Are Generic Drugs really the same as Brand?

Are generic drugs really the same as brand?  From a legal perspective, the answer is a resounding, “No, generic drugs are not the same as brand-name drugs.”  Not when it comes to liability for their respective makers, or the civil protections enjoyed by their users. Why is that? One might fairly ask. The answer is that five justices on the U.S. Supreme Court ruled in two landmark 5-4 votes that anyone injured by a generic version of a brand-name drug does not have the same civil protections as someone injured by the brand-name version of that same drug.  That can mean the difference between a $21 million jury award and nothing, which is what five members of the Supreme Court decided a woman’s injuries were worth after she was blinded and disfigured by a generic drug.

Supreme Court rulings on 5-4 votes in both Pliva v. Mensing (2010) and Bartlett vs. Mutual Pharmaceuticals (2013) gave generic drug makers virtual carte blanche to injure people at will without having to face the consequences of the drugs they make.  The latter ruling overturned a $21 million verdict for Karen Bartlett, who was blinded and disfigured by a generic version of sulindac, an anti-inflammatory drug.

Gross injustice like that in Ms. Bartlett’s case continues. The Supremes’ decision in favor of generic drug makers is a gift to drug companies that keeps on giving. Thanks to the high court, it is now either extremely difficult or virtually impossible for people hurt by the generic version of a drug to have their grievances heard in an American courtroom.

In addition to the fact that generic drugs fail to compare with branded ones in the American court system, there is much evidence to suggest that many generic drugs are not equivalent to brand name drugs from a medical perspective.

Fortune magazine reported in January 2013 on several controversies surrounding brand and generic drug “equivalence.”  Katherine Eban wrote a story which detailed how in 2012 the FDA took the rare step of declaring that a generic version of the antidepressant Wellbutrin – which the agency had previously approved – was not in fact “bioequivalent” to the name-brand version. In that case, the FDA withdrew its approval of that generic Wellbutrin.

Teva Pharmaceuticals (which made out like bandits in the Mensing v. Pliva decision over the generic version of Reglan), marketed the Wellbutrin generic in question.  Teva was forced to stop selling it.  Other drug companies are now testing their versions of Wellbutrin at the FDA’s request. Fortune reported that the episode brought momentum to a movement that was quietly building among many doctors and medical societies increasingly willing to ask whether generic drugs are in fact identical to the brands they try to copy.

Most people tend to think that generic drug versions are the same as their brand-name counterparts. Most people are happy to save some money at the pharmacy counter and not think past their pocketbook as they leave the drug store. Some people may be vaguely aware that generics are often much cheaper because generic drug makers don‘t have to spend as much money as brand-name drug makers to get their drug on the market. Most are likely unaware that the differences between brands and their generic versions can be significant.

The issue is a large one, because a whopping 80 percent of all U.S. prescriptions now dispensed are generic.  In 20112 alone, Americans saved $193 billion by buying generic drug versions, according to the Generic Pharmaceutical Association.

Generic drug makers may know some of the declared ingredients of a brand-name drug, but proprietary privilege helps the branders keep their processes secret. The patent that reveals the components does not explain how to make the drug. Consequently, generic drug makers must use reverse engineering to conjure their concoctions, hardly a panacea for perfection. The result is that a generic drug, is at best, an approximate copy, never a clean duplicate; and a generic drug will not behave in the same fashion as the branded drug will.

Though FDA rules acknowledge generic drugs’ duplication problems, the agency is a long way from solving them. The best the FDA can offer is a broad definition of “bioequivalence.” Fortune notes that “a generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.”

In addition, though the generic must contain the same active ingredient as the original, additional ingredients – excipients – can be different and are often of lower quality. Those differences can affect a drug’s bioavailability.  The American Heart Association has noted, “Some additives traditionally thought to be inert (may) alter a drug’s dissolution, thereby impacting its bioavailability.”

Are Generic Drugs really the same as Brand?

FDA standards also don’t regulate how quick medicine reaches peak concentration in the blood, and patients taking time-release drugs can be seriously affected by peak changes. Active ingredients releasing into the blood far more quickly can leave patients dizzy or nauseous.

The FDA is also somewhat hogtied by Chinese producers of generic drugs. The Chinese don’t allow U.S. FDA inspectors inside their plants. Officials from the U.S. can only show up at the plant, wait outside, and then accept (or not) whatever the Chinese generic drug makers give or tell them.

An estimated 80% of active drug ingredients and 40% of finished medications come from overseas, from some plants which the FDA has not inspected. In November 2013, generic Lipitor maker Ranbaxy Pharmaceuticals recalled some 480,000 bottles after tiny shards of glass were found inside pills. India’s largest generics company, Ranbaxy is the same entity for which the FDA granted permission to produce a version of Lipitor.  The approval came after a seven-year investigation in which the U.S. Justice Department concluded Ranbaxy had fabricated drug-approval data.  Ranbaxy agreed to pay $500 million and entered into a consent decree.

This is hardly the stuff which can help make people feel confident in filling their prescriptions with generic versions of brand-name drugs.

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Cook Medical loses $1.2 Million IVC Filter Verdict

(May 25, 2018)  .2 Million IVC Filter Verdict">Cook IVC Filter AttorneyCook Medical must pay $1.2 million to compensate a man who was implanted with a Cook Celect IVC filter, said a Texas jury Thursday.  Following a three-week trial, the jury of 12 ruled Cook must pay for injuries following a Celect filter’s implantation in Jeffrey Pavlock on March 3, 2015.   A 35-year-old Houston-area firefighter,  Mr. Pavlock sued Cook after its Celect inferior vena cava filter became stuck inside him and required open laparotomy surgery to remove.

Cook promoted its Celect IVC filter as retrievable, but the filter put into Mr. Pavlock’s inferior vena cava tilted, perforated his IVC, duodenum and aorta, and was pressing against his spine and renal artery.  That situation made it impossible to remove without major surgery. Two previous removal procedures had failed.

Much conjecture from both sides argued about how much the results of the removal surgery affected Mr. Pavlock now and could affect him in the future. For the present, despite the scar hidden beneath the button-down shirts he favored during the trial, the appearance of the burly firefighter and EMT appeared unremarkable.  He moved freely throughout the proceedings, without any apparent pain or visible injury, in full view of the jury just a few feet away.

One plaintiff’s expert in the case testified that Mr. Pavlock had a 90% chance of suffering future spinal stenosis from the surgery which involved cutting the metal filter into several pieces and digging them out.

”Spinal stenosis,” according to the Mayo Clinic, “is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine.  Spinal stenosis occurs most often in the lower back and the neck. Some people with spinal stenosis may not have symptoms.”

Defense pounced on the Plaintiff side’s analysis that any spinal stenosis Mr. Pavlock may have is asymptomatic for now but could become symptomatic in the future. Nobody could say for certain whether or not Mr. Pavlock would suffer symptomatic stenosis in the future.

Attorney David Matthews argued for the plaintiff in closing that Cook knew its Celect had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway.  He showed the jury several independent studies which found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.  Mr. Matthews also reminded the jury that he had showed evidence that as few as one percent of adverse events are reported by doctors to a medical device company.

Concerning the large gap between independent- and Cook-sponsored study findings, defense attorney John Mandler said, “They have their favorite studies and we have ours.”  Cook’s lawyers had also refuted trial evidence of doctors reporting only 1-5% of actual adverse events related to medical devices.  In closing, Mr. Mandler called the low-reporting evidentiary studies a “conspiracy theory.”

Cook issued a press release the next day vowing to appeal the jury verdict.

Cook Medical loses $1.2 Million IVC Filter Verdict

Freese & Goss and Matthews & Associates Law Firm represented the plaintiff. Cook Medical was represented by Faegre Baker Daniels of Minneapolis.  The actual jury award was $1,240,500.

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Medical Devices Wild West for Profits, Safety Problems

Dubious medical Cook Blood Clot Filter Lawsuitsdevices like IVC filters, heart stents, and metal-on-metal hip implants are allowed on the US market through some very questionable means. Most people assume the U.S. Food and Drug Administration extensively tests all medical devices before blessing them with the agency’s magic wand of approval. The fact of the matter is far different. The FDA performs no studies of its own. The FDA merely evaluates research that is usually submitted by medical device and drug makers with a vested interest in that research. The FDA hasn’t the time, the funding, or the personnel needed to do the job entrusted to it, the job that most Americans assume it is doing.

The FDA has – through budget cuts and restructuring of its funding, political pressures from Big Pharma lobbyists, and a revolving door which shuffles drug and medical device company employees in and out of FDA employment – now become little more than a pawn for medical device and drug makers. Medical device companies making billions of dollars on dubious devices – like overused IVC filters, over-prescribed heart stents, and dangerous metal-on-metal hip implants – use the FDA primarily as a cover. They use the agency to imply that it has verified the safety and efficacy of their medical devices, and to help them sidestep liability lawsuits.

Full FDA approval can and does help medical device makers sidestep many liability lawsuits; however, FDA approval does not verify the safety and efficacy of medical devices.

The Danger Within Us: America’s Untested, Unregulated Medical Device Industry
This is not Conspiracy Theory 101. This is the fact of the matter, and it is well documented in at least a dozen extensively-researched books. One of the latest, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, by Jeanne Lenzer, makes the case all over again.  Ms. Lenzer shows just how broken our medical regulatory system is.  The book should be required reading for the U.S. Supreme Court, which has ruled in some landmark cases that FDA approval grants medical device makers a free pass to harm people at will with poorly tested or even arguably worthless medical devices.

Despite the woeful state the FDA has been left in after billions of Big Pharma lobbying dollars have worked to undercut and weaken it, the U.S. Supreme Court has ludicrously ruled that FDA approval of a medical device gives its maker license to avoid legal responsibility for injuring people.

Riegel v. Medtronic:  Justice Denied by Preemption

In Riegel v. Medtronic and other miscarriages of justice, the highest court has ruled that medical device makers get a free pass when they make a device that injures or kills someone, if that device was approved by the FDA.  The ruse is called “preemption.” It adds an additional injury to people whose lives were taken entirely or perhaps only badly damaged by some dubious medical device. The preemption argument, in a nutshell, claims states can’t comply with both federal and state laws; therefore, federal laws “preempt” state’s rights.  Preemption is a Sophist argument easily refuted on both legal and ethical grounds by anyone (such as Justice Ginsburg) who believes in civil liberty, corporate responsibility, and the U.S. Constitution. But all is not lost, yet.

Medical devices which have not gone through the FDA’s full PMA approval process are still fair game for liability lawsuits. That is at least the case for now, though several bills written by medical device and drug company lobbyists are currently being pushed by Big Pharma’s lackeys in congress. The obvious goal for the Western medical “industry” is to remove all vestiges of remaining protections for people injured by dangerous drugs and medical devices. Unfettered profits with zero accountability has always been the goal of every corporation, of course, but in the case of the healthcare “industry,” that goal strikes one as especially unmoored from any basic semblance of human decency.

Related: 21st Century Cures Act a Disguised Handout to Drug Companies

The FDA 510(k) Clearance Process
But even in today’s wild west of a healthcare system broken both legally and morally, medical device makers can sometimes still be made to face some legal liability. Medical device makers can still sometimes be held accountable if, rather than gaining full FDA approval for the device in question, it was allowed on the market via the FDA’s 510(k) clearance process. The 510(k) clearance process has so lowered the bar to the open market that even the corporate-friendly judges of the high court have been forced to see that it does not even imply that the FDA has researched the product sufficiently to ensure its safety or effectiveness.

IVC Filter Lawsuits

Because IVC filters were allowed on the market via the FDA’s 510(k) clearance process, IVC filter makers like Cook Medical , C.R. Bard, Cordis, and Rex Medical can still be held accountable when their filters fail to perform as advertised.

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Metal-on-Metal Hip Implant Concerns

Metal-on-metal hip implant concerns have gotten the FDA’s attention. The agency announced in December 2017 that metal-on-metal (MoM) hip implants carry unique risks, in addition to the general risks of all hip implants.

The metal ball and metal cup in MoM hip implants slide against each other while an implantee is walking, sitting, or running. When metal from the two parts rubs together, tiny particles can wear off of the ball and cup, moving around or between them.

Metal Poisoning
The FDA notes that wear and corrosion at the connection between the metal ball and taper of the stem may also occur.  Some of the metal ions – such as cobalt and chromium – from the metal implant or from the metal particles will enter the bloodstream, according to the FDA.

Related:  Hip Implant Lawsuit

Surgical Cautions
To optimize the way in which the ball and socket rub against each other, the FDA says orthopaedic surgeons take several precautions before and during hip replacement surgery.  The idea is to produce and release as few metal particles as possible, but therein lies the problem. There is simply no way to fully avoid the production and release of some metal particles.

The agency acknowledges that different people will react to the released metal particles in different ways.  It also admits that it is not possible to predict who will have a reaction, what type of reaction might occur, when it will occur, or how severe it will be.

Adverse Local Tissue Reaction – ALTR
Metal particles around some implants can eventually damage bone and/or tissue surrounding the implant and joint.  An “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD)” can cause soft tissue damage. Such damage may lead to pain, implant loosening, device failure, and replacement surgery.  The agency says, “Patients with a progressing ALTR may be considered for earlier revision to prevent extensive damage to bone, muscle and nerves.”

Safety Alerts for MoM Hip Implants

•  April 2010: The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients with MoM hip replacements.  Recommendations included blood tests and imaging for patients with painful MoM hip implants.

•  February 2012:  MHRA published a medical device alert, updating it in June 2012 with advice on managing and monitoring MoM hip implant patients.

•  May 2012:  Health Canada issued a public health communication to orthopaedic surgeons and patients over MoM hip implants.

•  Sept. 2012:  Australia’s Therapeutic Goods Administration published safety information for healthcare professionals on MoM hips.

Metal-on-Metal Hip Implant Concerns

FDA adds that reports in orthopaedic literature, data from international orthopaedic implant registries and presentations from professional/scientific meetings have increasingly noted complications and potential problems of early MoM hip system failures.  Much of the available data comes from countries outside the U.S.  It may not be directly applicable to the experience in the U.S.  Some of the devices available outside the U.S. are not marketed in the U.S.; so   international regulatory agency recommendations may not apply to U.S. patients with MoM hips.

The FDA recommends that MoM hip implant patients who develop any symptoms promptly make an appointment with their orthopaedic surgeons.  Besides a physical exam, the  surgeon may consider several tests to evaluate the symptoms.  Tests may include:

•  Needling fluid from around the joint (joint aspiration)
•  Soft tissue imaging
•  Blood tests that measure metal ion levels in the blood

Patients who receive MoM hip implants should also pay close attention to changes in their general health including new or worsening symptoms outside their hip. If they are referred to a doctor to evaluate new conditions, they should let their physician know they have a MoM hip implant. Some case reports and articles in the medical literature suggest MoM hip implant patients may see certain symptoms or illnesses elsewhere in the body (systemic reactions).  These include:

•  General hypersensitivity reaction (skin rash)
•  Cardiomyopathy
•  Neurological changes including sensory changes (auditory or visual impairments)
•  Psychological status change (including depression or cognitive impairment)
•  Renal function impairment
•  Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold

FDA says that unless Mom hip implant patients have signs described above, there is not sufficient evidence to support the routine need for checking metal ion levels in the blood or soft tissue.  But the FDA is “recommending that asymptomatic patients with MoM hip implants continue to follow-up with their orthopaedic surgeon every 1 to 2 years to monitor for early signs of change in hip status.”

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Hernia Mesh Pains Irish Men

(April 20, 2018) – Hernia mesh pains Irish men, the BBC reported late last year.  In America there has been almost a complete news blackout concerning the tens of thousands of women injured by transvaginal mesh, despite several large jury verdicts.  There has also been a near-total blackout on people injured by hernia mesh.

In the UK, however, the BBC has reported on transvaginal mesh problems and also on men in Northern Ireland reporting personal injuries from hernia mesh.  Here’s the story from Sept. 20, 2017 at BBC News.

The men report post-surgical complications that include chronic pain and the inability to work or enjoy their lives.  As in the U.S., the denial of complications from the medical community is a constant complaint of the men interviewed in the BBC story.

Injured Men call for Mesh Ban
The use of mesh is Northern Ireland’s National Health Service’s recommended treatment for groin hernias.  The group of injured patients has called for a ban on the polypropylene (plastic) mesh material.

One Million Hernia Surgeries yearly
The U.S. Hernia Society says one million hernia mesh surgeries are performed yearly. Approximately one in ten people will develop a hernia in their lifetime.  Most doctors continue to use plastic mesh despite a complication rate estimated to be as high as 30%.

Owen Smith, Labor Party, Northern Ireland
A member of UK’s Shadow Cabinet of Northern Ireland, Owen Smith, said he has been shocked by the stories he has heard.  Mr. Smith believes the mesh issue will become one of the biggest in the UK since breast implants.  He has set up a parliamentary group to study mesh problems.

The Department of Health and the Public Health Agency recently conducted a workshop to establish a standard approach through northern Ireland for women with mesh complications.

Ten Deaths Associated With J&J Physiomesh Hernia Mesh
At least 10 deaths and seven injuries have been associated with Physiomesh™, hernia mesh made by J&J.  Those deaths were reported to the U.S. Food and Drug Administration. Experts know that a mere 1-10 percent of actual adverse events are reported to the FDA’s MAUDE database, which could mean the actual death toll is closer to 100.

Plastic Hernia Mesh
Johnson & Johnson and other transvaginal mesh makers continue to face thousands of lawsuits in the federal MDL court set up in West Virginia, as well as in state courts across the country. The polypropylene plastic used in the transvaginal mesh is virtually the same as the plastic mesh used in troublesome hernia meshes.  The material itself continues to be a bone of contention between companies that make and/or use the mesh and plaintiffs’ attorneys representing women and men who allege injuries from that mesh.

Foreign Body Reaction
The human body launches a foreign body reaction against any extraneous material with which it objects.  Mesh makers claim their meshes use the human body’s foreign body reaction in a complementary way which helpfully “meshes” the plastic material with the body’s tissues. Plaintiffs who attribute their injuries to the mesh often include in their claims the argument that the foreign body reaction sets off a chain of events that leads their bodies to completely reject the invading mesh. Some plaintiffs claim this foreign body reaction to reject the mesh is part of a design defect.  Some claim it causes an auto-immune response which exacerbates the physical pain mesh can bring when it fails to “mesh” with the human body as it is designed to do.  The foreign body reaction dispute is but one of many issues which become part of most hernia mesh lawsuits or transvaginal mesh lawsuits.

Our law firm and others have settled thousands of transvaginal mesh lawsuits.  Now, more lawyers are turning their attention to hernia mesh.  Unlucky hernia mesh recipients have reported the same complications which transvaginal mesh patients reported – chronic pain and infection, mesh shrinkage, mesh migration, organ perforation, auto-immune sickness, and more.

Physiomesh Hernia Mesh Lawsuits
Lawyers are focusing on coated hernia meshes. They are specifically examining Atrium C-Qur and Physiomesh™ made by Ethicon, a division of Johnson & Johnson.  J&J’s Ethicon division recalled Physiomesh™ from the market in May 2016.

Two unpublished studies found Physomesh™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical Registry.

Jane Akre of Mesh News Desk reported that the Voluntary product recall states that unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using Ethicon Physiomesh™  Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”

Estimates say 300,000 patients have been implanted with Physiomesh since it was cleared by the FDA for sale via the 510(k) process in 2010.

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First Cook IVC Filter State Trial

(April 18, 2018)  Cook IVC Filter AttorneyThe first Cook IVC filter lawsuit to be tried in state court in the U.S. will begin on May 7, 2017 in Houston, Texas.   The plaintiff is a Texas firefighter who has brought suit against Cook Medical Inc., based in Bloomington, Indiana.  He is represented by David Matthews of Matthews & Associates Law Firm, in Houston, as well as Tim Goss of Freese and Goss in Dallas, Texas.  The trial is expected to last two weeks.

The lawsuit petition states that the plaintiff was surgically implanted with a Cook Celect inferior vena cava filter at Methodist Hospital.  On or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were “unsuccessful because the filter had tilted and become embedded in the wall of Plaintiff’s inferior vena cava.”

The vena cava is the blood vessel located beneath the heart which returns blood to the heart from the lower body.

Relevant facts regarding IVC filter removal as stated in the petition show the difficulty of removing the filter from the plaintiff.

Attempts to remove Plaintiff’s Celect IVC Filter
Approximately two months after the Celect filter was implanted, an interventional radiologist  attempted to remove it.  He was unable to remove the filter because it had tilted and the tip was embedded into the wall of Plaintiff’s vena cava.  After multiple unsuccessful attempts to retrieve the filter via access through Plaintiff’s jugular vein, he aborted the procedure.

In June 2015, another jugular removal procedure was attempted by an interventional radiologist. In connection with this attempted removal, imaging revealed that at least two of the filter legs had perforated through the wall of Plaintiff’s vena cava. This retrieval attempt was also unsuccessful.

Finally, on July 20, 2017, Plaintiff had a life-threatening, invasive open surgery to remove the perforated Cook IVC filter. During the open removal surgery, it was determined that Plaintiff had at least three IVC filter legs poking outside of his vena cava: one in his duodenum (bowel); one beginning to perforate his aorta; and one inside his lumbar vein, which had to be resected for the filter leg to be removed. The degree to which Plaintiff will recover from surgery, and the lingering effects of the perforated filter struts, has yet to be determined.

The petition further alleges that the plaintiff is now at risk for future migrations, perforations, and/or fractures from the retained filter.  He also faces numerous other health risks, including increased risk of clots and risk of death.  He will “require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgery in an attempt to remove the filter.”

The lawsuit petition alleges that the implanting doctor knew or should have known, inter alia, several things, including that:

  • only certain patients were appropriate candidates for an IVC filter.
  • the longer a Celect IVC filter remains in the body, the higher the risk of device fracture or failure.
  • the Celect filter is not effective to prevent clots and/or increases the risks of clots.
  • safer alternatives to the Celect IVC filter existed.
  • IVC filters, such as the Celect filter, should not be used in certain patients, such as the plaintiff.

Cook Celect IVC Filter Problems
The petition alleges that Cook Celect filters frequently tilt, migrate, perforate or fracture and thus, involve a high and increasing degree of risk to a patient who has been implanted with a Celect filter.

The petition further claims that Cook knew or should have known that the Celect device was defective and unreasonably dangerous for several reasons, inter alia, including:

•   Cook failed to conduct any clinical testing, such as animal studies, to see how the device would function once permanently implanted in the human body;

•  The Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. Such failures exposed patients to serious injuries, including: death, hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, and organs; inability to remove the device;

•  Cook knew or should have known that certain conditions or post-implant procedures such as morbid obesity or open abdominal procedures could affect the safety and integrity of the device;

•  Cook knew or should have known these risks for the Celect filter were and are substantially higher than other similar devices;

•  Cook knew or should have known the Celect filter contained conditions which resulted in the device not performing as safely as the ordinary customer would expect;

•  Despite being aware of these risks, Cook misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use;

•  Cook failed to issue a recall of the Celect filter or otherwise notify consumers that a safer device was available.

IVC Filters
IVC filters first hit the medical market in the late 1960s. Several different medical device makers, including C.R. Bard, have introduced several different designs.

IVC filters are allegedly designed to filter or “catch” blood clots (called “Thrombi”) that travel from the lower portions of the body to the heart and lungs. The filters are designed to be implanted either permanently or temporarily within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portions of the body. In certain people, for various reasons, thrombi travel from the vessels in the legs and pelvis, through the vena cava and into the lungs. These thrombi often develop in the deep leg veins. They are called “deep vein thrombosis” or “DVT.” Once they reach the lungs they are called “pulmonary emboli.” Pulmonary emboli present grave risks to human health, including the risk of death.

Someone who undergoes knee or hip joint replacement is at risk for developing DVT/PE. Obese patients are also at risk. So too are those who have vascular diseases, or those who have experienced previous strokes. Several other conditions also predispose some people to DVT/PE.

At-risk people may be prescribed medications like Heparin, Warfarin, or Lovenox to regulate the blood clotting factors. Some at high risk who cannot manage with medications may receive an IVC filter in an effort to prevent thromboembolic events.

Wide Use with no Evidence of Efficacy
IVC filters have been implanted by the hundreds of thousands despite there being no reliable evidence which proves their safety and effectiveness. No evidence proves that IVC filters are worth their risks.

Evidence of harm without evidence of benefit
A 2013 paper published in the Journal of the American Medical Association by Vinay Prasad, MD and others offers a stern critique of IVC filters. The authors declare, “While the benefits of the IVC filter are hard to assess, the complications are evident.”  They conclude their paper with a warning: “Follow current standard of care and place filters where guidelines advise, or do not place filters, after informed consent informs patients that there is evidence of harm without evidence of benefit.”

First Cook IVC Filter State Trial
The Houston trial is expected to last two weeks.

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IVC Filter Controversy Rages

IVC filter lawsuits Cook Blood Clot Filter Lawsuitsare being filed because the preponderance of evidence fails to show that IVC filters are worth their risks.  We are consequently filing IVC filter lawsuits across the country.  Matthews & Associates Law Firm will try the first Cook IVC lawsuit in state court in the country in a trial beginning May 15, 2018 in Houston, Texas.

IVC filter makers such as Cook Medical and C.R. Bard sell fear, first, in order to promote their products.  They always point to the dangers of pulmonary embolism, and claim IVC filters are the only answer to PE when someone is contraindicated for blood-thinning medication.

Pulmonary embolism is undoubtedly a problem, for a reported 422 of 100,000 people in the United States. Left untreated, PE will occur in as many as 40% of all people who develop proximal deep vein thrombosis (DVT).

But identifying a problem doesn’t mean you’ve solved it, or even offered the best solution. Significant controversy surrounds the “appropriate indications” for IVC filter placement. Scientific literature regarding the safety and efficacy of IVC filters is woefully lacking.

Related: IVC Filters risk serious complications

All published guidelines agree IVC filters are indicated in patients who have an acute VTE and cannot receive anticoagulation medications.  Or they are indicated for those whom adequate anticoagulation has clearly failed despite evidence of appropriate use and effect.  Nevertheless, some indications are much more controversial.

Dr. Ido Weinberg and others pointed out in a 2012 IVC filter paper, Cardiovascular Interventions by the American College of Cardiology Foundation, that IVC filters are inserted perioperatively in patients undergoing surgical pulmonary embolectomy. The intent is to reduce the effect of post-surgical PE in this unstable population. In a retrospective analysis of mortality in 520 such patients who were unstable secondary to PE, and who underwent embolectomy – all of whom received an IVC filter – mortality was lower than in 430 patients who received no filter (25% to 58%). The authors wrote that other safety data are conflicting, yet the Society for Interventional Radiology guidelines and ACR appropriateness criteria inexplicably offer that data as a relative indication for placing an IVC filter.

IVC filters are also advocated for high-risk populations without VTE as a prophylactic measure, such as in trauma patients. But several points of controversy apply. First, placing a filter can add complications that include increased morbidity.  Second, patients are at risk for long-term complications if filters are not removed.  Third, studies have shown IVC filters are a poor choice for trauma patients.

IVC filters have also been advocated for people undergoing elective open gastric bypass surgery. Those who received the filters have not been shown to fare any better than those who did not. In fact, studies have shown IVC filter risks outweigh benefits for bariatric patients.

IVC filters are sometimes used in high-risk patients in conjunction with anticoagulation therapy. In a comparison of 251 patients who received both an IVC filter and anticoagulation meds, and 1,377 who received only anticoagulation, there was no difference in PE incidence at 90 days and 5 years, though a trend toward more DVTs in the IVC filter group.

Cochrane Review: compression and anticoagulation effective and safe
Dr. Weinberg and the authors write that, “It is noteworthy that a Cochrane review of combined intermittent compression and anticoagulation for VTE prevention in high-risk patients showed the combination to be effective and safe.”  Which would seem to seriously challenge the notion of IVC filter makers that their filters are the only option in town for high-risk patients.

Do IVC Filters prevent PE?
A population-based study analyzed hospital records from 1991-1995.  It found that the rate of rehospitalization for PE did not decrease with the use of IVC filters. Rehospitalizations for DVT, however, did increase with the increased filter use. Further, Cochrane database investigators could not draw firm conclusion as to whether the filters decreased PE at all.

IVC filter lawsuits filed against Cook and Bard argue that these companies did no relevant long-term studies which randomized patients to find the true effectiveness of their filters. They diligently avoided performing those tests because they knew their IVC filters had no true effectiveness, and that IVC filter benefits are often not worth their risks.

IVC Filter Risks
IVC filters can become embedded in the vena cava. They can also break apart, and their various pieces can travel to the heart, lungs, nearly anywhere the blood can take them in the human body. They have not been proven efficacious. They are decidedly dangerous, and that is why you see so many IVC filter lawsuits filed in state courts and in federal multi district litigation courts across the country.

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IVC Filter Makers Liability over FDA Process

Lawyers for bothBard IVC Filter Lawsuit | Blood Clot Filter Lawyer IVC filter plaintiffs and IVC filter manufacturers continue to tussle in court over the FDA’s role in allowing different IVC filters to be sold on the market. Defense lawyers would like juries to believe that IVC filters were approved by the FDA for implanting in people’s inferior vena cava. Plaintiff’s lawyers want juries to know that IVC filters were never approved by the FDA for use in people. Can both sides be right? What gives?  IVC filter makers face liability over a little-known but common FDA process.

Federal Preemption for Medical Devices
The makers of medical devices which have been approved by the FDA through its regular Pre-market Approval (PMA) process typically avoid lawsuits against those products. That vanishing liability is a a direct result of a 1970s act that changed the nation’s long-established tort law.  Federal regulatory preemption of medical devices began with the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act of 1938 (FDCA). 21 U.S.C. §§ 360c-1; 21 U.S.C. §§ 301 et seq.

Related:  IVC Filter Lawsuit | Lawyer

In a nutshell, the 1976 Act means that any medical device approved by the FDA through its PMA process immunizes its maker against legal liability. Whether or not the device turns out to hurt more people than it helps doesn’t matter. If the FDA approved it, people injured by such a device are out of luck. They had, and still have, little to no chance to remedy their grievances in court.

IVC Filters Not Approved by FDA
IVC filters, by contrast, have not been approved by the FDA.  They never went through the agency’s PMA process.  Instead, IVC filters have been “cleared” by the FDA under the auspices of the agency’s 510(k) clearance process. This process greatly abbreviates the PMA path. It allows the agency to “clear” devices for the market without putting them through the rigorous testing required of devices which seek full FDA approval.

The FDA web site explains, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”  The term “substantially equivalent” can, of course, be very subjective.

Because devices “cleared” through 510(k) are not subject to the same rigorous testing as products put through the PMA process, the companies that make them can still be subject to civil liability.

In the first IVC filter trial in the Phoenix MDL court against C.R. Bard last month, the plaintiff’s attorneys sought to keep misleading characterizations of the FDA’s device approval processes from coming before the jury. They felt that any mention of the FDA allowing the filter on the market could prejudice the jury. The Arizona federal judge overseeing the case denied the plaintiff’s motion to preclude evidence about the devices’ 510(k) clearance.  But the judge also moved to clarify for the jury the FDA’s role in the IVC filter’s market presence.

IVC Filter Makers Liability over FDA Process

The judge said that he would allow the FDA evidence “in context” and would not allow the 510(k) clearance to be used as evidence that the devices are approved by the FDA. (In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz., 2018 U.S. Dist.).

Bard loses $4.6 Million Verdict in First IVC Filter Trial
Having learned that the FDA had not approved the IVC filter but had only allowed it under the auspices of its 510(k) program may have helped sway the jury into seeing the problems caused by the product.  The jury awarded the plaintiff $4 million, $3.6 million of which was assigned to C.R. Bard, maker of the IVC filter.

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Warming Blanket Recall

More bad news came recently for a 3M warming blanket used for hip and knee replacement surgeries that may cause serious infection.  FDA issued a Class 2 recall of 165,000 Bair Hugger Forced Air Warming Blankets on Feb. 12, 2018. The blankets were recalled for a design problem that may prevent them from warming up people during surgery, which is the blanket’s sole intent.

3M’s recall notice said health care providers should identify and discard any Bair Hugger underbody blankets affected by the recall. Recalled lot numbers are R10359, R10360, R10361, R10362, R10363, R10364, R10365 and R10366. They represent some 33,108 cases of five units each distributed worldwide.

The Bair Hugger is a single-use blanket that keeps patients warm before surgery. Four out of five hospitals use the single-use device today. The blankets are used in approximately 90 percent of all hip and knee surgeries.

Warming Blanket Lawsuits
3M Co. faces warming blanket lawsuits from more than 4,200 people who claim the company’s popular “Bair Hugger” surgical warming blankets circulate contaminants and cause debilitating deep-joint infections.

The Bair Hugger forced-air warming blanket has been used in more than 200 million surgeries since 1987.  Lawyers for the Minnesota-based 3M company say no study has proved the blanket causes surgical infections.

3M company spokeswoman Donna Fleming Runyon told the Star Tribune:  “3M will vigorously defend the product and the science against these unwarranted lawsuits. (We) think (plaintiffs’) attorneys are using bad science to blame their clients’ infections on a device that has helped so many people.”

Inventor says Device Creates Infection Risk
Attorneys representing the injured people say research shows the device can spread airborne contaminants while warming up surgical patients.  Dr. Scott Augustine, the inventor of the device developed in the 1980s, is expected to testify that it creates infection risk, especially for joint-surgery patients.

“There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” said Dr. Augustine, a Minnesota Twin Cities anesthesiologist and entrepreneur who now opposes Bair Hugger use. “With regard to orthopedic infections, a scare is what’s needed. This product should never be [used] on another orthopedic patient.”

Dr. Augustine would be a witness with some baggage. He pleaded guilty to a health care-related misdemeanor in 2004, paid a $2 million fine, and denied any wrongdoing.  Today he is chief executive of Eden Prairie’s Augustine Temperature Management, which sells a competing patient-warming device called the HotDog, which uses conductive heat similar to an electric blanket.  The Bair Hugger uses forced air.

Dr. Augustine said he regularly lectures to health care professionals about his concerns regarding the Bair Hugger device.

3M sells various disposable Bair Hugger patient-warming blankets that retail from $6 to $24 each. The blankets include rows of inflatable tubes that fill with hot air to warm patients.  The goal is to improve surgical outcomes by preventing heat loss from the body’s core and reduce hypothermia risk from anesthesia.

A separate warming unit, connected by a hose, pumps air into the Bair Hugger blanket.

Dr. Augustine says that Arizant “stumbled onto” the discovery that the warming unit can disrupt the carefully designed flow of sterile air inside an operating room. He said waste heat from the unit builds up under the operating table and creates convection currents that can stir up contaminants from the floor and embed them on the surface of a knee or hip implant.

“We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,”said Dr. Augustine. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”

Bone and Joint Journal Backs Plaintiff’s Theory
In November 2011, the Bone and Joint Journal in the United Kingdom published a paper from a study of experiments with mannequins and research on past patient records that found the Bair Hugger created a “significant” increased risk for deep-joint infection compared with patients who used the HotDog. The study used statistical regression to report an infection rate of 3.1 percent with forced air, compared with 0.8 percent with the HotDog.

Defense Evidence
A medical-evidence entity, ECRI Institute, evaluated the Bair Hugger and HotDog data. ECRI concluded in 2014 that there wasn’t sufficient evidence to determine whether one system was better at reducing surgery-related infections.

A systematic review of past studies published in the Journal of Bone and Joint Surgery in Massachusetts last year concluded, “forced air warming can impact [air] flow under certain very specific conditions, but any actual clinical impact on surgical site infections must be considered unproven at this time.”

3M claims the Bair Hugger’s safety is supported by 60 randomized controlled clinical trials since its development in 1987.

One plaintiff’s attorney who represents some people suing 3M said the cases could be tough to prove because no direct evidence shows the Bair Hugger stirring up contaminants, then placing them into any particular patient’s surgical wound.

The burden of proof is on the plaintiffs to prove that the blankets are more likely than not causing infections.  The attorney noted that similar indirect evidence on relative risks was the basis for tens of thousands of lawsuits filed against Merck & Co. over its $4 aspirin Vioxx. Merck eventually agreed to pay $4.85 billion to resolve those cases.

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IVC Filter Verdict: $4 Million

(March 30, 2018)  The first Bard IVC filter verdict in the U.S. District Court for the District of Arizona yielded a $4 million jury award for a woman injured by one of the blood clot filter devices. The jury ordered C.R. Bard to pay plaintiff Sherr-Una Booker $1.6 million for failing to warn her surgeon about problems linked with the filter, and an additional $2 million in punitive damages.  The jury found Bard 80% responsible, a radiologist 20% responsible.

The woman’s C.R. Bard blood filter broke inside her body, causing her to suffer open heart surgery. The jury found that Bard had negligently failed to warn the plaintiff and doctors of the device’s problems despite numerous reports of IVC filter complications.

The jury found 20% of fault attributable to radiology errors.  Law 360 reported that a radiologist “failed to flag a visibly separated filter piece on an X-ray in 2009, before Booker’s injuries developed to the point where she needed open-heart surgery.”  Bard’s share of the total damages amounts to $3.6 million.  Despite Bard’s arguments blaming the surgeon, the jury found the surgeon was only partially able to remove pieces of the broken IVC filter from the plaintiff’s body, and was not a cause of her injuries.

IVC Filters show no proof of efficacy but proof of harm

“We expect to see many more of these verdicts,” said attorney David Matthews, who deposed Ms. Booker’s interventions radiologist in the case.  “IVC filters show no proof of efficacy with proof of harm.”

Ms. Booker’s federal case is one of nearly 3,500 claims consolidated in the Ariz. MDL, where U.S. District Court Judge David Campbell is presiding. Ms. Booker filed the case after her IVC filter broke apart in her body. The judge limited the legal claims to defective design, failure to warn, and punitive damages. The plaintiff won all but defective design.

In addition to the $1.6 million award for failure to warn, the jury added another $2 million in punitive damages.

IVC Filter Verdict: $4 Million

First filed in February 2016, Ms. Booker’s lawsuit claimed that her injuries included IVC filter tilting, fracture and perforation. The case is 2:15-md-02641-DGC)

C.R. Bard faces an additional several thousand IVC filter lawsuits filed in state courts across the country.

IVC Filter History
IVC filters were first introduced in 1979. Since then, hundreds of thousands of IVC filters have been implanted in people.

IVC Filter Lawsuits
In August 2010, the FDA issued a safety communication that stated IVC filters “are not always removed.” The agency indicated then that known long-term IVC filter risks included lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization, IVC perforation. More than 7,000 IVC filter lawsuits have been filed in state and federal courts against C.R. Bard, Cook Medical, Johnson & Johnson, Cordis Corporation, B. Braun, Rex Medical, and other filter makers.

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