TOV Injury and Safety Blog

Abbott Laboratories agrees to pay $1.6 billion dollar fine for illegal marketing of Depakote

The pharmaceutical maker announced this week that it would pay this combined criminal and civil fines by agreement with the federal government, after admitting that it violated federal law in marketing the anti-seizure medication.   As seems to be the case in most pharmaceutical manufacturers' punishments, the fines probably don't even approach the profits the company earned by its illegal conduct.

Although Depakote was approved for sale by the FDA, the FDA did not approve its use for schizophrenia or dementia.  Abbott illegally set up a "specialized sales force" that attempted to persuade nursing homes and others to purchase the drug to control patients' and residents' agitation.    This effort to "sedate" elderly patients, without securing FDA screening of the use for this purpose, was considered particularly egregious, given the patients' inability to protect themselves or to give their informed consent.

Abbott also wrongly marketed the drug for schizophrenia, even though its own clinical trials had not proven the drug to be more effective than existing antipsychotic medications.  Doctors may experiment with "off-label" or unapproved, untested uses of FDA-approved drugs, however, the manufacturer cannot market a drug for such an un-tested use.  In Michigan, drug manufacturers enjoy immunity for FDA-approved drugs--even though the approval was not secured for the marketed use of the drug.  Michigan is the only state that affords pharmaceutical manufacturers this form of immunity.

Sixth Circuit recognizes class action status of women whose Whirlpool washers developed mold

Gina Glazer and Trina Allison filed a class action lawsuit against Whirlpool Corporation after their front-loading washers developed mold in the detergent dispenser.  The trial court certified their complaint as a class action and Whirlpool appealed.  The Sixth Circuit Court of Appeals upheld the trial judge's certification after reviewing the necessary elements and the discretionary standard.

With profits down, Pfizer announces it will re-focus on research.

For years, apologists for the pharmaceutical industry have attempted to justify outrageous industry profits by arguing that they were necessary to support industry research that ultimately benefits consumers with new medications.  Last week's announcement by Pfizer that it now would re-focus on research in response to dwindling profits demonstrates how ill-founded the prior claim was.

Since Pfizer lost its monopoly on Lipitor last fall [parenthetically the best-selling drug in history], its profits have already dropped by 19% and company executives are announcing a radical shift.  Instead of buying up small competitors, Pfizer now plans to divest its animal health and infant nutrition subsidiaries, and instead focus its research efforts on only "the most promising" areas of pharmaceutical research.  One executive was quoted to the effect that "...we were spending huge amounts of money...we weren't producing the drugs we needed..." 

The Company also announced that it would spend less on research and development at the same time that it improved its focus on developing market-worthy new medicines.  Critics called this a risky and counter-intuitive strategy. In any event, it is yet another acknowledgement that enormous profits were not being directed to effective research in human medicine.

Merck pleads guilty to misbranding Vioxx

This week Merck & Co. pleaded guilty to mis-branding Vioxx in order to settle criminal charges that it sold Vioxx for unapproved uses and made false statements about its cardiovascular safety.  Merck had previously paid $4.85 billion dollars to some 50,000 patients who suffered strokes or heart attacks and blamed them on Vioxx.  Merck will also pay more than 300 million dollars in criminal fines.

Unfortunately, none of these reparations will benefit Michigan residents:  As part of "tort reform," Republican legislators adopted the nation's only statute granting complete immunity to any product that had been approved for sale by the FDA.  Even where, as here, the FDA approval is procured by fraud or the manufacturer evades the limitations on sale of the product, the immunity stands.  Recently the Republican majority of Michigan's Supreme Court upheld this immunity even with regard to expenses wrongfully incurred by the State as a result of a drugmaker's misdeeds.

Child cannot sue Meijer for second-degree burns suffered as a result of leak from pre-cooked deli chicken

Meijer's deli serves pre-cooked whole chickens which are maintained at a temperature above 140 degrees to prevent the growth of bacteria.  11-year-old Bailey Malthaner accompanied her mother to the grocery store after having a tooth removed and was seated in the main compartment of her mother's shopping cart.  When her mother purchased the chicken in an enclosed plastic container, Bailey asked if she could hold it.  Almost immediately she started to scream and mom discovered that hot grease was leaking from the plastic container and burning Bailey's leg.

Attention brought to immunity issue involving generic drugs

In most states, a drug manufacturer may be sued if a drug it patents is sold with inadequate warnings and instructions to consumers.  The FDA approves drug warnings and labeling, but the manufacturer remains liable if the language proves inadequate in practice.  Well, actually the manufacturer remains liable in all states except Michigan where "tort reformers" gave manufacturers immunity for all drug claims involving FDA-approved drugs (even if the approval was later withdrawn or originally achieved by fraud or falsified data).

Last year, the U.S. Supreme Court majority granted immunity to generic drug manufacturers for "failing to warn," with the conservative majority holding that since generic manufacturers were merely copying the drug and labeling from patented drugs, they owed no duty to consumers to provide further information.  This immunity grant created an unlikely situation. Consider this example:  Diana Levine, a professional musician who lost a hand when an injection of anti-nausea drug in the ER caused gangrene, collected $5.8 million dollars in damages against Wyeth, the drug manufacturer.  Debbie Schork suffered the identical injury in similar circumstances, however, her claim was dismissed without compensation, because the ER nurse injected her with a generic version of the drug.

Since 80 percent of prescriptions filled in the U.S. are now filled with generics; since many health insurers now require the use of generics and the law allows pharmacies to substitute generics for prescribed medications, there is little or no justification for granting generic manufacturers immunity for inadequate warnings and instructions.  The ultimate goal of a legal system should be to render justice that is uniform, predictable, and consistent.  The situation existing with regard to pharmaceutical manufacturers enjoys none of these characteristics.

USA Today points out that pharmaceuticals have paid at least 8 billion dollars in fraud penalties

In today's USA TODAY, it was pointed out that Pfizer has paid 3 billion dollars in fines and Merck an additional $1.6 billion, with other major pharmaceutical manufacturers paying more than $3.4 billion.  Despite this record of overwhelming fraud on Medicare and Medicaid, the companies continue to make record profits from sales to Medicare and Medicaid recipients, because under their patent protection, the consumers have no where else to purchase needed medications.  An Assistant inspector general for Health and Human Services pointed out that the government is "seeing some of the big companies a second and third time...the corporate integrity agreement [which convicted companies sign as part of the resolution of claims] is not sufficient to deter further misconduct."  In response, Republican Chuck Grassley of Iowa joined with Democrats to attempt to pass a federal bill that would include individual liability for corporate executives, however, heavy spending (over 200 million dollars including 12 million by Pfizer) and lobbying by the pharmaceutical companies has thus far prevented passage.

University of Michigan investigation demonstrates filthy surgical instruments are common hazard

It does little good for your surgeon to "scrub up" carefully, if the tools of his profession harbor bacteria.  In part because of a design flaw in many surgical instruments, it turns out that bacteria and debris are frequently carried from patient to patient in inflow/outflow cannulas, arthroscopic shavers, endoscopes and other instruments. Recent investigations have documented literally hundreds of infections, some fatal, transported within these instruments because the medical professionals using them had not followed manufacturers' instructions on cleaning.  In other cases, however, investigators have determined that the manufacturers' instructions are simply not adequate to remove surgical debris (and germs). 

Risperdal maker faces additional exposure (in hundreds of millions of dollars) for illegal marketing

In 2010, a Court in Louisiana awarded the State 257.7 million dollars against Johnson & Johnson, for its illegal marketing of the drug. In 2011, a South Carolina judge ordered the company to pay $327 million dollars because of its illegal marketing efforts in that state.  Two weeks ago, the company agreed to a one billion dollar civil settlement with the federal government over the latter's claim that Risperdal was marketed illegally.  This week a trial started in Texas over that state's claim that Johnson & Johnson owed more than one billion dollars in false marketing damages.    Risperdal is an antipsychotic drug that was never approved by the FDA for treatment of children or the elderly.  Despite that limited approval, courts and experts have determined that the manufacturer lied about the drug's efficacy and encouraged physicians to prescribe it for unsafe and unproven purposes.  Cases are also pending in seven additional states.  Cases in two states are on appeal, including a 330 million dollar judgment in Louisiana. There are also approximately 500 individual injury claims pending against the company.

Risperdal was once the company's best selling dru, generating sales in excess of 24 billion dollars from 2003 to 2007 when it lost patent protection. Profit margins were apparently pretty good, as the South Carolina judge concluded that Johnson & Johnson's profit on the drug was 97 percent of total sales.  Other competing manufacturers have paida total of2.66 billion dollars to resolve similar government marketing claims.

The Texas allegations against the manufacturer include claims that it paid $340,000.00 to Texas state mental health employees to promote the drug.  They also include claims that sales representatives were making marketing calls on doctors who only treat children--despite the company's claim that it did not market the drug for use with children or the elderly.  The Complaint filed in Texas includes specific facts that seem unlikely to be false, for example the allegation that the company's sales representatives called on one child psychiatrist a total of 96 times.

Michigan citizens won't be recovering any of their hundreds of thousands of mis-used tax dollars from the companies who defrauded our taxpayers:  Michigan Republicans passed the only law in the nation that grants immunity to drug manufacturers if their product was approved by the FDA.  They can safely lie, cheat, steal or bribe in our jurisdiction, apparently.

Scientists explore weighty data linking asthma and acetaminophen

In 1998 Dr. Arthur Varner, a fellow at the University of Wisconsin Medical School, published his suggestion that perhaps the dramatic rise in asthma occurring during the past thirty years was associated with the radical change from aspirin to acetaminophen as the treatment of choice for childhood fevers.  Since then, 20 different studies have been published suggesting a link between acetaminophen and asthma.  Unfortunately, most have been confounded by the fact that the subject children are likely to be receiving acetaminophen to address viral illnesses that have also been linked to asthma:  it has not been clear whether scientists are simply tracing the association between a treatment for infectious fever and an infectious cause of asthma.

One study intended to address this potential confounding of causation randomly assigned young patients to receive either ibuprofen or acetaminophen for fevers.  The acetaminophen patients did report significantly more asthma symptoms in the following year. A larger study is now being undertaken in an attempt to further quantify this relationship and scientists note that both acetaminophen and non-steroidal anti-inflammatories each have risks and advantages.  Nevertheless, one physician was quoted in the New York Times to the effect that he would prescribe his child ibuprofen for fever, given the present state of knowledge.

Merck pleads guilty to illegal marketing of Vioxx; pays additional 950 million dollars

This week Merck & Co., the second-largest U.S. drug manufacturer, agreed to plead guilty to making false statements in marketing the pain-killer Vioxx.  It acknowledged multiple incidents of sales persons informing doctors that Vioxx had been approved and was safe and effective in treating rheumatoid arthritis, when in fact it had not been approved.  Merck, Sharp and Dohme will actually enter the guilty plea.   Merck pulled Vioxx off the market in 2004 after research showed it increased the risk of heart attack and stroke.  It has since paid $4.85 billion dollars to settle thousands of civil lawsuits by injured patients.  Some 43 states have also sued Merck to recover Medicaid expenses incurred in reliance on false representations.  Michigan residents were not eligible to participate in these settlements because Michigan is the only state that provided Merck complete immunity from liability due to its FDA approval.  Vioxx had been generating $2.5 billion dollars in annual sales before it was pulled from the market.  Many of the civil suits allege that Merck failed to disclose research which demonstrated, early on, that Vioxx increased the risk of heart attack and stroke by as much as five times, when compared with a competing pain killer.

Underage press operator cannot sue owner of unguarded press

Joshua Sparks sued Century Tool & Die and several other defendants after severely injuring both hands operating an unguarded press.  The Court of Appeals ruled that the lower court erred in deciding the factual issue of who owned the press, but still upheld the dismissal of the claim against Century.  It ruled that the owner of a press owes no duty to assure that it is properly guarded once it is provided to other parties to operate.  Of course, the underaged employee cannot recover damages from his employer, either, because he is limited to workers' compensation benefits.  And, most likely, since he retains some residual earning capacity and worked for a low wage, he will get nothing in the way of wage loss if the Republicans are successful with "worker's compensation reform."

Drug companies seek to overturn rule prohibiting marketing for off-label uses

Several sources reported yesterday that the major drug manufacturers have initiated a campaign  to overturn the FDA Rule that prohibits them from actively marketing drugs for uses that have not been researched and approved.  As the law currently stands, drugs are approved by the FDA for particular uses, and while a physician may utlize a drug for a purpose not previously approved, the manufacturer cannot actively market and promote these "off-label" uses.  Now, Big Pharma is using its money and influence in Washington to eliminate this safety rule. Not hard to guess who will win this round, given the current influence of money in politics.

Anonymous company bids to set consumer product safety policy in secret court proceedings?

Is this how policy is made and justice meted out in the United States today?  The Consumer Product Safety Commission establishes a website where consumers can find data on product complaints.  A company files a federal lawsuit, under seal, seeking to overturn the CPSC's authority to maintain the website, and gets permission to keep the proceedings secret?  For the moment, yes.  And this is not China; not Iran; not North Korea.  It is our country and our court.  Our forefathers would roll over in their graves.  Let's hope the presiding judge injects some sanity into this action and makes the public court system public when it decides national policy on consumer protection.

Feds continue to document payments by device makers to surgeons

Still wondering why that recent hospital procedure was so expensive?  Maybe it was the several thousand dollar cost of the medical device used by the surgeon.  Wondering why that cost so much?  Maybe because some surgeons earn nearly a quarter million dollars annually with payments from medical device makers.  A study published in the Archives of Internal Medicine examining the disclosures of five major medical device manufacturers showed that they paid surgeons more than $198 million dollars in 2007, alone.  The data comes from a U.S. Senate investigation sparked by disclosures that Medtronic had paid surgeons to promote the use of it's since-discredited bone-growth implant Infuse and perhaps fudged their data on infections and complications.

"Gun enthusiast" who lost an eye cannot sue manufacturer or gun owner

Lynn Walton sued his friend Larry Miller, Midway Arms and Pacific Tool & Die after Miller's rifle exploed while Walton was firing it.  Walton, who lost an eye,  argued that Miller was negligient in placing a slot in the rifle chamber to accommodate a Sako-style exctractor; he argued that the other Defendants (who designed and built the extractor) were negligent in selling a product that was unsafe and prone to foreseeable mis-use by gun owner-purchasers.

Cantaloupe infections are traced to Jensen Farms' barn

The listeria outbreak related to cantaloupe that has so far caused 25 deaths and sickened more than 120 people, has been traced to a processing barn owned by Jensen Farms in Granada, Colorado.  Federal authorities found the deadly bacteria on a conveyor belt that carried the fruit, as well as a melon drying area, a floor drain, and in other locations within the shed.  The farm had "passed" a food safety audit by an outside contractor only days before the outbreak began, according to Eric Jensen, earning a score of 96 points out of 100! 

Most food suppliers are required by retail purchasers to undergo these "independent" audits in order to sell their fruit.  In this case, Jensen had contracted with PrimusLabs and it subcontracted the inspection to a Texas Company, Bio Food Safety.  The president of the latter company disclosed that the auditing employee had been hired in March of this year, and claimed that he had received two one-week training courses.  Incredibly, the company "thought he did a pretty good job" inspecting the facility and claimed it had reviewed the audit and "found no problems in how it was conducted or in the auditor's conclusions."  According to the New York Times, when the president of thecompany was asked how its inspector could give high marks to a facility that was described by the FDA as a "breeding ground for listeria," he responded that "There's lots of variations as to how people interpret unsanitary conditions." 

This is what passes for food safety in the anti-government, market-based economy that Texas Republicans like to celebrate.  Hopefully Jensen and the "auditors" will pay enough in personal injury verdicts and settlements to prove that superficial, cheap food safety "audits" aren't profitable.

Pediatricians warn against using bumper pads in cribs

The nation's American Academy of Pediatricians issued a recommendation on Tuesday, suggesting that parents not use bumper pads in cribs.  The doctors pointed out that the bumper pads are a suffocation hazard and apparently can contibute to the risk of Sudden Infant Death Syndrome (SIDS).  They are not effective in preventing injuries caused by limbs being trapped in slats.  The City of Chicago has already issued a ban on bumper pads and the State of Maryland is considering a ban.

Federally-sponsored task force recommends against prostate screening for men

The United States Preventative Services Task Force issued a recommendation this week that men not undergo routine prostate cancer screening.  So-called PSA or prostate-specific-antigen testing has become routine with many physicians and is now a very lucrative business for the manufacturers of the test, the labs who process tests, and the doctors who treat prostate cancer.  Nevertheless, the Task Force called for elimination of routine screening and cited five well-controlled clinical trials to support its conclusion that PSA screening does not save lives and does cause untold misery to many men.

Consumer Product Safety Commision votes 5-0 to seek guarding on table saws

The U.S. CPSCvoted 5-0 on October 5, 2011, to initiate an investigation into regulating tables saw safety.  It noted that they cause more than 4,000 serious finger, hand and arm injuries each year.  The agency plans to examine technologies such as that offered by SawStop LLC which will purportedly stop a blade instantly when human flesh is encountered. The Power Tool Institute (meaning Stanley Black and Decker, Ryobi and other manufacturers) objects to adopting SawStop's technology for fear that it "could create a monopoly" for the company.

Listeria outbreak appears to be third-most fatal food-borne illness outbreak since Feds began record-keeping

The New York Times reported today that the listeria outbreak associated with cantaloupe sold by Jensen Farms' Rocky Ford Company in Colorado is now the third-most deadly food-borne illness recorded in the U.S. since the early 1970s.  13 deaths have been recorded, with most of the victims being elderly.

Patients have no recourse when generics aren't supported with adequate instructions, warnings

The Sixth Circuit ruled this month that Lala Smith, Alice Wilson, Dennis Morris and other plaintiffs could not pursue a claim against Wyeth, Inc., and other drug manufacturers.  The Plaintiffs acquired tardive dyskenesia (a condition similar to Parkinson's Disease) as a result of taking metoclopramide, a generic prescribed to address gastro-esophageal reflux disease.  They argued that they relied--to their detriment--upon the product instructions and warnings written by Wyeth, Inc., and published in the Physician's Desk Reference.   The Plaintiffs claimed these warnings and instructions were inadequate.

The Court held that the claims against generic drug manufacturers were preempted by federal law intended to encourage the use of generics, and that the claims against the original manufacturer who wrote the product insert should also be dismissed, because the plaintiffs were never prescribed the name-brand medication.

NSAIDs increase risk of miscarriage

A study from Quebec, comparing the records of 5,000 women who miscarried with the medical records of 50,000 women who experienced a pregnancy but did not miscarry, demonstrated that women taking  NSAIDs during the first 20 weeks of pregnancy increase the risk of miscarriage by 2.64 times.  It is believed that NSAIDs may interfere with levels of prostaglandin hormones that are involved in inducing labor.  Therisk was greatest for diclofenac, and higher for naproxen (Aleve) than for ibuprofen.  The author recommended acetaminophen as a safe alternativefor use early in pregnancy.

FDA must look more closely at epidemic of all-metal hip implant failures

The New York Times reported this month that the Food and Drug Administration has received more than 5,000 reports THIS YEAR of failed metal-on-metal hip implants. At this rate, hip implant failures will be the most significant medical product failure since the Medtronic heart device failures in 2007.

All-metal implants account for about one-third of the estimated 250,000 replacements performed each year, and one of the most problematic devices is Johnson & Johnson's Articular Surface Replacement (ASR) which accounts for about 75% of the complaints examined by the Times.  The times found another 1600 complaints involving the Durom cup since 2007, 200 complaints about the all-metal DePuy Pinnacle device and 400 additional related complaints in Pinnacle patients.  One of the concerns raised by the complaints relates to metal debris and the dissemination of metallic ions through the patient's body.

FDA determines drug research firm faked results

Reuters reported on July 27 that contractor Cetero Research has faked documents and manipulated samples in research it performed on pharmaceuticals.  An series of studies and audits reportedly uncovered "significant instances of misconduct and violations."  The North Carolina firm was guilty of a pattern of misuse in research for several drugmakers during the period 2005-2010.  The lack of integrity in Cetero's research places in question the quality of research supporting drug applications by the involved drug makers, who were not identified.   Despite the lack of integrity and control in the drug approval process, the State of Michigan provides complete immunity for drug-makers whose pharmaceuticals are approved by the FDA.  Michigan is the only state that grants this immunity.

Woman's damage award against machiner manufacturer is overturned.

Gloria Rocha sued Better Built Manufacturing, Inc., in Montcalm County, after her arm was amputated while operating a Better Built potato seed cutting machine.  Rocha's sleeve caught in the conveyor of the machine, which she claimed lacked adequate safety features.  After a bench trial, the judge awarded her damages in the amount of $1.5 million dollars, but awarded nothing for lost wages or other economic damages.  The Court of Appeals found this outcome to be inconsistent with the court's ruling and reversed only that portion of the award that denied economic damages. 

We think it is likely that the Court made a clumsy attempt to award all of the available coverage to the woman with the amputated arm, while precluding repayment of the workers compensation insurance company's lien for medical expenses and lost wages.  The latter lien would typically take priority over Ms. Rocha's recovery.

Spine specialists repudiate Medtronic spinal fusion product; doctors who cashed in.

Medtronic earns something over 900 million dollars per year selling Infuse, a bone growth product used by surgeons performing spinal fusions.  The product is used in about one-quarter of the 432,000 spinal fusions performed in the U.S. annually (a number that has increased substantially as surgeons have created regional corporate entities to buy and sell to hospitals the products they use during fusion surgeries). It is used as a replacement for bone grafting material.

The Spine Journal devoted an entire edition to repudiating the research cited by Medtronic and the ethics of the company and its supporting surgeons.  The editors of The New England Journal of Medicine and the Journal of the American Medical Association told the New York Times that this situation was unprecedented.  Dr. Christopher Bono, editor of The Spinal Journal told the paper that the "spinal care field is currently at a precarious intersection of professionalism, morality and public safety."

According to the special edition of the journal, Infuse presents a much higher risk of complications (male sterility, infection, bone loss and unwanted bone growth), including dangerous complications, than was published by Medtronic.  Use of Infuse in the cervical spine was never approved, due to dangerous complications that were identified originally and not understated.  

In addition, the research conducted supporting the use of Infuse was the product of surgical consultants who earned--on median---between 12 and 16 million dollars from Medtronic.  One surgeon, Thomas a. Zdeblick of the University of Wisconsin, was reported to have claimed that he had no direct financial interest in the product, even though he has received more than 20 million dollars in royalty payments from Medtronic.  Zdeblick's colleagues were quoted in the paper describing his position as "hardly credible" and a "fascinating denial...[of an] enormous conflict of interest."

Nevada punitive damage claim against hormone replacement drug manufacturer upheld

This week the U.S. Supreme Court upheld a $58 million dollar damage award against Wyeth Pharmaceuticals, Inc., arising out of the company's failure to warn three women taking Premarin and Prempro of the risk associated with breast cancer.    The verdict, including 35 million dollars in punitive damages, was handed down in 2007.  The jurors had found that Wyeth acted recklessly in failing to warn women that taking estrogen replacement drugs significantly increased the risk of developing breast cancer. 

Generic drug companies shielded from liability; state statute limiting private information sharing is struck down

This week the conservative U.S. Supreme Court ruled that generic drug manufacturers cannot be sued for failing to provide patients with adequate warnings and instructions.  The ruling created the absurd circumstance that name-brand manufacturers are exposed to liability for inadequate warnings and instructions, but generic manufacturers are not.  The Court majority based its decision on federal regulations requiring generic manufacturers to adopt  FDA-approved package inserts.  The lead opinion was authored by Justice Clarence Thomas who acknowledged that it "makes little sense."

In the same term, the Court struck down a Vermont statute that prohibited the sale of pharmacy records and their use for marketing purposes.  The statute was intended to stop the practice of selling drug prescription information for unrelated marketing purposes and to reduce drug-marketing pressure on doctors.  The Court's conservative Justices held that it constituted a violation of First Amendment "free speech" guarantees.  Critics noted that in past years, this type of "speech" was deemed commercial speech and subject to greater restriction than political speech.  Obviously, the current court considers political and commercial speech to be one and the same thing--having tossed out limitations on campaign contributions and financing.  For this court majority, the right to "buy votes" is not only not illegal--it is constitutionally protected.  No surprise that it would also protect large corporations' right to buy your pharmacy records.

FDA issues warning regarding Spiriva inhaler

This week the Food and Drug Administration issued a warning to victims of Chronic Obstructive Pulmonary Disease (COPD), also described as chronic bronchitis or emphysema, about increased mortality associated with the use of the Spiriva Mist Inhaler.  Experts speculate that the mist inhaler increases the plasma (blood) concentration of Spiriva as a result of the improved drug delivery system.  In any event, a series of five recent studies demonstrated a 52% higher mortality rate among Spiriva mist inhaler users, when compared to patients given only a placebo.  Apparently in this form, Spiriva results in a higher risk of heart attack and stroke--conditions that former smokers, in particular, are likely to run.  Doctors were encouraged to avoid recommending the mist inhaler form of the medication to patients with heart disease.

Doctor is critical of FDA delay in recognizing danger of 80 mg doses of Simvastatin

Last week when the FDA warned against the use of 80 mg doses of simvastatin because nearly one percent of patients suffer severe muscle damage, Dr. Steven Nissen of the Cleveland Clinic publicly criticized the Agency for its dilatory action.  Nissen, who was widely applauded for his independent investigation and criticism of the pharmaceutical industry, pointed out that the drug has been recognized as unreasonably dangerous--with safer, effective options--for 11 years.  He noted that he stopped prescribing the 80 mg dose seven years earlier.

The drug poses an unacceptable risk of rhabdomyolysis, which can cause kidney failure and death.  Nevertheless, simvastatin is the second most widely prescribed drug in the U.S., with 2.1 million Americans currently taking it to lower cholesterol.  Thus the financial stakes are high and another cheap alternative won't be available until fall of 2011 when Lipitor becomes available in a generic.  Currently, non-generic statin drugs run about $1.20 per day for a patient, which simvastatin costs only four cents per day.

Expert supporting Non-Hodkins Lymphoma patient's claim against BP is excluded

Sue Pluck was diagnosed with Non-Hodkins Lymphoma (NHL) several years after a BP pipeline spill contaminated the groundwater under her home.   While it is acknowledged that benzene was present in her well water and soil, and that it is a carcinogen capable of causing NHL, the Federal Sixth Circuit Court of Appeals upheld the dismissal of her case because her retained expert could not quantify the extent of Pluck's exposure to Benzene.  Testing of her well never exceeded the 5 ppm considered the maximum  safe exposure by the EPA, and  testing of the soil at her home had not been completed at the time the expert testified.  The expert's argument that there is no safe level of exposure to benzene was rejected by the Court.

Glaxo announces plans to settle 1,000 more Avandia heart attack claims

Avandia, once the most commonly prescribed diabetes drug, created over $3 billion dollars in sales for its British manufacturer, GlaxoSmithKline, as recently as a few years ago.  It has since been removed from European markets and a "black box" warning has been imposed in the U.S, resulting in a decline of 43 percent of sales.  After Avandia was associated with an increased risk of heart attack, some 5,000 state-court product liability claims are pending against GSK and the manufacturer has already settled an estimated 12,000 suits, according to Bloomberg News.  Michigan residents cannot sue for damages because Michigan grants immunity to any drug manufacturer associated with a drug that was originally approved by the FDA.  Michigan is the only state that allows this blanket immunity, regardless of the subsequently-discovered negligence or misconduct of the manufacturer.

New study confirms heart attack and stroke risk associated with NSAIDs.

Circulation, a journal of the American Heart Association, published further documentatoin of the risk associated with ibuprofen, celebrex, bextra and other non-steroidal anti-inflammatory pain relievers (NSAIDs).  The study concluded that persons at risk of stroke or heart attack are placed in significantly greater risk if they take NSAIDs and that the risk increases with increased dosage or duration of treatment. NSAIDs are thought to increase the risk of clotting and vessel occlusion.  One expert concluded that patients at risk should take Tylenol or Naproxen, in that order.

Virginia Tech releases data on relative safety of football helmets

For eight years, Viriginia Tech has been outfitting college football players with helmets equipped with accelerometers to track the force of impacts involving the players and the incidence of concussion.   The study did not attempt to assess rotational forces involved in causing head injuries.  Football helmet manufacturers have agreed in the past not to publish similar studies, with the excuse that the information would be misleading or mis-used.

Window blinds remain a killer of children

Once every month in the United States, a young child is strangled by becoming entangled in window blind cords.  The CPSC is once again looking at possible mandatory regulations that were estimated to add $1-2 dollars per window to the cost of manufacture.  Cordless blinds, cord covers and retractable cords have been proposed, however, the unregulated industry has consistently rejected any significant improvement in design.  The magnitude of the problem was first uncovered in the 1980s when a federal study fou nd that  41 recent child strangultion deaths were caused by drapery and cord blinds.  In 2009, the CPSC recalled 50 million Roman shades and roll-up blinds, one of the largest recalls in history.

Mobile home sale is governed by longer statute of limitations, not UCC's one year

In a case of first impression, the Court of Appeals held that the specific three-year statute of limitations in the Mobile Home Commission Act applies to claims of product defects, rather thant he Uniform Commercial Code's one-year limitation on the sale of "goods."  On that basis, Robert and Amanda Johnson were allowed to pursue their claim for rescission and damages against QFD, Inc., d/b/a Landstar Homes.

Investigators question risks associated with long term use of Nexium and other PPIs used to treat acid reflux

Nexium, Priolsec, Prevacid and Zegerid, the so-called proton pump inhibitors (PPIs), are prescribed for treatment of acid reflux.  This week the FDA issued its second warning related to long-term use of PPIs.  The FDA's original warning related to possible increased risk of hip, wrist and spine fractures, particularly in patients over 50, higher doses or longer-term treatment.  The current warning suggests that with use over time, the drugs reduce patients' magnesium levels, putting them at  risk for seizures, irregular heartbeats, and muscle spasms.  118.5 million prescriptions for PPIs were written in 2010, making them the fourth most common class of drugs in the U.S., after antipsychotics, cholesterol-lowering statins, and antidepressants.

Toyota finally releases computer code necessary to interpret electronic data

Unlike Ford and General Motors, historically Toyota Motor Corp. has not shared the source code essential to interpreting the electronic data collected in Toyota vehicle "black boxes."  With its recent sudden acceleration and other reliability difficulties, Toyota last year cooperated with law enforcement authorities for the first time by revealing codes, however, it continued to refuse to share source codes with engineers outside law enforcement.  This month the source code was finally produced for examination by the attorneys and engineers representing persons alleging  sudden acceleration injuries or deaths.  They anticipated spending about 1.5 million dollars over 12 months, in an effort to independently identify a glitch in the electronic throttle.  A federal government report released in 2010 concluded that  there was no electronic defect, however, the attorneys and engineers supporting purported victims claim that the latter study was "biased and incomplete."

FDA creates new web page identifying recalled foods

This month the Food and Drug  Administration created a web page to display, in a more searchable form, the identifying information on recalled food.   The website shows the date of recall, product brand name, product description, reason for recall, and the recall firm.  It also contains a link to the press release generated with each recall.  The webpage is:  http://www.fda.gov/Safety/Recalls/default.htm.

Study links anti-depressants to narrowed arteries in "older men"

A cardiology fellow at Emory University presented a study involving 513 twin male patients at the American College of Cardiology meeting in New Orleans this month.  The study compared the artery thickness of twins who were taking anti-depressants with the artery thickness of twins who were not taking anti-depressants.  It found that the carotid arteries of men (average age of 55) taking Lexapro, Cymbalta, or Zoloft, were 41 microns thicker than their non-medicated twins.  The authors explained that 41 microns would represent about four years of advanced aging, or thickening of the measured arteries.

Michigan's unique statute confers immunity on drug makers even where fraud is alleged

Michigan's Attorney General sued Merck, Sharp & Dohme to recover the 20 million dollars that Michigan spent on Vioxx between 2000 and 2004.   The AG argued that it should be allowed to recoup these expenses because Merck fraudulently secured Food and Drug Administration approval of the drug by concealing its dangerous character and the risk of heart attack and stroke it presented.  The AG argued that if the state had known of these risks, it would not have approved payment of Vioxx for State Medicaid patients.

Woman's product liability claim is too late, where she was unaware of damage during statute of limitations period

The statute of limitations for a product liability claim is three years.  Robin Smith alleged that a pain pump manufactured by the Stryker Corporation was defective and marketed improperly (without FDA approval) for use in joints.  She used the pump in 2003 but did not sue until 2009.  She claimed that her suit was filed within three years of discovering her injury in 2007, when she experienced total destruction of the joint. 

U.S. Supreme Court holds vaccine makers immune from product design lawsuits

This week, the U.S. Supreme Court voted 6-2 to grant immunity to vaccine makers.  The ruling was in the case of Bruesewitz v. Wyeth, and arose out of Hannah Bruesewitz' parents' claim that she suffered a permanent brain injury after being administered a standard diptheria, tetanus and pertussis vaccine.  Hannah's parents claimed  that Wyeth negligently designed the vaccine, but the Court held it didn't matter:   the Justices concluded that a Congressional bill intended to provide limited compensation to some patients who suffer side effects impliedly created immunity for the  manufacturers--even though the bill does not say that.  

Deregulate the safety of toys?

After almost eight years of Bush Administration  deregulatory fervor, the Consumer Product Safety Commission staff had been cut by more than half to 385 people.  Literally millions of toys from China were recalled--including many  popular Christmas favorites sold by  major retailers--because of lead paint and other hazards.   Finally, Congress took one of its few truly bipartisan actions of the past decade and passed the Consumer Product Safety Improvement Act.  Twenty-six more recalls have been instituted in the two years since, due to detection of lead paint alone.

Most recalled medical devices were approved without FDA scrutiny

This week the National Research Center for Women and Families published data analyzed and compiled by Diana M. Zuckerman, Paul Brown and Dr. Steven E. Nissen, the Cleveland Clinic cardiologist who blew the whistle on defective cardiac devices several years ago.  The researchers noted that the FDA initiated 113  "high-priority" recalls from 2005 to 2009, in response to concerns about patient safety.  Fully seventy percent of these   "high priority recalls" involved devices that had not been subjected to the normal FDA investigation and scrutiny because they were deemed "equivalent" to a device already on the market.  This is called the "510K" process. The 510K process involves little or no testing but still grants the manufacturer immunity from liability under a recent activist U.S. Supreme Court interpretation that surprised most legal specialists.  The Court led by Justice Roberts has made many similar decisions that favor large corporations and wealthy individuals at the expense of consumers and citizens.

NHTSA concludes that Toyota acceleration problems did not result from electronic error

More than 85 deaths have been blamed on sudden acceleration problems in Toyota and Lexus automobiles.  It was early on determined that  sticky accelerator pedals and improperly designed floor mats played a role and 11 million vehicles  were eventually recalled.  Nevertheless, a question remained with regard to whether a glitch in the company's electronics also played a role.  NHTSA had taken flack for failing to investigate this issue when it early-on concluded that there was no electronic failure.  Today, NHTSA and the NASA engineers it belatedly consulted to address the question  weighed in with their opinion:  electronics were not at fault; sticky pedals, bad mats, poor pedal design and misapplication of pedals (i.e., driver error) were the causes of the collisions investigated.

Should we medicate kids' colds? Are there effective ways to prevent them? What works on cold symptoms?

The DailyDose weblog recently summarized the Food and Drug Administration's recommendations regarding treating kids' colds.  It pointed out that the FDA recommends that children under the age of four not be given any over-the-counter medicines for colds because of potentially life-threatening side effects.  Above age four, it noted that nutritional supplements such as Vitamin C, zinc and echinacea haven't been documented to relieve symptoms or to prevent colds.    Zicam nasal swabs carry a risk of permanent loss of smell, making them inappropriate for children.  Only topical nasal decongest drops will provide some relief of a stuffy nose, and the old-fashioned antihistamines like Contac and Benadryl (the ones that cause drowsiness) will reduce nasal discharge by 25 - 30 percent.

Avastin apparently significantly increases the risk of fatal complications from chemotherapy

Many new outlets, including Bloomberg, reported on  February  1 that  Avastin given in conjunction with chemotherapy apparently signfiicantly increases the risk of fatal complications.  They report that 2.5 percent of patients given Avastin suffered deadly side effects, making the complication rate 46 percent higher than it is for patients getting chemo alone.  The media is reporting  on a study published in  JAMA, the Journal of the American Medical Association.  It  reviewed clinical trials involving 10, 217  patients in 16 different trials.  The most common side effects were hemorrhage, gastrointestinal tract perforation and infection, and even with Avastin, the fatality rate is low.   The risk is greatest when Avastin is combined with taxanes or platinum agents, which are most  commonly used to treat lung and colon cancers.  It is believed that the drug may delay recurrence or spread of advanced cancers, althouth it has not been shown to lengthen survival times.   The Food and Drug  Administration had already moved, in 2008, to withdraw approval of the use of Avastin in breast cancer patients, based on its combined record of safety issues and ineffectiveness.  Its Swiss manufacturer reported Avastin sales of $5.75 billion dollars in 2009.

FDA announces plan to limit acetaminophen use

On January 14, the FDA announced that it would finally take action because too many patients poison themselves with the nation's most popular pain-killer. The FDA has given manufacturers three years to reformulate durgs like Percocet and Vicodin which combine acetaminophen with a narcotic: in future they will be allowed to contain no more than 325 mg of acetaminophen (in some cases a fifty percent reduction).

An advisory panel suggested 18 months ago that the government ban the latter medications as well as any over-the-counter formulation of acetaminophen with more than  325 mg of active ingredient.  The agency also plans stronger warning labels of the overdose risk. 

The New York Times reported that even recommended doses of acetaminophen (or APAP, or paracetamol) can cause liver failure or damage, and that 400 overdose deaths occur in the U.S. each year.  The drug also causes 42,000 hospitalizations in the U.S. annually.  Apparently, overdose frequently results from the use of more than one pain-killer or cough and cold remedy where the patient is unaware of the presence of acetaminophen in each of the products.