Bayer Can’t Keep Essure Cases in Fed. Court

(July 25, 2018)  Bayer can’t keep Essure cases in federal court, said a Pennsylvania federal judge on Monday.  The judge ordered 16 consolidated Essure lawsuits back to state court.  The cases were brought by women who allege they were hurt by Bayer’s Essure birth control / sterilization device.  The judge found Bayer had failed to establish federal jurisdiction over the lawsuits.  The Big Pharma giant – now trying to buy the much-despised Monsanto juggernaut – had filed a petition in an attempt to keep the Essure cases in federal court.

In his ruling against Bayer, U.S. District Judge John R. Padova cited a piece of the U.S. Supreme Court’s controversial Riegel v. Medtronic decision.  The judge said that ruling made clear that Congress intended the state courts to resolve cases like those of the women suing Bayer over Essure.  The women’s suits claim Bayer AG violated state laws that parallel federal requirements for medical devices. According to the high court’s Riegel opinion, under the 1976 Medical Device Amendments Act — which regulates medical devices for safety and effectiveness — state claims in medical device cases are barred only if they seek to impose non-federal requirements.

Judge Padova said, “[U]nder the congressionally-designed scheme, the MDA permits individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. (It) would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”

The judge’s using Riegel v. Medtonic to rule against a corporation’s wishes is more than a little ironic; the Riegel ruling by the nation’s highest court virtually erased liability for most medical device makers, if their device had been approved by the FDA.  In a scheme known as “preemption,” Medtronic had argued – in a nutshell – that it was impossible to fulfill both state and federal obligations regarding a warning label. It was a specious argument at best, but it was enough to give a majority of the U.S. Supreme Court cover to back corporate immunity at the expense of injured U.S. citizens.

Judge Padova’s ruling in this case recalls Macbeth’s hesitation in pondering the murder of Duncan.  He wisely worries, “That we but teach bloody instructions, which, being taught, return to plague the inventor.”  Thus Riegel v. Medtonic has returned to plague the inventors, corporations angling for total immunity from liability.

Judge Padova sent the 16 Essure lawsuits back to the Court of Common Pleas of Philadelphia County, where they had first been filed.

Bayer Halts Essure Sales
Bayer’s Essure birth control — or sterilization — device is a medical coil placed in a woman’s fallopian tubes to prevent pregnancy. On July 20, 2018, Bayer said it had decided to stop selling or distributing Essure in the U.S. by the end of the year. The company said in a statement that it had concluded its Essure business was no longer sustainable after years of declining U.S. sales, though Bayer was quick to note that it still stood by the safety and efficacy of Essure.

In April 2018, the FDA required an unusual limitation on Essure sales.  The agency said Essure can be used only if patients are directly informed of its potentially serious side effects.  Essure’s most serious risks – including perforation of the uterus or fallopian tubes – are listed on a black box warning which has appeared on Essure’s label since 2016.

The 16 women in these cases claim Essure migrates from the fallopian tubes and then breaks into pieces. The claimants allege that they’ve suffered severe and permanent injuries.

The women also charge that Bayer negligently trained doctors to implant the Essure device.  They claim Bayer failed to tell the FDA about Essure’s adverse event reports, and failed to include them in the company’s own risk analysis.

Bayer Can’t Keep Essure Cases in Fed. Court
The judge also rejected Bayer’s argument that the cases present substantial disputes of federal law.  He said Bayer didn’t elaborate on what those would be.

Judge Padova said, “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the ‘federal system as a whole.   (We) conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.”

The case is McLaughlin v. Bayer Essure Inc. et al., case number 2:14-cv-07315, in the U.S. District Court for the Eastern District of Pennsylvania.

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New Study questions IVC Filters

(July 16, 2018)  Bard IVC Filter Lawsuit | Blood Clot Filter LawyerA new study questions the use of IVC filters in DVT patients undergoing CDT, catheter-directed thrombosis. The study led by Temple University showed no in-hospital mortality benefit, and worse.  It  showed IVC filters associated with increased procedure-related hematomas, and it also showed that using IVC filters led to lengthier hospital stays and higher bills.

Related:  Cook Medical loses $1.2 Million Verdict

IVC filters are alleged by their makers to help treat DVT, deep-vein thrombosis.  They are advertised – by Cook Medical, C.R. Bard, and other IVCF makers – to be indispensable, life-saving devices.  But their effectiveness in every regard has been questioned by thousand of IVC filter lawsuits.

DVT occurs when blood clots develop in the deep veins of the legs, thigh, or pelvis.  These clots can break loose, travel to the lungs, and cause life-threatening pulmonary embolism (PE).  Proximal DVT – a clot in the thigh or pelvis – has been linked with a higher risk for post-thrombotic syndrome.

Post Thrombotic Syndrome (PTS) and Catheter-Directed Thrombosis (CDT)

PTS is a painful condition characterized by swelling, redness, and leg sores.  In hopes of reducing the high incidence of PTS in patients treated solely with a blood thinner, many doctors today use catheter-directed thrombolysis.  CDT is a minimally invasive procedure in which an infusion catheter delivers clot-busting drugs directly into the clot.  Fluoroscopically guided, CDT can potentially reestablish blood flow through a newly-blocked vein.

In hopes of preventing clots from breaking loose and migrating to the lungs during a CDT procedure, some doctors choose to simultaneously implant an inferior vena cava filter (IVCF).  IVCFs are wire-basket-like devices inserted into the inferior vena cava, a large vein that returns blood from the lower body to the heart and lungs.  IVCFs are used on the theory that they capture blood clots which would otherwise reach the lungs. There is some evidence, which has been produced by IVC filter makers, to support the IVCF theory; but it is scant, at best, and far from convincing, which has led to IVC filter lawsuits.

Any IVC Filter Benefit is Unclear

A research team led by Riyaz Bashir, MD, FACC, RVT, Professor of Medicine at the Lewis Katz School of Medicine at Temple University (LKSOM), and Director of Vascular and Endovascular Medicine at Temple University Hospital (TUH), sought to address the question of whether there is any benefit of IVCF placement at the time of CDT.  The team began by examining nationwide utilization rates of IVCFs in patients undergoing CDT.  They wanted to assess contemporary trends and compare outcomes with patients who do not undergo IVCF placement. The team’s findings were published online July 16, 2018 and also in the July 23rd issue of the journal JACC: Cardiovascular Interventions.

Limited Data for IVCF Patients – 7 Years

“Limited data exists on the effectiveness of IVCF use in patients undergoing CDT for the treatment of proximal DVT,” said Dr. Bashir. “This study is noteworthy because it is the first to evaluate national trends and comparative outcomes related to this practice.”

The research team used the National Inpatient Sample database to identify every person in the U.S. with DVT who underwent CDT (with and without IVCF placement) from January 2005 to December 2013.

The team’s findings include these conclusions:

  • IVCF used in patients undergoing CDT for DVT was not associated with any significant in-hospital mortality decrease compared to patients who did not receive an IVCF.
  • IVCF used in patients undergoing CDT for DVT was associated with an increase in procedure-related hematoma formation (3.4% vs. 2.1%), in-hospital costs ($104,049 vs. $92,881) and length of stay (7.3 days vs. 6.9 days) compared to patients who did not receive an IVCF.

Dr. Bashir said that based on these results, his team believes, “IVCFs should not be routinely placed in patients undergoing CDT.”  Dr. Bashir also called for more well-designed, randomized control trials “to elucidate the implications of IVCF placement in patients undergoing CDT.”

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Johnson & Johnson, Ethicon Mesh Losses Mount

(July 10, 2018) In 31 transvaginal mesh (TVM) trials so far, 22 have concluded with verdicts in favor of plaintiffs.  Eleven (or half) of those verdicts have gone against Johnson & Johnson and Ethicon, which has seen its mesh losses mount faster than any other TVM manufacturer.  J&J has lost five verdicts over its Gynecare Prolift mesh, three for its TVT-O mesh, one for TVT-Abbrevo, one for TVT-Secur, and one for its polypropylene tape used to treat stress urinary incontinence (SUI).

Related:  Transvaginal Mesh Lawsuit

In 2016, the FDA reclassified transvaginal mesh for prolapse repair (but not SUI) as Class III (high risk) medical devices. The reclassification made TVM implants ineligible for FDA’s 510(k) clearance program. That program had previously allowed mesh products on the market without prior clinical trial testing on human beings.  But 510(k) clearance does not amount to FDA approval.  TVM or pelvic mesh devices are not FDA approved.

Johnson & Johnson, Ethicon Mesh Losses Mount

Besides fighting TVM cases in the courts, Johnson & Johnson and other defendants have also quietly settled hundreds of them. As with most settlements, terms are not disclosed and the companies that pay admit no wrongdoing.

Johnson & Johnson (Ethicon) Trials have yielded at least eleven (11) wins for plaintiffs so far. These include:

March 8, 2018 – $35 Million for Plaintiff (Gynecare Prolift)
A U.S. District Court for Northern Indiana jury hit Johnson & Johnson’s Ethicon with a $35 million verdict over its Prolift pelvic mesh. ($10 million in damages and $25 million in punitive damages). Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012 after learning that the Prolift mesh her doctor implanted in 2009 to treat pelvic organ prolapse might be causing her low pelvic pain. The lawsuit petition accused J&J and Ethicon of concealing Prolift problems that included high failure, injury and complication rates, as well as “frequent and often debilitating re-operations.” Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” said the complaint.

The Kaisers also alleged that “[Ethicon] consistently under-reported and withheld information (about) Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”

The Kaisers also alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective. . .”

Dec. 14, 2017 – $15 Million for Plaintiff (Prolift)
A New Jersey woman was awarded $15 million by a Bergen County (New York) Superior Court jury in her transvaginal mesh lawsuit. The verdict followed 2 ½ weeks of trial testimony and nearly a day of jury deliberation. The woman testified that she had been in constant pain since receiving an Ethicon mesh implant. Jurors found the Johnson & Johnson subsidiary had failed to adequately warn her of the risks associated with Ethicon’s Prolift mesh implant. They awarded her $4 million in compensatory damages and $10 million in punitive damages, as well as awarding her husband $1 million for his loss of conjugal affection.

The jury also found Ethicon had failed to provide the woman with adequate safety warnings in regards to the TVT-O mesh implant, but they determined the Prolift mesh alone was responsible for her injuries. (Case No. L-13686-14)

September 6, 2017 – $57 Million for Plaintiff (TVT-Secur)
A Philadelphia jury awarded a woman $57.1 million in damages over a TVT-Secur mesh implant. Ella Ebaugh accused Johnson & Johnson unit Ethicon of making a defective pelvic mesh implant that scarred her urethra and left her incontinent. Her award included $50 million in punitive damages. The jury unanimously backed her claims that two negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.

May 26, 2017 – $2.16 Million for Plaintiff (Prolift)
A Pennsylvania jury awarded $2.16 million to a woman who suffered serious complications from Ethicon, Inc.’s Gynecare Prolift mesh. The verdict came in the Philadelphia Court of Common Pleas. It was the fourth straight loss for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)

April 28, 2017 – $20 Million for Plaintiff (TVT-Secur)
A state-court jury in Philadelphia ordered Johnson & Johnson to pay a New Jersey woman $20 million over a TVT-Secur pelvic mesh. The woman blames J&J’s vaginal-mesh inserts for leaving her in constant pain. The jury concluded that the TVT-Secur was defectively designed and caused Margaret Engleman’s injuries. They awarded her $2.5 million in damages and then hit J&J and Ethicon with $17.5 million in punitive damages.

February 2016 – $13.5 Million for Plaintiff (Polypropylene tape)
A jury in Philadelphia hit Johnson & Johnson subsidiary Ethicon with a $13.5 verdict in the second case involving its pelvic mesh products to go to trial in the city. The Philadelphia Court of Common Pleas jury awarded Sharon Carlino $3.5 million in compensatory damages, $10 million in punitive damages. It found Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective. It also found that Ethicon failed to adequately warn of its risks. Ms. Carlino required three revision surgeries to remove the eroded mesh.

March 4, 2015 – $5.7 Million for Plaintiff (TVT Abbrevo)
A California jury in Los Angeles hit Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict. The jury sided with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages. Ms. Perry had been implanted with Ethicon’s TVT Abbrevo mesh.

December 2015 – $12.5 Million for Plaintiff (Prolift)
A Philadelphia jury ruled Johnson & Johnson must pay $5.5 million to a Pennsylvania woman over its Ethicon unit’s Gynecare Prolift mesh implant. The jury found J&J liable based on the negligence of its scientists in relation to its Prolift pelvic mesh implant. They cited the mesh as the root cause of plaintiff Patricia Hammons’ inability to have sex after it was implanted. The jury later added $7 million in punitive damages.

A Pennsylvania state court judge ruled in 2014 that Johnson & Johnson and other pelvic mesh makers like Boston Scientific and Bard will need to challenge more than 860 product liability lawsuits on a case-by-case basis.

September 2014: $3.3 Million for Plaintiff (TVT-O)
In West Virginia, a federal jury in the MDL court hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling. The jury found in favor of plaintiff Jo Huskey on all counts, which included strict liability, design defect, failure to warn, negligence.

April 3, 2014: $1.2 Million for Plaintiff (TVT-O)
A Dallas jury ordered Johnson & Johnson to pay a Texas woman $1.2 million for a defective plastic sling – the TVT-O – which J & J’s Ethicon division makes and markets for stress urinary incontinence. Freese & Goss and Matthews & Associates represented the woman, Ms. Linda Batiste.

February 2013 – $11.11 Million for Plaintiff (Prolift)
A New Jersey jury awarded Linda Gross an $11.11 million verdict in her lawsuit against Johnson & Johnson’s Ethicon over the company’s Prolift vaginal mesh product. Ms. Gross suffered 18 surgeries in repeated attempts to remove the failed mesh and resultant scar tissue. The jury found J&J had failed to warn patients and doctors about the risks of its mesh products and that the company made fraudulent misrepresentations.

Johnson & Johnson TVM Court Wins
Johnson & Johnson settled at least one Prolift trial which had reached the MDL courtroom, and it has won two TVM trials so far. In February 2014, company lawyers were able to have Judge Goodwyn dismiss the case of a Texas woman against Ethicon and J&J (Lewis v. Ethicon/JJ) in a TVT-O case, and a Texas jury awarded nothing in a Nov. 2015 case over a Prosima device that reached trial (Cavness v. Ethicon/JJ). J&J also settled with the plaintiff in at least one TVM case which reached trial in March 2015 (Bellew v. Ethicon/JJ).

Transvaginal Mesh Lawsuits
Today, many thousands of TVM cases remain unresolved, parked in various state courts across the U.S. and in the federal MDL in West Virginia. The overseer of the federal MDL court, Justice Joseph Goodwyn, announced in June 2018 that he will no longer accept new mesh cases. Judge Goodwin has overseen several MDL trials and still has more than 100,000 cases on his books. He has urged the defendants to settle, some have occasionally obliged, but the sheer number of cases in the MDL makes it the largest federal court docket for mass tort litigation since asbestos.

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100,000 Women suing over Gynecological Mesh

(July 7, 2018)  The mainstream media has finally recognized that a huge number of women are suing mesh manufacturers over their plastic products.  A CBS news story reported last month that nearly 50,000 women are suing one mesh maker alone over gynecological mesh.  The polypropylene (plastic) mesh is often used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI),  which affect millions of women.  At least 100,000 women across the country are suing over gynecological mesh.  Many have filed their cases in the multidistrict litigation court in West Virginia.  Several other pelvic mesh lawsuits have been filed in various state courts throughout the country.

Related:  Transvaginal Mesh Lawsuit | Pelvic Mesh

Gynecological Mesh Makers

The CBS news story mentioned only Boston Scientific as a defendant in transvaginal mesh (TVM) cases, though several other gynecological mesh makers also face lawsuits.  Other defendants include Johnson & Johnson (Ethicon), American Medical Systems (AMS), C.R. Bard, Coloplast, and Cook Medical.

Sixty Minutes reported that Boston Scientific faces some 48,000 lawsuits in what has generated the largest multi-district litigation since asbestos. The suits claim mesh can inflict life-changing pain and injury.  Suits against Boston Scientific also claim the company used a mesh product never meant to be put inside the human body.

Related:  Johnson & Johnson Mesh Verdicts Mount 

More than two million American women have received gynecological mesh implants.  All the mesh makers claim their products are safe.

CBS News

CBS News reported the story of one woman implanted with a Boston Scientific gynecological mesh for stress urinary incontinence and also to lift organs that shifted after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.

Gwyn Madsen told CBS that the mesh “felt like a cheese grater inside of me.”

Ms. Madsen said she suffered pain which left her barely able to sit or play with her children.  She said, “It felt like the material was pulling on the muscles and I’d get shooting pains.  You almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk.”

Boston Scientific, which lost a $73 million verdict over  one of its TVM products following a 2016 trial in Texas, has fought allegations like Ms. Madsen’s for years.  The company told CBS: “Nearly one million women have been successfully treated.  (We) have extensively tested the [plastic] resin to confirm its composition, safety and performance.”

100,000 Women suing over Gynecological Mesh

The American Urogynecological Society – which has embraced the plastic mesh because it is easier to apply than the gold standard suture method for repairing POP or SUI – has also claimed plastic mesh is “safe and effective.”   Many doctors, however, disagree.

Dr. Michael Margolis testified for the woman who won a $73 million verdict in the Texas case.  He told CBS that the women’s mesh causes a chronic inflammatory reaction.  He has removed more than 350 mesh implants.

“The slings I’ve removed are substantially altered in their architecture,” Dr. Margolis told CBS.  “They are shrunk by at least 50% in width.  They are encased in scar tissue. The pores [in the mesh] shrunk substantially.”

Dr. Margolis showed CBS a mesh he removed which had been implanted.  It had shrunk substantially, he said, had folded, contracted, embedded in scar tissue, and was choking off the woman’s urethra.  He said it was half the size it had been upon implant.

Dr. Margolis told Scott Pelley the implant is “not supposed to change.”

Missing from the CBS story and interviews was the fact that Boston Scientific, as well as Johnson & Johnson (Ethicon, American Medical Systems (AMS), and Bard have all lost multi-million-dollar verdicts to women implanted with the companies’ transvaginal mesh products.

FDA:  Serious Adverse Events “not rare”

The story did include the fact that the FDA has issued a damning report regarding TVM mesh.  In 2011, the FDA said that it found mesh used to support organs after pregnancy had resulted in nearly 4,000 “reports of injury, death, and malfunction” and complications including “pain, infection, urinary problems, bleeding and organ perforation.”  The FDA wrote that, “Serious adverse events are not rare.”

Indeed.   At least 100,000 women would apparently agree with that statement.

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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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