According to a report from Newsinferno, Medtronic aggressively attempted to contain proof that Infuse (rhBMP-2)—specifically when used in unapproved medical procedures—is the culprit in numerous health issues, including cancer. It seems that prior to its approval in 2002, Medtronic paid surgeons very generously to provide research pointing to the product’s safety and, when research indicated that Infuse was linked to complications, Medtronic suppressed that research.

Although what had long been believed to be medically sound research indicating that Infuse was an effective bone growth product, was, in reality, not. Infuse has proven anything but safe and concern is high among surgeons not paid by Medtronic, that Infuse is, in truth, dangerous. The U.S. Food and Drug Administration (FDA), to date, has received at least 280 reports of serious complications linked to Infuse and lawsuits against Medtronic accuse the company of its dangers. The lawsuits allege Infuse has the potetial to cause serious complications, including unwanted bone growth, cancer, and sterility in male patients.

Medtronic has also been accused of pushing Infuse for off-label procedure like neck surgeries, which would be illegal. Patients who undewent such procedures sometimes suffered severe neck and throat swelling, breathing and speaking problems, and airway compression. In 2008, a growing number of such reports prompted the FDA to issue a warning about off-lable use of Infuse.

This past November, Infuse became mired in even more controversy after Standford University spine researcher, Dr. Eugene Carragee, presented a study at the North American Spine Society that raised serious questions about a possible association between rhBMP-2 and an increased risk of cancer. According to Carragee, his analysis of a Medtronic study for its Amplify product, a higher-dose version of Infuse, found that the researches failed to identify a significant cancer risk. While the FDA ultimately refused to approve Infuse, Carregee said his findings have important implications for Infuse, as doctors often administer Infuse off-label at doses equal to or higher than what is found in Amplify.

With Infuse sales dropping due to the controversies, Medtronic commissioned researchers Yale University to independently review Infuse data, said Med City News. And, while outcomes are highly anticipated by Omar Ishrak, Medtronic CEO, in the hopes he will see vindication for his controversial blockbuster product, at least one research analyst does not see increased sales in Infuse’s future, even if Yale reviewers deem it safe.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they go back to it, I don’t think so,” said Caroline Corner, an analyst with investment bank MLV & Co. who does not cover Medtronic, wrote Med City News.

Corner holds a PhD in biological and environmental engineering from Cornell University. According to Comer, talks with leading spine surgeons nationwide indicate that Infuse may continue to be used, but in a lesser capacity, for instance, in older people whose risk for cancer is decreased as well as hard-to-treat patients, according to Med City News.

“Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Corner said. “But doctors, in general, are definitely shying away from using Infuse (most of the time),” which increases opportunities for an alternative to Infuse, said Comer, wrote Med City News.

Rescue efforts have been halted over dangerous conditions inside the ship, while at least 16 people remain missing and are now presumed dead. Among them are a five-year-old girl from Italy and her father, said The Telegraph, and a couple from the United States.

Lawsuits are being filed and more are expected. For instance, NewsInferno recently wrote that the Italian consumer group, Codacons, was signing Concordia passengers for a class action lawsuit it planned to file. Now, said Bloomberg Businessweek, Carnival Cruise lines has been sued in a complaint that named six plaintiffs—four Americans and two Italians that was filed in Miami state court. Miami-based Carnival and Hollywood-based Costa Cruise Line are named as defendants.

Costa Concordia crew member Gary Lobaton, filed a complaint last week in federal court in Chicago saying in the complaint, “The defendants failed to properly and timely notify all plaintiffs on board of the deadly and dangerous condition of the cruise ship as to avoid injury and death.’ Passengers and crew “were abandoned by the captain,” he added.

According to the state complaint, plaintiffs were “in terror of catastrophic injury, death, drowning, having been placed in a situation where common sense said the vessel was sinking but the orders from the crew were to return to their cabins.”

Plaintiffs seek $460 million (£292 million) in damages and compensation and rejected the original offer as “insulting,” said The Telegraph.

Last week,Costa did offer T14,460 (11,000 Euros) to passengers not injured in the disaster to cover lost baggage and psychological distress,. One Italian consumer group deemed the Costa Concordia offer insufficient, and urged passengers to reject it; however, should survivors choose to accept the offer, they must agree to drop all future litigation.

The luxury liner struck a rock off the Italy’s Giglio Island, which left a 160-foot gash in the hull, causing the vessel to capsize. The ship, which is owned by Costa Crociera SpA, a subsidiary of Miami-based Carnival Corp., was carrying 4,200 passengers and crew when the accident occurred.

Moody’s Investors Service said, on January 23rd, that the accident’s insurance cost may go as high as $1 billion once environmental damage and injuries are taken into consideration, with the bulk of the losses being incurred by reinsurers, said Businessweek. Jefferies international Ltd. separately figured the total cost at $850 million. Assicurazioni Generali SpA, RSA Insurance Group Plc, and XL Group Plc were among the Costa Concordia’s insurers.

The ship’s captain, Francesco Schettino, remains under house arrest and faces charges of shipwreck, manslaughter, and abandoning ship.

According to research, said The Telegraph, medical regulators in the U.K. issued new advice for the more than 40,000 Britons implanted with the devices amid concerns that metal-on-metal devices are more dangerous than first believed.

Adverse reaction reports and research reveal that when the metal components of, say a hip device, experience normal friction—the type typically found when the device’s metal ball and its metal cup connect during activities such as walking—metal shards can break off and travel throughout the body, affecting blood levels, causing inflammation, and damaging muscle and bones.

As NewsInferno explained, Britain’s health regulators are particularly worried about Johnson & Johnson’s DePuy unit’s ASR hip implants and other all-metal devices and their likelihood of creating more damage than first believed. For instance, noted NewsInferno, the device could elevate blood cobalt and chromium levels, which could lead to toxicity in the kidneys, and can be passed from pregnant women to their unborn babies. The Telegraph also pointed out that the fragments could pose risks to the nervous system, the heart, and the lungs, due to long-term poisoning.

Although problems with the devices affect people in all age ranges, research has found that younger and more petite women are at greater risk, said The Telegraph. Regardless, all patients implanted with all metal devices are advised to undergo annual testing, including scans and blood tests to ensure they are not suffering from the effects of metal leakage. And, now, the U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) advisors seeking more stringent advice over concerns the devices could cause “systemic toxicity” in the body, said The Telegraph.

Emerging research reveals that some hip replacements previously withdrawn from the U.K. market have much greater failure rates that previously released—up to 50 percent within six years, said The Telegraph. And, a conference of senior surgeons described the metal-on-metal implant situation as “frightening,” citing the growing number of patients suffering from tissue reactions and “component failure of catastrophic proportions,” said The Telegraph.

Metal-on-metal implants were introduced in the U.K. in the 1990s and, today, of the 40,000 U.K. patients who received implants, 10,000 were implanted with two types of DePuy devices taken off the market in 2010 over significantly high and unexpected 12-13 percent failure rates in the first five years of receiving the devices. That figure has grown, according to the Sunday Telegraph, which has reported failure rates of up to 50 percent in the first six years for patients who underwent full hip replacement.

Friday, January 13, the Costa Concordia luxury liner struck the rocks off the Italian island of Giglio, tearing a 160-foot gash in its hull and causing the vessel to capsize. The Costa Concordia, owned by the Italian company Costa Crociere SpA, a subsidiary of Miami-based Carnival Corporation, was carrying 4,200 passengers and crew at the time of the crash that left 16 dead and at least 22 passengers and crew missing, including an American couple.

The ship’s captain, Francesco Schettino, remains under house arrest and has been accused of causing the wreck, manslaughter, and abandoning ship. Schettino allegedly detoured from the planned route to navigate closer to the island.

Now, unharmed passengers are being offered $14,460 apiece as compensation, said MSNBC. Compensation will also include the full cost of the cruise, travel expenses, and medical expenses incurred after the ship ran aground. The announcement followed negotiations between representatives from Costa Concordia and Italian consumer groups representing 3,206 people from 61 countries who suffered no physical harm in the crash, noted MSNBC.

The offer also followed announcement of the first of what is expected to be many United States lawsuit filings that seek class action status in the matter, said MSNBC, which noted that passengers and crew are free to pursue legal action if they are unsatisfied with the liner’s announced deal. In addition to seeking class action status, the lawsuit seeks to determine if the liner’s owner, Carnival, departed from established international safety standards for operating a cruise ship, said MSNBC.

Testimony presented by Costa Crociere to the Italian Senate revealed that it was aware—within minutes and, shockingly, more than one hour before the 4,200 passengers were told to evacuate—that the ship was flooding as a result of a crash off the Tuscan coast, wrote The Wall Street Journal. The testimony delivered by Pier Luigi Foschi, chief executive of Costa Crociere was, said The Journal, the first time the company publicly acknowledged that Captain Francesco Schettino had been keeping the company advised on crisis events.

On January 13, the Costa Concordia struck a rock off Tuscany’s Giglio Island, said NewsInferno. The crash tore a 160-foot gash in its hull, capsizing the vessel, and has left at least 16 people dead; 19 remain missing.

A Costa Crociere spokesman declined to comment on the matter to the Journal and Foschi has never said if the Costa Crociere’s head of marine operations, Roberto Ferrarini, tried to reach the Coast Guard. “Either one of them should have called the Coast Guard,” said Bill Doherty, an experienced shipmaster with Nexus, a maritime-safety consultancy, wrote The Journal. When a ship collides with rock, the standard operating procedure for ship commanders is to immediately advise the coast guard, alert other ships in the area, and ensure passengers are positioned for evacuation, Doherty told The Journal.

It seems, noted The Journal, that Foschi’s testimony was based on a memo that Ferrarini wrote. Ferrarini “fielded” at least six calls from Schettino during the 73 minutes from when the ship crashed and its evacuation alarm was sounded, said Foschi, who also said that the first four calls, made between 9:57 and 10:33, involved Schettino discussing water flooding the hull and problems in keeping the vessel upright and afloat. Foschi’s recent account, said The Journal, contradicts what he first said on January 16, in which he alleged that Schettino only first alerted the cruise line of an “unidentified” emergency at 10:06.

Ferrarini, despite the numerous phone call attempts from the liner’s captain, said he “didn’t understand that the situation was taking such an extreme form,” according to Ferrarini and a lawyer for Schettino, wrote The Journal

While Schettino and Ferrarini were on the phone, the Italian Coast Guard began receiving passenger complaints, which led to the Coast Guard radioing the ship’s bridge at 10:14. In his testimony last week, Schettino, told the Italian judge that passengers were not immediately advised of the situation because he didn’t want to create a panic situation, wrote the Journal. Instead, said Schettino, he focused on evacuation.

NewsInferno recently wrote that Tuscany’s chief prosecutor, Beniamino Deidda, said Schettino is not the only one responsible for the disaster and that investigators should focus beyond Schettino’s behavior and into that of the luxury liner’s owners. Initially, Costa Cruises blamed Schettino for the accident, citing, in part, his cowardly behavior during the crisis, said NewsInferno.

In all, 72 plaintiffs allege reactions that also include internal bleeding, blood disorders, and death after taking the drug manufactured and marketed by Bristol-Myers Squibb Company and Sanofi Aventis, The Madison-St. Clair Record wrote.

Plaintiffs allege they took Plavix after the drug makers touted the drug as more effective than aspirin in the prevention of heart attacks and strokes and that Plavix “would give a person even greater cardiovascular benefits than a much less expensive, daily aspirin while being safer and easier on a person’s stomach than aspirin,” according to the lawsuit, said The Madison-St. Clair Record. Plaintiffs also allege that Bristol-Myers Squibb and Sanofi marketed Plavix as safe for use with aspirin, despite that that claim has not been established. The Madison-St. Clair record wrote that plaintiffs also alleged that this claim was proven false and the Plavix-aspirin combination is actually more dangerous to patients not diagnosed with peripheral arterial disease and acute coronary syndrome.

The complaint also noted that the U.S. Food and Drug Administration (FDA) warned the drug makers multiple times for this and other advertising that misinformed patients and doctors. “The result is that physicians are prescribing Plavix to people who could be cheaply and effectively protected against ischemic events by a simple aspirin, to pay approximately $4.00 a day for a dose of Plavix,” according to the lawsuit, said The Madison-St. Clair Record. “Defendants’ nearly eight-year run of lying to physicians and to the public about the safety and efficacy of Plavix for the sole purpose of increasing corporate profits has now been uncovered by scientific studies that not only is Plavix not worth its high price—it is dangerous,” the complaint continued.

The plaintiffs also claim that because of Bristol-Myers Squibb’s and Sanofi’s lies and omissions, $3.8 billion of Plavix have been sold yearly, all while the drug makers neglected to appropriately issue warnings about Plavix’s dangers in packaging documentation, wrote The Madison-St. Clair Record. “Despite the growing body of scientific knowledge that the four-dollar Plavix pill was not much better than a four-cent-a-day aspirin, Defendants kept promoting it to the public and to physicians, using hyperbole and outright falsification in the process,” the suit stated. These actions caused plaintiffs to suffer severe and permanent injuries, as well as heart attacks, strokes, excessive bleeding, and stent replacements; physical impairment, disfigurement; physical pain and suffering; loss of their enjoyment of life; and incurred medical costs, the complaint stated.

The lawsuit alleges that the insurance giants did not hand unclaimed life insurance policies to Illinois’ abandoned property department, said The Wall Street Journal. The lawsuit was just unsealed by a Cook County, Illinois state-court judge.

Life insurers are typically mandated to pay claims after receiving notification of policyholder’s death and a valid death certificate. If a beneficiary does not claim a death benefit on his/her own, insurance companies can utilize the Social Security Administration’s “Death Master,” a database of all Americans who die. The database is meant to better ensure death benefits are paid to rightful beneficiaries.

While it is has long been known that insurance companies use the Death Master for other aspects of their business—such as to cease annuity payments when a recipient dies—insurers are also known to ignore database information when it comes to their having to pay out claims, noted NewsInferno

The plaintiff in this case, Total Asset Recovery Services LLC of Auburn Hills, Michigan, an investigative firm specializing in unclaimed-property searches, alleges that its use of public records and detective work led it to find that from 1988 to 2010, MetLife and Prudential neglected to transfer 4,766 policies valued at $524.3 million to Illinois, and that both insurers “knew or should have known” these policies were overdue for transferring as abandoned property, explained The Journal. The lawsuit also alleged that MetLife and Prudential committed “massive fraud” by not transferring the policies.

MetLife told The Journal that the lawsuit “vastly overstates” the dollar figures on the policies involved and Prudential declined to comment; however both companies say they obey state unclaimed-property laws, exceeding contractual requirements in their policies and that they are cooperating with the investigations.

Representative Henry Waxman (Democrat-California) and three fellow lawmakers have asked key Republicans in the House Energy and Commerce Committee to hold the hearing and order involved device makers to provide documentation, said Bloomberg News. The timing of the request is significant given that Congress is considering a U.S. Food and Drug Administration (FDA) overhaul of medical device rules, said Democratic lawmakers in a statement.

Earlier this month, the agency mandated Johnson & Johnson and 32 other device makers to conduct safety studies of vaginal implants following reports of internal injuries to patients, said Bloomberg. Also, the Democratic group pointed out that studies indicate increased complication rates for Allergan’s Lap-Band device.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Democrats said. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks,” they added.

Of particular concern, according to the letter, regarding the Lap-Band, is that “Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults … despite concerns among some physicians that the procedure is too drastic or ‘extreme’ for a young person’s developing body.” The group also cited a recently published study that revealed that nearly half of all patients implanted with the gastric Lap-Band either experienced no weight loss needed to undergo device removal after six years, with 40 percent suffering long-term complications, noted Bloomberg.

NewsInferno recently wrote that Lap-Band gastric banding complications continue to rise, citing a study about potential issues years after the surgery. The surgery involves band placement around the top of the stomach, which creates a small pouch for food that makes patients feel full after eating smaller portions. Gastric banding is used when non-surgical weight loss methods have failed.

Transvaginal mesh is a surgical treatment for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women, said NewsInferno. Thousands of women nationwide claim they’ve suffered and continue to suffer injuries because of defective transvaginal mesh devices. According to NewsInferno, transvaginal mesh has failed in one of several ways, typically eroding through the vaginal wall or skin, causing horrific pain; women complain of being unable to sit, stand, or lay in any position for more than a few minutes at a time. The FDA has received at least 1,500 reports in which a transvaginal mesh device failed to treat SUI or POP and, in the summer of 2011, the FDA issued a public safety notice about the growing number of incidents and the potential dangers of the devices, said NewsInferno.

“In 20I0 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women. The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. Even with multiple surgeries, some women are never able to recover from the damage,” the Democrats wrote. Meanwhile, according to the Democrats, said Bloomberg, Republicans continue to fail to respond to a request in October for a hearing on artificial hips and implanted brain stents that have also been linked to safety issues.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot.

More than 10,000 lawsuits claiming the birth control pills caused young women to suffer serious blood clots and other serious side effects, are pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in federal court in Illinois. Plaintiffs’ lawyers have cited at least 50 reports of death linked to the drugs from 2004 to 2008.

According to Kessler, it was conflicts of interest that corrupted a meeting with two FDA advisory committees whose findings kept Yaz and Yasmin on the public market, said The Madison Record. On December 8, FDA advisors voted on two issues: If Yaz and Yasmin’s benefits outweighed its risks and if current labeling sufficiently presented the drugs’ risk benefit profile, said The Madison Record.

The FDA advisory committee voted, 15-to-11, that Yaz and Yasmin’s benefits outweigh its risk, said The committee also voted, 21-to-11, that the drugs’ risk benefit profile was not adequately presented. Denton indicated that the agency advised the members and temporary voting members at the start of the meeting that they were subject to federal conflict of interest laws, The Madison Record, said. The decision to allow Yaz and Yasmin to remain on the market, but with some additional information about blood clot risks,.

According to plaintiffs attorneys, Kessler analyzed paperwork on the backgrounds of committee members Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson and opined that, “Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members’ impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such,” The Madison Record reported.

According to plaintiffs’ attorneys, Kessler cited documents that identified one committee member as a “huge advocate” for Yasmin and a “Bayer trained speaker,” noting that either Bayer hid its connections to these individuals from its experts or that Bayer experts “intentionally omitted” these associations from their reports, The Madison Record said.