Defective Hip Implant Verdict $1 Billion

A defective hip Billion">DePuyimplant verdict of $1 billion came last week. On Dec. 2, 2016 a Texas federal jury found Johnson & Johnson’s DePuy Orthopaedics Inc. unit liable for more than $1.04 billion in a six-plaintiff trial. The plaintiffs had all claimed injury from DePuy metal-on-metal artificial hips, which were part of the company’s Pinnacle line. In a previous bellwether trial over the same product, a jury awarded a $150 million verdict.

Metal on Metal Product Problems
The multi district litigation court in the DePuy hip litigation has been assembled over allegations that friction between the device’s metal socket and metal ball head rubs away billions of microscopic particles. Those particles pollute the bloodstream and surround tissue with “wear debris.”

The jury deliberated less than a day after a two-month trial. The jury found J&J and DePuy had negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to it, and concealed the implant’s risks.

The verdict included $4 – $6 million per person in damages for injuries, pain and suffering; $1 million to each of four spouses for loss of consortium; $504 plus million against both defendants in punitive damages. The punitive damages came after the jury found the companies had acted with malice or fraud.

Negligent Design, Failure to Warn
Both DePuy and J&J were found liable for negligent design defect, negligent failure to warn, strict liability failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation, fraudulent concealment. The jury found J&J did not conspire with DePuy on the design defect claim, but did find J&J liable for conspiracy on the other six claims. J&J was also found liable for aiding and abetting DePuy, in seven different causes of action.

The jury awarded $4 million plus medical costs to each of four people who had a single hip replaced, and $6 million plus medical costs to each of two plaintiffs who had both hips replaced. Each of the plaintiffs was awarded $84 million in punitive damages against J&J and DePuy.

$84 Million Headache Money for Illegal Kickbacks
In closing arguments the plaintiffs’ lawyer reminded jurors of J&J testimony related to an $84 million settlement J&J made to end an investigation into allegations it paid doctors kickbacks. A witness for Johnson had said J&J wasn’t admitting wrongdoing, but had paid the money to make a headache go away.

A headache? $84 million is aspirin money to them,” the attorney said during closing arguments. He urged the jury to impose a penalty stiff enough to make Johnson & Johnson change its future behavior with medical devices.

Plaintiffs are from California; therefore, they are not subject to the same punitive damages cap that slashed by more than two-thirds the $502 million verdict from the second bellwether trial, which involved Texas plaintiffs.

J&J did win the first metal-on-metal hip trial, which involved a Montana plaintiff.

DePuy Responds to Verdict
DePuy said it would challenge the verdict on appeal. The company claimed it has strong grounds for appeal.

The attorney on the losing side complained that the, “[billion-dollar] verdict provides no guidance on the merits of the overall Pinnacle litigation because the court’s rulings precluded a fair presentation to the jury.” (Now) the appellate court will need to review errors repeated in two trials, and we will continue to urge that no further trials be conducted until we receive appellate court guidance.”

Defective Hip Implant Verdict $1 Billion

The cases involved six plaintiffs from California who had each undergone “revision surgeries” after being fitted with metal-on-metal artificial hip systems of DePuy’s Pinnacle Ultamet variety.

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Morcellator Options for Fibroids

Power Morcellator Surgery Riskmorcellators are not the only option for hysterectomy, myomectomy, or the removal of uterine fibroids, which some 80% of women can develop in their lifetimes.

In April 2014, the FDA announced in a safety alert that it wants to discourage the use of power morcellators. the problem is that some women may have undiagnosed uterine cancer which a morcellator can upstage, magnify, and make more dangerous, even deadly.

FDA Warning

FDA warned on April 17, 2014:

“Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

Risk of Power Morcellaton

Power morcellation is less invasive than traditional forms of surgery; but it also carries the risk of spreading benign or malignant tissue when used during myomectomies or hysterectomies for fibroid treatment or uterus removal.

Alternatives to Power Morcellation
The FDA acknowledged that power morcellators are less invasive (as advertised) than traditional approaches. They require fewer sutures; but nonetheless the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommends that women seek, and that surgeons use, alternative methods. Several non-surgical treatments exist for fibroids, including expectant management, pharmaceutical therapy, uterine artery embolization, endometrial ablation.

Surgical Options for Fibroid Treatment
If a woman does require surgery, she and her doctor can decide between a hysterectomy, complete removal of the uterus; or a myomectomy, which targets only the fibroids. Many factors enter into this decision, including age, a (possible) desire for pregnancy, history of atypical cervical or endometrial cells, family history of cancer, risk of fibroids’ return.

Traditional Options: Hysterectomy & Myomectomy

The traditional option for removing the uterus is total abdominal hysterectomy, which the FDA says is the most common surgical choice. This involves a surgical incision in the wall of the lower abdomen, compared with laparoscopic hysterectomy, which takes less time and usually produces fewer urinary tract injuries.

Supracervical, or subtotal, hysterectomy and total vaginal hysterectomy are other options. According to the American College of Obstetricians and Gynecologists, vaginal hysterectomy is the most preferred option due to benefits it provides compared with alternatives. FDA says vaginal hysterectomy allows faster recovery and less of a chance of inducing infections than abdominal hysterectomy.

When fibroids are removed instead of the entire uterus, an open abdominal myomectomy is a traditional option. This involves an abdominal wall incision similar to an abdominal hysterectomy, and it precludes the need for morcellation.

Risks of Laparoscopic Treatment

According to FDA, compared with vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room. Laparoscopic hysterectomy uses multiple small incisions in the abdomen wall along with gas and visualization instruments. It is during these types of procedures that surgeons often use power morcellators to allow large tissue to be extracted.

The types of laparoscopic hysterectomy include laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy. Each of these types may, at some point during the procedure, require some form of morcellation to allow for complete uterine removal.

In minimally invasive laparoscopic myomectomy, power morcellation or the extending of incisions are ways of removing the cut fibroids. Morcellation may also be used during hysteroscopic myomectomy, a transvaginal procedure that does not require an abdominal incision, for fibroids found within the endometrial cavity and inner myometrium.

Alternative Surgical Techniques

To promote surgical techniques that mitigate the risks of power morcellation, various options have been suggested as possible ways to prevent spreading of tissue while maintaining the claimed benefits of minimally invasive procedures.

En-bloc resection techniques remove tissue completely intact, hoping to avoid power morcellation and the risk of spreading tissue pieces. To that end, methods could be used such as minilaparotomy, a surgically enlarged ancillary port; or transvaginal extraction. Each of those procedures comes with its own set of potential complications, however, and it is unclear whether any alleviate the risk of tissue dissemination.

Containment Bags and Other Strategies

Some industry representatives argue that leaving power morcellators on the market will drive companies to find new solutions to mitigate their risks. Proposed methods include vaginal morcellation and transvaginal extraction. Most common are techniques that involve containment bags.

Morcellator Options for Fibroids

Techniques in “bag morcellation” have been floated as a means of reducing the risk of spreading (potentially) cancerous tissue. But after the FDA examined the limited data for the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the agency could not verify the efficacy of any of those methods for reducing the morbid and cancer-spreading risks of power morcellators.

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Power Morcellator Investigation by Government

The U.S. Government morcellator uterine cancerAccountability Office (GAO) has still not issued any statement regarding its investigation into power morcellators used for hysterectomy or uterine fibroids. The GAO announced in Sept. 2015 that it would investigate controversy which had stemmed from wide use of power morcellators, and subsequent morcellator lawsuits. These gynecological devices are known to spread undetected cancers during hysterectomies and myomectomies.

Congressional Letter to GAO
The GAO’s action came after a dozen members of Congress wrote a letter requesting that the agency investigate. The legislators wrote the GAO a letter dated August 2, 2015:

“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator. (This) device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”

The representatives’ letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).

FDA Limits Morcellator Use
FDA severely limited power morcellator use in November 2014, a year after doctors and patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign against the device.

Morcellator National Security Threat
Dr. Amy Reed became a power morcellator victim after one was used on her for a hysterectomy. Her husband, Dr. Hooman Noorchashm then became something of a whistleblower. He announced that morcellators were a national security threat, given that 1 in 350 women have undetected uterine cancer prior to hysterectomy or fibroid removal. When that woman with undetected cancer undergoes surgery with a morcellator, her cancer can be morcellated – sliced and diced – into millions of pieces which are then spread everywhere throughout the uterus. The result can be aggressive uterine cancer or other type of cancer that can be fatal.

Doctors push Back
Some doctors, meanwhile, have pushed back against the proposed morcellator ban. The morcellator offers the convenience of a less invasive procedure. Fewer sutures are needed in using the morcellator, compared with the old methods used for hysterectomy and myomectomy or fibroid removal. The problem remains, however, that the ovarian cancer testing which doctors have used prior to surgery in order to diagnose possible cancer has not proven reliable.

Morcellator Lawuits
Against this backdrop, morcellator lawsuits have been filed across the country for women with undetected cancer who then underwent surgery with a power morcellator, only to find that the machine spread and worsened their undetected cancer.

Power Morcellator Investigation by Government

Meanwhile, the power morcellator investigation by the U.S. government continues. Stay tuned for further developments. . .

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New Laser Technique removes IVC Filters

Despite thereIVC Filter Graphic being no evidence blood clot filters help the overall population, or that they increase mortality for trauma patients, some 250,000 IVC filters are implanted in people yearly. Even more concerning, many of these devices are not removed as soon as they should be. Research has meanwhile shown that the longer IVC filters remain in the body, the more likely they are to cause problems.  Fortunately, help may be on the way.

New Technology could save Lives

New technology is showing some promise, paving the way for the possible safe removal of IVC filters. New technology and methods could potentially save thousands of lives.

FDA recommends Quick IVC Filter Removal
Studies estimate that only 8% of IVC filters are removed from patients within 3.8 years of their being implanted. The FDA, meanwhile, recommends IVC filters be removed 24 to 59 days after being implanted.

The problem is that IVC filters aren’t always easy to remove, even within the recommended window; and the longer they remain implanted, the more difficult they can be to remove. IVC filters like those made by C.R. Bard, Cook Medical, and Cordis Corporation, have been named in blood clot filter lawsuits which allege they are prone to perforating the inferior vena cava wall. They can also migrate throughout the body and fracture, causing their parts to embed into vital organs. One client at Matthews & Associates Law Firm, which represents people who have filed IVC filter lawsuits, has an IVC filter embedded in a kidney. The entire kidney will likely need to be removed to safeguard the person’s life.

When an IVC filter fails within a person’s body, it can be extremely difficult to remove the device. Besides the kidneys, pieces can lodge in the heart or lungs,  and devices that have perforated the vena cava wall often can’t be removed without causing further damage.

Serious, Life-threatening Complications

IVC filters left inside one’s body can cause serious, life-threatening complications, including internal bleeding or strokes. Patients left with the defective devices may live in constant fear that the wrong movement could jar a jagged piece loose and cause fatal damage. Into this fearful scenario comes this hopeful news.

Five-Year Study shows Promise for Filter Removal

A five-year study examined the safety and efficacy of using advanced laser technology to remove previously irretrievable IVC filters. Endovascular laser-assisted retrieval has been applied to successfully remove several different types of IVC filters. Researchers who worked in the study believe that nearly all defective IVC filters can be removed using this laser technology.

New Laser Technique removes IVC Filters

More clinical studies need to be performed using this procedure, which for now appears able to give many thousands of people hope for a better, healthier future unencumbered by IVC filter fears.

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Morcellator Cancer Complaint Filed

A medical Morcellator-btndoctor has filed a formal legal complaint demanding full investigation and prosecution of corporations that have made and promoted morcellation devices. The doctor also calls for prosecution of doctors who have used morcellators on women with (undetected) cancer, as well as organizations that have promoted their use, such as ACOG – the American Congress of Obstetricians and Gynecologists.

Dr. Vikki G. Hufnagel, MD, is Director of the Institute for Ethics Law, Science and Medicine. She addresses her complaint to the FTC, SEC, FINRA, BBB, FBI, OIG, Calif. Attorney General, California Senators Boxer and Feinstein, the Calif. Dept. of Insurance, Calif. Dept. of Affairs, members of the US Congress, and The Hague.

Crime of Morcellation Worldwide

Dr. Hufnagel writes: “To The Hague: This crime of morcellation with a device that spreads disease and death is taking place around the globe. Poor women have been used as experimental animals without being educated or given informed consent. The WHO does many fine things. However WHO also promotes testing on women in underdeveloped nations who are taken advantage of. Money is given to WHO for the promotion of studies on these women for corporations’ research and development.”

The doctor says The Hague must lead the action to educate and protect women around the world from medical abuse, harm and battery, and to insure their health and welfare.

The Mayhem of Morcellation

The doctor also said she is available to debate any agent for the ACOG, AMA etc. She says she will not stop her “attack” until the truth is known worldwide.

The Politics of Medicine
Physicians in other parts of the world do not get all the information they need to learn about the politics of medicine in America, according to Dr. Hufnagel. She writes that organizations such as the WHO and others take on research projects using poor, uneducated women to benefit corporations. The doctor demands to know who has been harmed in the development of morcellation.

Dr. Hufnagel asks that all agencies of the government stop these abuses by physicians and corporations which have killed or injured women worldwide. The doctor says she redesigned the device herself in 1995, then demonstrated her redesign to the medical device committee of the FDA.

She said she is filing the complaint “as a gynecological surgical ethics specialist, a creator of a new surgical branch of gynecology called Female Reconstructive Surgery prior to 1985, a student of Kurt Semm (Germany) and Viktor Bonney (UK), as the first physician to write law to protect patients in the U.S., Calif., Texas, New York with informed consent for hysterectomy, as an internationally known women’s health care expert and whistle-blower.

The doctor also advertises her services to assist law firms in morcellator lawsuits against morcellation device makers, doctors, medical organizations that have injured women. She said she wants to work towards “actual jail time for these crimes,” not just a slap on the wrist and monetary damages.

“Our society must change and be leaders of ethics protecting the people,” she wrote.

Morcellator Cancer Complaint Filed

Dr. Hufnagel lists her contact information on her complaint.

Dr. V.G. Hufnagel MD
Director of the Institute for Ethics Law, Science and Medicine.
vikkihufnagel@gmail.com
PST 323–210–3371 vm,
4244 Canoga Ave
Woodland Hills Ca 91364

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IVC Filters don’t help outcomes

IVC filters don’t IVC Filters fail to improve Anticoagulant Therapyhelp outcomes. Patients implanted with IVC filters were no more likely to survive more than 24 hours after injury than those who received no filter, according to a study published September 28, 2016. The research examined 451 trauma patients given an IVC filter, against a control group of 1,343 not given a filter. The study also referenced several other points which give cause to question whether the benefits of IVC filters are worth their risks.

No Significant Difference

The research study concluded there was “no significant difference” in survival for trauma patients with or without an IVC filter, whether or not they had venous thrombosis.

Death Risks rise with IVC Filter Dwell Time

The authors’ conclusions called for a reexamination of the use of filters in the trauma population, especially given the fact that removal rates are low “and there is increased risk of morbidity in patients with filters that remain in place.”  The longer the filter remains in place, the more likely it is to cause problems.

Venous Thromboembolism (VTE)
VE is a significant cause of morbidity and mortality in the U.S., with some 900,000 patients a year developing VTE or pulmonary embolism (PE). Blood thinners are typically used for VTE prophylaxis in hospitalized patients or for treatment of acute venous thromobosis. Blood clot filters are often implanted in patients for whom blood thinners are contraindicated, as they often are for trauma patients.

IVC Filter Use Increased despite Lack of Evidence

Study authors Shayna Sarosiek, MD; Denis Rybin, PhD; Janice Weinberg, ScD; and others point out that despite a “lack of high-quality evidence” to prove the safety and effectiveness of IVC filter placement, IVC filter use has increased in the trauma population. The authors set out to “delineate the long-term mortality risk associated with IVC filter placement in trauma patients with and without a VTE. They performed a retrospective cohort study of trauma patients at Boston Medical Center at Boston University School of Medicine.

IVC Filters –No Benefit

Once the trauma patients survived the initial injury for 24 hours, there was no significant difference in mortality between those who received an IVC filter and those who did not. The data the researchers saw showed no benefit or decrement in long-term mortality for trauma patients with IVC filter insertion, whether or not patients had DVT or PE. Most filters were placed in those without VTE, with 91.6% (413/451) not removed. That indicates long-term IVC filter placement did not increase survival through prevention of future PE or decrease survival because of IVC filter complications (embolism, ruptured viscera, filter fracture).

IVC Filters Need Removal
The authors also noted that most IVC filters are not retrieved in a timely fashion and no clear protocol has been set for a timetable to retrieve them. But the authors said that their study was designed to examine mortality only, “and any nonlethal morbidity attributed to filter insertion would not be evident in these data.

Study Conclusion
The authors concluded that their data indicate IVC filters “should not be placed in trauma patients in an effort to decrease all-cause mortality.”  They also noted that “given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

IVC Filter Lawsuits

The failure of IVC filter manufacturers to inform implanting surgeons of the need to closely monitor IVC filter implantees, and to remove their filters as soon as anticoagulation resolves, is just one factor which leaves IVC filter makers vulnerable to IVC filter lawsuits.

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Baby Powder Cancer Risks hidden, Jury told

A woman whoTalc Powder Lawsuit used Johnson & Johnson baby powder on her genitals and then developed ovarian cancer urged a Missouri jury on Oct. 4, 2016 to find J&J liable. In opening statement, her lawyer said J&J has known for years about a talc-based baby powder cancer link but failed to warn people about it. All talcum powder cancer lawsuits charge that J&J failed to warn of a talc-cancer link.

J&J prepared Defense Early

During opening arguments in St. Louis, Deborah Giannecchini’s attorney said J&J’s own inside documents showed the company anticipated the talc-cancer litigation to the point of writing out “a question and answer” to prepare for questions from plaintiffs’ attorneys who would sue J&J for women’s ovarian cancer cases. Another internal document feared the company would be compared to the cigarette industry if it failed to warn of the ovarian cancer link with talc powder. The attorney said J&J had been urged since at least 1982 to add warning labels to its talc-based baby powder.

Stage 4 Ovarian Cancer

Ms. Giannecchini has Stage 4 ovarian cancer, her lawyer told jurors, complications from her treatment, a greatly reduced life expectancy.

The attorney said the woman has had her spleen removed, along with part of her stomach and colon, and all of her ovaries and uterus.

Failure to Warn Key

A failure to warn is the legal terminology which sets the bar a plaintiff’s attorney must meet in order to make a case of this nature. The plaintiff’s attorney must not only prove a talc-cancer link, but also show that the company failed to warn of it. Her attorney argued: “[Ms. Giannecchini] said if there would have been a warning on the bottle to not use this on the genital area, she would not have done it and we might not be here.”

Defense Opening

J&J’s attorney argued in opening statement that there is no solid link between talc and ovarian cancer. He said the U.S. FDA and CDC were among “trusted medical institutions” that looked for a potential link but found none. “No one knows what causes ovarian cancer,” the attorney argued.

Imerys Talc America Inc., another defendant, which mines talc for J&J, repeated J&J’s contention that talc is not linked to cancer. Imerys’ attorney added that Imerys did not market the baby powder used by Mrs. Giannecchini, but simply provided the materials used to make it.

Plaintiffs 3-0 against J&J in Talc Cases

Ms. Giannecchini’s trial follows two huge verdicts against J&J in similar cases in 2016.

In February, a Missouri jury rendered a $72 million verdict to the family of Jacqueline Fox.  Ms. Fox died of ovarian cancer after using talc-based powder for decades. It was the first case in which J&J was ordered to pay damages over a talc-cancer link tied to its products.

The Fox family verdict involved $10 million in compensatory damages, $62 million in punitive damages, which are assessed by a jury when it is outraged and wants to send a message to a company it deems has done wrong.

In another J&J loss, in May 2016, a Missouri jury shocked the company with a $55 million verdict in a lawsuit brought by Gloria Ristesund.

J&J also lost a third jury trial, the first ovarian cancer-talc case to go to a jury, in 2013. In that one, a South Dakota jury ruled that J&J had failed to warn a woman about the link between talc-based powders and ovarian cancer. In that case, however, the woman’s cancer had been in remission for six years, though ovarian cancer is usually fatal. The fact that she was apparently recovered, according to legal experts, may have kept the jury from awarding damages despite its ruling that the company failed to warn of a talc-ovarian-cancer link. South Dakota, however, is a staunchly conservative state, which might give J&J pause in considering how long to fight talc cases before coming to the settlement table.

Baby Powder Cancer Risks hidden, Jury told

The case is Giannecchini v. Johnson & Johnson et al., case number 1422-CC09012-01, in the 22nd Judicial Circuit Court of the State of Missouri.

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Bill to make Drugmakers “Justify” Price Hikes

Democrat and epipensRepublican Senate and House representatives introduced a bill last week to make drugmakers “justify” price hikes greater than 10 percent. USA Today reported that the bill was proposed due to the firestorm surrounding Mylan’s recent EpiPen price hikes. The lawmakers were also careful to point out that this move was not “regulation,” per se, so as not to offend any  Reagananomics worshippers.

Related: How Deregulation Destroyed U.S. Dominance

Facing public outrage over recent exorbitant EpiPen price hikes, Mylan recently announced it was taking the unprecedented step of offering a generic version of EpiPen at roughly half the price of the brand item. Drugmakers typically milk the profits from a brand name of a drug as long as possible before federal drug pricing guidelines force them to introduce or allow generic versions to hit the market.

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act is co-sponsored by Sen. Tammy Baldwin (D-Wis.); Sen. John McCain (R-Ariz.); Rep. Jan Schakowsky (D-Ill.).

Drug Company Disclosure Demands

At least 30 days before raising the price of a particular drug by more than ten (10) percent, the bill would require a drugmaker to disclose to HHS – the U.S Department of Health and Human Services – the company’s spending on advertising, development, manufacturing, and research for the drug. The drugmaker would also need to report net profits from the sale of the drug.

Transparency Buzzword Sounds Good

Mr. McCain, with his heavy constituency of retirees using prescription drugs in his state of Arizona, said the bill “would bring much-needed transparency to prescription drug prices. Transparency leads to accountability, and it is past time that mantra applied to the skyrocketing cost of prescription medication.”

Ms. Schakowsky also echoed the transparency theme: “Prescription drug corporations should not be allowed to hide behind a curtain, refusing to disclose information on drug prices, and price gouging with impunity.”

Tammy Baldwin, (Rep. Wis.)
According to Ms. Baldwin, the bill is not likely to pass this year because it was introduced so late in the session. She said the main effort is “intended to create momentum” for 2017 when the lawmakers plan to reintroduce the measure.

Campaign for Sustainable Rx

Executive director for the Campaign for Sustainable Rx Pricing, John Rother, called the lawmakers’ effort a first step in repairing the “broken prescription drug market.” If it is a first step, it certainly seems to be a very small one.*

USPSTF Listing
Consumer advocates, as well as Mylan, seek to add EpiPen to USPSTF’s list of preventive medical services. Under the Affordable Care Act, insurers must cover services with that exclusive status at no cost to patients.

Mylan Profits Secure Either Way

The New York Times noted that while that designation could limit out-of-pocket costs for insured patients, it would also allow Mylan to raise prices further, because insured patients wouldn’t bear any of the treatment’s cost. Moreover, consumers could still be strapped with higher costs through higher premiums or copays for other drugs, if their insurers seek to mitigate the costs of covering the EpiPen at no cost.

Bill to make Drugmakers “Justify” Price Hikes

According to the Times, the USPSTF list does not include any other prescription drugs for diagnosed conditions, so it could be tough to get EpiPen listed. USPSTF has recommended at least one over-the-counter drug, aspirin. It usually lists treatments for patients only if there are “no signs or symptoms of the specific disease or condition” (O’Donnell, USA Today, 9/15; Flom, Roll Call, 9/15; Lipton/Abrams, New York Times, 9/16; Abrams, New York Times, 9/16).

Meanwhile, as more and more people are becoming aware of just how little power they have in deciding drug prices, more and more are turning to alternative healthcare, which is really a contradiction in terms. Whatever care one chooses is an “alternative.” The important thing is to choose yours wisely.

*As for the drug pricing flap, what difference could it make if companies had to disclose these things whenever they want to raise a price more than ten percent? They will likely be able to find a workaround even if only to save the “shame” of broadcasting their profits. Maybe just raising the prices by 9.9% over different periods of time will easily defeat the purpose of this bill, even if the bill ever reaches the point of being put into law in the distant future. This bill would appear to have no teeth to really control drug prices. Real action would require “regulation,” which most Washington D.C. politicians and most of the people of the U.S. have been brainwashed to believe would signal the death knell for Capitalism.

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Law Firm Filing IVC Filter Lawsuits

Matthews & Associates Law FirmIVC Filter is handling IVC filter lawsuits nationwide against all the major makers of IVC – Inferior Vena Cava – blood clot filters. The firm, with offices in Houston and New York, is engaged in litigation against Bard, Cook, Cordis, and Rex, the major IVC filter manufacturers.

IVC Filter Injury Research

Matthews & Associates attorneys have reviewed thousands of internal documents and dozens of published medical studies. They have also consulted with several leading experts in the field. These reviews and consultations have found, unfortunately, that mounting evidence indicates most IVC filters will eventually fail. In addition, many temporary filters are not being retrieved in a timely fashion, and many IVC filter implantees are unaware they have a filter implanted.

Several different injuries may constitute a potential IVC filter case. The firm is investigating cases in which one of the following IVC filter injuries obtain:

1) any part of the IVC filter fractured or broke off;
2) the IVC filter or a part of the IVC filter moved or migrated from its original location;
3) the filter perforated the inferior vena cava or other organ;
4) the filter is embedded or tilted;
5) a doctor tried to remove the filter without success;
6) a doctor recommended removal but felt the procedure was too risky;
7) a doctor diagnosed someone, AFTER the filter was implanted, with one of the following medical conditions, which could be associated with the IVC filter:
a. caval thrombosis;
b. pulmonary embolism;
c. DVT /post-thrombotic syndrome; or
d. thrombosis/embolism.

Filter Failure more likely over time

Virtually all of the medical evidence that our attorneys have reviewed indicates that the longer an IVC filter remains in the body, the more likely it is to fail. In addition, the medical literature we have reviewed indicates that damage caused by the filter tends to be progressive.

For these reasons, people with an IVC filter in place might be wise to get screened even if they have had a prior test which showed that the filter was intact and in place.

Statutes of Limitations Issues

If upon testing and screening by a doctor, someone is diagnosed with one of the seven conditions listed above, that person might may want to contact an attorney to consider an IVC filter lawsuit. Anyone who has had complications arising from the removal or attempted removal of an IVC filter, or has been diagnosed by a doctor with any of the conditions above, or who has experienced a failed attempted removal of the filter, could trigger a deadline to file a lawsuit in court. That person might be wise to contact an attorney if they do not already have legal representation. Lawsuits have strict time limits for filing, and IVC filter lawsuits are no different.

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Epi Pen Scandal takes Generic Turn

Mylan has jacked epipensup the price of EpiPens – a lifesaving allergy treatment – 15 times since 2009. EpiPens now give a list price of $609 for a two pack, a 400% increase since 2009. The obscene price gouging has inflamed social media. To mollify the steaming public, Mylan has this week taken the almost unprecedented step of offering EpiPen in a generic turn years before the company would have been forced to do so by FDA and Congressional regulations.

Brand name drugs typically enjoy a long run at high prices – sometimes for as long as 20 years – before they must be offered in cheaper generic forms. (Sometimes brand names makers cheat a little bit, with pay-to-delay schemes, keeping generics off the market a little longer in order to make more profits, but that’s another story.)

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Expensive at Half the Price

Mylan Pharmaceuticals and its now infamous CEO Heather Bresch knew they needed to respond to a relentless social media campaign that took umbrage at Mylan’s taking advantage of sick people. The company response was to announce the launching of a generic version of EpiPen, at 50% off its current price. The company also announced that it would work to make EpiPen treatment more affordable.

Congress Investigates EpiPen

Where social media goes, votes go, especially in an election year; so now Congress has announced that it is investigating Mylan. The House Oversight Committee sent a letter to Ms. Bresch Monday, August 29, 2016 to request a briefing as well as company documents regarding EpiPen.

Mylan has sought to pin the blame for its price gouging on a shadowy health care system and supply chain. Ms. Bresch has responded to criticism by calling the system “broken.” She has said it is in “crisis,” comparing it to the 2008 financial crisis. She took no blame (or credit, for that matter – depending on your viewpoint and stock portfolio) for her company’s wildly jacking up prices because they can.

Critics say Mylan lacks Empathy

Ms. Bresch’s arguments don’t wash with many.

Wells Fargo analyst David Maris said Mylan doesn’t understand the “very emotional, very stressful situation” parents are going through when their children need this drug.

“No one’s expecting Mylan to give away their products,” said Mr. Maris. But empathy is the most human emotion. And when you raise prices year after year, by a lot, for a drug that’s lifesaving, it shows a complete lack of empathy.”

No one forced Mylan to dramatically raise EpiPen prices, Mr. Maris pointed out: “It’s outrageous. People shouldn’t be fooled by the idea that the system made them do it. Mylan is to blame for the high prices of EpiPen.”

Broken System or Opportunistic?

The most recent round of price hikes looks more opportunistic rather than a result of health care system problems. In November 2015, Mylan raised EpiPen prices by 15% (the 14th price raise since 2009), just one month after EpiGen’s main rival Auvi-Q was pulled from the market. Six months later, Mylan again raised prices, by another 15%.

Bernstein analysts wrote in a recent report that Mylan was in a position to raise prices because competitors were out of the market; so Mylan raised prices.

EpiPen CEO made $19 million last year

Ms. Bresch made a cool $19 million as Mylan CEO last year. Maybe the outrageous EpiPen price hikes were needed to help pay her outrageous salary. The daughter of a U.S. Senator (Joe Manchin), Ms. Bresch is nobody’s fool. She has shown that she knows how to fire back with a good sound bite as well as her daddy or any other Washington D.C. politician.

Do Good and Do Well?

Ms. Bresch said to the nation’s paper of record, The New York Times: “You can do good and do well, and I think we strike that balance around the globe.”

She did also add, perhaps for the benefit of her shareholders and the American way: “I am running a business. I am a for-profit business. I am not hiding from that.”

Some people, however, no doubt wish they could hide from her company’s prices.

$1,260 out of pocket expenses

A New York Post story of August 26, 2016 details the lives of Tom and Samantha Marino trying to keep up with their son’s EpiPen meds. While Ms. Bresch also told the Times that most of EpiPen’s costs for people are paid by insurance, that doesn’t appear to be the case with the Marinos.

Mrs. Marino told the Post that earlier this year, the couple paid $1,260 out of pocket for three EpiPens that will expire in February 2017. That was before the latest price increases.

The Marinos said they need three EpiPen Jr 2-Paks for their young son, who has a severe reaction to peanuts that can be life threatening They keep one at home, one in Mrs. Marino’s pocket, and one at school.

Epi Pen Scandal takes Generic Turn

This might be an easy story to ignore for those of us who don’t need EpiGen, but there for the grace of God go we. How many more drugs will Big Pharma be able to gouge people for before some sort of reasonable regulation is put into place to protect us from the unreasonable booty taken by a $19 million per year CEO and her rapacious company?

Perhaps her senator father will get the job done and protect us all from future gougings?  You think?

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