud at PIP, which managed to conceal the implants' ingredients from regulators, thereby allowing them to be sold on international markets.

Before annual audits to the PIP factory by private certification company TUV Rheinland, employees would clear away evidence of the cheaper gel it used to fill implants.

For a special report on the PIP scandal, click here:

TUV sued PIP for fraud, but a French court ruled last month the German company had failed in its obligations of "vigilance and caution" and ordered it to pay 3,000 euros to each of the 1,600 plaintiffs, women wearing PIP implants who had sued.

Health experts insist that no link has been established between PIP implants and breast cancer.

Still, women around the world with PIP implants, whether in Venezuela, France or Britain, have rushed to their surgeons to have them removed, fearing health complications.

Since France recommended removal, some 14,729 women in France - nearly half of all French women with PIP implants - have chosen this option, according to French regulators.

Regulators say a quarter of PIP implants removed were found to be faulty, most having ruptured.

Only one case of anaplastic large cell lymphoma, a rare type of cancer originating in the lymphatic system, has been documented in France from a women wearing PIP implants.

National health agencies have given differing advice. While France and Venezuela offered to reimburse women who have their PIP implants removed, other countries, such as Britain, recommended that women merely have them checked.

Other legal cases related to PIP are still pending in France, including one related to the 2010 death of a woman wearing PIP implants. Another relates to tax fraud by Mas, his former girlfriend and Chief Executive Claude Couty.

(Writing By Alexandria Sage; Editing by Mark John and Ruth Pitchford)

Where are consumer protections? Not FDA!

http://mobile.reuters.com/article/idUSBRE8AK0T520121121?irpc=932

REUTERS

FDA took 684 days to warn meningitis-linkedfirm: files

Wed, Nov 21 14:28 PM EST   FiDA highlight

By Tim McLaughlin

BOSTON (Reuters) - The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents show.

The New England Compounding Center (NECC) chastised the FDA in a letter dated January 5, 2007, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released under an open records request.

"We believe that FDA's nearly two year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products," NECC co-owner and chief pharmacist Barry Cadden said in the letter, released by the FDA under an open records request.

The FDA acknowledged in a letter to Cadden dated October 31, 2008, that there had been a "significant delay" in its response but insisted that the delay "in no way diminishes our serious concerns about your firm's operations."

On Wednesday, a spokeswoman for the FDA, Erica Jefferson, said the delay in issuing the warning letter was due to the agency's limited, unclear and contested authority.

"During the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA," she said.

The FDA has asked lawmakers to clarify its authority to oversee large-scale drug compounders such as NECC. But several Republicans have argued that the agency already had the authority that could have prevented the outbreak.

And on November 19, a congressional panel investigating the outbreak told the FDA not to expect new authority until it releases documents about its role.

According to the Centers for Disease Control and Prevention, 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped a tainted steroid, methylprednisolone acetate, to medical facilities throughout the United States. The steroid is typically used to ease back pain.

On Tuesday, defense lawyers for NECC's owners told a U.S. District Judge in Boston there was nothing to show they had a direct hand in the cause of the meningitis outbreak.

INDIGNANT AND UNCOOPERATIVE

NECC has consistently pushed back against attempts by regulators to discipline it, despite a series of violations dating back to 1999.

And the pharmacy's principals have sometimes shown little respect for the FDA or its inspectors.

During a re-inspection of the pharmacy in 2004 following up on certain marketing and packaging violations, Cadden and his brother-in-law, Gregory Conigliaro, a co-owner of NECC, became indignant, according to a 2005 memorandum from the FDA inspector. Cadden declined to cooperate without speaking to a lawyer first and at one point instructed his brother-in-law not to answer any more questions.

Conigliaro said he had "a lot of things to finish and just did not have the time to sit with us to answer our questions," the inspector said in his memo.

The FDA's eventual warning letter to NECC in December 2006 was based on an inspection that began in September 2004 and ended on January 19, 2005, according to the documents.

(Reporting by Tim McLaughlin; Editing by Jeffrey Benkoe and Andre Grenon)

Insurance companies demand failed implant device reimbursements.

http://www.reuters.com/article/2012/10/08/us-devices-recall-idUSBRE8970E220121008

Analysis: When implanted medical devices go wrong, who pays?

By Debra Sherman

CHICAGO | Mon Oct 8, 2012 7:03am EDT

(Reuters) - Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.

Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.

Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.

"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.

Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.

In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.

Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.

He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.

WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.

Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.

Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.

"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.

The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.

FALLOUT OVER THE RIATA RECALL

A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.

Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.

The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.

The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.

A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.

Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.

Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.

"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.

"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.

St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.

"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.

TALLYING THE COSTS

Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.

Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.

The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.

The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.

"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.

(Editing by Michele Gershberg, Bernard Orr)

Reuters: Nearly $5B failed metal hip implants

http://reut.rs/NneL9r

Insight: As lawsuits climb, J&J may have new hip trauma

Thu, Jul 12 2012

By Debra Sherman  Reuters  (FiDA blog bold, highlight color)

CHICAGO (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.

A successor to ASR, the Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending in U.S. courts. Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years.

Metal-on-metal hip implants were sold on being more durable than those made of other materials, such as polyethylene or ceramic. They are meant to last up to 15 years, but as controversy over all metal-on-metal implants heats up, fewer surgeons are using them.

A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal implants before the U.S. Food and Drug Administration warned of potential problems. That number dropped to 10 percent since the FDA warning, and doctors say the number probably has dwindled further.

Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.

"We're simply seeing the tip of the iceberg with metal-on-metal failures," Dr Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, said of the entire class of metal-on-metal devices. O'Connor said she does not use metal-on-metal hip implants because she has been concerned about metal poisoning for years.

The new round of complaints represents a significant threat for J&J's DePuy Orthopedics unit, whose Pinnacle line includes non-metal models and covers a much wider range of products than ASR. The diversified healthcare giant, under new Chief Executive Alex Gorsky, has also just raised its bet on orthopedic products with the $20 billion purchase of device maker Synthes.

"Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance" than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. "We recalled it because it was not performing as it should."

She said DePuy is closely monitoring the performance of the Pinnacle metal-on-metal system, but is "very confident" in the product and will vigorously defend itself against lawsuits. DePuy did not make other executives available for comment.

DePuy and FDA officials said there is not sufficient evidence linking metal ions in the blood to health risks.

A total of 500,000 patients in the United States have received metal-on-metal hips, according to government data. Of those patients, an estimated 150,000 received the Pinnacle device, and 37,000 got the ASR implant. But while J&J has set aside $3 billion to settle the 3,000 ASR lawsuits, it is fighting complaints related to the Pinnacle device -- meaning that patients with virtually identical problems are facing different financial burdens.

Frances Grisham, 50, from Jackson, Tennessee, recently had surgery to repair a fracture to her left hip caused by the ASR implant. She was reimbursed for most of her out-of-pocket expenses and could be eligible for some of the settlement funds.

Harriett Bowen, 64, from Salisbury, Maryland, received the Pinnacle all-metal hip in 2008. She soon developed the same symptoms as Grisham: pain, limited mobility and elevated levels of cobalt and chromium in her blood. In July 2011, Bowen's left hip fractured at the implant site, requiring more surgery.

Bowen's doctor determined she had a cobalt and chromium count of 7 micrograms per liter (mcg/L), a level flagged by UK health authorities as worrying. "He said, 'Look, we've got to get this thing out of you.' It nearly scared me to death."

Unlike Grisham, she has received no compensation for the repair from J&J. Bowen is suing J&J.

"I have never done anything like this before, but considering what I went through for three years, I feel like I should be compensated," said Bowen.

PROBLEMS WITH ALL-METAL CITED ACROSS INDUSTRY

While other makers of total hip replacement systems -- including Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc -- face similar complaints, the numbers of devices involved is much smaller. The next most widely used product belongs to Biomet, which is defending itself against lawsuits over its metal-on-metal M2a Magnum Hip System.

Legal experts say J&J is taking a harder line defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices - known as revision surgery. It maintains the device performs better than other all-metal hip implants.

Paul Voorhorst, director of biostatistics and data management at DePuy, told an FDA advisory panel last month that the Pinnacle metal-on-metal device "is performing consistent with or better than other metal-on-metal products."

Should the Pinnacle lawsuits be found to have merit, J&J could end up paying nearly $5 billion to cover revision surgeries alone, according to plaintiff attorneys. DePuy revenue last year was $5.81 billion, or 9 percent of J&J's total.

Legal experts not involved in the cases say J&J probably is just taking its chances to see how the first few lawsuits play out - a common strategy for Big Pharma in major drug litigation cases. They say J&J may be aided in its defense by the lack of any U.S. program to track the performance of medical devices once they are implanted in people's bodies.

"The last thing plaintiff lawyers want is to go one by one (for each case). With so much unknown, proving cause and effect may be difficult," said Carl Tobias, Williams professor of law at the University of Richmond School of Law.

Cindy Schipani, professor of business law at the University of Michigan, said J&J could be playing with fire if the Pinnacle metal-on-metal devices are shown to be defective.

"They lose credibility if they keep saying they're not responsible and then it turns out the product is the problem," she said. "I question this strategy."

NO HARD DATA

While doctors can report problems about the Pinnacle to an FDA database, products with that name also include artificial hips that are not exclusively made of metal. One product is metal-on-polyethylene, the most popular of the Pinnacle devices, and another is metal-on-ceramic. A Reuters search of the database could not isolate adverse events reported for the all-metal Pinnacle, which is the least used of the Pinnacle products.

There is also no hard data yet on the Pinnacle's failure rate, partly because DePuy does not publicly disclose how many were implanted. DePuy's Voorhorst told the FDA advisory panel that 4 percent to 4.5 percent of these Pinnacle implants require a second surgery to fix the devices within five years after implantation, which is in line with other hip devices.

Felecia Stern, an attorney with Bernstein Liebhard LLP, represents Bowen, Grisham and many other patients who received the ASR and Pinnacle all-metal devices. She noted that the recall of 93,000 ASR implants in 2010 led doctors to notify patients and monitor for high metal levels. But problems with the Pinnacle are being reported less systematically since the devices weren't pulled from the market.

"At the end of the day we will see a similar occurrence of high metal levels in Pinnacle metal-on-metal recipients as more and more of them get their blood tested. That is certainly what we are seeing in our client population," she said.

Her firm also serves on the Plaintiffs Steering Committee for the federal Pinnacle lawsuits, which have been consolidated into a multi-district litigation in Texas.

The FDA has been monitoring problems with all-metal hip implants and convened the panel of outside advisers last month to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

In May 2011, the agency ordered device makers to conduct follow-up studies in cases in which an implant's failure could have serious consequences. Companies would be expected to take blood samples from patients to measure metal ion levels. But more than a year later, the FDA and device manufacturers agreed on study protocols for less than one quarter of the devices. Most of the study plans, including DePuy's, have not been finalized.

"We need more data to better understand how these devices perform," FDA spokeswoman Michelle Bolek said. "We are open to a more collaborative effort, if it helps us get the data we need."

MINIMIZING RISK

The final failure rate for the ASR device has not yet been established, but a study released last March by the British Orthopaedic Association and the British Hip Society indicated a failure rate of up to 49 percent after six years - nearly four times the rate cited by DePuy when it recalled the device.

Dr David Langton is an orthopedist who has studied all-metal implants for years and supplied the two British organizations with data. He said he expects the ASR failure rate to rise to 80 percent at eight years. Based on a cohort of about 1,000 patients he is tracking at North Tees Hospital in the UK, the Pinnacle metal-on-metal hip has a failure rate of 8 percent at five years. He said that rate climbs to 16 percent after 6-1/2 years.

About 150,000 Pinnacle metal-on-metal devices are estimated to be implanted in patients outside the United States.

Several differences between the ASR and Pinnacle metal-on-metal could explain a lower failure rate.

One main reason is that the Pinnacle has a smaller head; larger heads are associated with higher failure rates because there is more friction.

Langton believes it is just be a matter of time before Pinnacle all-metal device failure rates climb, as more metal debris from the implant are released into the bloodstream and tissue. And while the failure rate might be lower than ASR, the absolute number of patients is higher.

"We believe the (Pinnacle) failure rate will be far above 10 percent," said attorney Brian Devine of Seeger Salvas LLP, which is handling both ASR and Pinnacle cases.

That would translate into second replacement surgery for 15,000 patients, he said. In 2002, Sulzer Medica AG paid an average of $250,000 per revision on its 2001 recall of its InterOp hip. Adjusting for inflation, an average J&J settlement could be $319,000 per revision, or $4.785 billion in total, he said.

Mayo Clinic's O'Connor is worried that the entry of metal ions into the bloodstream will damage internal organs, not just the surrounding tissues in the hip socket. There are also concerns high ion levels cause cancer, though that has not been proven.

"Autopsy studies of patients with metal-on-metal implants showed metal ions were everywhere the body - in the liver, the spleen, all over the place," O'Connor said.

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)