TOV Injury and Safety Blog

FDA panel recommends ban on Percocet and Vicodin

On June 30, 2009, a panel created by the Food and Drug Administration recommended that the agency ban Percocet (a combination of acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).  The panel also voted almost unanimously to limit children's medicines containing acetaminophen to a single formulation in order to avoid confusion among doctors and patients over appropriate dosing.  The panel acted out of concern over the effects of these medications on the liver. 

Defective Chinese drywall brings to prominence concerns about inability to hold Chinese manufacturers accountable

The Kansas City Star pointed out on June 30, 2009, that the enormous problems associated with defective Chinese drywall have brought to the surface the compounding problems associated with holding Chinese manufacturers accountable.  The paper reminded readers that in recent months the list of faulty Chinese products identified in the media have included:

    "highchairs whose seat backs failed, steam cleaners that burned their users, bikes whose front-wheel forks broke, saunas that overheated, illuminated exit signs that stopped working when commercial power failed, dune buggies whose seat belts broke on impact and coffee makers that overheated and started fire...a soccer goal net that entrapped and stangled a child and a toy chest whose poorly supported lid fell on a toddler's neck and killed him."

During 2007, fully 69 percent of products recalled in the U.S. were manufactured in China, and previously recalled products continue to be imported, including "breakable toys on which infants can choke, lead toys, toys painted in lead-based colors and cribs whose slats are far enough apart to trap babies' heads."

Roche Holding AG removes Accutane acne medicine from market after verdicts.

On June 26, Bloomberg.com reported that Roche would take Accutane off the market following a reevaluation of personal injury verdicts and generic competition.  Roche has "vigorously" defended claims that the drug causes bowel disease, but jurors have awarded a total of $33 million dollars in damagesin several cases, and there are as many as 5,000 claims still pending.  One of the attorneys who attained a successful verdict claims that six cases have gone to trial and that all have been losses for the manufacturer.

G. M. agrees to maintain legal liabilty for future claims involving defective products after bankruptcy

As it was initially envisioned, the bankruptcy process involving General Motors would have resulted in the elimination of any liability for injuries caused by defective products, whether filed currently or in the future.  That would have closed the doors on a number of pending claims alleging death or serious injury resulting from a defective product.  After several state Attorneys General protested on behalf of injury victims, the company  and the Obama Administration have agreed to continue to recognize G.M.'s pre-existing product liability obligations, but apparently only with respect to unfiled claims. 

Nestle denied FDA information related to contaminated cookie dough

USA Today reported on June 29, 2009, that Nestle repeatedly  (from 2004 thorough 2007) refused to provide Food and Drug Administration inspectors with data including complaint logs, pest-control records and other pertinent information.   Perhaps if the information had been produced, or if the FDA had reacted more vigorously, Nestle Toll House cookie dough would not be implicated in the poisoning of 69 people with E.coli.  The Center for Disease Control has now become involved in the investigation.  An FDA spokesperson suggested that Nestle was within its rights in refusing to provide the information, however critics point out that the FDA could have insisted on access if public health is at stake.  FDA inspectors would have been obligated to secure an administrative warrant, which they did not do.

420,000 pounds of beef recalled in Michigan and other states

In a further indictment of the safety of our food supply, the Marler Blog reported this morning that the JBS Swift Beef Company had expanded its beef recall on June 24 from the original 40,000 pounds to more than 400,000 pounds.  E.coli contamination was alleged. The recall results from the investigation of 24 illnesses in multiple states.  Additional information can be obtained at the reporting website (www.marlerblog.com) or through FSIS.

FDA shuts down Detroit-area drug manufacturer Caraco Pharmaceuticals

Bloomberg.com reported on June 25 that U.S. authorities seized generic drugs produced by Caraco Pharmaceutical Laboratories, Ltd., citing multiple violations of manufacturing standards.  Inspectors found "serious violations" of manufacturing standards and "serious deficiencies" in quality control when they inspected the facility in May of 2009.  

Nestle cookie dough recalled

On Friday, Toll House refrigerated cookie dough was recalled after E-coli contamination was traced to the dough.  As many as 66 people in 28 states may have been afflicted with E.coli O157 which causes severe cramping, vomiting and bloody diarrhea and which may damage kidneys.  E. coli O157 is associated with contaminated meat and a Nestle spokeswoman could not explain how cookie dough became contaminated with this particular pathogen. 

Nestle suggests that it is not responsible for the illnesses because its label proclaims "Bake before consuming."   Most of the victims were young women, and 25 have been hospitalized, including seven who suffered a severe complication called hemolytic uremic syndrome.

Newly assertive FDA warns about use of Zicam and loss of smell

The Food and Drug Administration has been roundly criticized for its failure to act in numerous matters over the past 8 years and for the consequent deaths, illnesses and corporate fraud that have resulted.  The FDA has become more proactive under the Obama administration, despite its inadquate resources and funding, and on June 17 it issued a warning about the use of Zicam, a popular homeopathic cold remedy that can permanently damage or even eliminate a consumer's sense of smell.  The FDA has received 130 reports of olfactory injury resulting from the use of Zicam nasal products, dating back to 1999.  The manufacturer has received more than 800 reports of Zicam users losing their sense of smell, but failed to provide those complaints to the FDA.

Concern expressed over asthma drug Singulair

U.S. regulators concluded that Merck & Co.'s top-sulling asthma drug, Singulair, should come with a caution about psychiatric problems.  The caution would also apply to Accolate, manufactured by AstraZeneca, Zyflo and Zyflo CR, made by Cornerstone Therapeutics.  A "caution" is less serious than a warning, according to Reuters News Service, and applies to problems incluidng agitation, aggression, suicidal ideation, depression, insomnia and irritability, which may be associated with the medications in some patients.  Singulair is prescribed to tens of millions of patients since approval in 1998 and has annual sales of $4.5 billion dollars.

Deadly consequences of FDA's failure to shutdown tainted syringe manufacturer

The June 7, 2009 edition of the Chicago Tribune carried a long article discussing the consequences of the Food and Drug Administration's failure to shut down a contaminated plant operated by a syringe manufacturer now associated with four deaths and hundreds of illnesses.   The plant in North Carolina was inspected in July of 2007 by the FDA in response to reports of contamination with "red, brown and black particles."  She reported that the plant had a plan to respond to  the "rust contamination" and took no action beyond reporting that the plant had "switched to an unreliable sterilization method."

Mattel fined $2.3 million over lead in toys

On June 5, Bloomberg reported that Mattel and Fisher-Price (a subsidiary) have agreed with the U.S. Consumer Product Safety Commission to resolve pending complaints over selling Chinese-made toys with hazardous levels of lead.  The settlement relates to the sale of 95 tainted toys, including Barbie accessories.  Mattel imported about 900,000 illegal toys from September 2006 to August 2007.  Fisher-Price reportedly imported another 1.1 million during the same period.  Ultimately Mattel recalled almost 21 million toys.  Unfortunately, the current statistics suggest that only a small proportion of recalled toys are actually removed from circulation.

Lawsuits claim zinc in denture cream builds up in body causing health problems

A dozen claims are pending around the country, alleging that PoliGrip and Fixodent contain unsafe levels of zinc. The lawsuits allege that zinc competes with copper in the body to bind to certain receptors, and a build up over time negatively affects neurological function.  The manufacturers claim the amount of zinc ingested is safe and comparable to eating six ounces of beef.

Fiat can take Chrysler assets without its responsibilities

Bankruptcy judge Arthur J. Gonzalez held last week that Fiat need not assume Chrysler's product liability defect responsibilities along with its assets.  A bankruptcy judge has broad discretion in deciding whether a successor entity must stand behind its predecessor's liabilities for personal injuries.  Many judges, and most common law decisions outside bankruptcy, hold that a successor entity that takes over the valuable assets of a company must also assume its existing duties to injury victims.

Michigan Senate Republicans reject pharmaceutical liability

On June 2, 2009, the State Senate majority voted on a straight party line to maintain immunity for drug company negligence.  After several years of disclosures evidencing the inability of the FDA to adequately monitor drug safety, and the U.S. Supreme Court's rejection of pharmaceutical immunity, State legislators attempted to revoke Michigan's one-of-a-kind immunity for FDA-approved drugs.  The immunity had been granted as part of "tort reform" during the Engler era, even for drugs that were approved as a result of fraud by the manufacturer.

Recent developments in cancer therapy, including hormone replacement and use of anti-depressants

It has long been understood that hormone therapy to mediate the symptoms of menopause probably has a deleterious impact on cancer treatment.  Nearly twenty years ago, we prevailed in a malpractice claim against a General Surgeon who continued estrogen therapy throughout a woman's treatment for breast cancer.  Our claim was supported by an oncologist from the National Cancer Institute, and even the Defendant's expert was forced to concede the connection.  Even at that time, the medical research showed a likely negative impact, and continuing estrogen therapy was not recommended.  A new study out of the UCLA Medical Center adds weight to the argument and also suggests a tie between hormone replacement therapy, smoking and an enhanced cancer risk.

Controversy over lead and toxic chemicals in common products

The Campaign for Safe Cosmetics (CSC) has brought national attention to the fact that lead and other known carcinogens are found in a number of daily-use consumer products.  Manufacturers of the products and some authorities argue that the chemicals are present in such small quantities that they do not pose a health risk.  The New York Times has published several columns on the issue, including potential sources of further information.

JAMA article relates increased risk of pneumonia to acid-reflux drugs

The Journal of the American Medical Association today published an article disclosing research that ties the routine, prophylactic use of acid-reflux drugs to an increased risk of pneumonia in hospitalized patients.  The study followed more than 63,000 patients at Beth Israel Deaconess Hospital for three years.  The drugs involved, so-called proton pump inhibitors, including Nexium, Prilosec and Prevacid, are given to an estimated 40-70 percent of hospitalized patients, with about one-half receiving them for the first time.  They are intended to prevent the development of stress ulcers, but are not currently recommended for patients who are not at high risk.

Profile of an autism "expert"

Perhaps looking at the record of Dr. Mayer Eisenstein from Chicago will shed some light on why courts have recently refused to allow testimony from some of the doctors who are willing to testify that mercury  preservative formerly used in childhoon vaccines caused autism.  Large European and American studies involving literally hundreds of thousands of children have failed to show any causal link between mercury preservatives and autism, yet some physicians continue to suggest there is a link.  If Dr. Eisenstein is typical of these "scientists," we may have a little better understanding of why the courts have been reluctant to allow them to offer expert testimony.

Vermont requires publication of drug company payments to doctors; Medtronic rebuked

In the absence of meaningful regulation at the federal level, states have begun to act to achieve greater transparency in the relationship between medical manufacturers and doctors.   Vermont took the most meaningful step thus far, with the Vermont legislature adopting a statute that requires drug and medical device manufacturers to publicly disclose all payments to physicians or health care providers.  It also bans all free meals.  While a drug industry spokesman claimed the legislation would be "onerous" for doctors, it was supported by the Vermont Medical Association, which represents 65 percent of the state's doctors.  It is explected that the Governor will sign the act into law next month.

Lawsuit filed, claims baby shampoo and other products contaminated with formaldehyde

Bloomberg.com reported on Tuesday that Johnson & Johnson, Procter & Gamble and other personal-care product retailers were selling items contaminated with known carcinogens.  Bloomberg only identified the contaminated products as "shampoos and soaps," although a spokesperson for the firm involved suggested that Johnson's Baby Shampoo was one of the contaminated products.

Experts who connect autism to mercury-based vaccines are struck by court

Many parents sincerely believe that their children suffer from autism as a result of mercury used as a preservative in childhood vaccines.  We have addressed that issue previously in this web log.  Their arguments have consistently been undercut, however, by major studies, involving hundreds of thousands of vaccinated children, that have not supported any causal relationship.  The Centers for Disease Control now concludes that "the weight of the evidence indicates that vaccines are not associated with autism."

Trial demonstrates Merck's Vioxx liability

An Australian class-action lawsuit against Merck over its painkiller Vioxx should be causing the large pharmaceutical company embarrassment.  Evidence has shown that the company circulated its own marketing publication touting the drug, which it passed off to doctors as an independent medical journal. It created an "independent" board of doctors, whom it groomed to market the drug, without informing them of the safety risk, and it prepared sales staff with a "training manual" of talking points to address safety concerns as early as 2001.

Medtronic, Inc., implicated in doctor's fraudulent study supporting bone-growth product, Infuse.

Dr. Timothy Kuklo, a West Point graduate, attorney and surgeon specialist who recently retired from the Army, is alleged to have falsified information used in an article he wrote supporting the effectiveness of Medtronic's "Infuse" to assist bone-growth after trauma.  His article was originally published in a British medical journal, which retracted the article after one of the three physicians whom Kuklo listed as co-authors challenged his claims. 

FDA warns of contamination in Olay cosmetics plant

Reuters reported on May 5 that the FDA had warned Procter & Gamble that it had not adequately addressed contamination and other manufacturing problems at its Puerto Rico manufacturing plant.  The plant produces over-the-counter drugs such as Vicks Sinex nasal spray, and Olay cosmetics such as Revitalizing Daily Foam and Foaming Face Wash.  The FDA's previous inspection report pointed out that products were packaged or prepared in "unsanitary conditions" and that they may have been "contaminated by filth...or... rendered injurious to health." 

Boy, there's an endorsement for your next "Face Wash."  The warning letter is posted on the FDA's website.

FDA alerts doctors to heightened suicide warnings on anti-seizure drugs

On May 5, the FDA reminded doctors that new warnings are being placed on 20 medications used to control seizures, psychiatric disorders and nerve pain.   The warnings point out the "risk of suicidal thoughts or behavior" in patients taking the medications, including Lamictal, Topamax and Lyrica and applies to all medicines in the antiepileptic class.  These medications were the fourth-best-selling class of drugs in the U.S. last year, with total sales of more than 11 billion dollars, according to the Associated Press. 

ProDisc maker settles conflict of interest allegations

The Synthes company makes an artificial device, the ProDisc, which is surgically implanted between spinal vertebrae in a high-risk, expensive procedure that remains controversial.  The company did not disclose for several years that the very doctors who were recommending use of the device were being compensated with shares in the company.  In a negotiated settlement with the New Jersey Attorney General, the company agreed to pay $236,000.00 to the State for the cost of its investigation and to disclose all financial arrangements with medical "researchers."  It also agreed to stop paying with stock or stock options doctors who conduct clinical trials of its products.   

Injury claim dismissed where victim cannot document product failure

Ron Paquin filed suit against Control Chief Corporation after he was injured by a 15-ton mandrel which he was re-locating by crane.  He had no memory of the injury, but claimed that the remote controller malfunctioned, causing the mandrel to strike him.  He offered the evidence of a mechanical engineer who claimed that the remote controller showed evidence of contact welds on the control pads which would have caused an unintended movement of the crane. 

OBTape removed from market--despite and after FDA approval

The Mentor Company of Santa Barbara, California, devised a "simple" solution to manage urinary incontinence it called a "vaginal sling."  The trade name is "OB Tape."  It stopped selling the product in 2006, and Mentor, a California company, was sold to Johnson & Johnson not long after.  Now, the device is a subject of litigation brought by women claiming that they would have been better off living with incontinence, after enduring ugly complications and undergoing as many as five operations to remove elements of the device.

National Consumer Law Center criticizes Michigan's gutted consumer protection law

The NCLC identified Michigan and Rhode Island as the "terrible two" states with the most dismal record for consumer protection.  While Michigan formerly had an effective consumer protection act, it was gutted several years ago by the Engler Majority of the Michigan Supreme Court, rendering the Act virtually non-existent, even in cases where unfair, deceptive or unconscionable practices were identified. 

Hydroxycut diet aids recalled after FDA warns regarding liver injury

Television advertising has made "Hydroxycut" a household name in dieting.  After the Food and Drug Administration received 23 reports of significant adverse health effects related to Hydroxycut, including heart damage, muscle damage leading to kidney failure, and a liver transplant, the drug has been removed from the U.S. market. 

CPSC recalls 96,000 more baby cribs

The U.S. Consumer Product Safety Commission recalled cribs manufactured by Jardine Enterprises for the third time in two years.  This time because of slats that fracture and can trap or strangle a child.  The Commission has received reports of 31 events involving slats breaking, including two episodes of children who were trapped as a result. In ten of the cases, the child broke the slat while in the crib.  Almost half-a-million cribs have now been recalled.   The cribs were manufactured in China or Vietnam.  A list of recalled crib models is maintained at cpsc.gov.

Tylenol and Advil to carry bolder liver-damage and gastrointestinal bleeding warnings

The FDA announced on April 29 that over-the-counter pain relievers such as Tylenol and Advil (known as NSAIDs, and including aspirin, ibuprofen, naproxen and ketophrofennlude, for example) will need to carry bolder packaging warnings because of the continuing injury resulting from over-use of the products.

More litigation regarding poison gas in the Holiday Inn pool

Last month the Court of Appeals held that the Holiday Inn Express in Ludington had insurance coverage for a substantial injury verdict rendered against it.  This month, the court set aside the verdict in Bronkema v. Ferwerda Enterprises, Inc.  The case arose when a maintenance man, hurrying with repairs so that he could return to jail after work release, did not successfully accomplish his repairs and allowed poison gas to injure the Bronkema family.  The trial judge had directed a verdict in favor of the family on the issue of Holiday Inn negligence, but the judge threw out the case against the pool component manufacturer, whom the Holiday claimed failed to adequately inform it about proper safety measures. 

Doctor's opinion that chemical exposure caused loss of smell is admissible

When a Lowe's employee opened the packaging on some pool chemicals, one bottle was punctured, but still placed on a retail shelf.  David Best suffered a chemical burn on his face and hands when he pulled the bottle off the shelf to examine it.  Soon after, he lost his sense of smell completely.  His doctor confirmed that he suffered from "permanent anosmia" and by means of differential diagnosis the doctor excluded other possible causes of the loss.  Lowes persuaded the trial judge to dismiss Best's case, however, by persuading the judge that the doctor's expert opinion was unduly "speculative".

Coast Independent Review Board suspends drug studies

After approving a scam drug trial (that its competitors rejected) in a government sting operation, Coast agreed on April 15 to suspend its operations. The Company's CEO, one pompous and bombastic Dan Dueber, initially complained to Congress that his company had been defrauded by the FDA; now he says "Coast IRB is changing everything... revamping every aspect of the Company."  In other words, creating a company to do the work it had been paid to do for the past five years:  investigators told Congress the company had earned $9.3 million dollars in 2008, and approved 355 of 356 study proposals it had reviewed in the past five years (including the one make-believe proposal that finally got it in trouble). 

Sounds like someone was pocketing too much of that multimillion dollar income and not spending it on real investigation.  Hopefully we've seen the last of Dueber and his company.  Its incredible to think that our drug safety is dependent on a regulatory scheme that relies upon operations like this.

Depakote, taken for epilepsy and migraine headache, injures fetal IQ

The New England Journal of Medicine published a study this month documenting the fact that children born to women who took Depakote (valproate) scored lower on IQ tests administered at age three.  The children scored 9 points lower than children of women taking other antiseizure medications.  Only about one-half of the women taking Depakote suffer from epilepsy.  The five-year study followed 300 pregnant women and 258 children, including 53 who took Depakote.  IQ correlated closely with mothers' IQs, except among moms taking Depakote.  The mean IQ of children taking other anti-seizure meds was almost 101, but only 92 for children whose mothers took valproate.  Doctors confirmed that Depakote should never be the first drug of choice for a pregnant mother.

Experts agree on the need to overhaul regulation of US food supply

Roughly 76 million Americans suffer foodborne illnesses each year, 300,000 are hospitalize, and 5,000 die, according to the Centers for Disease Control.  Most likely victims are children under four and adults over the age of 50. 

Insurance study warns about small-car danger

The Insurance Institute for Highway Safety reported this week that the Honda Fit, Toyota Yaris and the Smart Fortwo, three very small new vehicles touted for their light environmental impact, performed poorly in crash safety testing.  In testing that simulated head-on collisions with mid-size vehicles, with each model traveling at 40 miles per hour, the three minimodels suffered a disproportionate deceleration (and likely greater injuries to the occupants).  While the heavier vehicle changed speed by 27 mph on impact, the minimodels decelerated by 53 mph [essentially being driven backward at 13 mph immediately upon impact]; they were far more likely to be sent airborne and spun.

Obama administration suggests it will be tougher on food safety

The immense pistachio recall, falling hard on the heels of the peanut paste poisonings, signaled to food companies that the Obama administration will act more aggressively to protect consumers than its predecessor did.  We'll have to wait and see if the federal government is able to dedicate adequate resources to the problem, however, as efforts to shrink the government continue and our food production increasingly moves overseas or under the control of bottom line cost-cutters such as WalMart. 

Removal of "recalled" heart defibrillator cables presents difficult choice for pateints and families

In 2007, Medtronic recalled its Sprint Fidelis heart defibrillator cable because its thin wires were prone to fracture and had caused at least five patient deaths.  The cable was approved by the FDA without adequate research. Now, the cables have been surgically placed in the bodies of more than 150,000 patients, who are faced with a Hobson's choice of undergoing dangerous surgery to remove them, or leaving them intact and praying that they continue to function properly.

Defibrillator recall

Zoll Medical Corporation has recalled 180,000 external defibrillators with unreliable batteries and computer software that does not properly detect the battery problem.  The company is urging purchasers to download new software that will help detect defective batteries.  Units that have been installed on sites for three years or more are at highest risk. 

18 of 20 psychiatrists writing treatment guidelines have financial ties to pharmaceutical industry

Bostom.com reported last week that ethics researchers investigating physician-pharmaceutical ties found that treatment guidelines for depression, bipolar disorder and schizophrenia were written by doctors with significant financial ties to the pharmaceutical industry.  These three common diagnoses generate some $25 billion dollars in drug sales, annually, and the 20 authors of the treatment guidelines had significant entanglements with the industry.  12 of the authors had ties in at least three categories, including consulting, research grants, speaking fees or stock ownership. 

Third Circuit creates split regarding preemption for vaccine design

In Bruesewitz v. Wyeth Inc., the Third Circuit of the Federal Court of Appeals prohibited children injured by a vaccine from taking legal action.  The Georgia Supreme Court had ruled the opposite way in American Home Products Corp. v.  Ferrari.  The U.S. Supreme Court has granted cert. in Ferrari.  The Bruesewitz decision was based on the concept of preemption, i.e., the argument that Congress legislated in a particular topic area, thereby precluding states from acting in that area to protect their citizens.  Preemption has been a fertile ground for Bush-era efforts to immunize manufacturers from liability.

Drug oversight by sham

If you have wondered why so many FDA-approved pharmaceuticals have been withdrawn after approval, perhaps one answer is sham clinical trials.  At a Congressional hearing on March 26, a Colorado company reportedly drew scorn over its record.  Coast Independent Review Board was snared when federal investigators devised a study trial for a make-believe product.  While two other companies refused to approve the sham design, Coast did approve the nonexistent product, Adhesiabloc, and the non-existent researchers. 

Pfizer settles Rezulin cases

Bloomberg reported on April 1 that Pfizer had resolved all but 3 of the 35,000 pending claims arising out of its withdrawn diabetes drug Rezulin.  It reportedly paid about $750 million dollars.  Rezulin was approved by the FDA and administered to almost 2 million patients before it was linked to at least 63 deaths caused by liver failure.  It was then withdrawn from the market.  

Big pistachio recall announced

Reuters reported on March 31 that a California grower had issued a nationwide recall on pistachio products, due to a risk of Salmonella poisoning.  The FDA says several illnesses have been reported.  Kraft Foods was the first retailer to identify contamination in its Back to Nature Trail Mix.  It notified the grower/processer Setton Pistachio of Terra Bella, Inc.  Kroger has since recalled its Private Selection shelled pistachios.  Some recalled products are sold under the Planters trademark. Over two million pounds of pistachios have been recalled.

State Farm recalls defective promotional teddy bears

MSNBC announced today that State Farm was recalling 800,000 cheap, Chinese-made promotional "Good Neigh Bears" it handed out between 2005 and 2007.  The plush toys do not comply with standards requiring the elimination of detachable choking hazards and had already been recalled by Health Canada.  State Farm's subsequent recall was instituted in agreement with the US Consumer Product Safety Commission.  Kind of ironic when a company that advertises its concern for safety and touts itself as a good neighbor resorts to handing out cheap, unsafe foreign imports as a promotion, don't you think?  It's another example of the need for consumers to distinguish between these large corporations' marketing identity and reality:  Allstate may be the best example of the chasm that may lie between the two.

BPA to be restricted by manufacturer and probably by Congress

Yesterday, an AP business writer reported that Sunoco plans to restrict the sale of bisphenol-A, or BPA because of safety concerns.  Reportedly, Sunoco is no longer selling the controversial chemical for use in food containers and baby bottles.  Sunoco's action contradicts claims by larger manufacturers of BPA, such as Dow Chemical, Bayer and Hexion Specialty Chemicals, and the American Chemistry Council, that BPA poses no health risk.

13 deaths associated with Medtronic leads

Last week Medtronic acknowledged at least 13 deaths and about 2200 serious injuries that were tied to discontinued Sprint Fidelis leads, pulled from the market in October, 2007.  Four of the deaths occurred during surgery to remove the leads.  Recently disclosed FDA data indicated that Medtronic became aware of the problem with fractured leads soon after releasing the devices in 2004.  2000 legal claims have been filed against the company over the very thin, prone-to-fracture leads, however, at the moment it is protected from liability by a controversial Supreme Court decision that granted the manufacturer immunity.  The immunity was conferred by FDA approval of the device, even though the approval was "grandfathered" upon prior approval of a different device with thicker wires, less prone to fracture.

It is believed that the Fidelis leads were implanted in about a quarter million people, with thousands receiving them after the company was fully alert to, and investigating the fracture problem.  Some 150,000 people still have implanted leads, and surgeons stress that if they are to be removed, the removal should occur at a facility that handles a high volume of these surgeries.