Feds will study factors affecting commercial driver safety.

DC Velocity (4/29, Gooley) quoted DOT's Federal Motor Carrier Safety Administration chief Anne Ferro, as wanting the agency to study "to what extent driver compensation practices, and detention time at shippers' loading and receiving docks affect drivers' ability to drive safely." One study "will explore whether long waiting times in a parked vehicle at a shipper's dock -- which as of Feb. 27 became "off-duty time" under the new driver hours-of-service rule -- would contribute to driver fatigue and influence performance, Ferro said in a keynote speech April 20 at the annual Spring Forum of the Council of Supply Chain Management Professionals' Columbus (Ohio) Roundtable." The other study "would examine whether a link exists between the way drivers are compensated-either by the load or by the mile -- and driver behavior behind the wheel, according to Ferro." 

Iowans file class-action pollution suit against Grain Processing Corp.

The Des Moines (IA) Register (4/24, Beeman) reported that a group of Muscatine, Iowa citizens "on Monday sued Grain Processing Corp., contending that emissions from the agriculture giant's plant is harming their health. It's the second lawsuit filed against the Muscatine mainstay in four months. The Iowa Department of Natural Resources sued the company in December, alleging that the firm had recorded a long string of environmental violations." The citizens' suit asks the county district court to certify the action as a class action lawsuit. The company says it plans to spend $100 million upgrading the plant to reduce emissions.

        The AP (4/23, Foley) added that the lawsuit alleges pollution from the plant "has damaged homes, cars and property across the city," and seeks to add about 17,000 people living within three miles of the plant as members of the class. The plaintiff's attorney, Texas environmental litigator Tony Buzbee, "said he filed the lawsuit after recent testing at homes and public parks revealed dangerously high levels of acetaldehyde and sulfuric acid, among other substances." 

Nissan recalling hundreds of 2012 Titan pickups.

The Chicago Tribune (4/24) reports, "Nissan is recalling 918 model-year 2012 versions of the Titan pickup truck because a label lists the incorrect seating capacity, according to the National Highway Traffic Safety Administration." According to the article, "The affected vehicles were built from June 10 through July 22, 2011, and are equipped with the Sport Appearance Package." Specifically, "these vehicles are equipped with two bucket seats in front and a three-seat bench in the rear; the tire information label indicates a capacity of six passengers." 

Jury hits Pfizer with $4m damage award in Prempro case.

Bloomberg News (4/21, Feeley) reported that Pfizer "must pay at least $4 million in damages to a woman who developed breast cancer after taking the company's Prempro menopause drug, a jury in Connecticut ruled. Jurors in federal court in New Haven ruled that Pfizer's Wyeth unit is liable for causing Margaret Fraser's cancer and that Prempro is an 'unreasonably dangerous product,' Greg Bubalo, one of Fraser's attorneys, said yesterday. The panel also found that Wyeth should pay punitive damages over its handling of the drug." Bloomberg also noted that Wyeth and Upjohn have lost 11 of 20 Prempro verdicts since 2006, although some awards were later reduced or voided. 

Merck unit pleads guilty to one count of misbranding Vioxx.

Bloomberg News (4/20, Feeley, Lawrence) reports, "A unit of Merck & Co., the second-largest US drugmaker, pleaded guilty to a criminal misdemeanor charge as part of a $950 million settlement of a US government probe of its illegal marketing of the painkiller rofecoxib [Vioxx]." It added that "an official of Merck Sharp & Dohme said today that the company agreed to plead guilty to one count of misbranding Vioxx," and "US District Judge Patti Saris in Boston accepted the plea as part of the drugmaker's agreement to pay a $321.6 million criminal fine and $628.3 million to resolve civil claims that it sold Vioxx for unapproved uses and made false statements about its cardiovascular safety."

        The AP (4/20) reports, "Merck won about two-thirds of the Vioxx personal injury lawsuits that went to trial." The company "settled around 50,000 patient lawsuits in November 2007 for $4.85 billion, which was much less than Wall Street had initially expected."

        "Thursday's sentencing related specifically to Merck's admission that it had marketed Vioxx as a treatment for rheumatoid arthritis between 1999 and 2001, even though the Food and Drug Administration did not approve the drug for that use until 2002," Modern Healthcare (4/20, Carlson, Subscription Publication) explains. "When the civil settlement was announced, Merck said the agreement did not constitute any admission of liability or wrongdoing by the company." 

FDA warns physicians to stop buying medications from unapproved sources.

Medscape (4/19, Hitt) reports, "Clinicians in several states have been warned by the US Food and Drug Administration (FDA) to stop purchasing medications from foreign or unlicensed suppliers that sell illegal prescription medications." The agency "has sent letters to medical practices in 12 states who reportedly engaged in purchasing these illegal prescription medications." In a statement posted this week, the FDA said, "These medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous," and added, "To minimize the chance of patients receiving a counterfeit, unsafe, or ineffective medication, FDA is requesting that the medical practices stop administering drugs purchased from any foreign or unlicensed source." 

North Carolina insurer claims tort reform lowered malpractice premiums.

The Raleigh (NC) News & Observer (4/16, Jarvis, Christensen) reports, "A medical malpractice insurer has lowered its premiums and is crediting what is often called tort reform in this and other states. Mag Mutual Insurance Co., the second-largest such firm in the state, credits the new laws with almost half of its recent 7.4 percent average cut in insurance premiums for doctors. The legislature last year overrode Gov. Bev Perdue's veto of a bill capping "noneconomic" damages at $500,000." The president of N.C. Advocates for Justice countered by saying that insurance companies "have long over-charged doctors, racking up huge profits and using a fictional tort 'crisis' to limit the rights of those catastrophically hurt by medical errors." He also faulted state political leaders for not addressing "the real problem -- preventable medical errors that leave scores of North Carolinians injured or dead."

        Ohio insurance report shows decline in malpractice claims, payments. The Columbus (OH) Dispatch (4/15, Johnson) reported, "Ohio's tort-reform law is having a dramatic impact on medical malpractice cases in the state, with closed claims dropping 41 percent between 2005 and 2010, and average payments declining 38 percent over that period. The Ohio Department of Insurance annual report also shows more than 3 of 4 closed claims resulted in no payment." An official with the Ohio State Medical Association notes that malpractice premiums have fallen by over 26%, and points to that as "proof that tort reform accomplished what it set out to do - slow the growth of what we thought were runaway lawsuits and to stabilize the market for physicians."

        Advocates say California shows tort reform may not lower premiums. In contrast, the Center for Justice & Democracy's Pop Tort website (4/13) claims that the experience of California shows that tort reform does not necessarily lower insurance rates. It charges that the state's "medical malpractice insurance industry has simply became bloated, with insurers paying out only tiny percentages of the premiums they are collecting from doctors." It hailed actions by the state's insurance commissioner to force lower rates, and urged support for a ballot initiative that would extend the commissioner's rate regulatory powers to the health insurance industry. 

Medical malpractice bill returns to House.

The Hill (4/17, Pecquet) reports in its "Healthwatch" blog, that the House Judiciary Committee "will mark up medical malpractice legislation on Tuesday, even though the full House passed identical legislation just last month." A $250,000 cap on non-economic damages, passed by the House, though languishing in the Senate, as part of a bill to repeal the Independent Payment Advisory Board that is part of the Obama healthcare reform law, will be taken up as a separate bill. The Hill explains, "The reason: money. Marking up the tort reform bill would allow the committee to claim $41 billion in savings to the deficit over the next 10 years -- more than enough to meet the committee's $39 billion savings requirement under the House Republican budget." It also notes that the gambit "is raising some hackles, even on the right," as some Republican committee members complain that it intrudes on states' rights. 

Bayer said to pay $110 million in birth-control cases tied to blood clots.

Bloomberg News (4/13, Feeley, Fisk) reports that Bayer AG will pay at least $110 million to settle about 500 lawsuits over claims that its drospirenone and ethinyl estradiol [Yasmin] line of birth-control tablets caused blood clots, according to persons familiar with the settlement agreements. Specifically, "officials of Bayer...agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and drospirenone and ethinyl estradiol [Yaz] contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said."

Michelin Tire settles tire case after big sanction

By R. Robin McDonald, Daily Report

Two months after a federal judge in Atlanta sanctioned Michelin North America with a finding that one of its tires was defective and unreasonably dangerous, the company has settled with an Alabama man left paralyzed after a 2008 auto accident he claimed was caused by a defective tire.

The dollar amount of the deal was confidential at Michelin's request, said lawyers at Butler, Wooten & Fryhofer, which represented accident victim Johnny Bates and his wife Patricia.

It ends three years of litigation during which Michelin "obfuscated and abused the discovery process" by withholding evidence in a fashion that Bates attorney George Fryhofer called "pervasive" and "unrelenting."

"We have encountered other product manufacturers who abused discovery," Fryhofer said, "but Michelin's conduct in this case was particularly egregious."

Michelin attorney Robert Monyak at Peters & Monyak in Atlanta referred the Daily Report to Michelin spokesman Tony Fouladpour, who said the settlement "was in no way a result of the sanction order and was being discussed well before the judge's decision."

"Michelin is open to discussing the resolution of litigation before trial, and in this case both parties were able to reach an agreement," he said. "It's a reasonable agreement, and we believe it's in the best interest of both parties."

The settlement was hatched after U.S. District Court Judge Amy Totenberg blasted Michelin's national discovery counsel, Kate Helm of Nelson Mullins Riley & Scarborough in Atlanta, for engaging "in a pattern of subterfuge" by withholding relevant documents.

Totenberg's 61-page order also said that Michelin had made multiple "inaccurate or false representations" to plaintiffs lawyers and the court and "acted willfully" in repeatedly violating court orders. The relevant documents regarding the safety of the Michelin tires that formed the basis of the litigation "would likely never have emerged but for plaintiffs' persistence in seeking the court's intervention," Totenberg wrote.

Helm did not reply to a request for comment. Her partner, Richard K. Hines of Nelson Mullins, said the two lawyers were referring all queries to Michelin per the company's instructions.

Wreck followed by discovery fight

At the heart of the case is a Michelin-manufactured Uniroyal Laredo tire on the Bateses' sports utility vehicle. The tire came apart while they were driving through Atlanta to visit family on Christmas Day 2008, causing their SUV to go out of control and overturn.

Bates, a truck driver who was then 63, was left a quadriplegic by the accident. Butler Wooten lawyers said his medical bills totaled more than $870,000 and estimated that his future medical expenses, coupled with wage losses caused by his injuries, totaled more than $3.6 million.

Bates' lawyers alleged that the accident was caused by the catastrophic disintegration of the tire, which was caused by design and manufacturing defects. But from the time the case was filed in 2009, Michelin lawyers balked at turning over company documents that the Bates lawyers believed would help prove their case. By the time a discovery hearing was held in December 2010, "Michelin had not even produced a full banker's box of documents," Totenberg's order noted.

In January 2011, U.S. District Judge Richard W. Story, who was presiding over the case at the time, ordered Michelin to produce nearly all of the documents that the Bates attorneys had sought for nearly two years. Among them were a list of numerical codes that Michelin had assigned to tires that had been returned to the company as faulty, according to court records.

Totenberg took over the case after she became a judge last year, and in June 2011, she fined Michelin $17,000 for not turning over the information.

On Jan. 13 of this year, following a September sanctions hearing after which Michelin surrendered much of the data it had previously withheld, Totenberg issued a second sanctions order. That order included a preclusion determination that the Uniroyal tire at issue in the litigation was defective and unreasonably dangerous; the order barred Michelin from contesting the issue at trial.

In her order, Totenberg said the harsh sanction was warranted, because "Michelin received more than adequate notice from the court's multiple warnings that it would not tolerate further hampering of the discovery process or violations of its orders; plaintiffs' multiple sanctions requests; and its own flagrant disregard of the federal discovery rules and the court's discovery orders." She also noted that the previous monetary sanction "did not serve to remedy Michelin's cavalier attitude toward its obligations."

Totenberg left open the question of whether the Bateses' tire failed as a result of its defective and unreasonably dangerous condition, saying that such a determination would be "the death knell to any Michelin defense to liability." She said she did so because Michelin finally began producing the sought-after documents in compliance with previous court orders.

Totenberg's order also detailed the discovery battle that prompted the sanctions. By June of last year, despite court orders compelling Michelin to do so, the company's lawyers had failed to turn over numerical codes and other data critical to analyzing customer returns of faulty tires. Totenberg admonished Michelin attorneys with a $17,000 sanction while warning company lawyers that "any further delays, manipulation of discovery … or basically failure to function in good faith" would result in further sanction.

Less than a month later, Butler Wooten lawyers sought sanctions again after learning during the depositions of two Michelin employees that Michelin had withheld additional documents that the company previously had been ordered to surrender. But at a July 7 conference, "Michelin vehemently denied that it had not produced all the adjustment codes," Totenberg's order noted.

"However, on July 14, 2011, Michelin produced another 144 pages of adjustment conditions with codes, pictures and descriptions," that included 113 new conditions that had previously been withheld, the order said.

At a daylong sanctions hearing last September, Helm testified as the sole witness in Michelin's defense and took responsibility for the missing data.

"Ms. Helm was evasive in response to plaintiffs' questioning of who redacted the list, stating repeatedly she did not recall," before finally taking personal responsibility for what she said were human errors after attempting to assert attorney-client privilege, Totenberg wrote.

"Michelin contended that the additional 144 pages were produced on its own initiative and not because plaintiffs had caught Michelin red-handed," Totenberg wrote. "However, Michelin's alleged 'self-reporting' did not occur until after plaintiffs pointed out there were missing codes and sought sanctions for Michelin's withholding of the documents. Michelin did not simply discover the error on its own and voluntarily come forward with the documents as it would have the court believe."

As a result, Totenberg wrote, "The veracity of Michelin's contentions regarding its conduct in the discovery process for a variety of reasons has proven unreliable. It appears plaintiffs are correct in their assertion that every one of Michelin's counsel's representations to the court regarding the production of the adjustment codes and adjustment data has proven to be inaccurate."

Totenberg also wrote that while she "originally believed Ms. Helm's affidavit testimony that the failure to produce the missing adjustment codes was an innocent oversight, and while this may very well be true, the credibility of her statements over time has been eroded by the actual course of discovery events.

"In light of Ms. Helm's evasive and inconsistent testimony at the Sept. 19 hearing and defendant Michelin's shifting representations made to the court since June 3, 2011, the court cannot simply rely on Michelin's avowals of good faith regarding any of these discovery issues."

Totenberg also chastised Helm for misleading the court by saying in December 2010 that certain documents sought by the plaintiffs had been given to them, even though they had not. Helm's "subsequent failure to correct the mistake once she realized the court relied on her statements to conclude that the documents had been produced … is plainly unacceptable," she wrote.

"Michelin effectively kept the plaintiffs and the court in the dark by allowing them to rely on inaccurate information, which Michelin knew to be false."

Totenberg also noted that "an essential purpose" of her orders directing Michelin to turn over specific data to the Bates lawyers "was to ensure that plaintiffs were provided the information necessary to analyze and evaluate the adjustment data to determine how many tires were being returned for the conditions at issue in this case."

But, she continued, "Not only did Michelin produce the adjustment data in a format that was indecipherable to plaintiffs, not even a Michelin employee who was experienced in analyzing adjustment data could understand the information provided in the chart. … Michelin's production of the adjustment date in this completely unusable format was patently unacceptable… ."

The case is Bates v. Michelin North America, 1:09-cv-03280 (N.D. Ga.).

Company recalls 36,000 light truck tires for sidewall defects.

Bloomberg BusinessWeek (4/11) reports that "Multistrada Arah Sarana is recalling more than 36,000 light truck tires because sidewall defects can cause them to lose air, increasing the risk of a crash." US safety regulators say that "the 16-inch tires were sold under the name of Achilles Desert Hawk and Radar Radial RLT." BusinessWeek adds that, according to the National Highway Traffic Safety Administration, these defects could cause both tires to lose air suddenly. 

Fearing potential motor failure, Ford recalls 140,000 Focus models.

Christopher Jensen writes in the New York Times (4/10) "Wheels" blog, "Ford is recalling about 140,000 Focus models from the 2012 model year because the windshield wiper on the passenger side could fail." Jensen adds, "According to a summary posted over the weekend on the Web site of the National Highway Traffic Safety Administration, Ford said a plug on an electrical connector intended to keep water from entering the motor might not have been installed. If water were to enter the motor, it could fail."

        NHTSA ending investigation of Ford vans. Meanwhile, in related coverage, the Detroit News (4/10, Shepardson) reports, "NHTSA said it was ending a 27-month investigation into the 1997-2008 E350 and E450 Ford Cab/Chassis vans and other vehicles without demanding a recall after the agency did not identify a safety defect trend." The NHTSA said that the "Dearborn automaker has agreed to take two actions to reduce the likelihood of a fire," after the agency received "1,036 complaints, claims and field reports of failed blower motor control switches." However, "Ford said the vehicles -- some used as airport shuttles, school buses, ambulances or in public transit -- have run an estimated 128 billion miles, and argued that they have performed extremely well." 

Amputation hazard brings baby bicycle seat recall.

The Attleboro (MA) Sun Chronicle (4/6, Foster) reported that the Consumer Product Safety Commission has issued a consumer alert advising consumers to stop using an infant baby bicycle seat due to a possible amputation hazard. The agency says that Topeak Babyseat II bicycle carrier seats imported from Taiwan, following two incidents of lacerations and nearly amputated fingertips when the grab bar used to attach and remove the seat from the bicycle is used while children have their fingers on the mechanism's opening. The company, which is cooperating with the agency, is making available free retrofit kits to render the seats safe and has set up a toll-free phone line for consumers. 

Judge grants class action status to Tata wage suit

Reuters (4/2, Baynes) reported that a California federal judge has granted class-action status to a lawsuit filed against Indian conglomerate Tata Sons Ltd. and its Tata Consultancy Services subsidiary on behalf of its employees detailed to work in information technology in the US. The lawsuit claims that the companies violated employee contracts and state labor law by requiring non-US citizen workers to sign over to their employer their US federal and state tax refunds.

        Bloomberg News (4/2, Rosenblatt) added that the company also "deprived employees in California of earned wages by deducting their Indian salary from their compensation," according to the a statement from their lawyers.