Thursday, March 26, 2009

Wyeth ruling seen as win for consumers.

The Toledo Blade (3/25) editorialized, "Consumers have been handed an important victory by the U.S. Supreme Court in the form of a 6-3 decision in a case in which the high court dismissed the argument of drug makers and the Bush administration that federal approval of drugs shields them from lawsuits by injured patients." The Blade concluded, "The high court didn't buy the" Bush "administration's view that the policy constituted federal law, noting that Congress has passed laws regulating drugs for a century without prohibiting consumers from suing drug makers. And if the threat of lawsuits is the incentive to better scrutinize all drugs in development as well as existing drugs, so much the better."

Wednesday, March 18, 2009

Seroquel study exposed, drug risks kept secret.

In an story that appears on its front page, the Washington Post (3/18, A1, Vedantam) reports, "The study would come to be called 'cursed,' but it started out just as Study 15" which "was a long-term trial of the antipsychotic drug Seroquel." Recently exposed "documents show" that "Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried" and "it took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised serious concerns about an entire new class of expensive drugs." The study's findings "were never published" or distributed to physicians, and marketing campaigns were developed based on "less rigorous studies" that yielded "positive results." The FDA received the results of the study but "the agency has strenuously maintained that it does not have the authority to place such studies in the public domain." Only through lawsuits have the "details of Study 15...emerged."

Monday, March 16, 2009

California proposes campaign reforms for judges.

The National Law Journal (3/16, MacLean) reports, "Proposed reforms to ethical and campaign requirements for California's judiciary would for the first time require trial judges to disqualify themselves in cases in which they received $1,500 or more in campaign donations from either side" and "in a second major change, lawyers challenging sitting judges for election would be evaluated using the same evaluation system that the Judicial Nominations and Evaluations Commission uses for appointed judges." William McLaughlin, chairman of judicial campaign finance task force, "referring to the West Virginia case" said that "there are indications elsewhere that caused us to think that, to maintain the trust and confidence of the public, we need not only to honor [the canons] but also establish a rule to require recusal." He added, "The $1,500 donation limit was selected because that is already the amount set by law for recusal if a judge owns stock in a company with a matter before him or her."

Friday, March 13, 2009

Families awarded $150 million from Exxon oil spill in Maryland.

The AP (3/13, Nuckols) reports, "A jury awarded about $150 million to 91 families Thursday who sued Exxon Mobil over wells contaminated by a gasoline leak north of Baltimore." A leak in "an underground storage tank bled about 26,000 gallons of gasoline over 37 days in Jacksonville." The company had already "paid a $4 million settlement to the state – the largest civil penalty ever levied by the Maryland Department of the Environment."

Wednesday, March 11, 2009

Expert witness testifies in Libby trial.

The AP (3/11) reports that Dr. Aubrey Miller, "a medical expert testifying Tuesday in the W.R. Grace trial described his disbelief when, arriving in Libby 10 years ago, he found that people who had never worked at Grace's vermiculite mine were dying from asbestos-related disease." He said, "To see an individual who had died of asbestos-related disease who was not a worker was unheard of." He added, "I had never seen a case or heard of a case like that." The doctor "testified about a range of product tests that Grace officials used to assess the hazards of Libby vermiculite." He said, "Among its findings, Grace learned that the vermiculite had a high tendency to release asbestos fibers into the air."

Widow wins $4 million in medical malpractice case.

The Legal Intelligencer (3/10, Needles) reported, "The wife of a man who died after his doctor allegedly failed to diagnose and treat him for heart disease has been awarded $4 million by a Berks County jury." The jury deliberated for nearly five hours at the close of an eleven day trial and "found Dr. Donald J. McBryan Jr. and his group, Berks Internal Medicine, negligent in the death of Gregory S. Volutza."

Tuesday, March 10, 2009

Wyeth seen as "body blow" to Bush administration efforts of pre-emption.

The Legal Times (3/9, Mauro) reported, "Last week's decisive Supreme Court ruling against Wyeth in a landmark pharmaceutical product liability case may also close off a major front in a hard-fought battle by businesses and the Bush administration to insulate national corporations from state tort litigation." Justice John Paul Stevens wrote for the majority, saying, "Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling." He added that "until recent years, the Food and Drug Administration viewed state litigation as complementary to its regulations." David Vladeck, a Georgetown University Law Center professor, said that "the ruling represents 'a real body blow to the Bush administration's efforts to change tort law through implied pre-emption.'"
Congress should extend protections to patients harmed by medical devices, paper says. The St. Louis Post-Dispatch (3/9) editorialized, "Americans who are injured by prescription drugs won an important protection last week: the right to sue for damages in state courts." The Dispatch said, "Tragically, last year the Supreme Court failed to extend the same protection to patients injured by defective medical devices such as replacement hip and knee joints." Concluding, the Dispatch wrote, "It's not realistic to expect the FDA, with a few hundred employees monitoring more than 11,000 drugs and medical devices, to be able to spot every safety problem before a product gets to market" and that "Congress should give people harmed by defective devices the same protections the Court has now given those harmed by dangerous drugs."

Monday, March 9, 2009

Supreme Court's Wyeth ruling "a major setback" for drug industry.

In a story that received coverage from many news sources, the New York Times (3/5, A1, Liptak) reports on its front page, "In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators." The decision "could have significant implications beyond drug manufacturing" and "many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation."
The Washington Post (3/5, A2, Barnes) reports, "The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them."
The AP (3/5) reports, "The Supreme Court" upheld "a $6.7 million jury award to a musician who lost her arm to gangrene following an injection." The plaintiff, "Diana Levine of Vermont once played the guitar and piano professionally" and "her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered." There were many other outlets that covered the Wyeth ruling, including: BusinessWeek (3/5, Johnson), CBS News (3/5, Cohen), the San Francisco Chronicle (3/5, Egelko), the Wall Street Journal (3/5, Bravin), the Legal Times (3/5, Mauro) reports, the AP (3/5, Curran), the Legal Intelligencer (3/4, Passarella), the Los Angeles Times (3/5, Savage), Dow Jones Newswires (3/5, Anderson), USA Today (3/5, Biskupic, Appleby), UPI (3/4) ABC World News (3/4, story 9, 0:30, Gibson), CBS Evening News (3/4, story 4, 2:00, Couric) and NBC Nightly News (3/4, story 5, 2:05, Williams).
Drug industry may face more litigation after ruling. The Financial Times (3/5, Jack) reports, "Pharmaceutical companies face substantial extra litigation after the US Supreme Court ruled yesterday that safety warnings on their drugs approved by federal regulators did not protect them from lawsuits in individual states." The ruling "marks the failure of efforts by the industry to fight legal settlements by imposing federal pre-emption, an argument that had been supported by George W. Bush's administration."
Bloomberg News (3/4, Stohr) reported that now drugmakers can be sued "for failing to provide adequate safety warnings." Justice John Paul Stevens wrote in the opinion, "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." The ruling "might help former users of Wyeth's Prempro and Premarin menopause drugs and consumers of AstraZeneca Plc's antipsychotic drug Seroquel." However, "the impact isn't clear for allegations that Pfizer Inc. and GlaxoSmithKline Plc should have done more to warn that their anti-depressants might cause suicidal tendencies."
The Philadelphia Inquirer (3/5, Hill) reports that Sol Weiss, a Philadelphia plaintiffs' lawyer, said, "This doesn't mean you're going to win, but you get your day in court." He is "not involved in this case" but "he is hoping that the decision will revive his cases involving Pfizer Inc.'s antidepressant Zoloft and GlaxoSmithKline P.L.C.'s antianxiety agent Paxil." The Wall Street Journal (3/5, Johnson, Mundy, Bravin) also covers the story.
Ruling may make drugmakers more cautious, halt development. The AP (3/5) reports that the ruling "could make drugmakers more cautious about safety issues and may lead them to halt development of some medicines and even pull others off the market." Erik Gordon, an analyst and professor at University of Michigan's Ross School of Business, said, "'They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug."
Ruling seen as contradictory to medical device case. The New York Times (3/5, B1, Meier, Singer) reports on the front page of its Business Day section that the "result of a decision Wednesday by the Supreme Court" was that "federal law does not protect drug companies from product liability suits in state courts." However, "in contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices." David C. Vladeck, a professor at Georgetown University Law Center, said, "I think this is going to force Congress to revisit the issue of why medical devices should be insulated from lawsuits."
Wyeth loss seen as possible victory in disguise. Forbes (3/5, Fisher) reports, "Wyeth's loss dashes the hopes of those who support pre-emption as a tactic for cutting back on excessive jury awards in product-liability cases, which the court affirmed last year in Riegel v. Medtronic." However, "Wyeth v. Levine may be a victory in disguise. By stepping back from the brink and refusing to give drug companies federal immunity from suits under state laws, the court has likely prevented an even more toxic response from the Democrat-controlled Congress."
Papers weigh in on Wyeth ruling. The Wall Street Journal (3/5) editorializes, "The decision is a huge victory for plaintiffs lawyers, but it's a much bigger defeat for drug innovation and public health." The Journal adds, "Yesterday's ruling will expose drug companies to a kind of double innovation jeopardy." Concluding, the Journal argues that now drug companies "will have to contemplate paying up front -- and paying later, even if the tragic mistake in applying the drug is someone else's. Wyeth is a dream come true for the plaintiffs bar."
In stark contrast, the New York Times (3/5) editorializes, "The Supreme Court made a wise and surprising decision on Wednesday when it rejected a drug company's claim that it cannot be sued for damages in state courts if a product and its label have been approved by the Food and Drug Administration." The ruling "demolished the notion that federal regulatory rulings automatically pre-empt the states from enforcing even tougher standards on drugs" and "also exposed as a sham the Bush administration's strenuous efforts to protect its allies in industry with phony pre-emption claims." The Times concludes, "We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well."
Wyeth decision seen as not enough to end Michigan's drug law. In an op-ed in the Detroit Free Press (3/5) Henry Greenspan, who teaches about the FDA, ethics and policy at the University of Michigan, writes, "Today was a good one for justice in America – but we in Michigan remain saddled with a law that is based on precisely the argument the high court rejected." He adds that the court's decision in Wyeth "is not enough to end Michigan's statute." Greenspan concludes, "The state senators who have blocked repeal will now have to argue that they know better than two-thirds of the Supreme Court" and "they will have to explain why they maintain a view of the FDA that the court called 'meritless' and 'untenable.'"

Democrats introduce legislation to reverse Supreme Court ruling on medical device lawsuits.

The AP (3/6, Perrone) reports that one "day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits," Democratic lawmakers "reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices." In 2008, "the Supreme Court agreed with the pre-emption policy in a case [Riegel v. Medtronic] involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices," but "there's no similar provision for drugs." Rep. Frank Pallone (D-NJ) "and other Democrats said...that decision ignored decades of precedent." The AP adds that "the bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman (D-CA)," who "is expected to hold hearings on the issue in coming weeks."
The Wall Street Journal (3/5) Health Blog reports that "the proposed legislation was long expected, even more so after the Supreme Court's ruling yesterday seemed to create different rules for drug and device manufacturers." But, "the question now is whether the bills have enough votes to pass. Similar legislation failed last year, although it may have better odds now as a result of the Democrats' election gains." Dow Jones Newswires (3/6, Favole) also covers the story.